ParagraphFour.com | parryashford | Activity https://paragraphfour.com/members/parryashford/activity/ Activity feed for parryashford. Wed, 13 May 2026 19:25:53 -0400 https://buddypress.org/?v= en-US 30 hourly 2 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 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 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

]]> 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 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 a13227d924bf1c9faa45911542a9117e parryashford updated 'Hetlioz LQ®(tasimelteon) Oral Suspension ': Hetlioz LQ®(tasimelteon) Oral Suspension Annual Sales $76.7 […] https://paragraphfour.com/activity/p/11890/ Thu, 30 Apr 2026 20:11:57 -0400 Hetlioz LQ®(tasimelteon) Oral Suspension
Annual Sales $76.7M (product family)
Company VANDA PHARMACEUTICALS
Date of First Filing April 1, 2024

Paragraph IV Applicant: MSN Laboratories
Case Name: VANDA PHARMACEUTICALS INC v. MSN PHARMACEUTICALS INC et al
Court/Case #: Delaware District Court (dedc) 1:2024cv00815
Date Filed:…Read more

]]> 0 5f9bad476ea3c292af76f1a19d2829d0 parryashford updated 'Evrysdi®(risdiplam) For Oral Solution ': Evrysdi®(risdiplam) For Oral Solution Annual Sales Compan […] https://paragraphfour.com/activity/p/11888/ Thu, 30 Apr 2026 20:00:30 -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 3cc42b97b4732a95e8b471d3c86e0c96 parryashford updated 'Crexont®(carbidopa and levodopa) Extended-release Capsules ': Crexont®(carbidopa and levodopa) Extended-release Capsules A […] https://paragraphfour.com/activity/p/11887/ Thu, 30 Apr 2026 19:02:22 -0400 Crexont®(carbidopa and levodopa) Extended-release Capsules
Annual Sales
Company AMNEAL
Date of First Filing September 23, 2024

Paragraph IV Applicant: Sandoz
Case Name: AMNEAL PHARMACEUTICALS LLC et al v. SANDOZ INC
Court/Case #: New Jersey District Court (njdc) 3:2025cv00181
Date Filed: 1/7/25
Judge: Choe-Groves
Product…Read more

]]> 0 e6ed5444238267bd61f7dd4104ada55b parryashford updated 'Caplyta®(lumateperone) Capsules ': Caplyta®(lumateperone) Capsules Annual Sales $462M Company […] https://paragraphfour.com/activity/p/11886/ Thu, 30 Apr 2026 18:55:24 -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 d79ec27ccd9b1a20d84878efbd9bf16b parryashford updated 'Byfavo®(remimazolam) Powder for Injection ': Byfavo®(remimazolam) Powder for Injection Annual Sales Co […] https://paragraphfour.com/activity/p/11885/ Thu, 30 Apr 2026 18:47:46 -0400 Byfavo®(remimazolam) Powder for Injection
Annual Sales
Company ACACIA
Date of First Filing October 7, 2024

Paragraph IV Applicant: Galencium
Case Name: ACACIA PHARMA LIMITED et al v. GALENCIUM HEALTH SLU
Court/Case #: Delaware District Court (dedc) 1:2025cv00010
Date Filed: 1/3/25
Judge:
Product Strength: 20 mg/vial
Litigated…Read more

]]> 0 7074d35bea062b8cc318d79ad4c98087 parryashford updated 'Cabometyx®(cabozantinib) Tablets ': Cabometyx®(cabozantinib) Tablets Annual Sales $1.8B […] https://paragraphfour.com/activity/p/11884/ Thu, 30 Apr 2026 18:42:33 -0400 Cabometyx®(cabozantinib) Tablets
Annual Sales $1.8B
Company EXELIXIS
Date of First Filing August 16, 2019

Paragraph IV Applicant: MSN Laboratories
Case Name: EXELIXIS, INC v. MSN LABORATORIES PRIVATE LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2019cv02017
Date Filed: 10/29/19
Judge: Andrews
Product Strength:…Read more

]]> 0 6579f4fdc016670e5f8997579b936adb parryashford updated 'Breo Ellipta®(fluticasone and vilanterol) Inhalation ': Breo Ellipta®(fluticasone and vilanterol) Inhalation Annual […] https://paragraphfour.com/activity/p/11883/ Thu, 30 Apr 2026 18:39:07 -0400 Breo Ellipta®(fluticasone and vilanterol) Inhalation
Annual Sales 436M GBP
Company GLAXOSMITHKLINE
Date of First Filing June 16, 2025

Paragraph IV Applicant: Transpire
Case Name: GLAXO GROUP LIMITED et al v. TRANSPIRE BIO INC
Court/Case #: Florida Southern District Court (flsdc) 0:2025cv61939
Date Filed: 9/25/25
Judge: Damian
Produ…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 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

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