ParagraphFour.com | Site-Wide Activity https://paragraphfour.com/activity/ Activity feed for the entire site. Sat, 13 Jun 2026 13:15:49 -0400 https://buddypress.org/?v= en-US 30 hourly 2 31193bba9d78e080efa1416f98f9e470 gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/12017/ Thu, 11 Jun 2026 16:01:59 -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)

ABBVIE…Read more

]]> 0 cdd585cfa55305c8ffb6f08a52f10016 gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/12016/ Thu, 11 Jun 2026 16:01:19 -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 79e446df097a7fc9efc1d5d8bd7135e5 parryashford started the topic Rinvoq LQ®(upadacitinib) Oral Solution in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/rinvoq-lqupadacitinib-oral-solution/ Thu, 11 Jun 2026 16:00:33 -0400 Rinvoq LQ®(upadacitinib) Oral Solution
Annual Sales
Company ABBVIE
Date of First Filing March 2, 2026

Paragraph IV Applicant: MSN Laboratories
Case Name: ABBVIE INC v. MSN PHARMACEUTICALS INC et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00680
Date Filed: 6/10/26
Judge:
Product Strength: 1 mg/mL
Litigated Patents…Read more

]]> 4e4a6ed42b2e9cfccfff13a111f71366 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/12014/ Thu, 11 Jun 2026 13:31:11 -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 d1b11c6250b26a01bcb8bfe6b9806be2 parryashford updated 'Opzelura®(ruxolitinib) Cream ': Opzelura®(ruxolitinib) Cream Annual Sales $508M Company […] https://paragraphfour.com/activity/p/12013/ Thu, 11 Jun 2026 13:28:52 -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 c06e6bca7228ab6f5b90f5476d15111e parryashford updated 'Evrysdi®(risdiplam) Tablets ': Evrysdi®(risdiplam) Tablets Annual Sales Company GENENTE […] https://paragraphfour.com/activity/p/12012/ Wed, 10 Jun 2026 19:37:56 -0400 Evrysdi®(risdiplam) Tablets
Annual Sales
Company GENENTECH
Date of First Filing February 17, 2026

Paragraph IV Applicant: Zenara
Case Name: GENENTECH INC et al v. ZENARA PHARMA PRIVATE LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2026cv06555
Date Filed: 6/4/26
Judge: Choe-Groves
Product Strength: 5…Read more

]]> 0 0c4c4c45903d4ce46c76e33304e22376 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/12011/ Tue, 09 Jun 2026 21:49:24 -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 a2fa85a28ae3ca3bad92ae81c37a45c5 gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/12010/ Tue, 09 Jun 2026 21:48:44 -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 c33797a18f787365c9b4abb664329f83 parryashford started the topic Austedo XR®(deutetrabenazine) Extended-release Tablets in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/austedo-xrdeutetrabenazine-extended-release-tablets/ Tue, 09 Jun 2026 21:36:58 -0400 Austedo XR®(deutetrabenazine) Extended-release Tablets
Annual Sales
Company TEVA
Date of First Filing March 2, 2026

Paragraph IV Applicant: Alkem
Case Name: TEVA NEUROSCIENCE INC et al v. ALKEM LABORATORIES LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2026cv06612
Date Filed: 6/5/26
Judge: Padin
Product…Read more

]]> 46bed6b353465ab6b7e4691631ebec97 parryashford updated 'Radicava ORS®(edaravone) Oral Suspension ': Radicava ORS®(edaravone) Oral Suspension Annual Sales Com […] https://paragraphfour.com/activity/p/12008/ Tue, 09 Jun 2026 21:20:48 -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 ca3be7865f8dc763c581b59b40cece5e gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/12007/ Tue, 09 Jun 2026 20:46:42 -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 852506e906ccec7d59221bd07c1b1ef5 parryashford updated 'Recorlev®(levoketoconazole) Tablets ': Recorlev®(levoketoconazole) Tablets Annual Sales $64.3M Co […] https://paragraphfour.com/activity/p/12006/ Tue, 09 Jun 2026 20:45:38 -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 dca501182da09623f477dd7e88d71d95 parryashford updated 'Opzelura®(ruxolitinib) Cream ': Opzelura®(ruxolitinib) Cream Annual Sales $508M Company […] https://paragraphfour.com/activity/p/12005/ Tue, 09 Jun 2026 20:12:16 -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 dc6ad2bd0e9a23152e9ee094bfd6a142 gregoryglass updated 'Generic Companies Report #3 (Q-Z) ': The Paragraph Four Report ® Generic Companies Report #3 […] https://paragraphfour.com/activity/p/12004/ Tue, 09 Jun 2026 19:51:34 -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 17089babfd0e118d0fa2a771b0b0bb43 parryashford updated 'Evrysdi®(risdiplam) For Oral Solution ': Evrysdi®(risdiplam) For Oral Solution Annual Sales Compan […] https://paragraphfour.com/activity/p/12003/ Tue, 09 Jun 2026 19:50:24 -0400 Evrysdi®(risdiplam) For Oral Solution
Annual Sales
Company GENENTECH
Date of First Filing August 7, 2024

Paragraph IV Applicant: Natco
Paragraph IV Applicant: Zydus
Case Name: GENENTECH INC et al v. NATCO PHARMA LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2024cv10567
Date Filed: 11/18/24
Judge: Choe-Groves
Prod…Read more

]]> 0 22fa677a3fa2dff3404ab28c1f8c0f2a parryashford started the topic Evrysdi®(risdiplam) Tablets in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/evrysdirisdiplam-tablets/ Tue, 09 Jun 2026 19:49:23 -0400 Evrysdi®(risdiplam) Tablets
Annual Sales
Company GENENTECH
Date of First Filing February 17, 2026

Paragraph IV Applicant: Zenara
Case Name: GENENTECH INC et al v. ZENARA PHARMA PRIVATE LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2026cv06555
Date Filed: 6/4/26
Judge: Choe-Groves
Product Strength: 5…Read more

]]> cfd3291a0d822bf3f79263ac2715f4ec gregoryglass updated 'Branded Companies Report ': The Paragraph Four Report ® Branded Companies […] https://paragraphfour.com/activity/p/12001/ Tue, 09 Jun 2026 19:33:36 -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 3ffa996bb400fe52913d4d238519ef23 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/12000/ Tue, 09 Jun 2026 19:32:58 -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 0cc636cfb65c6a3b5bd0ed0b3c339a0e parryashford started the topic Wegovy®(semaglutide) Tablets in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/wegovysemaglutide-tablets/ Tue, 09 Jun 2026 19:31:58 -0400 Wegovy®(semaglutide) Tablets
Annual Sales 6.1B DKK (product family)
Company NOVO NORDISK
Date of First Filing March 11, 2026

Paragraph IV Applicant: Apotex
Case Name: NOVO NORDISK INC et al v. APOTEX INC
Court/Case #: New Jersey District Court (njdc) 1:2026cv06553
Date Filed: 6/4/26
Judge: Bumb
Product Strength: 1.5 mg, 4 mg, and…Read more

]]> 6f3409f8213b238bf9d98116fcb6b09d gregoryglass updated 'Paragraph IV Appellate Judges (Schall – Wallach) ': The Paragraph Four Report® The Appellate Judges (Schall - […] https://paragraphfour.com/activity/p/11998/ Tue, 09 Jun 2026 18:56:29 -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 211129415e0305e8765130cd3bde564b gregoryglass updated 'Paragraph IV Appellate Judges (Bryson-Hughes) ': The Paragraph Four Report® The Appellate Judges (Bryson - […] https://paragraphfour.com/activity/p/11997/ Tue, 09 Jun 2026 18:55:59 -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 6dfaec614e39843304a3a6bf95c12460 gregoryglass updated 'Court of Appeals Decisions – by Case Name ': The Paragraph Four Report® Court of Appeals Opinions by […] https://paragraphfour.com/activity/p/11996/ Tue, 09 Jun 2026 18:53:10 -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 c74d83d2280bc01ca2058c386449827e gregoryglass updated 'OxyContin®(oxycodone) ER Tabs (NDA 22-272) Part 2 ': OxyContin®(oxycodone) Extended-release Tablet (NDA 22-272) […] https://paragraphfour.com/activity/p/11995/ Tue, 09 Jun 2026 18:50:47 -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 43f3bcad6872c5d9643dcc121e7ea5ff gregoryglass updated 'Paragraph IV Appellate Judges (Prost – Reyna) ': The Paragraph Four Report® The Appellate Judges (Prost - […] https://paragraphfour.com/activity/p/11994/ Mon, 08 Jun 2026 12:31:57 -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 7095b8870868b5d6079a5597285f486d gregoryglass updated 'Paragraph IV Appellate Judges (Bryson-Hughes) ': The Paragraph Four Report® The Appellate Judges (Bryson - […] https://paragraphfour.com/activity/p/11993/ Mon, 08 Jun 2026 12:30:50 -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 2cab1e033cd04ab6fff1a6929efd7e46 gregoryglass updated 'Court of Appeals Decisions – by Case Name ': The Paragraph Four Report® Court of Appeals Opinions by […] https://paragraphfour.com/activity/p/11992/ Mon, 08 Jun 2026 12:28:32 -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 51d901b7e27f9cbc9452c98285ce8014 parryashford updated 'Minocin®(minocycline) Injection ': Minocin®(minocycline) Injection Annual Sales Company MEL […] https://paragraphfour.com/activity/p/11991/ Mon, 08 Jun 2026 12:23:48 -0400 Minocin®(minocycline) Injection
Annual Sales
Company MELINTA
Date of First Filing October 16, 2020

Paragraph IV Applicant: Nexus
Case Name: MELINTA THERAPEUTICS LLC et al v. NEXUS PHARMACEUTICALS
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1281
Date Filed: 12/13/24
Judge: Prost, Bryson,
Product…Read more

]]> 0 1fc7c2d602cdd3fca8473423c06d49c0 gregoryglass updated 'Last Month’s Paragraph IV Highlights ': May 2026 https://paragraphfour.com/activity/p/11989/ Sun, 31 May 2026 11:58:31 -0400 May 2026

]]> 0 21d3de0c4cb40b05df5afad3f6085d45 parryashford updated 'April 2026 ': The Paragraph Four Report® Paragraph IV Activity for April […] https://paragraphfour.com/activity/p/11988/ Sun, 31 May 2026 11:57:41 -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

]]> 0 37ec83a3f97b95a7b4a4a7874972d45f parryashford started the topic May 2026 in the forum Last Month's Paragraph IV Highlights https://paragraphfour.com/forums/topic/may-2026/ Sun, 31 May 2026 11:56:47 -0400 The Paragraph Four Report®
Paragraph IV Activity for May 2026

New Certifications as reported by FDA on May 11, 2026

1. Prevymis®(letermovir) Intravenous Solution 240 mg/12 mL and 480 mg/24 mL on 3/26/2026
2. Verzenio®(ademaciclib) Tablets 50 mg, 100 mg, 150 mg, and 200 mg on 3/23/2026
3. Trelegy Ellipta®(fluticasone, umeclidinium, vil…Read more

]]> eb2fae9962217b9889f8e33e818a8805 gregoryglass updated 'Generic Companies Report #1 (A-E) ': The Paragraph Four Report ® Generic Companies Report #1 […] https://paragraphfour.com/activity/p/11986/ Sat, 30 May 2026 20:20:31 -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 f585db10ef52b811c28d3bd3d6517913 gregoryglass updated 'Inlyta®(axitinib) Tablets ': Inlyta®(axitinib) Tablets Company PFIZER Date of First […] https://paragraphfour.com/activity/p/11985/ Sat, 30 May 2026 20:19:21 -0400 Inlyta®(axitinib) Tablets
Company PFIZER
Date of First Filing February 23, 2018

Paragraph IV Applicant: Apotex
Case Name: PFIZER INC et al v. APOTEX INC et al
Court/Case #: Delaware District Court (dedc) 1:2018cv00795
Date Filed: 5/25/18
Judge: Andrews
Product Strength: 1 mg and 5 mg
Litigated Patents (expiration): 8,791,140…Read more

]]> 0 eb672c9b43f9e5492334a93e3be56540 gregoryglass updated 'Representation List (Branded) ': The Paragraph Four Report® Representation List (Branded […] https://paragraphfour.com/activity/p/11984/ Sat, 30 May 2026 20:05:50 -0400 The Paragraph Four Report®
Representation List (Branded Companies)

In March 2019, we reconstructed this section. The original section covered all law firms representing brand companies in PIV cases filed since 2003. The original list of branded companies with represented law firms is in this pdf file, if you need it for reference:
Legacy…Read more

]]> 0 9c36ae98e03e66835d7a7c695d9a197a gregoryglass updated 'Generic Companies Report #2 (F-P) ': The Paragraph Four Report ® Generic Companies Report #2 […] https://paragraphfour.com/activity/p/11983/ Sat, 30 May 2026 20:03:00 -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 a221f330968824cd9496663a307f236e parryashford updated 'Pyrukynd®(mitapivat) Tablets ': Pyrukynd®(mitapivat) Tablets Annual Sales Company AGIOS […] https://paragraphfour.com/activity/p/11982/ Sat, 30 May 2026 20:02:26 -0400 Pyrukynd®(mitapivat) Tablets
Annual Sales
Company AGIOS
Date of First Filing February 17, 2026

Paragraph IV Applicant: Hetero
Case Name: AGIOS PHARMACEUTICALS INC v. ANNORA PHARMA PRIVATE LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00603
Date Filed: 5/26/26
Judge:
Product Strength: 5 mg, 20 mg, 50…Read more

]]> 0 38e95ed972e0ee75b60a7e4dad16a7c2 parryashford updated 'Wegovy®(semaglutide) Injection ': Wegovy®(semaglutide) Injection Annual Sales 6.1B […] https://paragraphfour.com/activity/p/11981/ Sat, 30 May 2026 19:43:14 -0400 Wegovy®(semaglutide) Injection
Annual Sales 6.1B DKK
Company NOVO NORDISK
Date of First Filing October 20, 2022

Paragraph IV Applicant: Viatris
Case Name: NOVO NORDISK INC et al v. VIATRIS INC et al
Court/Case #: Delaware District Court (dedc) 1:2023cv00101
Date Filed: 1/27/23
Judge: Connolly
Product Strength: 0.25mg/0.5mL,…Read more

]]> 0 126eb7cc1a8b9787ba4ce18f62061989 parryashford updated 'Vyndamax®(tafamidis) and Vyndaqel® Capsules ': Vyndamax®(tafamidis) Capsules Vyndaqel®(tafamidis) C […] https://paragraphfour.com/activity/p/11980/ Sat, 30 May 2026 19:38:30 -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 1b460fd04d0eab1e510f907c800594f1 parryashford updated 'Sodium Thiosulfate Intravenous Injection ': Sodium Thiosulfate Intravenous Injection Annual Sales Comp […] https://paragraphfour.com/activity/p/11979/ Sat, 30 May 2026 19:30:14 -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 6bb833066fcdc8caf6e9c61076cf7d05 parryashford updated 'Korsuva®(difelikefalin) Intravenous Solution ': Korsuva®(difelikefalin) Intravenous Solution Annual Sales […] https://paragraphfour.com/activity/p/11978/ Sat, 30 May 2026 19:16:58 -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 d64be3b054a7911163e74a9af68fd297 parryashford updated 'Emrosi®(minocycline) Extended-release Capsules ': Emrosi®(minocycline) Extended-release Capsules Annual […] https://paragraphfour.com/activity/p/11977/ Sat, 30 May 2026 18:57:26 -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 caa04be7cb7675861b6c9a8f17f12355 gregoryglass updated 'Eliquis®(apixaban) Tablets ': Eliquis®(apixaban) Tablets Company BRISTOL-MYERS Date of […] https://paragraphfour.com/activity/p/11976/ Sat, 30 May 2026 18:55:52 -0400 Eliquis®(apixaban) Tablets
Company BRISTOL-MYERS
Date of First Filing December 28, 2016

Special Note 1: On 4/5/17, Bristol-Myers filed PIV cases against 9 ANDA filers and on 4/10/17, PIV cases against 15 ANDA filers. All of these 24 cases were filed in Delaware and involve the 2.5mg and 5mg strengths. Please also see Special Note 2 below…Read more

]]> 0 a96574ec89d0c7ef531c537ba95ffd1b parryashford updated 'Edarbyclor®(azilsartan and chlorthalidone) Tablets ': Edarbyclor®(azilsartan and chlorthalidone) Tablets Company […] https://paragraphfour.com/activity/p/11975/ Sat, 30 May 2026 18:53:55 -0400 Edarbyclor®(azilsartan and chlorthalidone) Tablets
Company ARBOR PHARMACEUTICALS
Date of First Filing April 19, 2022

Paragraph IV Applicant: Alkem
Case Name: AZURITY PHARMACEUTICALS INC et al ALKEM LABORATORIES LTD
Court/Case #: Delaware District Court (dedc) 1:2022cv00940
Date Filed: 7/15/22
Judge: Noreika
Product Strength:…Read more

]]> 0 60651baafc7aa13e93ca3c93262537bb parryashford updated 'Calcium Gluconate in Sodium Chloride Solution ': Calcium Gluconate in Sodium Chloride Solution Annual Sales […] https://paragraphfour.com/activity/p/11974/ Sat, 30 May 2026 18:47:24 -0400 Calcium Gluconate in Sodium Chloride Solution
Annual Sales
Company HQ SPECIALTY PHARMA
Date of First Filing August 26, 2025

Paragraph IV Applicant: Sagent
Case Name: HQ SPECIALTY PHARMA CORP et al v. SAGENT PHARMACEUTICALS
Court/Case #: Delaware District Court (dedc) 1:2025cv01227
Date Filed: 10/3/25
Judge: Noreika
Product…Read more

]]> 0 47316e27b871e5b52b0b88342f2ab6b3 gregoryglass updated 'Belrapzo®(bendamustine) Injection ': Belrapzo®(bendamustine) Injection Company EAGLE Date of […] https://paragraphfour.com/activity/p/11973/ Sat, 30 May 2026 18:43:05 -0400 Belrapzo®(bendamustine) Injection
Company EAGLE
Date of First Filing Not applicable/reported by FDA

Paragraph IV Applicant: Slayback
Case Name: EAGLE PHARMACEUICALS INC v. SLAYBACK PHARMA LLC
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 19-1924
Date Filed: 5/24/19
Judge: O’Malley, Reyna, Chen
Product Strength:…Read more

]]> 0 6a62c8f37acc4418afb963b688db2b4b parryashford updated 'Opzelura®(ruxolitinib) Cream ': Opzelura®(ruxolitinib) Cream Annual Sales $508M Company […] https://paragraphfour.com/activity/p/11972/ Sat, 30 May 2026 14:56:31 -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 cd871295e276bef3169f4c1ebdf8ec67 parryashford updated 'Radicava ORS®(edaravone) Oral Suspension ': Radicava ORS®(edaravone) Oral Suspension Annual Sales Com […] https://paragraphfour.com/activity/p/11971/ Sat, 30 May 2026 14:47:45 -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 b166ca62ff94dbb2f0e97772d2150bc0 parryashford updated 'Zejula®(niraparib) Tablets ': Zejula®(niraparib) Tablets Annual Sales 305M GBP Company […] https://paragraphfour.com/activity/p/11970/ Sat, 30 May 2026 14:17:28 -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 7154c75de42454659793282fca894cd7 parryashford updated 'Qelbree®(viloxazine) Extended-release Capsules ': Qelbree®(viloxazine) Extended-release Capsules Annual […] https://paragraphfour.com/activity/p/11969/ Sat, 30 May 2026 13:59:32 -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 06e941485a318784cdb94de710e2d344 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/11968/ Sat, 30 May 2026 13:41:27 -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 d7abab74b2b9778350ce41a8c9bf2bb5 parryashford updated 'Likmez®(metronidazole) Oral Suspension ': Likmez®(metronidazole) Oral Suspension Annual Sales Comp […] https://paragraphfour.com/activity/p/11967/ Sat, 30 May 2026 13:35:38 -0400 Likmez®(metronidazole) Oral Suspension
Annual Sales
Company SAPTALIS
Date of First Filing November 13, 2025

Paragraph IV Applicant: MSN Laboratories
Case Name: SAPTALIS PHARMACEUTICALS LLC et al v. MSN PHARMACEUTICALS INC et al
Court/Case #: New Jersey District Court (njdc) 2:2026cv01084
Date Filed: 2/3/26
Judge: Padin
Product…Read more

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