Para IV Winners and Losers: Complex generics dominate; Cadila, Sandoz and Apotex grab low competition opportunities

Updated : January 21, 2019 05:00 PM IST

Para IV litigations remains the main stay for any generic company focused on the US generics market and consequently account for the largest chunk of revenues for all the major pharma companies in India. Para IV Winners and Losers is an analyses of major developments in the space in a particular month.

December 2018 Para IV developments indicate that future of Para IV will be dominated by non-oral solids (largely sterile products). Almost all of the developments this month relate to non oral solid products. In addition, 9 of the 10 Para IVs filed this month are on complex generic drugs.

While the no of Para IV filed (incl FTFs) in this month continues to increase, no of settlements/outcome continue to decline. We believe settlements offer the highest predictibility in earnings for both – innovator as well as generics.

Some of the notable settlements/outcomes were related to Zydus cadila for Cardizem LA, Sandoz for Rytary and Apotex for Forteo. Cardizem LA ($94 mn in US sales, indicated for high blood pressure) will likely be a longer term opportunity for Cadila. Rytary ($50 mn in US sales, indicated for Parkinsons) and Forteo (&770 mn in US sales, indicated for Osteoporosis) too will offer low competition opportunities to Sandoza and Apotex respectively.

Other company specific notable development includes Suven lifesciences Para IV filing and subsequen litigation on Cuvposa. Traditionally, Suven has remained away from generics let alone Para IVs and have largely focused on the custom synthesis business.

One interesting fact was a patent litigation with a compounding pharmacy on Stendra ($70 mn in US sales, indicated for Erectile Dysfunction/Urology). Compounding pharmacies are those that combine products as per the requirement of the patient (like dosage etc.). They combine the existing drugs available in the market in an approved facility.

On the other hand, increasing competition is seen in complex products like Xarelto and Prolensa.

Para IV Winners and Losers: Complex generics dominate; Cadila, Sandoz and Apotex grab low competition opportunities

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