It is a common phenomenon in the health care sector in which a branded drug making company files a lawsuit against a company trying to get its generic version approved. Earlier in the week, Mylan Inc. (MYL) has been sued by Baxter International, Inc. (BAX) for filing an Abbreviated New Drug Application (ANDA) with the FDA for the generic version of the latter’s Brevibloc injection.
Brevibloc is approved for the treatment of supraventricular tachycardia or noncompensatory sinus tachycardia and intraoperative and postoperative tachycardia and/or hypertension. According to IMS Health, Brevibloc sales in the U.S. for the 12 months ending on Sep 30, 2014, came in at $49 million.
Mylan mentioned in its press release that it is the first company to file a substantially complete ANDA containing a Paragraph IV certification for the generic version of Brevibloc. Mylan believes that it will be eligible for 180 days of marketing exclusivity for its generic version on approval.
We note that Mylan has 287 ANDAs filed with the FDA pending decisions, out of which 44 are potential first-to-file opportunities. According to IMS Health, these 287 ANDAs represent $111.6 billion in annual sales while the 44 first-to-file opportunities represent $29.5 billion in annual brand sales for the 12 months ending Jun 30, 2014.
Mylan meanwhile continues with its generic launches. Earlier in the month, it launched the generic version of Actavis’ (ACT) Loestrin 24 Fe approved for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. As per IMS Health, Loestrin 24 Fe sales in the U.S. for the 12 months ending Sep 30, 2014, were $24.4 million.
Last month, Mylan launched the generic version of Boehringer Ingelheim’s Viramune XR which is approved for the treatment of HIV-1 infection in adults and children aged (six years to 18 years). According to IMS Health, Viramune XR sales in the U.S. for the 12 months ending Sep 30, 2014, came in at $61.9 million.
Mylan’s Generics division reported revenues of $4.7 billion for the first nine months of 2014. We expect additional generic launches in the coming months as well.
Mylan carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is AMAG Pharmaceuticals, Inc. (AMAG) with a Zacks Rank #1 (Strong Buy).
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