ParagraphFour.com | Site-Wide Activity https://paragraphfour.com/activity/ Activity feed for the entire site. Thu, 30 Apr 2026 15:21:31 -0400 https://buddypress.org/?v= en-US 30 hourly 2 fadda50ab09f274888c20d5f62ec5108 gregoryglass updated 'Vasostrict®(vasopressin) Injection ': Vasostrict®(vasopressin) Injection Company PAR Date of […] https://paragraphfour.com/activity/p/11880/ Wed, 29 Apr 2026 19:08:31 -0400 Vasostrict®(vasopressin) Injection
Company PAR
Date of First Filing March 23, 2018 (20 units/mL, 1 mL) and June 29, 2018 (20 units/mL, 10 mL) and February 28, 2022 (40 units/100 mL and 60 units/100 mL) and December 20, 2022 (20 units/100 mL)

Paragraph IV Applicant: Eagle
Case Name: PAR PHARMACEUTICAL INC et al v. EAGLE PHARMACEUTICALS,…Read more

]]> 0 bf45f6a04044994a1cdbf38d285e41da parryashford updated 'Trulance®(plecanatide) Tablets ': Trulance®(plecanatide) Tablets Annual Sales Company BAUS […] https://paragraphfour.com/activity/p/11879/ Wed, 29 Apr 2026 19:00:25 -0400 Trulance®(plecanatide) Tablets
Annual Sales
Company BAUSCH HEALTH
Date of First Filing January 19, 2021

Paragraph IV Applicant: MSN Laboratories
Case Name: BAUSCH HEALTH IRELAND LIMITED et al v. MSN LABORATORIES PRIVATE LTD et al
Court/Case #: New Jersey District Court (njdc) 2:2021cv10057
Date Filed: 4/22/21
Judge: Chesler
Pro…Read more

]]> 0 b8d937624601dc329fe4cef14d998902 parryashford updated 'Tavneos®(avacopan) Capsules ': Tavneos®(avacopan) Capsules Annual Sales $256M Company AM […] https://paragraphfour.com/activity/p/11878/ Wed, 29 Apr 2026 18:55:50 -0400 Tavneos®(avacopan) Capsules
Annual Sales $256M
Company AMGEN
Date of First Filing November 13, 2025

Paragraph IV Applicant: Zydus
Case Name: CHEMOCENTRYX INC v. ZYDUS PHARMACEUTICALS (USA) INC et al
Court/Case #: New Jersey District Court (njdc) 2:2026cv00556
Date Filed: 1/16/26
Judge: Semper
Product Strength: 10 mg
Litigated…Read more

]]> 0 59ecaf1d72d80714e6a1d67e40ebdc62 parryashford updated 'Tarpeyo®(budesonide) Delayed-release Capsules ': Tarpeyo®(budesonide) Delayed-release Capsules Annual Sales […] https://paragraphfour.com/activity/p/11877/ Wed, 29 Apr 2026 18:52:16 -0400 Tarpeyo®(budesonide) Delayed-release Capsules
Annual Sales
Company CALLIDITAS
Date of First Filing December 26, 2024

Paragraph IV Applicant: Zydus
Case Name: CALLIDITAS THERAPEUTICS AB v. ZYDUS PHARMACEUTICALS (USA) INC et al
Court/Case #: Delaware District Court (dedc) 1:2025cv00368
Date Filed: 3/25/25
Judge: Choe-Groves
Product…Read more

]]> 0 c1db48ec04059879909cf60c62b95ad6 parryashford updated 'Sodium Thiosulfate Intravenous Injection ': Sodium Thiosulfate Intravenous Injection Annual Sales Comp […] https://paragraphfour.com/activity/p/11876/ Wed, 29 Apr 2026 18:49:19 -0400 Sodium Thiosulfate Intravenous Injection
Annual Sales
Company HOPE PHARMACEUTICALS
Date of First Filing April 29, 2022

Special Note: While this product’s NDA has no brand name and is sold as “Sodium Thiosulfate,” it apparently is also marketed and sold as part of the branded produt Nithiodate® Kits.

Paragraph IV Applicant:…Read more

]]> 0 6d605198df5f043231dc05f3972149a9 parryashford updated 'Recorlev®(levoketoconazole) Tablets ': Recorlev®(levoketoconazole) Tablets Annual Sales $64.3M Co […] https://paragraphfour.com/activity/p/11875/ Wed, 29 Apr 2026 18:41:52 -0400 Recorlev®(levoketoconazole) Tablets
Annual Sales $64.3M
Company XERIS
Date of First Filing December 30, 2025

Paragraph IV Applicant: Somerset
Paragraph IV Applicant: Torrent
Case Name: XERIS PHARMACEUTICALS INC et al v. SOMERSET THERAPEUTICS LLC et al
Court/Case #: New Jersey District Court (njdc) 3:2026cv02044
Date Filed:…Read more

]]> 0 51b55465348524b230099446b6633f57 parryashford updated 'Radicava ORS®(edaravone) Oral Suspension ': Radicava ORS®(edaravone) Oral Suspension Annual Sales Com […] https://paragraphfour.com/activity/p/11874/ Wed, 29 Apr 2026 18:34:49 -0400 Radicava ORS®(edaravone) Oral Suspension
Annual Sales
Company MITSUBISHI
Date of First Filing April 20, 2023

Paragraph IV Applicant: Cipla
Case Name: MITSUBISHI TANABE PHARMA CORPORATION v. CIPLA USA INC et al
Court/Case #: Delaware District Court (dedc) 1:2023cv00759
Date Filed: 7/12/23
Judge: Hall
Product Strength: 105…Read more

]]> 0 a5e59b7203740dbe7e37380482a9b522 parryashford updated 'Qulipta®(atogepant) Tablets ': Qulipta®(atogepant) Tablets Annual Sales $628M Company AB […] https://paragraphfour.com/activity/p/11873/ Wed, 29 Apr 2026 18:30:32 -0400 Qulipta®(atogepant) Tablets
Annual Sales $628M
Company ABBVIE
Date of First Filing September 29, 2025

Paragraph IV Applicant: Apotex
Case Name: ABBVIE INC et al v. APOTEX INC
Court/Case #: New Jersey District Court (njdc) 3:2025cv18972
Date Filed: 12/23/25
Judge: Quraishi
Product Strength: 10 mg, 30 mg, and 60 mg
Litigated…Read more

]]> 0 f23f3b842bea5d30a5a1d1d6aa139bf8 parryashford updated 'Orgovyx®(relugolix) Tablets ': Orgovyx®(relugolix) Tablets Annual Sales Company SUMITOM […] https://paragraphfour.com/activity/p/11872/ Wed, 29 Apr 2026 16:34:27 -0400 Orgovyx®(relugolix) Tablets
Annual Sales
Company SUMITOMO
Date of First Filing December 18, 2024

Paragraph IV Applicant: Apotex
Case Name: SUMITOMO PHARMA SWITZERLAND GMBH et al v. APOTEX INC et al
Court/Case #: Delaware District Court (dedc) 1:2025cv00311
Date Filed: 3/12/25
Judge: Noreika
Product Strength: 120 mg
Litigated…Read more

]]> 0 3c4b254f920605040cff4cf222ed61b8 parryashford updated 'Neffy®(epinephrine) Nasal Spray ': Neffy®(epinephrine) Nasal Spray Annual Sales Company ARS […] https://paragraphfour.com/activity/p/11871/ Wed, 29 Apr 2026 16:18:50 -0400 Neffy®(epinephrine) Nasal Spray
Annual Sales
Company ARS PHARMACEUTICALS
Date of First Filing June 30, 2025 and December 29, 2025 (1 mg/spray)

Paragraph IV Applicant: Lupin
Case Name: ARS PHARMACEUTICALS OPERATIONS INC et al v. LUPIN INC et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv15123
Date Filed: 8/29/25
Judge: …Read more

]]> 0 afb5418aea96b1749190ea36138d6ef7 parryashford updated 'Nexletol®(bempedoic) Tablets and Nexlizet® ': Nexletol®(bempedoic) Tablets Nexlizet®(bempedoic and e […] https://paragraphfour.com/activity/p/11870/ Wed, 29 Apr 2026 16:18:10 -0400 Nexletol®(bempedoic) Tablets
Nexlizet®(bempedoic and ezetimibe) Tablets
Annual Sales $115.7M (product family)
Company ESPERION
Date of First Filing February 21, 2024 (both products)

Paragraph IV Applicant: Micro Labs
Case Name: ESPERION THERAPEUTICS INC v. MICRO LABS USA INC et al
Court/Case #: New Jersey District Court (njdc) 2…Read more

]]> 0 6ef67e7ea4ae34e78247a56d13e6c060 parryashford updated 'Mekinist®(trametinib) Tablets ': Mekinist®(trametinib) Tablets Annual Sales $1.92B […] https://paragraphfour.com/activity/p/11869/ Wed, 29 Apr 2026 16:03:23 -0400 Mekinist®(trametinib) Tablets
Annual Sales $1.92B (global)
Company NOVARTIS
Date of First Filing September 28, 2023

Paragraph IV Applicant: Novugen
Case Name: NOVARTIS PHARMACEUTICALS CORPORATION et al v. NOVUGEN ONCOLOGY et al
Court/Case #: Delaware District Court (dedc) 1:2023cv01449
Date Filed: 12/20/23
Judge: Williams
Product…Read more

]]> 0 11869ab37d38cb01952668308a2c2786 parryashford updated 'Lumify®(brimonidine) Ophthalmic Solution ': Lumify®(brimonidine) Ophthalmic Solution Annual Sales Com […] https://paragraphfour.com/activity/p/11868/ Wed, 29 Apr 2026 15:45:53 -0400 Lumify®(brimonidine) Ophthalmic Solution
Annual Sales
Company BAUSCH HEALTH
Date of First Filing July 12, 2021

Paragraph IV Applicant: Slayback
Paragraph IV Applicant: Dr. Reddy’s
Case Name: BAUSCH & LOMB INC et al v. SLAYBACK PHARMA LLC et al
Court/Case #: New Jersey District Court (njdc) 3:2021cv16766
Date Filed:…Read more

]]> 0 16bbff8f3d281ec1bb532f64330d70fd parryashford updated 'Lonsurf®(trifluridine and tipiracil) Tablets ': Lonsurf®(trifluridine and tipiracil) Tablets Annual Sales […] https://paragraphfour.com/activity/p/11867/ Wed, 29 Apr 2026 15:41:41 -0400 Lonsurf®(trifluridine and tipiracil) Tablets
Annual Sales JPY 38.7B
Company TAIHO PHARMACEUTICAL
Date of First Filing September 23, 2019

Paragraph IV Applicant: Aurobindo
Case Name: TAIHO PHARMACEUTICAL CO LTD et al v. EUGIA PHARMA SPECIALTIES LTD et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1407
Date…Read more

]]> 0 3269fbc56c51140bede3b4aa3a55a3fe parryashford updated 'Livtencity®(maribavir) Tablets ': Livtencity®(maribavir) Tablets Annual Sales 20B […] https://paragraphfour.com/activity/p/11866/ Wed, 29 Apr 2026 15:33:55 -0400 Livtencity®(maribavir) Tablets
Annual Sales 20B JPYen
Company TAKEDA
Date of First Filing November 24, 2025

Paragraph IV Applicant: Qilu
Case Name: TAKEDA PHARMACEUTICAL COMPANY LIMITED v. QILU PHARMACEUTICAL (HAINAN) CO LTD
Court/Case #: New Jersey District Court (njdc) 2:2026cv01633
Date Filed: 2/18/26
Judge: Salas
Product…Read more

]]> 0 ddd5411f3f2d0a83748985c68aa110c8 parryashford updated 'Korsuva®(difelikefalin) Intravenous Solution ': Korsuva®(difelikefalin) Intravenous Solution Annual Sales […] https://paragraphfour.com/activity/p/11865/ Wed, 29 Apr 2026 15:20:15 -0400 Korsuva®(difelikefalin) Intravenous Solution
Annual Sales
Company VIFOR
Date of First Filing August 25, 2025

Paragraph IV Applicant: Gland
Paragraph IV Applicant: Somerset
Paragraph IV Applicant: Qilu
Case Name: VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD et al v. GLAND PHARMA LIMITED et al
Court/Case #: Delaware District…Read more

]]> 0 10faaf2b390b34a98a0f517cb26c17fa parryashford updated 'Jynarque®(tolvaptan) Tablets ': Jynarque®(tolvaptan) Tablets Annual Sales JPY 130.3B […] https://paragraphfour.com/activity/p/11864/ Wed, 29 Apr 2026 15:00:58 -0400 Jynarque®(tolvaptan) Tablets
Annual Sales JPY 130.3B
Company OTSUKA
Date of First Filing April 8, 2021

Paragraph IV Applicant: Lupin
Case Name: OTSUKA PHARMACEUTICAL CO LTD v. LUPIN LIMITED et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 24-2297
Date Filed:
Judge:
Product Strength: 15mg, 30mg, 45mg, 60mg,…Read more

]]> 0 79bb1c468537f085d256b633947073fb gregoryglass updated 'Invega Sustenna®(paliperidone) ER Inj Suspension ': Invega Sustenna®(paliperidone) Extended-release Injectable […] https://paragraphfour.com/activity/p/11863/ Wed, 29 Apr 2026 14:55:14 -0400 Invega Sustenna®(paliperidone) Extended-release Injectable Suspension
Annual Sales $3.1B (product family)
Company JANSSEN
Date of First Filing November 21, 2017

Paragraph IV Applicant: Teva
Case Name: JANSSEN PHARMACEUTICALS INC et al v. TEVA PHARMACEUTICALS USA INC et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc)…Read more

]]> 0 a4b5b1fffc7d8135c3bc1cd45207731d parryashford updated 'Horizant®(gabapentin) Extended-release Tablets ': Horizant®(gabapentin) Extended-release Tablets Annual […] https://paragraphfour.com/activity/p/11862/ Wed, 29 Apr 2026 14:44:53 -0400 Horizant®(gabapentin) Extended-release Tablets
Annual Sales
Company AZURITY
Date of First Filing April 29, 2019

Paragraph IV Applicant: Aurobindo
Case Name: AUROBINDO PHARMA LTD v. AZURITY PHARMACEUTICALS INC et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00265
Date Filed: 3/12/26
Judge: Noreika
Product Strength:…Read more

]]> 0 98f0b0a36f66cf9f1dbda2c2bcff53d0 parryashford updated 'Emrosi®(minocycline) Extended-release Capsules ': Emrosi®(minocycline) Extended-release Capsules Annual […] https://paragraphfour.com/activity/p/11861/ Wed, 29 Apr 2026 14:39:58 -0400 Emrosi®(minocycline) Extended-release Capsules
Annual Sales
Company JOURNEY MEDICAL
Date of First Filing December 16, 2025

Paragraph IV Applicant: Lupin
Case Name: JOURNEY MEDICAL CORPORATION v. LUPIN LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00202
Date Filed: 2/25/26
Judge: Connolly
Product Strength:…Read more

]]> 0 825538ba7f40fcaff672306cf46eb7c2 parryashford updated 'Edarbi®(azilsartan) Tablets ': Edarbi®(azilsartan) Tablets Company ARBOR […] https://paragraphfour.com/activity/p/11860/ Wed, 29 Apr 2026 14:33:53 -0400 Edarbi®(azilsartan) Tablets
Company ARBOR PHARMACEUTICALS
Date of First Filing April 10, 2020

Paragraph IV Applicant: Lupin
Case Name: ARBOR PHARMACEUTICALS LLC et al v. LUPIN LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2020cv00922
Date Filed: 7/8/20
Judge: Noreika
Product Strength: 40 mg and 80 mg
Litigated…Read more

]]> 0 037b763c78377d7dd42bdff4ed71f1e4 parryashford updated 'Dojolvi®(triheptanoin) Oral Liquid ': Dojolvi®(triheptanoin) Oral Liquid Annual Sales $88M […] https://paragraphfour.com/activity/p/11859/ Wed, 29 Apr 2026 14:31:05 -0400 Dojolvi®(triheptanoin) Oral Liquid
Annual Sales $88M (global)
Company ULTRAGENYX
Date of First Filing July 1, 2024

Paragraph IV Applicant: Navinta
Paragraph IV Applicant: Aurobindo
Paragraph IV Applicant: Esjay
Case Name: ULTRAGENYX PHARMACEUTICAL INC et al v. NAVINTA LLC et al
Court/Case #: New Jersey District Court (njdc)…Read more

]]> 0 bfe24ce9b4dd4c2cad04a4fe7f023fe9 parryashford updated 'Cinvanti®(aprepitant) Intravenous Emulsion ': Cinvanti®(aprepitant) Intravenous Emulsion Annual Sales $100 […] https://paragraphfour.com/activity/p/11858/ Wed, 29 Apr 2026 14:14:05 -0400 Cinvanti®(aprepitant) Intravenous Emulsion
Annual Sales $100M
Company HERON
Date of First Filing April 29, 2022

Paragraph IV Applicant: Fresenius Kabi
Case Name: HERON THERAPEUTICS INC v. FRESENIUS KABI USA LLC et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1355
Date Filed:
Judge:
Product Strength: 130…Read more

]]> 0 dea5f5a1e211ebbc3a940970d6756471 parryashford updated 'Cibinqo®(abrocitinib) Tablets ': Cibinqo®(abrocitinib) Tablets Annual Sales $284M Company […] https://paragraphfour.com/activity/p/11857/ Wed, 29 Apr 2026 14:10:08 -0400 Cibinqo®(abrocitinib) Tablets
Annual Sales $284M
Company PFIZER
Date of First Filing January 14, 2026

Paragraph IV Applicant: Micro Labs
Case Name: PFIZER INC et al v. MICRO LABS LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00439
Date Filed: 4/16/26
Judge: Hall
Product Strength: 50 mg, 100 mg, and 200…Read more

]]> 0 a6ca395bf99d0e1c1b3705e8bfa7c6ce parryashford updated 'Abilify Maintena Kit®(aripiprazole) Extended-release Injectable Suspension ': Abilify Maintena Kit®(aripiprazole) Extended-release […] https://paragraphfour.com/activity/p/11856/ Wed, 29 Apr 2026 14:02:08 -0400 Abilify Maintena Kit®(aripiprazole) Extended-release Injectable Suspension
Annual Sales JPY 144B
Company OTSUKA
Date of First Filing December 20, 2021

Paragraph IV Applicant: Mylan
Case Name: OTSUKA PHARMACEUTICAL CO LTD et al v. MYLAN LABORATORIES LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2022cv00464
Date…Read more

]]> 0 b80374f5d799acacc0596a76de6ebbed gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11855/ Tue, 28 Apr 2026 14:24:33 -0400 The Paragraph Four Report ®
Generic Companies Report #3 (Q-Z)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 0a0df52d6bae9ebd2b3dd02a560b1382 gregoryglass updated 'Xarelto®(rivaroxaban) Tablets ': Xarelto®(rivaroxaban) Tablets Annual Sales $2.36B (as […] https://paragraphfour.com/activity/p/11854/ Tue, 28 Apr 2026 14:23:39 -0400 Xarelto®(rivaroxaban) Tablets
Annual Sales $2.36B (as reported by J&J)
Company BAYER (JANSSEN)
Date of First Filing July 1, 2015 and November 15, 2018 (2.5mg)

Special Note 1: On 10/9/15, Bayer filed its PIV case against 7 ANDA filers (Aurobindo through Torrent). Bayer included all three patents against all of the defendants except where…Read more

]]> 0 472d024151df52f2b2fb9c714972018c parryashford updated 'Envarsus XR®(tacrolimus) Extended-release Tablets ': Envarsus XR®(tacrolimus) Extended-release Tablets Company […] https://paragraphfour.com/activity/p/11853/ Sat, 25 Apr 2026 15:36:41 -0400 Envarsus XR®(tacrolimus) Extended-release Tablets
Company VELOXIS
Date of First Filing March 31, 2022

Paragraph IV Applicant: Accord
Case Name: VELOXIS PHARMACEUTICALS INC v. ACCORD HEALTHCARE INC et al
Court/Case #: Delaware District Court (dedc) 1:2022cv00909
Date Filed: 7/7/2022
Judge: Noreika
Product Strength: 0.75mg, 1mg, and…Read more

]]> 0 15f7455851860b988cf784d475d532dd gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11852/ Sat, 25 Apr 2026 14:48:13 -0400 The Paragraph Four Report ®
Generic Companies Report #3 (Q-Z)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 7f196f69cebaac03c314b8d068e8b059 parryashford updated 'Envarsus XR®(tacrolimus) Extended-release Tablets ': Envarsus XR®(tacrolimus) Extended-release Tablets Company […] https://paragraphfour.com/activity/p/11851/ Sat, 25 Apr 2026 14:47:33 -0400 Envarsus XR®(tacrolimus) Extended-release Tablets
Company VELOXIS
Date of First Filing March 31, 2022

Paragraph IV Applicant: Accord
Case Name: VELOXIS PHARMACEUTICALS INC v. ACCORD HEALTHCARE INC et al
Court/Case #: Delaware District Court (dedc) 1:2022cv00909
Date Filed: 7/7/2022
Judge: Noreika
Product Strength: 0.75mg, 1mg, and…Read more

]]> 0 aa2a5a8b1bfe92bf40c334a8589a0179 parryashford updated 'Cuvrior®(trientine) Tablets ': Cuvrior®(trientine) Tablets Company ORPHALAN Date of […] https://paragraphfour.com/activity/p/11850/ Sat, 25 Apr 2026 14:30:54 -0400 Cuvrior®(trientine) Tablets
Company ORPHALAN
Date of First Filing June 21, 2023

Paragraph IV Applicant: Novitium
Case Name: ORPHALAN SA v. NOVITIUM PHARMA LLC
Court/Case #: Delaware District Court (dedc) 1:2023cv01079
Date Filed: 9/29/23
Judge: Williams
Product Strength: 300 mg
Litigated Patents (expiration): 10,988,436…Read more

]]> 0 50c07935a0b27dde522e352f6c16c4b3 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11849/ Thu, 23 Apr 2026 17:10:31 -0400 The Paragraph Four Report ®
Generic Companies Report #3 (Q-Z)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 7064ba5e9b6c9b3e6e8167aa7f2e4982 gregoryglass updated 'Bromsite(r)(bromfenac) Ophthalmic Solution ': Bromsite(r)(bromfenac) Ophthalmic Solution  Company SUN […] https://paragraphfour.com/activity/p/11848/ Thu, 23 Apr 2026 17:09:12 -0400 Bromsite(r)(bromfenac) Ophthalmic Solution 
Company SUN
Date of First Filing October 25, 2017

Paragraph IV Applicant: Lupin
Case Name: SUN PHARMA GLOBAL FZE et al v. LUPIN LIMITED et al
Court/Case #: New Jersey District Court (njdc) 3:2018cv02213
Date Filed: 2/15/18
Judge: Wolfson
Product Strength: 0.075%
Litigated Patents…Read more

]]> 0 709e85bde096e69c0036414d66440e2f parryashford updated 'Wakix®(pitolisant) Tablets ': Wakix®(pitolisant) Tablets Annual Sales $437M Company HAR […] https://paragraphfour.com/activity/p/11847/ Thu, 23 Apr 2026 16:57:54 -0400 Wakix®(pitolisant) Tablets
Annual Sales $437M
Company HARMONY
Date of First Filing August 14, 2023

Paragraph IV Applicant: Lupin
Paragraph IV Applicant: Novugen
Case Name: HARMONY BIOSCIENCES LLC et al v. LUPIN LIMITED
Court/Case #: Delaware District Court (dedc) 1:2023cv01286
Date Filed: 11/9/23
Judge: Hall
Product Strength:…Read more

]]> 0 fbc397ae878cc3ef381c4ed790607b71 parryashford updated 'Livtencity®(maribavir) Tablets ': Livtencity®(maribavir) Tablets Annual Sales 20B […] https://paragraphfour.com/activity/p/11846/ Tue, 21 Apr 2026 20:13:58 -0400 Livtencity®(maribavir) Tablets
Annual Sales 20B JPYen
Company TAKEDA
Date of First Filing November 24, 2025

Paragraph IV Applicant: Qilu
Case Name: TAKEDA PHARMACEUTICAL COMPANY LIMITED v. QILU PHARMACEUTICAL (HAINAN) CO LTD
Court/Case #: New Jersey District Court (njdc) 2:2026cv01633
Date Filed: 2/18/26
Judge: Salas
Product…Read more

]]> 0 4fa8e48371d739713f67529652deb22f gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11845/ Tue, 21 Apr 2026 20:08:44 -0400 The Paragraph Four Report ®
Generic Companies Report #1 (A-E)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 b958330b1db808b57acf63c4c928053b parryashford updated 'Xtandi®(enzalutamide) Tablets ': Xtandi®(enzalutamide) Tablets Annual Sales: JPY 912B […] https://paragraphfour.com/activity/p/11844/ Tue, 21 Apr 2026 20:07:45 -0400 Xtandi®(enzalutamide) Tablets
Annual Sales: JPY 912B (global family)
Company ASTELLAS
Date of First Filing March 31, 2021 and December 27, 2024 (120 mg and 160 mg)

Paragraph IV Applicant: Sandoz
Case Name: ASTELLAS PHARMA INC et al v. SANDOZ INC
Court/Case #: New Jersey District Court (njdc) 2:2021cv13177
Date Filed: 6/30/21
Judge: …Read more

]]> 0 6be446b180bc636cac4ef36366f63f4e gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11843/ Tue, 21 Apr 2026 19:49:12 -0400 The Paragraph Four Report ®
Generic Companies Report #2 (F-P)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 e0a03c22f246227ce87b9bfb16628b82 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11842/ Tue, 21 Apr 2026 19:48:41 -0400 The Paragraph Four Report ®
Generic Companies Report #1 (A-E)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 804fd3de7bea3ce8d5ebbac494aab81f gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/11841/ Tue, 21 Apr 2026 19:47:43 -0400 The Paragraph Four Report ®
Branded Companies Report

List of Companies with Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1, 2003)

ABBOTT LAB…Read more

]]> 0 a5290915e82d0dd65e1fcdd5ad8d6957 parryashford started the topic Cibinqo®(abrocitinib) Tablets in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/cibinqoabrocitinib-tablets/ Tue, 21 Apr 2026 19:47:01 -0400 Cibinqo®(abrocitinib) Tablets
Annual Sales $284M
Company PFIZER
Date of First Filing January 14, 2026

Paragraph IV Applicant: Micro Labs
Case Name: PFIZER INC et al v. MICRO LABS LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00439
Date Filed: 4/16/26
Judge: Hall
Product Strength: 50 mg, 100 mg, and 200…Read more

]]> f5ff90cfcb287f1d08aa427fbdbe8d08 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11839/ Fri, 17 Apr 2026 17:35:00 -0400 The Paragraph Four Report ®
Generic Companies Report #3 (Q-Z)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 b655d7a29caf953e45fa872d86da621f parryashford updated 'Nayzilam®(midazolam) Nasal Spray ': Nayzilam®(midazolam) Nasal Spray Annual Sales 124M […] https://paragraphfour.com/activity/p/11838/ Fri, 17 Apr 2026 17:33:56 -0400 Nayzilam®(midazolam) Nasal Spray
Annual Sales 124M EUR
Company UCB
Date of First Filing June 1, 2021

Paragraph IV Applicant: Cipla
Case Name: UCB INC et al v. CIPLA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2021cv01229
Date Filed: 8/26/21
Judge: Hall
Product Strength: 5 mg
Litigated Patents (expiration): 8,217,0…Read more

]]> 0 8048a19e9857ae82ade66f91e27624ef gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11837/ Fri, 17 Apr 2026 17:00:08 -0400 The Paragraph Four Report ®
Generic Companies Report #2 (F-P)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 eb5c84297115252b3f87009eab51fd80 parryashford updated 'Cyclophosphamide (cyclophosphamide) Injection ': Cyclophosphamide (cyclophosphamide) Injection Annual Sales […] https://paragraphfour.com/activity/p/11836/ Fri, 17 Apr 2026 16:59:20 -0400 Cyclophosphamide (cyclophosphamide) Injection
Annual Sales
Company INGENUS
Date of First Filing March 7, 2022 (500 mg/2.5 mL and 1 g/5 mL) and January 17, 2023 (2g/10 mL)

Paragraph IV Applicant: Nexus
Case Name: INGENUS PHARMACEUTICALS LLC et al v. NEXUS PHARMCEUTICALS INC
Court/Case #: Court of Appeals for the Federal Circuit (cafc)…Read more

]]> 0 c629388f534986c96e1123bfa66e3794 parryashford updated 'Radicava ORS®(edaravone) Oral Suspension ': Radicava ORS®(edaravone) Oral Suspension Annual Sales Com […] https://paragraphfour.com/activity/p/11835/ Tue, 14 Apr 2026 15:21:13 -0400 Radicava ORS®(edaravone) Oral Suspension
Annual Sales
Company MITSUBISHI
Date of First Filing April 20, 2023

Paragraph IV Applicant: Cipla
Case Name: MITSUBISHI TANABE PHARMA CORPORATION v. CIPLA USA INC et al
Court/Case #: Delaware District Court (dedc) 1:2023cv00759
Date Filed: 7/12/23
Judge: Hall
Product Strength: 105…Read more

]]> 0 6e15884e87624c6c0ff12aea09034259 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11834/ Tue, 14 Apr 2026 15:03:46 -0400 The Paragraph Four Report ®
Generic Companies Report #3 (Q-Z)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 b7b5595fbcd61603be33719de4375b71 parryashford updated 'Cabtreo®(clindamycin, adapalene, and benzoyl peroxide) Topical Gel ': Cabtreo®(clindamycin, adapalene, and benzoyl peroxide) […] https://paragraphfour.com/activity/p/11833/ Tue, 14 Apr 2026 14:58:05 -0400 Cabtreo®(clindamycin, adapalene, and benzoyl peroxide) Topical Gel
Annual Sales
Company BAUSCH
Date of First Filing Not yet reported by FDA

Paragraph IV Applicant: Taro
Case Name: BAUSCH HEALTH IRELAND LIMITED et al v. TARO PHARMACEUTICALS INC et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv02000
Date Filed:…Read more

]]> 0 72b9501bbd8270ba72436cc6c33c3217 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11832/ Tue, 14 Apr 2026 14:47:43 -0400 The Paragraph Four Report ®
Generic Companies Report #1 (A-E)

List of Companies and Products under active Paragraph IV Certification
Data includes total number and product and includes products that do not have a lawsuit filed (only when verified by other sources). An Asterisk (*) indicates an “Old Case” (terminated after November 1,…Read more

]]> 0 855064833aaea75258251c7875a3e1c9 parryashford updated 'Neffy®(epinephrine) Nasal Spray ': Neffy®(epinephrine) Nasal Spray Annual Sales Company ARS […] https://paragraphfour.com/activity/p/11831/ Tue, 14 Apr 2026 14:47:04 -0400 Neffy®(epinephrine) Nasal Spray
Annual Sales
Company ARS PHARMACEUTICALS
Date of First Filing June 30, 2025 and December 29, 2025 (1 mg/spray)

Paragraph IV Applicant: Lupin
Case Name: ARS PHARMACEUTICALS OPERATIONS INC et al v. LUPIN INC et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv15123
Date Filed: 8/29/25
Judge: …Read more

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