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Recent P-IV filings And Entresto (Sacubitril/Valsartan): Novartis vs MSN

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Contents Recent P-IV filings General information Regeneron and Samsung Bioepis Settle EYLEA® BPCIA Litigations Related to Opuviz™ Brazil Seeks API Localization From India, Eyes Pharma Self-Reliance Intellectual Property Entresto (Sacubitril/Valsartan): Novartis vs MSN Recent P-IV filings We follow P-IV filings on the FDA website. The recent update was on 02 February 2026. General information Regeneron and Samsung Bioepis Settle EYLEA® BPCIA Litigations Related to Opuviz™ On February 11, 2026, Regeneron and Samsung Bioepis dismissed Case Nos. 1:23-cv-00094 (N.D.W. Va.) and 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) due to settlement. The preliminary injunction previously granted by the Court and affirmed by the Federal Circuit (previously reported Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon) was also vacated. Under the settlement agreement, Samsung Bioepis can launch its EYLEA® (afliber...
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1.) ANDA approvals-January 2026 2.)Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited

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 Contents ANDA approvals-January 2026 General information Aspire Biopharma Files Provisional Patent Application for a Fast-Acting Sublingual Powder Formulation of Ondansetron (Generic Zofran(R)) Technology Platforms Spanning the Full Biopharmaceutical Development Lifecycle Intellectual Property Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited ANDA approvals-January 2026 We follow ANDA approvals. In January 2026, the USFDA issued 83 ANDA approvals, of which 19 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in November were as follows.  Some of our other comments about a few ANDA ...
Location: Mumbai, Maharashtra, India
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Recent 505 (b) (2) filings and The "Skinny Label" Dispute (sec viii) in the US. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

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  Contents Recent 505 (b) (2) filings General information Novo Nordisk to take legal action against Hims & Hers for Wegovy compounding SanegeneBio and Genentech sign $1.5bn global RNAi licensing deal Intellectual Property The "Skinny Label" Dispute (sec viii) in the US. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. Recent 505 (b) (2) filings We follow 505 (b) (2) filings.  Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2)  FDA approvals can be found here .  The details of January 2026, 505 (b) (2) filings are as follows: Drug Name Comments QUIOFIC         NDA   #216395.           FOLIC ACID.    ...
Location: Mumbai, Maharashtra, India
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First Generic Drug Approvals by USFDA and Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia)

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Contents First Generic Drug Approvals General information Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks Big Pharma Tight-Lipped on Details of API Stockpile Deals Intellectual Property Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia) First Generic Drug Approvals The FDA’s 2025 First-Time Generic Drug Approvals list represents the very first generic alternatives to previously exclusive brand-name medications. This list is specific because it only includes first generics, which are the first versions of a drug that can be sold in the U.S. after patent protections and exclusivities on the brand-name version expire. Being the "first" generic approved carries significant strategic and financial advantages for a pharmaceutical company: 180-Day Market Exclusivity: The most significant advantage is that the first generic applicant (on...
Location: 28GX+G3 Naiheda, Madhya Pradesh, India
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Recent ANDAs P-IV filings and EirGen Pharma Ltd Vs DSM Nutritional Products AG

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Contents Recent P-IV filings General information Local division Mannheim imposes over €1.7 million penalty against Kodak FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use Intellectual Property EirGen Pharma Ltd Vs DSM Nutritional Products AG Recent P-IV filings We follow P-IV filings on the FDA website. The recent update was on January 05, 2026. ANDAs with P-IV filing were recently filed for two products. Details are as follows. General information Local division Mannheim imposes over €1.7 million penalty against Kodak The local division Mannheim has ruled that Kodak has not complied with the conditions of a first-instance injunction in its printing plate dispute with FujiFilm. The US company must pay a substantial penalty, although the court rejected automatic enforcement by the UPC in non-EU countries such as the UK. News here FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use M4Q(R2) is a globally harmonized framework for s...
Location: Mumbai, Maharashtra, India
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