Sidvim LifeSciences Private Limited

Contents Recent ANDA approvals General information Eli Lilly Invests $6 Billion as Active Pharmaceutical Ingredient (API) Production Expands in Huntsville, Alabama China’s Fosun Pharma Soars After Pfizer Snaps Up Global Rights to New Weight-Loss Drug Intellectual Property Trademark Case: Chemco Plastic Industries Vs Chemco Plast Recent ANDA approvals We follow ANDA approvals. In November 2025, the USFDA issued a total of 91 ANDA approvals, of which 25 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 approvals sought by Indian companie...

Contents Recent 505 (b) (2) filings General information TQ Therapeutics GmbH Enters into Technology Access Agreement with Kytopen Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug Intellectual Property Allergan Vs. Sandoz Recent 505 (b) (2) filings We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison 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)). For more details on 505(b)(2) FDA approvals, please visit this link .  In November 2025, a tentative approval was granted for the Ruxolitinib NDA (#219660) for Apotex. Ruxolitinib tablets are marketed as ruxolitinib phosphate salt under the brand name Jakafi. We are trying to understand why Apotex filed an NDA instead of an ANDA. There is one new strength, 2 MG, but other str...