Sidvim LifeSciences Private Limited

Contents Recent 505 (b) (2) filings General information Almost 85% of overcharged amount claimed by NPPA yet to be recovered CNIPA- The Added Value of Patent-Intensive Industries Nationwide in 2024 was 18,038.1 Billion RMB, Accounting for 13.38% of GDP Intellectual Property Mandeep Singh Vs Shabir Momin: Instant Bollywood 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. This month, some of the 505 (b) (2) applications filed by the Brand companies are for marketing differentiated dosage and dosage forms, sometimes for different patient populations. The details of December 2025, 505 (b) (2) filings are as follows: General information Almost 85% of overcha...

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...