ParagraphFour.com | Site-Wide Activity https://paragraphfour.com/activity/ Activity feed for the entire site. Thu, 09 Apr 2026 07:33:06 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ff71e260ca91d95bd6a5fa879adcfe5e gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11799/ Tue, 07 Apr 2026 14:52:43 -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 be5075b270b3f65dac19670bd5eccfa4 gregoryglass updated 'Omidria®(phenylephrine and ketorolac) Injection ': Omidria®(phenylephrine and ketorolac) Injection Company OMER […] https://paragraphfour.com/activity/p/11798/ Tue, 07 Apr 2026 14:51:54 -0400 Omidria®(phenylephrine and ketorolac) Injection
Company OMEROS
Date of First Filing May 29, 2015

Paragraph IV Applicant: Par
Case Name: OMEROS CORPORATION v. PAR STERILE PRODUCTS LLC et al
Court/Case #: Delaware District Court (dedc) 1:2015cv00773
Date Filed: 9/3/15
Judge: Andrews
Product Strength: 1%/0.3%
Litigated Patents…Read more

]]> 0 959b3a17d3bdd2d82fd24273e52106a8 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11797/ Tue, 07 Apr 2026 14:37:53 -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 b6984dc78a4eb44a824adefb39c50c94 gregoryglass updated 'Jardiance®(empagliflozin) Tablets ': Jardiance®(empagliflozin) Tablets Annual Sales $1.6B […] https://paragraphfour.com/activity/p/11796/ Tue, 07 Apr 2026 14:37:10 -0400 Jardiance®(empagliflozin) Tablets
Annual Sales $1.6B (product family) (as reported by Eli Lilly)
Company BOEHRINGER INGELHEIM
Date of First Filing August 1, 2018

Special Note: When these cases were filed, several of them also involve the combination product Glyxambi®(empagliflozin and linagliptin), Synjardy®(empagliflozin and me…Read more

]]> 0 f66fdb1f72a6dcc43c3f06ba218fb6aa gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11795/ Tue, 07 Apr 2026 12:06:38 -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 08d1dfb8364a8e35c803bc9956e6d25e gregoryglass updated 'Abraxane®(paclitaxel) For Injection Suspension ': Abraxane®(paclitaxel) For Injection Suspension Company ABRAX […] https://paragraphfour.com/activity/p/11794/ Tue, 07 Apr 2026 12:06:04 -0400 Abraxane®(paclitaxel) For Injection Suspension
Company ABRAXIS
Date of First Filing December 11, 2015

Paragraph IV Applicant: Actavis
Case Name: ABRAXIS BIOSCIENCE LLC et al v. ACTAVIS LLC
Court/Case #: New Jersey District Court (njdc) 2:2016cv01925
Date Filed: 4/6/16
Judge: Vazquez
Product Strength: 100 mg/vial
Litigated Patents…Read more

]]> 0 34c81ffc39a326ee29422bcdf5181109 parryashford updated 'Qelbree®(viloxazine) Extended-release Capsules ': Qelbree®(viloxazine) Extended-release Capsules Annual […] https://paragraphfour.com/activity/p/11793/ Tue, 07 Apr 2026 11:56:28 -0400 Qelbree®(viloxazine) Extended-release Capsules
Annual Sales $241M
Company SUPERNUS
Date of First Filing April 2, 2025

Paragraph IV Applicant: Somerset
Case Name: SUPERNUS PHARMACEUTICALS, INC v. APPCO PHARMA LLC et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv12183
Date Filed: 6/26/25
Judge: Farbiarz
Product…Read more

]]> 0 26baae5eda492e6ac19390eb5a17c308 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11792/ Tue, 07 Apr 2026 11:46:11 -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 8b3c6fa55b4bac5a968d1d3f01dac457 parryashford updated 'Dojolvi®(triheptanoin) Oral Liquid ': Dojolvi®(triheptanoin) Oral Liquid Annual Sales $88M […] https://paragraphfour.com/activity/p/11791/ Tue, 07 Apr 2026 11:45:35 -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 e6cdf98de81096f4492123e1512abcfb gregoryglass updated 'Last Month’s Paragraph IV Highlights ': March 2026 https://paragraphfour.com/activity/p/11789/ Thu, 02 Apr 2026 19:12:55 -0400 March 2026

]]> 0 7c3e266faccca4bcb37451559ed2d2a3 parryashford wrote a new post https://paragraphfour.com/?p=23665 Thu, 02 Apr 2026 14:21:00 -0400 Lawyers Behaving Badly While a judges decide cases, it is really the lawyers who run it – their pace and interactions with the court. Sometimes, lawyers can frustrate judges […]

]]> c4612349bd6b45afb54fd62c8cf64d2b parryashford updated '267. February 2026 ': The Paragraph Four Report® Paragraph IV Activity for […] https://paragraphfour.com/activity/p/11786/ Wed, 01 Apr 2026 21:03:13 -0400 The Paragraph Four Report®
Paragraph IV Activity for February 2026

New Certifications as reported by FDA on February 2, 2026

1. Neffy®(epinephrine) Nasal Spray 1 mg/spray on 12/29/2025
2. Motpoly XR®(lacosamide) Extended-release Capsules 200 mg on 12/29/2025
3. Leqvio®(inclisiran) Injection 284 mg/1.5 mL on 12/22/2025
4. Trelegy Ell…Read more

]]> 0 2ca2efbfc48957485ce0be0719330cf4 parryashford started the topic March 2026 in the forum Last Month's Paragraph IV Highlights https://paragraphfour.com/forums/topic/march-2026-2/ Wed, 01 Apr 2026 21:02:43 -0400 The Paragraph Four Report®
Paragraph IV Activity for March 2026

New Certifications as reported by FDA on March 2 and 19, 2026

1. Motpoly XR®(lacosmide) Extended-release Capsules 100 mg and 150 mg on 2/10/2026
2. Kerendia®(finerenone) Tablets 40 mg on 2/2/2026
3. Recorlev®(levoketoconazole) Tablets 150 mg on 12/30/2025
4. Pre…Read more

]]> a9a926b799d5cd342734633e32e67f7e parryashford updated 'Ztlido®(lidocaine) Topical Patch ': Ztlido®(lidocaine) Topical Patch Annual Sales Company […] https://paragraphfour.com/activity/p/11784/ Wed, 01 Apr 2026 18:59:19 -0400 Ztlido®(lidocaine) Topical Patch
Annual Sales
Company SCILEX
Date of First Filing March 17, 2022

Paragraph IV Applicant: Apotex
Case Name: SCILEX PHARMACEUTICALS INC et al v. AVEVA DRUG DELIVIERY SYSTEMS INC et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1002
Date Filed: 10/2/24
Judge:
Product Strength:…Read more

]]> 0 59d196e30db7703f2798736d142c521a parryashford updated 'Zepzelca®(lurbinectedin) Powder for Injection ': Zepzelca®(lurbinectedin) Powder for Injection Annual Sales […] https://paragraphfour.com/activity/p/11783/ Wed, 01 Apr 2026 18:57:00 -0400 Zepzelca®(lurbinectedin) Powder for Injection
Annual Sales $289M
Company JAZZ PHARMACEUTICALS
Date of First Filing June 17, 2024

Paragraph IV Applicant: Sandoz
Case Name: JAZZ PHARMACEUTICALS IRELAND LIMITED et al v. SANDOZ INC et al
Court/Case #: New Jersey District Court (njdc) 3:2024cv09110
Date Filed: 9/11/24
Judge: Kirsch
Prod…Read more

]]> 0 3313f2bab7313b8a46997a4acff12b94 parryashford updated 'Yupelri®(revefenacin) Inhalation Solution ': Yupelri®(revefenacin) Inhalation Solution Annual Sales $22 […] https://paragraphfour.com/activity/p/11782/ Wed, 01 Apr 2026 18:54:22 -0400 Yupelri®(revefenacin) Inhalation Solution
Annual Sales $220M
Company MYLAN
Date of First Filing November 9, 2022

Paragraph IV Applicant: Mankind
Case Name: THERAVANCE BIOPHARMA R&D IP LLC et al v. EUGIA PHARMA SPECIALTIES LTD et al
Court/Case #: New Jersey District Court (njdc) 1:2023cv00926
Date Filed: 2/16/23
Judge: Williams
Pro…Read more

]]> 0 eabbebfdfc992c2f6fef10529a75b997 parryashford updated 'Xywav®(calcium oxybate, et al) Oral Solution ': Xywav®(calcium oxybate, magnesium oxybate, potassium […] https://paragraphfour.com/activity/p/11781/ Wed, 01 Apr 2026 18:50:32 -0400 Xywav®(calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate) Oral Solution
Annual Sales $1.27B (global)
Company JAZZ PHARMACEUTICALS
Date of First Filing April 12, 2021

Paragraph IV Applicant: Lupin
Case Name: JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD. et al
Court/Case #: New Jersey District Court (njdc)…Read more

]]> 0 319da42ac9cd6dd2e3ee8e66abfe284e parryashford updated 'Vyndamax®(tafamidis) and Vyndaqel® Capsules ': Vyndamax®(tafamidis) Capsules Vyndaqel®(tafamidis) C […] https://paragraphfour.com/activity/p/11780/ Wed, 01 Apr 2026 18:38:26 -0400 Vyndamax®(tafamidis) Capsules
Vyndaqel®(tafamidis) Capsules
Annual Sales $975M
Company PFIZER
Date of First Filing May 3, 2023 (Vyndamax) and May 3, 2023 (Vyndaqel)

Special Note: We have combined these two products into this one Product Topic. These products have different strengths (61 mg for Vyndamax and 20 mg for Vyndaqel) and s…Read more

]]> 0 4567b6477ce15ca9a19ef50d551d55b4 parryashford updated 'Vraylar®(cariprazine) Capsules ': Vraylar®(cariprazine) Capsules Company ALLERGAN Date of […] https://paragraphfour.com/activity/p/11779/ Wed, 01 Apr 2026 18:35:02 -0400 Vraylar®(cariprazine) Capsules
Company ALLERGAN
Date of First Filing September 17, 2019

Paragraph IV Applicant: Sun
Paragraph IV Applicant: Aurobindo
Paragraph IV Applicant: Zydus
Case Name: ALLERGAN USA INC et al v. SUN PHARMACEUTICASL INDUSTRIES LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2019cv02317
Date Filed:…Read more

]]> 0 86e080f33c5522cce58b979d1ab8ef95 parryashford updated 'Veklury®(remdesivir) Injection ': Veklury®(remdesivir) Injection Annual Sales $892M Company […] https://paragraphfour.com/activity/p/11778/ Wed, 01 Apr 2026 18:32:07 -0400 Veklury®(remdesivir) Injection
Annual Sales $892M
Company GILEAD
Date of First Filing April 22, 2025

Paragraph IV Applicant: Aspiro
Case Name: GILEAD SCIENCES INC v. ASPIRO PHARMA LTD et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv13936
Date Filed: 7/30/25
Judge: Chesler
Product Strength: 100 mg/vial
Litigated…Read more

]]> 0 a27bdccde81a48c087f235afb1e479cb parryashford updated 'Uptravi®(selexipag) Tablets ': Uptravi®(selexipag) Tablets Company ACTELION Sales: $1.3B […] https://paragraphfour.com/activity/p/11777/ Wed, 01 Apr 2026 18:26:56 -0400 Uptravi®(selexipag) Tablets
Company ACTELION
Sales: $1.3B (product family, as reported by J&J)
Date of First Filing December 23, 2019

Paragraph IV Applicant: Alembic
Paragraph IV Applicant: MSN Laboratories
Paragraph IV Applicant: Vgyaan
Paragraph IV Applicant: Zydus
Case Name: ACTELION PHARMACEUTICALS LTD et al v. MSN…Read more

]]> 0 b778ff058765f70952b790d44310197c parryashford updated 'Prolia®/Xgeva®(denosumab) Injection ': Prolia®/Xgeva®(denosumab) Injection Annual Sales $2.88B […] https://paragraphfour.com/activity/p/11776/ Wed, 01 Apr 2026 16:51:57 -0400 Prolia®/Xgeva®(denosumab) Injection
Annual Sales $2.88B
Company AMGEN
Date of First Filing Not applicable, aBLA

Paragraph IV Applicant: Sandoz
Case Name: AMGEN INC et al v. SANDOZ INC et al
Court/Case #: New Jersey District Court (njdc) 2:2023cv02406
Date Filed: 5/1/23
Judge: O’Hearn
Product Strength: 60 mg/mL and 70 m…Read more

]]> 0 2118e41197f666fddffe3324e4162a08 parryashford updated 'Orgovyx®(relugolix) Tablets ': Orgovyx®(relugolix) Tablets Annual Sales Company SUMITOM […] https://paragraphfour.com/activity/p/11775/ Wed, 01 Apr 2026 16:41:05 -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 117a6812ca2e84e2577d6475ed05a4c4 parryashford updated 'Opzelura®(ruxolitinib) Cream ': Opzelura®(ruxolitinib) Cream Annual Sales $508M Company […] https://paragraphfour.com/activity/p/11774/ Wed, 01 Apr 2026 16:35:24 -0400 Opzelura®(ruxolitinib) Cream
Annual Sales $508M
Company INCYTE
Date of First Filing July 31, 2023

Paragraph IV Applicant: Padagis
Case Name: INCYTE CORP et al v. PADAGIS ISRAEL PHARMACEUTICALS LTD
Court/Case #: New Jersey District Court (njdc) 2:2023cv21826
Date Filed: 11/2/23
Judge: Arleo
Product Strength: 1.5%
Litigated…Read more

]]> 0 6ec21275e435ce437111d5abb7336ac0 gregoryglass updated 'Myrbetriq®(mirabegron) Extended-release Tablets ': Myrbetriq®(mirabegron) Extended-release Tablets Annual […] https://paragraphfour.com/activity/p/11773/ Wed, 01 Apr 2026 15:54:36 -0400 Myrbetriq®(mirabegron) Extended-release Tablets
Annual Sales
Company ASTELLAS
Date of First Filing June 28, 2016

Special Summary Note #1: In 2016, Astellas brought PIV actions against 9 ANDA filers as listed below. By October 2020, all of the parties settled these original cases. On 11/24/20, the USPTO issued a new patent (10,842,780,…Read more

]]> 0 8c788e1b27658d7041b7c95c627229da parryashford updated 'Multrys® and Tralement®(cupric sulfate, manganese sulfate, selenious acid, zinc sulfate) Injection ': Multrys® and Tralement®(cupric sulfate, manganese sulfate, s […] https://paragraphfour.com/activity/p/11772/ Wed, 01 Apr 2026 15:43:28 -0400 Multrys® and Tralement®(cupric sulfate, manganese sulfate, selenious acid, zinc sulfate) Injection
Annual Sales
Company AMERICAN REGENT
Date of First Filing November 16, 2024

Special Note: See also the Selenious Acid Product Topic

Paragraph IV Applicant: Somerset
Case Name: AMERICAN REGENT INC v. SOMERSET THERAPEUTICS LLC et a…Read more

]]> 0 852383ec9f00ba51a03c0cbdfae7adb2 parryashford updated 'Livmarli®(maralixibat) Oral Solution ': Livmarli®(maralixibat) Oral Solution Annual Sales Company […] https://paragraphfour.com/activity/p/11771/ Wed, 01 Apr 2026 15:32:00 -0400 Livmarli®(maralixibat) Oral Solution
Annual Sales
Company MIRUM PHARMACEUTICALS
Date of First Filing September 29, 2025

Paragraph IV Applicant: Hetero
Case Name: MIRUM PHARMACEUTICALS INC et al v. ANNORA PHARMA PRIVATE LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2025cv01537
Date Filed: 12/19/25
Judge: Hall
Produc…Read more

]]> 0 eb47fe55bc646fc279dee20b50e0a55f parryashford updated 'Korsuva®(difelikefalin) Intravenous Solution ': Korsuva®(difelikefalin) Intravenous Solution Annual Sales […] https://paragraphfour.com/activity/p/11770/ Wed, 01 Apr 2026 15:04:23 -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 e1a58ce103d92ffb9ac4f00114759dfe parryashford updated 'Kerendia®(finerenone) Tablets ': Kerendia®(finerenone) Tablets Annual Sales EU 436M […] https://paragraphfour.com/activity/p/11769/ Wed, 01 Apr 2026 15:01:00 -0400 Kerendia®(finerenone) Tablets
Annual Sales EU 436M (global)
Company BAYER
Date of First Filing September 9, 2025 and February 2, 2026 (40 mg)

Paragraph IV Applicant: Aurobindo
Case Name: BAYER HEALTHCARE PHARMACEUTICALS INC et al v. AUROBINDO PHARMA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2025cv01246
Date…Read more

]]> 0 851584c419be536a6b9a0da885eb1121 parryashford updated 'Kalydeco®(ivacaftor) Oral Granules ': Kalydeco®(ivacaftor) Oral Granules Annual Sales Company […] https://paragraphfour.com/activity/p/11768/ Wed, 01 Apr 2026 14:57:49 -0400 Kalydeco®(ivacaftor) Oral Granules
Annual Sales
Company VERTEX
Date of First Filing April 13, 2022.

Special Note: This product has several over-lapping patents with the table form. See also Kalydeco®(ivacaftor) Tablets Product Topic.

Paragraph IV Applicant: Lupin
Case Name: VERTEX PHARMACEUTICALS INCORPORATED v. LUPIN LIMITED et a…Read more

]]> 0 c4aebc9a90ee85449a336fb524d081e4 gregoryglass updated 'Jardiance®(empagliflozin) Tablets ': Jardiance®(empagliflozin) Tablets Annual Sales $1.6B […] https://paragraphfour.com/activity/p/11767/ Wed, 01 Apr 2026 14:54:12 -0400 Jardiance®(empagliflozin) Tablets
Annual Sales $1.6B (product family) (as reported by Eli Lilly)
Company BOEHRINGER INGELHEIM
Date of First Filing August 1, 2018

Special Note: When these cases were filed, several of them also involve the combination product Glyxambi®(empagliflozin and linagliptin), Synjardy®(empagliflozin and me…Read more

]]> 0 6c4b3d9124d09d0a49a97454a3fd3fac gregoryglass updated 'Injectafer®(ferric carboxymaltose) Injection ': Injectafer®(ferric carboxymaltose) Injection Company VIFOR […] https://paragraphfour.com/activity/p/11766/ Wed, 01 Apr 2026 14:48:17 -0400 Injectafer®(ferric carboxymaltose) Injection
Company VIFOR INTERNATIONAL
Date of First Filing March 27, 2019 and February 22, 2024 (50 mg/10 mL)

Paragraph IV Applicant: Mylan
Case Name: VIFOR (INTERNATIONAL) AG et al v. MYLAN LABORATORIES LTD
Court/Case #: New Jersey District Court (njdc) 3:2019cv13955
Date Filed: 6/18/19
Judge: Wolfs…Read more

]]> 0 564decd17892f1f21cafc958d896ed23 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11765/ Wed, 01 Apr 2026 13:24:05 -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 cf50f3aa6fac10ccd7cb8ee6d574fc20 parryashford updated 'Vemlidy®(tenofovir alafenamide) Tablets and Combination Products Descovy® and Odefsey® ': Vemlidy®(tenofovir alafenamide) […] https://paragraphfour.com/activity/p/11764/ Wed, 01 Apr 2026 13:23:13 -0400 Vemlidy®(tenofovir alafenamide) Tablets
Descovy®(emtricitabine and tenofovir alafenamide) Tablets
Odefsey®(emtricitabine, rilpirivine and tenofovir alafenamide) Tablets
Annual Sales $2.78B+ (products)
Company GILEAD
Date of First Filing November 5, 2019 (all three products)

Special Note: While it is our typical protocol to place each pr…Read more

]]> 0 3f6ba2ca1f18e8c13467bc94ac1d7b71 gregoryglass updated 'Inter Partes Review List ': The Paragraph Four Report® Inter Partes Review List In […] https://paragraphfour.com/activity/p/11763/ Wed, 01 Apr 2026 13:11:18 -0400 The Paragraph Four Report®
Inter Partes Review List

In late 2012, the Inter Partes Review procedure went into effect allowing anyone to file a Petition with the US Patent and Trademark Office requesting that the USPTO invalidate an issued patent. Over time, this procedure became more common for Paragraph IV products and Orange Book Patents…Read more

]]> 0 715744ede820c0b41ebd5cfd6a532114 gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11762/ Wed, 01 Apr 2026 13:04:37 -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 707e6da0713be21d4237dca6e60619a5 gregoryglass updated 'Tradjenta®(linagliptin) Tablets ': Tradjenta®(linagliptin) Tablets Jentadueto®(linagliptin a […] https://paragraphfour.com/activity/p/11761/ Wed, 01 Apr 2026 13:02:38 -0400 Tradjenta®(linagliptin) Tablets
Jentadueto®(linagliptin and metformin) Tablets
Jentadueto XR®(linagliptin and metformin) Extended-release Tablets
Annual Sales EUR 1.621B (global)
Company BOEHRINGER INGELHEIM
Date of First Filing May 5, 2015 (both products) and March 28, 2018 (Jentadueto XR)

Special Note: On 8/4/15, Boehringer In…Read more

]]> 0 61c352d636f67a734391c8fed4f47359 gregoryglass updated 'Jardiance®(empagliflozin) Tablets ': Jardiance®(empagliflozin) Tablets Annual Sales $1.6B […] https://paragraphfour.com/activity/p/11760/ Wed, 01 Apr 2026 12:50:23 -0400 Jardiance®(empagliflozin) Tablets
Annual Sales $1.6B (product family) (as reported by Eli Lilly)
Company BOEHRINGER INGELHEIM
Date of First Filing August 1, 2018

Special Note: When these cases were filed, several of them also involve the combination product Glyxambi®(empagliflozin and linagliptin), Synjardy®(empagliflozin and me…Read more

]]> 0 6710e32d6f48158f405ee35fffb26167 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11759/ Wed, 01 Apr 2026 12:30:48 -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 cf910598b2fc76eebf7156f2ea75f29d gregoryglass updated 'Invega Sustenna®(paliperidone) ER Inj Suspension ': Invega Sustenna®(paliperidone) Extended-release Injectable […] https://paragraphfour.com/activity/p/11758/ Wed, 01 Apr 2026 12:30:18 -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 9371467325e84366bf30f5cd78db2e74 gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11757/ Wed, 01 Apr 2026 12:21:40 -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 671ac4472c1833962fb6bbc94eb1980d gregoryglass updated 'Kyprolis®(carfilzomib) For Injection ': Kyprolis®(carfilzomib) For Injection Annual Sales: […] https://paragraphfour.com/activity/p/11756/ Wed, 01 Apr 2026 12:15:35 -0400 Kyprolis®(carfilzomib) For Injection
Annual Sales: $948M
Company ONYX THERPEUTICS
Date of First Filing July 20, 2016 and October 5, 2017 (30mg/vial) and November 28, 2018 (10mg/vial)

Paragraph IV Applicant: Cipla
Case Name: ONYX THERAPEUTICS INC v. CIPLA LIMITED et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc)…Read more

]]> 0 ed342e0bcab3363469fd2097136bc46b gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11755/ Wed, 01 Apr 2026 12:01:29 -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 b82a76fe00129dbc924258751768fa18 gregoryglass updated 'Adempas®(riociguat) Tablets ': Adempas®(riociguat) Tablets Company BAYER Date of First […] https://paragraphfour.com/activity/p/11754/ Wed, 01 Apr 2026 12:00:38 -0400 Adempas®(riociguat) Tablets
Company BAYER
Date of First Filing October 10, 2017

Paragraph IV Applicant: Alembic
Case Name: ADVERIO PHARMA GMBH et al v. ALEMBIC PHARMACEUTICALS LTD et al
Court/Case #: Delaware District Court (dedc) 1:2018cv00073
Date Filed: 1/9/18
Judge: Salas
Product Strength: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5…Read more

]]> 0 ad41495cf0e8b0ff3f8f8d2d70dbb3ad parryashford updated 'Firdapse®(amifampridine) Tablets ': Firdapse®(amifampridine) Tablets Annual Sales $306M Compan […] https://paragraphfour.com/activity/p/11753/ Tue, 24 Mar 2026 18:07:14 -0400 Firdapse®(amifampridine) Tablets
Annual Sales $306M
Company CATALYST
Date of First Filing November 28, 2022

Paragraph IV Applicant: Teva
Case Name: CATALYST PHARMACEUTICALS INC et al v. TEVA PHARMACEUTICALS INC et al
Court/Case #: New Jersey District Court (njdc) 2:2023cv01190
Date Filed: 3/1/23
Judge: Farbiarz
Product Strength:…Read more

]]> 0 f8514daffb303a0c8f0ee22341b35ddb parryashford updated 'Exparel®(bupivacaine) Injectable Suspension ': Exparel®(bupivacaine) Injectable Suspension Company PACIRA […] https://paragraphfour.com/activity/p/11752/ Tue, 24 Mar 2026 18:04:09 -0400 Exparel®(bupivacaine) Injectable Suspension
Company PACIRA
Date of First Filing August 20, 2021 (266 mg/20 mL) and Not yet reported (133 mg/10 mL)

Paragraph IV Applicant: eVenus
Case Name: PACIRA PHARMACEUTICALS INC et al v. EVENUS PHARMACEUTICALS LABORATORIES INC et al
Court/Case #: Court of Appeals for the Federal Circuit…Read more

]]> 0 f91bbc2fe3cc7d9d424029e28a101a20 parryashford updated 'Cresemba®(isavuconazonium) For Injection ': Cresemba®(isavuconazonium) For Injection Annual Sales $489M […] https://paragraphfour.com/activity/p/11751/ Tue, 24 Mar 2026 17:48:42 -0400 Cresemba®(isavuconazonium) For Injection
Annual Sales $489M (product family, per Basilea)
Company ASTELLAS
Date of First Filing September 6, 2024

Paragraph IV Applicant: Cipla
Paragraph IV Applicant: Hetero
Case Name: ASTELLAS PHARMA INC et al v. CIPLA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2024cv01287
Date…Read more

]]> 0 878c4e652ed62758f3ea8b38946878d5 parryashford updated 'Caplyta®(lumateperone) Capsules ': Caplyta®(lumateperone) Capsules Annual Sales $462M Company […] https://paragraphfour.com/activity/p/11750/ Tue, 24 Mar 2026 17:42:44 -0400 Caplyta®(lumateperone) Capsules
Annual Sales $462M
Company INTRA-CELLULAR
Date of First Filing December 20, 2023

Special Note: FDA listed this product twice on its PIV List separating the two entries by product strength (10.5 mg and 21 mg for the first, 42 mg for the second). Both sets of products strengths received their first PIV…Read more

]]> 0 d150f7a7add977640e2a58a8fe488850 gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/11749/ Tue, 24 Mar 2026 15:36:15 -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 5a6c5382659c62722ef7625d2af991c9 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11748/ Tue, 24 Mar 2026 15:35:18 -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

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