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Showing posts from April, 2025

API and IP Newsletter: DMF filings in February 2025 and Nicotin tablet/FERTIN PHARMA decision by EPO, -Article 123(2) and (3) EPC

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Contents Recent DMF filings- February 2025 General information Lilly sues four compounders over copies of weight-loss drugs Liquidia Corp files patent infringement suit against United Therapeutics Intellectual Property T 1330/23 (Nicotin tablet/FERTIN) 20-02-2025 Recent DMF filings- February 2025 We track DMFs filed each month. The FDA publishes the list of DMF filings quarterly. The first quarter DMF filing list was released in the first week of April, and this month we are analysing DMFs filed in February 2025. A total of 57 DMFs were filed in January 2025. The top DMF filers are listed below. About 18 DMFs were filed by Chinese companies, and about 24 DMFs were filed by Indian companies. After a long time, we are noticing that Indian companies have submitted a greater number of DMFs than Chinese companies. This month, perhaps due to the Chinese New Year holidays, the number of DMFs filed by Chinese companies is lower than that of Indian companies.  Some of our other ...

DMF filings in January 2025 and the CAFC's decision on Invega Trinza (paliperidone palmitate-PP3M)

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Contents Recent DMF filings General information Bitter pill for Lupin, Zydus Life shares as patent case over Myrbetriq lost in US court Novartis and Accord settle UPC dispute over drug administration with apple sauce Intellectual Property Janssen vs. Mylan: CAFC's decision on Invega Trinza (paliperidone palmitate-PP3M) Recent DMF filings We track DMFs filed each month. The FDA publishes the list of DMF filings quarterly. The first quarter DMF filing list was released in the first week of April, and this month we are analysing DMFs filed in January 2025. A total of 81 DMFs were filed in January 2025. The top DMF filers are listed below. About 40 DMFs were filed by Chinese companies, and about 32 DMFs were filed by Indian companies. The Chinese have overtaken Indian companies in the DMF filing list for some time now.  Some of our other observations are as follows. General information Bitter pill for Lupin, Zydus Life shares as patent case over Myrbetriq lost in US court T...

API and IP Newsletter- Recent ANDA approvals and Roxadustat decision by EPO: T 0072/23

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Contents Recent ANDA approvals General information Jazz pays $145m to resolve Xyrem antitrust disputes Bristol Myers Freed From Blood Cancer Drug Antitrust Litigation Intellectual Property Roxadustat decision: T 0072/23 (Photostable roxadustat formulation/FIBROGEN) Recent ANDA approvals We track ANDA approvals monthly. This report discusses the ANDA approvals obtained by generic companies in March 2025. There are approximately 86 ANDA approvals for March 2025, of which 23 are tentative approvals. Interestingly, out of the total 86 approvals, 47 were received by Indian companies.  Below is the list of top ANDA approvals. Some of our observations for the approved products are as follows. General information Jazz pays $145m to resolve Xyrem antitrust disputes Jazz Pharma has agreed to pay $145 million to settle lawsuits claiming it illegally acted to prevent generic versions of its narcolepsy therapy Xyrem from entering the US market. The lawsuits – which date back to 2020...