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API and IP News 29 March 2026: Abrocitinib P-IV Filings, Oral Semaglutide, and EPO Patent Decisions

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The Future of Pharma: Key Insights from the March 2026 API and IP Newsletter Summary for this blog post: Staying ahead in the pharmaceutical industry requires a keen eye on Paragraph IV (P-IV) filings, intellectual property litigation, and regulatory shifts. This latest update covers significant developments in atopic dermatitis treatments, oral semaglutide legal battles, and landmark patent office decisions. Abrocitinib: The Next Big Frontier in Paragraph IV Filings The landscape for Abrocitinib (Pfizer’s Cibinqo) is shifting rapidly following recent FDA updates. As a selective JAK1 inhibitor indicated for refractory, moderate-to-severe atopic dermatitis, it represents a high-stakes market with 2025 US sales reaching approximately $115 million. Key Market Insights: NCE-1 Date: January 14, 2026. ANDA Activity: Three Abrocitinib ANDAs with P-IV certificates have been submitted to the FDA. Indian Market: Glenmark Pharmaceuticals recently launched the drug in India as Jabryus in par...
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Patent applications filed by Natco Pharma Limited and Pfizer Inc., et al. v. Dexcel Pharma Technologies Limited, et al. Tafamidis case

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Contents Patent applications filed by Natco Pharma Limited General information FDA: Novo Nordisk failed to report deaths of weight-loss drug patients FTC monitoring how drug companies react to patent cliff, official says Intellectual Property Pfizer Inc., et al. v. Dexcel Pharma Technologies Limited, et al.: Tafamidis case Patent applications filed by Natco Pharma Limited We analysed Natco's patent application and evaluated its development activities. We tried to gather data on PCT applications filed over the last 2 years for this analysis. There is a lag in the publication of applications, so this analysis indicates Natco’s development activities from about 3-4 years ago. Some comments regarding PCT applications are summarised below. Some general comments Natco identifies molecules in very late stages of development, possibly in Phase III. Those patent families that are not interesting from a business perspective are abandoned immediately. There appears to be a robust ...
Location: Mumbai, Maharashtra, India
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ANDA approvals-February 2026 and Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc.,

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Contents ANDA approvals-February 2026 General information Generics suspect GSK of playing “divisional game” after EPO revocation CDSCO issues advisory against promotion of prescription obesity drugs Intellectual Property Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc., ANDA approvals-February 2026 We follow ANDA approvals. In February 2026, the USFDA issued 91 ANDA approvals, of which 24 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 February were as follows. Some of our other comments about a few ANDA approvals sought by Indian companies are listed below. General information Generics suspect G...
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Recent 505 (b) (2) filings and Bardy Diagnostics Vs. iRhythm : Claim construction

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Contents Recent 505 (b) (2) filings General information Top 10 patent cases in France India’s pharma industry trails behind: The digital validation technology gap Intellectual Property Bardy Diagnostics Vs. iRhythm : Claim construction 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 February 2026, 505 (b) (2) filings are as follows General information Top 10 patent cases in France French courts recorded a decline in the number of cases in 2024, and recent research suggests that the downward trend continued last year. Nevertheless, French courts handed down a number of decisions in high-profile cases, particularly concerning patents fr...
Location: Mumbai, Maharashtra, India
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Generic Drug Program Activity Report FY 2025 by US FDA and Case: Ipsen Biopharm Ltd vs Sandoz AG et al

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Contents Generic Drug Program Activity Report FY 2025 by US FDA. General information Novartis settles with Henrietta Lacks’ estate over use of her ’stolen’ cells to advance medicine Can Pharma Companies Reverse String of Judicial Defeats at SCOTUS? Intellectual Property Ipsen Biopharm Ltd vs Sandoz AG et al Generic Drug Program Activity Report FY 2025 by US FDA. FDA publishes Generic Drugs Program Activities Report. The FY 2025 report was recently published. The details can be found here . The FDA’s Fiscal Year 2025 Generic Drugs Program Activities Report reveals a highly active year for regulatory submissions, totalling 600 original Abbreviated New Drug Application (ANDA) receipts. Activity peaked significantly in September 2025, which saw 114 ANDA submissions—nearly double the monthly average. Beyond original applications, the program managed a massive volume of supplemental filings, including 11,715 total supplements and 2,087 amendments. * = Original Receipts are reported a...
Location: Mumbai, Maharashtra, India
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