Darunavir Paragraph IV litigation


Tibotec, on Nov 15th 2010, has sued Lupin and Mylan on 7,700,645 patent which expires on Dec 2026.

7,700,645:
htmlpdf
Pseudopolymorphic forms of a HIV protease inhibitor
by Vermeersch et. al.; USPC #514/456;

It is not sure who is First to file (Lupin OR Mylan); View on PriorSmart

Lupin is seeking approval of 400 MG and 600 MG only and in case of other ANDA filer, Mylan is seeking approval of 75 MG, 150 MG, 300 MG and 600 MG.

Even though many patents listed in Orange book, Tibotec has sued only on ‘645 polymorph patent. Probably Para III certification might have been filed on Product patent(s) 5843946 (Dec 2015), 6248775 (Aug 2014), and 6335460 (Aug 2012) and Para IV on  combination patents 6037157 and 6703403 (both Aug 2016) and Polymorph patent 7700645 (Dec 2026).

In addition to above listed patents, US 7470506 (Jun 2019) is also listed in OB and assigned to University of Illinois, covers method of treating HIV treatment resistant patients. University of Illinois has sued  only Mylan and Lupin on this patent. Lupin is not sued on this patent (‘506). View on PriorSmart

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About Guna

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