Lupin Receives USFDA Approval for Generic Celebrex Capsules

Lupin Receives USFDA Approval for Generic Celebrex Capsules: Lupin Limited (Lupin) has received final approval for its Celecoxib Capsules, 50 mg from the United States Food and Drugs Administration (FDA) to market a generic version of G.D. Searle LLC’s (a subsidiary of Pfizer Inc.) Celebrex® Capsules 50 mg. Lupin also received tentative approvals for its Celecoxib capsules 100 mg, 200 mg and 400 mg strengths from the FDA. Lupin’s Celecoxib Capsules 50 mg, 100 mg, 200 mg and 400 mg are the AB-rated generic equivalents of G.D. Searle LLC ‘s Celebrex® Capsules 50 mg, 100 mg, 200 mg and 400mg and are indicated for Osteoarthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis in patients 2 years and older; Ankylosing Spondylitis, and Acute Pain. Celebrex® Capsules had annual U.S sales of US$ 2.44 billion (IMS MAT June, 2014). Currently there is a limited competition for the product and the company can, conservatively garner sales of US $50-60mn in sales for the 50 mg capsules. We maintain our neutral, on back of valuations.

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