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Global Generic Drug Litigation Updates on the Latest Para IV Events

  • ID: 4801583
  • Report
  • Region: Global
  • Research Delta Advisors
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Provides an Insight into Each Product Opportunity for Generic Companies


  • Actavis
  • Aurobindo
  • Fresenius Kabi
  • MSN Labs
  • Pharma
  • Teva
  • MORE

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.
Note: Product cover images may vary from those shown
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Companies covered in previous issues include:

  • Actavis
  • Alkem
  • Alvogen
  • Amneal
  • Apotex
  • Aurobindo
  • Bion pharma Lupin
  • Cipla
  • Dr Reddy's
  • Emcure
  • Fresenius Kabi
  • Hetero
  • Jubiliant
  • Lupin
  • Medicare
  • MSN Labs
  • Mylan
  • Natco
  • Par
  • Perrigo
  • Pharma
  • Quilu
  • Sandoz
  • Shilpa
  • SigmaPharma
  • Teva
  • Teva Actavis
  • Torrent
  • Twi
  • Watson
  • Zydus Cadila
Note: Product cover images may vary from those shown