ParagraphFour.com | parryashford | Activity https://paragraphfour.com/members/parryashford/activity/ Activity feed for parryashford. Fri, 17 Apr 2026 22:15:40 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b655d7a29caf953e45fa872d86da621f parryashford updated 'Nayzilam®(midazolam) Nasal Spray ': Nayzilam®(midazolam) Nasal Spray Annual Sales 124M […] https://paragraphfour.com/activity/p/11838/ Fri, 17 Apr 2026 17:33:56 -0400 Nayzilam®(midazolam) Nasal Spray
Annual Sales 124M EUR
Company UCB
Date of First Filing June 1, 2021

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

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

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

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

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

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

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

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

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

]]> 0 e9c895ba3d4fa4b22aec975167897395 parryashford updated 'Reyvow®(lasmiditan) Tablets ': Reyvow®(lasmiditan) Tablets Annual Sales Company ELI […] https://paragraphfour.com/activity/p/11830/ Tue, 14 Apr 2026 14:26:04 -0400 Reyvow®(lasmiditan) Tablets
Annual Sales
Company ELI LILLY
Date of First Filing January 31, 2024

Paragraph IV Applicant: Qilu
Case Name: ELI LILLY & COMPANY et al v. QILU PHARMACEUTICAL CO LTD et al
Court/Case #: New Jersey District Court (njdc) 2:2024cv05847
Date Filed: 5/3/24
Judge: Wigenton
Product Strength: 50 mg and 100…Read more

]]> 0 f52d31eb0cab0b8fa8c981530bd4dc97 parryashford updated 'Trulance®(plecanatide) Tablets ': Trulance®(plecanatide) Tablets Annual Sales Company BAUS […] https://paragraphfour.com/activity/p/11829/ Tue, 14 Apr 2026 14:16:36 -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 2ccd26c934e0e84b7c17890989fe5ba8 parryashford updated 'Januvia®(sitaglpitin) Oral Solution ': Januvia®(sitaglpitin) Oral Solution Company MERCK Date […] https://paragraphfour.com/activity/p/11827/ Mon, 13 Apr 2026 14:53:41 -0400 Januvia®(sitaglpitin) Oral Solution
Company MERCK
Date of First Filing Not applicable

Special Note: In May 2024, the case below appeared. It stems from a 505(b)(2) NDA filing Azuirty filed over an oral solution form of sitagliptin). Merck does not make an oral solution form yet filed the suit after it received a PIV Notice letter and to…Read more

]]> 0 7022e349ded17fff2098af16a498cbab parryashford updated 'Trijardy XR®(empagliflozin, linagliptan and metformin) Extended-release Tablets ': Trijardy XR®(empagliflozin, linagliptan and metformin) […] https://paragraphfour.com/activity/p/11824/ Mon, 13 Apr 2026 14:49:21 -0400 Trijardy XR®(empagliflozin, linagliptan and metformin) Extended-release Tablets
Company BOEHRINGER INGELHEIM
Date of First Filing May 26, 2020

On April 13, 2026, we moved this Product Topic into the Old Cases Forum. All of the cases settled except for, perhaps, Lupin. The Lupin case was consolidated to the Sun case and has not seen a Lupin…Read more

]]> 0 349197713b09a9ef0488c9173c724159 parryashford updated 'Zonisade®(zonisamide) Oral Suspension ': Zonisade®(zonisamide) Oral Suspension Annual Sales Compan […] https://paragraphfour.com/activity/p/11815/ Sat, 11 Apr 2026 11:32:58 -0400 Zonisade®(zonisamide) Oral Suspension
Annual Sales
Company AZURITY
Date of First Filing February 4, 2025

Paragraph IV Applicant: Alkem
Case Name: AZURITY PHARMACEUTICALS INC v. ALKEM LABORATORIES LIMITED
Court/Case #: Delaware District Court (dedc) 1:2025cv00563
Date Filed: 5/7/25
Judge: Williams
Product Strength: 100 mg/5…Read more

]]> 0 70c28f3d867fa5e2ccc42733eb5bc303 parryashford updated 'Valtoco®(diazepam) Nasal Spray ': Valtoco®(diazepam) Nasal Spray Annual Sales Company NEUR […] https://paragraphfour.com/activity/p/11814/ Sat, 11 Apr 2026 11:29:28 -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 c82a96e57c37c8f43cc1441f919be2a0 parryashford updated 'Slynd®(dropirenone) Tablets ': Slynd®(dropirenone) Tablets Company EXELTIS Date of […] https://paragraphfour.com/activity/p/11812/ Thu, 09 Apr 2026 14:58:39 -0400 Slynd®(dropirenone) Tablets
Company EXELTIS
Date of First Filing January 7, 2022

Paragraph IV Applicant: Lupin
Case Name: EXELTIS USA INC et al v. LUPIN LTD et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1239
Date Filed:
Judge:
Product Strength: 4 mg
Litigated Patents (expiration): 9,603,860…Read more

]]> 0 44a59026df98fd49e7474fbc4059f3f9 parryashford updated 'Perjeta®(pertuzumab) Injection ': Perjeta®(pertuzumab) Injection Company GENENTECH Date of […] https://paragraphfour.com/activity/p/11810/ Thu, 09 Apr 2026 14:50:14 -0400 Perjeta®(pertuzumab) Injection
Company GENENTECH
Date of First Filing aBLA – not applicable

Paragraph IV Applicant: Shanghai Henlius
Case Name: GENENTECH INC et al v. SHANGHAI HENLIUS BIOTECH INC et al
Court/Case #: New Jersey District Court (njdc) 2:2025cv14648
Date Filed: 8/14/25
Judge: Cecchi
Product Strength: 420 mg/14…Read more

]]> 0 f01e3fc6c85cb2ab47c84e50587c34b6 parryashford updated 'Mayzent®(siponimod) Tablets ': Mayzent®(siponimod) Tablets Company NOVARTIS Date of […] https://paragraphfour.com/activity/p/11809/ Thu, 09 Apr 2026 14:44:43 -0400 Mayzent®(siponimod) Tablets
Company NOVARTIS
Date of First Filing March 27, 2023

Paragraph IV Applicant: Cipla
Case Name: NOVARTIS PHARMACEUTICALS CORPORATION et al v. CIPLA LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2025cv00186
Date Filed: 2/14/25
Judge: Murphy
Product Strength: 0.25 mg, 1 mg, and 2 mg
Litigated…Read more

]]> 0 39bd6b1344d59fcdac946d0a5c88f4e0 parryashford updated 'Hemangeol®(proponalol) Oral Solution ': Hemangeol®(proponalol) Oral Solution Company PIERRE […] https://paragraphfour.com/activity/p/11807/ Thu, 09 Apr 2026 14:37:52 -0400 Hemangeol®(proponalol) Oral Solution
Company PIERRE FABRE
Date of First Filing July 21, 2022

Paragraph IV Applicant: Annora
Case Name: PIERRE FABRE DERMATOLOGIE et al v. ANNORA PHARMA PRIVATE LIMITED
Court/Case #: Delaware District Court (dedc) 1:2022cv01442
Date Filed: 11/2/22
Judge: Hall
Product Strength: 4.28 mg/mL
Litigated…Read more

]]> 0 0e7c7f701dcaabf9d611c039303d3a36 parryashford updated 'Galafold®(migalastat) Capsules ': Galafold®(migalastat) Capsules Company AMICUS Date of […] https://paragraphfour.com/activity/p/11803/ Thu, 09 Apr 2026 14:33:35 -0400 Galafold®(migalastat) Capsules
Company AMICUS
Date of First Filing August 10, 2022

Paragraph IV Applicant: Teva
Case Name: AMICUS THERAPEUTICS US LLC et al v. TEVA PHARMACEUTICALS USA INC et al
Court/Case #: Delaware District Court (dedc) 1:2022cv01461
Date Filed: 11/7/22
Judge: Connolly
Product Strength: 123 mg
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 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 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 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 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 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 70a59705ee3426ee444d77b4aa687ad3 parryashford started the topic Motpoly XR®(lacosamide) Extended-release Capsules in the forum The Paragraph IV Products https://paragraphfour.com/forums/topic/motpoly-xrlacosamide-extended-release-capsules/ Tue, 24 Mar 2026 15:33:59 -0400 Motpoly XR®(lacosamide) Extended-release Capsules
Annual Sales
Company SHANGHAI AUCTA
Date of First Filing December 29, 2025 (200mg) and February 10, 2026 (100mg and 150mg)

Paragraph IV Applicant: Zydus
Case Name: SHANGHAI AUCTA PHARMACEUTICALS CO LTD et al v. ZYDUS PHARMACEUTICALS (USA) INC et al
Court/Case #: New Jersey District…Read more

]]> d52e02bbf90432c7fa46ef8f35ce54f0 parryashford updated 'Kalydeco®(ivacaftor) Tablets ': Kalydeco®(ivacaftor) Tablets Company VERTEX Date of […] https://paragraphfour.com/activity/p/11745/ Tue, 24 Mar 2026 15:13:24 -0400 Kalydeco®(ivacaftor) Tablets
Company VERTEX
Date of First Filing April 9, 2021. Please note that FDA reported this product on its FDA PIV List of July 13, 2021. It states that the Date of First Filing occurred April 9, 2021. This date may be a simple clerical error (as April 9, 2020 would be a likely date when the first case appears July 24,…Read more

]]> 0 266bc077f1533c414081fc084096156e parryashford updated 'Envarsus XR®(tacrolimus) Extended-release Tablets ': Envarsus XR®(tacrolimus) Extended-release Tablets Company […] https://paragraphfour.com/activity/p/11744/ Tue, 24 Mar 2026 14:58:15 -0400 Envarsus XR®(tacrolimus) Extended-release Tablets
Company VELOXIS
Date of First Filing March 31, 2022

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

]]> 0 ce18dfb4de549426afb5a5ec28a09a16 parryashford updated 'Simponi®(golimumab) Injection ': Simponi®(golimumab) Injection Annual Sales $2.68B Company […] https://paragraphfour.com/activity/p/11743/ Mon, 23 Mar 2026 19:57:34 -0400 Simponi®(golimumab) Injection
Annual Sales $2.68B
Company JANSSEN
Date of First Filing aBLA – not applicable

Paragraph IV Applicant: Accord
Case Name: JANSSEN BIOTECH INC et al v. ACCORD BIOPHARMA INC et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00222
Date Filed: 3/3/26
Judge: Williams
Product Strength: 50…Read more

]]> 0 54739ca85fc21508306906d97c1e9afc parryashford updated 'Recorlev®(levoketoconazole) Tablets ': Recorlev®(levoketoconazole) Tablets Annual Sales $64.3M Co […] https://paragraphfour.com/activity/p/11741/ Mon, 23 Mar 2026 19:38:33 -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 744b23f4787fb537aedef5a80824cab4 parryashford updated 'Zejula®(niraparib) Tablets ': Zejula®(niraparib) Tablets Annual Sales 305M GBP Company […] https://paragraphfour.com/activity/p/11740/ Sat, 21 Mar 2026 17:41:58 -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 b9f0297b04fcf8ce58ee18968f1029b6 parryashford updated 'Slynd®(dropirenone) Tablets ': Slynd®(dropirenone) Tablets Annual Sales Company EXELTIS […] https://paragraphfour.com/activity/p/11739/ Sat, 21 Mar 2026 16:29:23 -0400 Slynd®(dropirenone) Tablets
Annual Sales
Company EXELTIS
Date of First Filing January 7, 2022

Paragraph IV Applicant: Lupin
Case Name: EXELTIS USA INC et al v. LUPIN LTD et al
Court/Case #: Court of Appeals for the Federal Circuit (cafc) 25-1239
Date Filed:
Judge:
Product Strength: 4 mg
Litigated Patents (expiration): 9,603,8…Read more

]]> 0 816479084bab4ebc8e62f03c2c9250d6 parryashford updated 'Rybelsus®(semaglutide) Tablets ': Rybelsus®(semaglutide) Tablets Annual Sales Company NOVO […] https://paragraphfour.com/activity/p/11738/ Sat, 21 Mar 2026 16:25:18 -0400 Rybelsus®(semaglutide) Tablets
Annual Sales
Company NOVO NORDISK
Date of First Filing July 15, 2024 and December 11, 2025 (reformulation R2)

Paragraph IV Applicant: Apotex
Case Name: NOVO NORDISK INC et al v. APOTEX INC
Court/Case #: New Jersey District Court (njdc) 1:2024cv09729
Date Filed: 10/10/24
Judge: Bumb
Product…Read more

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