The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' Abbreviated New Drug Applications (ANDA) for rizatriptan benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), and rizatriptan benzoate tablets, 5 mg (base) and 10 mg (base). These products are the generic versions of Merck's Maxalt MLT tablets and Maxalt tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for rizatriptan benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), and was awarded 180 days of marketing exclusivity.
Mylan CEO Heather Bresch commented: "Mylan's immediate launch of the first generic rizatriptan benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), and the company's simultaneous launch of rizatriptan benzoate tablets, 5 mg (base) and 10 mg (base), further demonstrates our commitment to continue expanding access to high quality medicines for patients who need them in the US and around the world. We look forward to continue growing our portfolio of more than 1,100 generic pharmaceutical products to further support this cause."
Rizatriptan benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), had US sales of approximately $262.5 million for the 12 months ending September 30, 2012, according to IMS Health, and rizatriptan benzoate tablets, 5 mg (base) and 10 mg (base), had US sales of approximately $344.7 million for the same period. Mylan is shipping the orally disintegrating and immediate-release versions of this product immediately.
Currently, Mylan has 183 ANDAs pending FDA approval representing $79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.