Alembic & Alembic Pharma

Every quarter USFDA uploads the DMF filing of all the players till the end of the quarter (I keep a tab on it as it gives an indication about the future ANDA filing for players like Alembic who are backward integrated). The DMF filing upto September 30, 2015 is out and Alembic had filed DMF for one fast growing and limited competition (upto September 30, 2015) molecule during the quarter. The details of this along with one more molecule which was filed in April to June, 2015 quarter is given below:

• APIXABAN (gELIQUIS; innovator – BRISTOL MYERS SQUIBB [Pfizer is the partner in the US market] – Filed on September 30, 2015. Exclusivity Expiry – Dec 28, 2017 and Patent Expiry – Dec 22, 2019. gEliquis (apixaban) helps to prevent platelets in your blood from sticking together and forming a blood clot. Eliquis is used to lower the risk of stroke caused by a blood clot in people with a heart rhythm disorder called atrial fibrillation. Other DMF Holders – MSN LABORATORIES PRIVATE LTD, ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD, DR REDDYS LABORATORIES LTD. Total sales US in 2014 – USD 404 million (424% increase y-o-y); USD 355 million sales (186% increase y-o-y) in H1CY2015 in US markets. Its a fast growing molecule with just four players who have filed DMF till September 30, 2015.
• AZILSARTAN MEDOXOMIL MONOPOTASSIUM (gEDARBI; innovator – ARBOR PHARMS IRELAND [marketed by Takeda in US]). Exclusivity Expiry – Feb 25, 2016& Patent Expiry – Jan 7, 2025. Azilsartan is an angiotensin II receptor antagonist used in the treatment of hypertension. On 25 February 2011, the U.S. Food and Drug Administration approved azilsartan medoxomil for the treatment of high blood pressure in adults. Other DMF Holders – MSN LABORATORIES PRIVATE LTD, HEC PHARM CO LTD, JUBILANT GENERICS LTD, ALP PHARM BEIJING CO LTD. US sales – USD 37 million (source: Bloomberg).