Dr Reddys Laboratories has launched generic Depakote ER tablets in the US (approved back in March, 2012). There are six generic approvals so far. Mylan Inc and Wockhardt dominate the market with 43% and 38% market share respectively, followed by Anchen at 6%.
Based on industry sources, it appears that Wockhardt’s product (38% prescription share) is likely affected by its import alert. Based on the trade channel feedback, we believe current incumbents have taken a 400-800% price increase (similar to doxycycline price increase in February, 2013 benefiting Sun), which together could make the target market for Dr Reddy’s very lucrative.
Divalproex ER tablet market is about $193 million, of which generics is about $120 million. Assuming a 400% price increase, this could potentially be a $500 million market, and excluding rebates, about $300-350 million market opportunity.
Assuming market dynamics don’t change and 10-15% market share for Dr Reddy’s, this could potentially be a US$30-50 miilion revenue opportunity, with high margins, on a 12 month basis. As per USFDA orange book, Cadila has ANDA approved, but doesn’t seem to be active in the market.
We reiterate our ‘overweight’ rating, citing steady growth outlook (India, US, RoW), longer-term growth drivers (especially complex generics), and inexpensive valuations.
Building capabilities in complex injectables, patches, topicals and bio-similars should keep multiples healthy.