Mylan and Apotex Received final USFDA Approval for Generic Version of Anti-Psychotic Risperdal (Risperidone) Tablets USP, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.
Risperidone Tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal® Tablets. This product had annual U.S. sales of approximately $2.67 billion for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
The generic version from Mylan and Apotex will soon be available in US market.
Risperidone Tablets, used to treat schizophrenia and bipolar disorder, are the generic version of Janssen's Risperdal® Tablets. This product had annual U.S. sales of approximately $2.67 billion for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
The generic version from Mylan and Apotex will soon be available in US market.
As per USFDA records, following generic players have received final approval:
1) Teva (Approved on June 30, 2008)
2) Mylan (Approved on September 15, 2008)
3) Apotex (Approved on September 15, 2008)
4) Pliva (Tentative approval)
1) Teva (Approved on June 30, 2008)
2) Mylan (Approved on September 15, 2008)
3) Apotex (Approved on September 15, 2008)
4) Pliva (Tentative approval)
Eralier, a US court allowed USFDA to grant final approval to pending ANDA's of other generic companies due to Teva's 180 days exclusivity. The said ruling has severely hit Teva, as the expected sale target of $200-300 million from this product, during exclusivity will not be acheived.
Earlier news on Risperidone here
Details on litigation Here
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