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Recent 505 (b) (2) filings and Bardy Diagnostics Vs. iRhythm : Claim construction

March 08, 2026

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...

Generic Drug Program Activity Report FY 2025 by US FDA and Case: Ipsen Biopharm Ltd vs Sandoz AG et al

February 28, 2026

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...

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

February 22, 2026

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...

1.) ANDA approvals-January 2026 2.)Tapentadol: Grunenthal GmbH Vs MSN Laboratories Private Limited

February 14, 2026

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 ...

Recent 505 (b) (2) filings and The "Skinny Label" Dispute (sec viii) in the US. Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.

February 09, 2026

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. ...