ParagraphFour.com | Site-Wide Activity https://paragraphfour.com/activity/ Activity feed for the entire site. Sat, 23 May 2026 01:15:52 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ae79b48879b3971fc94fce2be3e7f9c3 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11941/ Fri, 22 May 2026 19:26:22 -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 be542a287e0bfb473ed9a8a1135cf81b gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/11940/ Fri, 22 May 2026 19:25:39 -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 4df9c74881f4787c4df28e2df793e435 parryashford started the topic Spinraza®(nusinersen) Intrathecal Solution in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/spinrazanusinersen-intrathecal-solution/ Fri, 22 May 2026 19:25:07 -0400 Spinraza®(nusinersen) Intrathecal Solution
Annual Sales $625M
Company BIOGEN
Date of First Filing March 10, 2026

Paragraph IV Applicant: Somerset
Case Name: BIOGEN MA INC et al v. SOMERSET THERAPEUTICS LLC et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00580
Date Filed: 5/20/26
Judge:
Product Strength: 12 mg/5…Read more

]]> 338e087e8b606af0a7b490c732a5440e gregoryglass updated 'Paragraph IV Appellate Judges (Bryson-Hughes) ': The Paragraph Four Report® The Appellate Judges (Bryson - […] https://paragraphfour.com/activity/p/11938/ Fri, 22 May 2026 19:01:42 -0400 The Paragraph Four Report®
The Appellate Judges (Bryson – Hughes)

This Section provides data on federal judges who preside in The Federal Circuit Court of Appeals. The Federal Circuit has exclusive appellate jurisdiction over Paragraph IV cases which means that a party that loses in the district court can only appeal the decision to the…Read more

]]> 0 c3830ad47787019710fe4d2205854775 gregoryglass updated 'Court of Appeals Decisions – by Case Name ': The Paragraph Four Report® Court of Appeals Opinions by […] https://paragraphfour.com/activity/p/11937/ Fri, 22 May 2026 18:59:03 -0400 The Paragraph Four Report®
Court of Appeals Opinions by Case Name

Opinions from the Court of Appeals for the Federal Circuit can be found in several places in ParagraphFour.com. Each Opinion issued for a particular product can be found under the product name, and you can also see how each individual Appellate Judge ruled in their various…Read more

]]> 0 8f727ff5da0dfc41bda1ea84ce49a0c6 parryashford updated 'Jynarque®(tolvaptan) Tablets ': Jynarque®(tolvaptan) Tablets Annual Sales JPY 130.3B […] https://paragraphfour.com/activity/p/11936/ Fri, 22 May 2026 18:55:35 -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 bdb0b14a2e0c73cdbb6a78f74fe20490 parryashford updated 'Jynarque®(tolvaptan) Tablets ': Jynarque®(tolvaptan) Tablets Annual Sales JPY 130.3B […] https://paragraphfour.com/activity/p/11935/ Fri, 22 May 2026 14:27:01 -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 e94e5b01a0875514f3ff9f8984b6b634 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11934/ Thu, 21 May 2026 14:32:48 -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 a703d416b81d5cee4a55f481350b2721 gregoryglass updated 'Hetlioz®(tasimelteon) Capsules ': Hetlioz®(tasimelteon) Capsules Annual Sales $76.7M […] https://paragraphfour.com/activity/p/11933/ Thu, 21 May 2026 14:29:57 -0400 Hetlioz®(tasimelteon) Capsules
Annual Sales $76.7M (product family)
Company VANDA PHARMACEUTICALS
Date of First Filing January 31, 2018

Paragraph IV Applicant: Teva
Case Name: VANDA PHARMACEUTICALS INC v. TEVA PHARMACEUTICALS USA INC
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 23-1247
Date Filed: 12/15/22
Judge: Dyk…Read more

]]> 0 43ba5d6be9e8b6aa195784c603a44411 gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/11932/ Thu, 21 May 2026 13:53:53 -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 dc9bfdbdcaa8822fd08777f579a74253 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11931/ Thu, 21 May 2026 13:53:08 -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 3a725b99c4ea94d4e4f23633dc127b02 parryashford started the topic Pyrukynd®(mitapivat) Tablets in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/pyrukyndmitapivat-tablets/ Thu, 21 May 2026 13:52:03 -0400 Pyrukynd®(mitapivat) Tablets
Annual Sales
Company AGIOS
Date of First Filing February 17, 2026

Paragraph IV Applicant: Apotex
Case Name: No PIV Case Pending
Court/Case #:
Date Filed:
Judge:
Product Strength:
Litigated Patents (expiration): 11,878,049 (7/31/2041)
Non-Litigated Patents (expiration): 9,193,701 (10/26/2032);…Read more

]]> b3f863120a5788182572119a57b7f671 gregoryglass updated 'Inter Partes Review List ': The Paragraph Four Report® Inter Partes Review List In […] https://paragraphfour.com/activity/p/11929/ Thu, 21 May 2026 13:42:40 -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 d7cb3d725a97ba502ea3fa18ecacf35d gregoryglass updated 'Paragraph IV Appellate Judges (Prost – Reyna) ': The Paragraph Four Report® The Appellate Judges (Prost - […] https://paragraphfour.com/activity/p/11928/ Thu, 14 May 2026 21:27:40 -0400 The Paragraph Four Report®
The Appellate Judges (Prost – Reyna)

This Section provides data on federal judges who preside in The Federal Circuit Court of Appeals. The Federal Circuit has exclusive appellate jurisdiction over Paragraph IV cases which means that a party that loses in the district court can only appeal the decision to the Federal…Read more

]]> 0 3cbebac8e2bce5e60703657b988ff726 gregoryglass updated 'Paragraph IV Appellate Judges (Schall – Wallach) ': The Paragraph Four Report® The Appellate Judges (Schall - […] https://paragraphfour.com/activity/p/11927/ Thu, 14 May 2026 21:27:03 -0400 The Paragraph Four Report®
The Appellate Judges (Schall – Wallach)

This Section provides data on federal judges who preside in The Federal Circuit Court of Appeals. The Federal Circuit has exclusive appellate jurisdiction over Paragraph IV cases which means that a party that loses in the district court can only appeal the decision to the…Read more

]]> 0 ad90bbe69f2725c46fb5c1f877326239 gregoryglass updated 'Court of Appeals Decisions – by Case Name ': The Paragraph Four Report® Court of Appeals Opinions by […] https://paragraphfour.com/activity/p/11926/ Thu, 14 May 2026 21:24:15 -0400 The Paragraph Four Report®
Court of Appeals Opinions by Case Name

Opinions from the Court of Appeals for the Federal Circuit can be found in several places in ParagraphFour.com. Each Opinion issued for a particular product can be found under the product name, and you can also see how each individual Appellate Judge ruled in their various…Read more

]]> 0 30b37e785fa74f9e8d2a8e3ee67331b3 gregoryglass updated 'Veletri®(epoprostenol) Injection ': Veletri®(epoprostenol) Injection Company ACTELION Date of […] https://paragraphfour.com/activity/p/11925/ Thu, 14 May 2026 21:17:32 -0400 Veletri®(epoprostenol) Injection
Company ACTELION
Date of First Filing March 31, 2017

Paragraph IV Applicant: Sun
Case Name: ACTELION PHARMACEUTICALS LTD v. SUN PHARMACEUTICAL INDUSTRIES INC et al
Court/Case #: New Jersey District Court (njdc) 3:2017cv05015
Date Filed: 7/7/17
Judge: Sheridan
Product Strength: 1.5mg/vial and…Read more

]]> 0 32b17577248699ade32b40580625a677 parryashford wrote a new post https://paragraphfour.com/?p=23670 Thu, 14 May 2026 13:52:00 -0400 Lawyers Behaving Badly, the sequel My last Blog Post covered when lawyers behave so badly they wear out the presiding judge, this Post covers another lawyer topic that was included in […]

]]> cb2c59f58c37d6b7dbe1c4fe6efa6828 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/11923/ Wed, 13 May 2026 14:01:22 -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 b60370e3cd432f6e9a4b065187fa34e9 parryashford updated 'Vitrakvi®(larotrectinib) Capsules ': Vitrakvi®(larotrectinib) Capsules Annual Sales Company […] https://paragraphfour.com/activity/p/11922/ Wed, 13 May 2026 13:55:18 -0400 Vitrakvi®(larotrectinib) Capsules
Annual Sales
Company BAYER
Date of First Filing May 6, 2025

Paragraph IV Applicant: Alembic
Case Name: ARRAY BIOPHARMA INC et al v. ALEMBIC PHARMACEUTICALS LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2025cv01016
Case Name: BOW RIVER LLC v. ALEMBIC PHARMACEUTICALS LIMITED et…Read more

]]> 0 d18243cc4afec7dcbfd97eb241dd4957 gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11921/ Fri, 08 May 2026 16:00:20 -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 d817224142fc58ad990953ec75d48187 gregoryglass updated 'Xifaxan®(rifaximin) Tablets ': Xifaxan®(rifaximin) Tablets Company SALIX Date of First […] https://paragraphfour.com/activity/p/11920/ Fri, 08 May 2026 15:59:44 -0400 Xifaxan®(rifaximin) Tablets
Company SALIX
Date of First Filing December 18, 2015 and January 28, 2019 (200mg)

Paragraph IV Applicant: Actavis
Case Name: SALIX PHARMACEUTICALS LTD et al v. ACTAVIS LABORATORIES FL INC
Court/Case #: Delaware District Court (dedc) 1:2016cv00188
Date Filed: 3/23/16
Judge: Sleet
Product Strength: 550…Read more

]]> 0 ed1af2bea179aa67054246c9eb8546cf gregoryglass updated 'Injectafer®(ferric carboxymaltose) Injection ': Injectafer®(ferric carboxymaltose) Injection Company VIFOR […] https://paragraphfour.com/activity/p/11919/ Tue, 05 May 2026 15:35:56 -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 b2432175f60bdff9189b216f7e166934 parryashford updated 'Livtencity®(maribavir) Tablets ': Livtencity®(maribavir) Tablets Annual Sales 20B […] https://paragraphfour.com/activity/p/11918/ Tue, 05 May 2026 15:14:23 -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 572853b67d4eb25b283d207dac3a0190 gregoryglass updated 'Invega Sustenna®(paliperidone) ER Inj Suspension ': Invega Sustenna®(paliperidone) Extended-release Injectable […] https://paragraphfour.com/activity/p/11917/ Tue, 05 May 2026 15:08:44 -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 8775a9aefe2e1c120cb56c3efe1ea953 gregoryglass updated 'Last Month’s Paragraph IV Highlights ': April 2026 https://paragraphfour.com/activity/p/11916/ Fri, 01 May 2026 16:59:31 -0400 April 2026

]]> 0 c8e547e83ea9f697dba6a7e94b1cce66 parryashford updated '268. March 2026 ': The Paragraph Four Report® Paragraph IV Activity for March […] https://paragraphfour.com/activity/p/11915/ Fri, 01 May 2026 16:59:07 -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

]]> 0 68960ba8e66dc01dde6b967a1aff3131 parryashford started the topic April 2026 in the forum Last Month's Paragraph IV Highlights https://paragraphfour.com/forums/topic/april-2026/ Fri, 01 May 2026 16:56:09 -0400 The Paragraph Four Report®
Paragraph IV Activity for April 2026

New Certifications as reported by FDA on April 12, 2026

1. Spinraza®(nusinersen) Intrathecal Solution 12 mg/5 mL on 3/10/2026
2. Austedo XR®(deutetrabenazine) Extended-release Tablets 6 mg, 12 mg, and 24 mg on 3/2/2026
3. Rinvoq LQ®(upadacitinib) Oral Solution 1 mg/mL on 3/2…Read more

]]> 389d7ae4f501e0a875281951f97cffc4 gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11913/ Fri, 01 May 2026 16:30:23 -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 6643344dfa8ce805f652d38551d2aba4 parryashford updated 'Jynarque®(tolvaptan) Tablets ': Jynarque®(tolvaptan) Tablets Annual Sales JPY 130.3B […] https://paragraphfour.com/activity/p/11912/ Fri, 01 May 2026 16:29:44 -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 0d8415dc22535276eb64a8e20dc4f7d3 parryashford updated 'Ryzumvi®(phentolamine) Ophthalmic Solution ': Ryzumvi®(phentolamine) Ophthalmic Solution Annual Sales C […] https://paragraphfour.com/activity/p/11911/ Fri, 01 May 2026 16:21:08 -0400 Ryzumvi®(phentolamine) Ophthalmic Solution
Annual Sales
Company OPUS GENETICS
Date of First Filing December 16, 2024

Paragraph IV Applicant: Sandoz
Case Name: OPUS GENETICS INC et al v. SANDOZ INC
Court/Case #: New Jersey District Court (njdc) 3:2025cv01895
Date Filed: 3/15/25
Judge: Quraishi
Product Strength: 0.75%
Litigated…Read more

]]> 0 589f4696d0dbd41fb5fb717aff86552f parryashford updated 'Zejula®(niraparib) Tablets ': Zejula®(niraparib) Tablets Annual Sales 305M GBP Company […] https://paragraphfour.com/activity/p/11910/ Fri, 01 May 2026 16:05:36 -0400 Zejula®(niraparib) Tablets
Annual Sales 305M GBP
Company GLAXOSMITHKLINE
Date of First Filing June 17, 2025

Paragraph IV Applicant: Sun
Case Name: GLAXOSMITHKLINE LLC et al v. SUN PHARMACEUTICAL INDUSTRIES LTD
Court/Case #: Delaware District Court (dedc) 1:2025cv01170
Date Filed: 9/18/25
Judge: Connolly
Product Strength: 100 mg,…Read more

]]> 0 c12a6e6ec5b2f7f24233c67c9651c5b8 parryashford updated 'Vyndamax®(tafamidis) and Vyndaqel® Capsules ': Vyndamax®(tafamidis) Capsules Vyndaqel®(tafamidis) C […] https://paragraphfour.com/activity/p/11909/ Fri, 01 May 2026 13:38:45 -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 12407934bb50ff8590c0b37ff9867321 parryashford updated 'Valtoco®(diazepam) Nasal Spray ': Valtoco®(diazepam) Nasal Spray Annual Sales Company NEUR […] https://paragraphfour.com/activity/p/11908/ Fri, 01 May 2026 13:14:40 -0400 Valtoco®(diazepam) Nasal Spray
Annual Sales
Company NEURELIS
Date of First Filing February 14, 2024 and April 3, 2025 (5 mg/spray and 7.5 mg/spray)

Paragraph IV Applicant: Padagis
Case Name: NEURELIS INC v. PADAGIS LLC et al
Court/Case #: Delaware District Court (dedc) 1:2024cv00562
Date Filed: 5/8/24
Judge: Noreika
Product…Read more

]]> 0 60b1f16711be12698d5f22041a91c522 parryashford updated 'Uptravi®(selexipag) Tablets ': Uptravi®(selexipag) Tablets Company ACTELION Sales: $1.3B […] https://paragraphfour.com/activity/p/11907/ Fri, 01 May 2026 13:12:19 -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 4f4240cb1e4564f9ff30dff924879fd4 parryashford updated 'Ubrelvy®(ubrogepant) Tablets ': Ubrelvy®(ubrogepant) Tablets Annual Sales $803M Company […] https://paragraphfour.com/activity/p/11906/ Fri, 01 May 2026 13:08:23 -0400 Ubrelvy®(ubrogepant) Tablets
Annual Sales $803M
Company ABBVIE
Date of First Filing December 26, 2023

Paragraph IV Applicant: Aurobindo
Case Name: ABBVIE INC et al v. AUROBINDO PHARM USA INC et al
Court/Case #: New Jersey District Court (njdc) 3:2024cv04403
Date Filed: 3/29/24
Judge: Choe-Groves
Product Strength: 50 mg and 100…Read more

]]> 0 04545ac17af357ef2fa72a544612b8f8 parryashford updated 'Sunosi®(solriamfetol) Tablets ': Sunosi®(solriamfetol) Tablets Annual Sales $90.3M Company […] https://paragraphfour.com/activity/p/11905/ Fri, 01 May 2026 12:52:54 -0400 Sunosi®(solriamfetol) Tablets
Annual Sales $90.3M
Company AXSOME
Date of First Filing June 20, 2023

Paragraph IV Applicant: Alkem
Paragraph IV Applicant: Aurobino
Paragraph IV Applicant: Hetero
Paragraph IV Applicant: Hikma
Paragraph IV Applicant: Sandoz
Paragraph IV Applicant: Unichem
Case Name: AXSOME MALTA LTD et al v.…Read more

]]> 0 21c16b0b81ca0262f7b88af0193310bf parryashford updated 'Suflave®(polyethylene glycol 3350 et al) For Oral Solution ': Suflave®(polyethylene glycol 3350 et al) For Oral Solution A […] https://paragraphfour.com/activity/p/11904/ Fri, 01 May 2026 12:49:11 -0400 Suflave®(polyethylene glycol 3350 et al) For Oral Solution
Annual Sales
Company BRAINTREE
Date of First Filing April 4, 2025

Paragraph IV Applicant: Lupin
Case Name: BRAINTREE LABORATORIES INC v. LUPIN LIMITED et al
Court/Case #: New Jersey District Court (njdc) 1:2025cv13133
Date Filed: 7/10/25
Judge: Choe-Groves
Product…Read more

]]> 0 df36511b6bccd0afbf7ed04435d694fc parryashford updated 'Radicava ORS®(edaravone) Oral Suspension ': Radicava ORS®(edaravone) Oral Suspension Annual Sales Com […] https://paragraphfour.com/activity/p/11903/ Fri, 01 May 2026 12:32:55 -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: Choe-Groves
Product Strength:…Read more

]]> 0 9d5e9799b6a067ae5ceb09744e85b510 parryashford updated 'Qelbree®(viloxazine) Extended-release Capsules ': Qelbree®(viloxazine) Extended-release Capsules Annual […] https://paragraphfour.com/activity/p/11902/ Fri, 01 May 2026 12:27:54 -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 8d27f121aeb2971a203b8806541e7b63 parryashford updated 'Pedmark®(sodium thiosulfate) Injection ': Pedmark®(sodium thiosulfate) Injection Annual Sales Comp […] https://paragraphfour.com/activity/p/11901/ Fri, 01 May 2026 12:22:12 -0400 Pedmark®(sodium thiosulfate) Injection
Annual Sales
Company FENNEC
Date of First Filing October 7, 2022

Paragraph IV Applicant: Cipla
Case Name: FENNEC PHARMACEUTICALS INC et al v. CIPLA LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2023cv00123
Date Filed: 1/10/23
Judge: Semper
Product Strength: 12.5 g/100…Read more

]]> 0 6ada29cb221ce544bee1bbe83e533fce gregoryglass updated 'OxyContin®(oxycodone) ER Tabs (NDA 22-272) Part 2 ': OxyContin®(oxycodone) Extended-release Tablet (NDA 22-272) […] https://paragraphfour.com/activity/p/11900/ Fri, 01 May 2026 12:18:03 -0400 OxyContin®(oxycodone) Extended-release Tablet (NDA 22-272) Part 2
Company PURDUE
Date of First Filing October 4, 2010 (40mg), October 18, 2010 (30, 60, and 90mg), October 25, 2010 (10mg), October 28, 2010 (15mg), and October 29, 2010 (20mg).

Editor’s Note This Product Topic covers the fifth set of cases filed on this product since 2001.…Read more

]]> 0 6f6ed6ec05737f7fd5b3186e2c51cef1 gregoryglass updated 'Xarelto®(rivaroxaban) Tablets ': Xarelto®(rivaroxaban) Tablets Annual Sales $2.36B (as […] https://paragraphfour.com/activity/p/11899/ Thu, 30 Apr 2026 22:12:48 -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 6a26bb4dcdcf1a0747ae9575d0e2de33 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/11898/ Thu, 30 Apr 2026 21:39:00 -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 2b8ad0297d02e194b62fb7ebcf4f868a parryashford updated 'Lynparza®(olaparib) Tablets ': Lynparza®(olaparib) Tablets Annual Sales $1.33B Company […] https://paragraphfour.com/activity/p/11897/ Thu, 30 Apr 2026 21:31:59 -0400 Lynparza®(olaparib) Tablets
Annual Sales $1.33B
Company ASTRAZENECA
Date of First Filing November 1, 2022

Paragraph IV Applicant: Natco
Case Name: ASTRAZENECA PHARMACEUTICALS LP et al v. NATCO PHARMA LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2023cv00796
Date Filed: 2/10/23
Judge: Kirsch
Product Strength: 100…Read more

]]> 0 357eefdd84baf7727371c93db917a6fb parryashford updated 'Lonsurf®(trifluridine and tipiracil) Tablets ': Lonsurf®(trifluridine and tipiracil) Tablets Annual Sales […] https://paragraphfour.com/activity/p/11896/ Thu, 30 Apr 2026 21:24:00 -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 d43c75302d13e6b8767a5dbf2020cee1 parryashford updated 'Livmarli®(maralixibat) Oral Solution ': Livmarli®(maralixibat) Oral Solution Annual Sales Company […] https://paragraphfour.com/activity/p/11895/ Thu, 30 Apr 2026 21:17:48 -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 750eb53ec4ec8a71881acb0090739af6 parryashford updated 'Korsuva®(difelikefalin) Intravenous Solution ': Korsuva®(difelikefalin) Intravenous Solution Annual Sales […] https://paragraphfour.com/activity/p/11894/ Thu, 30 Apr 2026 21:12:19 -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 95a9d21ff078fe795dc5a1c65eb656a7 parryashford updated 'Katerzia®(amlodipine) Oral Suspension ': Katerzia®(amlodipine) Oral Suspension Company AZURITY Dat […] https://paragraphfour.com/activity/p/11893/ Thu, 30 Apr 2026 21:09:37 -0400 Katerzia®(amlodipine) Oral Suspension
Company AZURITY
Date of First Filing December 29, 2020

Paragraph IV Applicant: Amneal
Case Name: AZURITY PHARMACEUTICALS INC v. AMNEAL PHARMACEUTICALS LLC
Court/Case #: New Jersey District Court (njdc) 3:2021cv08717
Date Filed: 4/8/2021
Judge: Bumb
Product Strength: 1 mg/mL
Litigated Patents…Read more

]]> 0 cbc7015de52a56ce99216d3f37c76188 gregoryglass updated 'Jakafi®(ruxolitinib) Tablets ': Jakafi®(ruxolitinib) Tablets Annual Sales $2.79B Company […] https://paragraphfour.com/activity/p/11892/ Thu, 30 Apr 2026 21:04:32 -0400 Jakafi®(ruxolitinib) Tablets
Annual Sales $2.79B
Company INCYTE
Date of First Filing December 17, 2015

Special Note: After this product received its first PIV Notice in 2015, Incyte did not file any PIV cases until 2024 when a case against Apotex. We had placed this product as a “No Litigation Pending” product, and we keep that entry…Read more

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