ParagraphFour.com | parryashford | Activity https://paragraphfour.com/members/parryashford/activity/ Activity feed for parryashford. Tue, 09 Jun 2026 01:15:52 -0400 https://buddypress.org/?v= en-US 30 hourly 2 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 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

]]> 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 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 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

]]> 0 6572a2c614c5b143a11dd9c93a36d794 parryashford updated 'Erleada®(apalutamide) Tablets ': Erleada®(apalutamide) Tablets Annual Sales $1.28B Company […] https://paragraphfour.com/activity/p/11965/ Sat, 30 May 2026 13:18:43 -0400 Erleada®(apalutamide) Tablets
Annual Sales $1.28B
Company JANSSEN
Date of First Filing February 14, 2022 and March 20, 2025 (240 mg)

Paragraph IV Applicant: Lupin
Case Name: ARAGON PHARMACEUTICALS INC et al v. LUPIN LIMITED et al
Court/Case #: New Jersey District Court (njdc) 2:2022cv02825
Date Filed: 5/13/22
Judge: Chesler
Product…Read more

]]> 0 fa61005a880aeb05b794ac9f9fa1bf2f parryashford updated 'Xtandi®(enzalutamide) Tablets ': Xtandi®(enzalutamide) Tablets Annual Sales: JPY 912B […] https://paragraphfour.com/activity/p/11964/ Fri, 29 May 2026 20:41:20 -0400 Xtandi®(enzalutamide) Tablets
Annual Sales: JPY 912B (global family)
Company ASTELLAS
Date of First Filing March 31, 2021 and December 27, 2024 (120 mg and 160 mg)

Paragraph IV Applicant: Sandoz
Case Name: ASTELLAS PHARMA INC et al v. SANDOZ INC
Court/Case #: New Jersey District Court (njdc) 2:2021cv13177
Date Filed: 6/30/21
Judge: …Read more

]]> 0 ace4aceeba06ea9da78bbaee36e4ec0a parryashford updated 'April 2026 ': The Paragraph Four Report® Paragraph IV Activity for April […] https://paragraphfour.com/activity/p/11963/ Fri, 29 May 2026 20:37:14 -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 530d8f2bc13782f85ac45de9da899d17 parryashford updated 'Voxzogo®(vosoritide) Powder for Injection ': Voxzogo®(vosoritide) Powder for Injection Annual Sales $735 […] https://paragraphfour.com/activity/p/11962/ Fri, 29 May 2026 20:34:58 -0400 Voxzogo®(vosoritide) Powder for Injection
Annual Sales $735M
Company BIOMARIN
Date of First Filing November 19, 2025

Paragraph IV Applicant: Zydus
Case Name: BIOMARIN PHARMACEUTICAL INC v. ZYDUS LIFESCIENCES LIMITED et al
Court/Case #: New Jersey District Court (njdc) 1:2026cv01005
Date Filed: 2/2/26
Judge: Bumb
Product Strength:…Read more

]]> 0 258c92568cfa0124150d5745c0a86045 parryashford updated 'Tyrvaya®(varenicline) Nasal Spray ': Tyrvaya®(varenicline) Nasal Spray Annual Sales Company […] https://paragraphfour.com/activity/p/11961/ Fri, 29 May 2026 20:26:24 -0400 Tyrvaya®(varenicline) Nasal Spray
Annual Sales
Company OYSTER POINT
Date of First Filing April 21, 2023

Paragraph IV Applicant: Apotex
Case Name: OYSTER POINT PHARMA INC v. APOTEX INC
Court/Case #: New Jersey District Court (njdc) 2:2023cv03860
Date Filed: 7/19/23
Judge: Chesler
Product Strength: 0.03 mg/spray
Litigated Patents…Read more

]]> 0 e5f7a854cc8dfac600a89229b3a76b09 parryashford updated 'Trelegy Ellipta®(fluticasone, umeclidinium, vilanterol) Powder for Inhalation ': Trelegy Ellipta®(fluticasone, umeclidinium, vilanterol) […] https://paragraphfour.com/activity/p/11960/ Fri, 29 May 2026 19:44:29 -0400 Trelegy Ellipta®(fluticasone, umeclidinium, vilanterol) Powder for Inhalation
Annual Sales GBP 2.18B
Company GLAXOSMITHKLINE
Date of First Filing November 26, 2025

Paragraph IV Applicant: Transpire
Case Name: GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMTED et al v. TRANSPIRE BIO INC
Court/Case #: Florida Southern District…Read more

]]> 0 082ca376f6e62c8ed78bdf915e9a10a5 parryashford updated 'Tavneos®(avacopan) Capsules ': Tavneos®(avacopan) Capsules Annual Sales $256M Company AM […] https://paragraphfour.com/activity/p/11959/ Fri, 29 May 2026 19:39:31 -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 a029d789bf62a69dbc1b89ff6c788f49 parryashford updated 'Tarpeyo®(budesonide) Delayed-release Capsules ': Tarpeyo®(budesonide) Delayed-release Capsules Annual Sales […] https://paragraphfour.com/activity/p/11958/ Fri, 29 May 2026 19:36:10 -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 56ab4f18adfef76c6800baf46993729d parryashford updated 'Spinraza®(nusinersen) Intrathecal Solution ': Spinraza®(nusinersen) Intrathecal Solution Annual Sales $62 […] https://paragraphfour.com/activity/p/11957/ Fri, 29 May 2026 19:31:16 -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: Connolly
Product Strength: 12…Read more

]]> 0 ea7146736db8677e72617932fb90380b parryashford updated 'Simponi®(golimumab) Injection ': Simponi®(golimumab) Injection Annual Sales $2.68B Company […] https://paragraphfour.com/activity/p/11956/ Fri, 29 May 2026 19:29:33 -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 590c3fc4180cdb1dbd6599e105075d6a parryashford updated 'Recorlev®(levoketoconazole) Tablets ': Recorlev®(levoketoconazole) Tablets Annual Sales $64.3M Co […] https://paragraphfour.com/activity/p/11955/ Fri, 29 May 2026 19:22:02 -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 24fe746094fe7aabb27cd6b1f683d55e parryashford updated 'Nexletol®(bempedoic) Tablets and Nexlizet® ': Nexletol®(bempedoic) Tablets Nexlizet®(bempedoic and e […] https://paragraphfour.com/activity/p/11954/ Thu, 28 May 2026 20:16:52 -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 8e1ae01f2b5031eb946b01b4496a8656 parryashford updated 'Neffy®(epinephrine) Nasal Spray ': Neffy®(epinephrine) Nasal Spray Annual Sales Company ARS […] https://paragraphfour.com/activity/p/11953/ Thu, 28 May 2026 17:45:15 -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 92600a4f2033f6185c781fd944d3c5f5 parryashford updated 'Nayzilam®(midazolam) Nasal Spray ': Nayzilam®(midazolam) Nasal Spray Annual Sales 124M […] https://paragraphfour.com/activity/p/11952/ Thu, 28 May 2026 17:40:19 -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 f723e324a06a90f33f9ff870c6eb0c2c parryashford updated 'Livtencity®(maribavir) Tablets ': Livtencity®(maribavir) Tablets Annual Sales 20B […] https://paragraphfour.com/activity/p/11950/ Thu, 28 May 2026 17:17:10 -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 80b0291d532b76b9b81caca595e27ca3 parryashford updated 'Livmarli®(maralixibat) Oral Solution ': Livmarli®(maralixibat) Oral Solution Annual Sales Company […] https://paragraphfour.com/activity/p/11949/ Thu, 28 May 2026 17:09:59 -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 ae5ea1c597c899258f3bf0f36416b5ed parryashford updated 'Kalydeco®(ivacaftor) Oral Granules ': Kalydeco®(ivacaftor) Oral Granules Annual Sales Company […] https://paragraphfour.com/activity/p/11947/ Wed, 27 May 2026 20:55:38 -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 c36617bcee1330a9eea8274cd4c4269e parryashford updated 'Firdapse®(amifampridine) Tablets ': Firdapse®(amifampridine) Tablets Annual Sales $306M Compan […] https://paragraphfour.com/activity/p/11945/ Wed, 27 May 2026 20:37:39 -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 e47710ec96adba111a4ddbc305e1c95d parryashford updated 'Vemlidy®(tenofovir alafenamide) Tablets and Combination Products Descovy® and Odefsey® ': Vemlidy®(tenofovir alafenamide) […] https://paragraphfour.com/activity/p/11944/ Wed, 27 May 2026 20:32:08 -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 da8dd910fba7607ad79f961413d86f65 parryashford updated 'Cibinqo®(abrocitinib) Tablets ': Cibinqo®(abrocitinib) Tablets Annual Sales $284M Company […] https://paragraphfour.com/activity/p/11943/ Wed, 27 May 2026 20:09:44 -0400 Cibinqo®(abrocitinib) Tablets
Annual Sales $284M
Company PFIZER
Date of First Filing January 14, 2026

Paragraph IV Applicant: Micro Labs
Case Name: PFIZER INC et al v. MICRO LABS LIMITED et al
Court/Case #: Delaware District Court (dedc) 1:2026cv00439
Date Filed: 4/16/26
Judge: Hall
Product Strength: 50 mg, 100 mg, and 200…Read more

]]> 0 83f6440cec0b7a45f529927f91806b81 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: Connolly
Product Strength: 12…Read more

]]> 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 674d7bdfb228c4d1ae5280a8d8a3a7b2 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: 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

]]> 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 […]

]]> 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 6371de287b7d7747ac90a44cc5c6d4eb parryashford started the topic 269. April 2026 in the forum Monthly Highlights Archives 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

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