Para IV litigations remains the mainstay for any generic company focused on the US generics market and consequently account for a significant chunk of revenues for all the major pharma companies in India. Para IV Winners and Losers is an analysis of major developments in the space in a particular month.
This month witnessed the lowest no. of Para IV filings on complex generics (non-oral solids) in the last 6 months. 1 out of the 19 Para IV filed this month are on complex generic drugs. Para IV on complex generics remains a key growth driver for the industry.
Similar to August, significant settlements were observed in September 2019 as well. 13 out of the 19 developments this month relate to settlements/outcomes vs 22 out of 28 in Aug 2019. Settlement offers the highest predictability in earnings for both – innovator as well as generics.
FTF filing increased modestly this month with 2 in September vs none in August 2019.
4 of the 19 developments in Sept 2019 were Para IV filing (ex-FTFs) vs 6 of 28 in August 2019.
Interesting developments this month:
- Some of the notable developments were related to Tirosint. Low competition opportunity emerges in
- Sklice, Mitigare, Thalomid, Riomet and Doryx MPC for some companies.
- Other company-specific development includes Para IV filing (ex FTFs) followed by litigation on
- Vimovo, Xifaxan, Tradjenta and Sensipar were also observed.
- Finally, on biosimilars – Genentech and Pfizer Settled on Bevacizumab Biosimilar Litigation.
Companies covered in previous issues include:
- Bion pharma Lupin
- Dr Reddy's
- Fresenius Kabi
- MSN Labs
- Teva Actavis
- Zydus Cadila