Sidvim LifeSciences Private Limited

Content Recent Paragraph-IV filings General information 2026 & beyond: Indian pharma hinges hopes on innovation impetus & regulatory agility How GLP-1s, Digital Tech, and 505(b)(2) Strategies Are Reshaping the CDMO Landscape Intellectual Property Merck vs Hopewell : Mavenclad (cladribine) Recent Paragraph-IV filings We follow ANDA filings with P-IV certificates. The FDA published the recent list on December 15. Avacopan Three ANDAs seems to have been filed on the NCE-1 date. While the specific names of the generic filers are typically withheld in initial FDA listings, major generic players such as Teva and Sandoz are often among the first to file (FTF) for such high-growth orphan drugs. Sandoz has filed a patent family for the crystalline form, WO2022263263. Teva filed a patent family for Avacopan intermediates, WO2023158722A2. Tavneos is a first-in-class oral C5a receptor antagonist used as an adjunctive treatment for adults with severe active ANCA-associated va...

Contents Recent DCGI approvals Erdafitinib Tablets 3 mg, 4 mg and 5 mg. Vorasidenib Tablets 10 mg/ 40 mg General information FDA Conditionally Approves Drug to Treat New World Screwworm in Dogs Novo Nordisk Submits NDA to FDA for CagriSema Intellectual Property Honeywell International Inc. Vs ARKEMA FRANCE. Recent DCGI approvals We follow the approvals of the Drugs Controller General of India (DCGI). DCGI serves as the head of the Central Drugs Standard Control Organisation (CDSCO) and is the regulatory authority for approving new medicines, vaccines, and medical devices in India. In October 2025, there are two approvals for drug products. Erdafitinib Tablets 3 mg, 4 mg and 5 mg. Approval Approval date: 01.10.2025 The DCGI granted approval to Natco Pharma Limited for the treatment of locally advanced or metastatic urothelial carcinoma. The decision was reached during technical committee meetings, where the committee recognised an unmet medical need for this indicatio...

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...