Caraco launches generic ketorolac tromethamine (Acular) eye drops on first day of patent expiry in US

Caraco Pharmaceutical Laboratories, subsidiary of Indian generic firm Sun Pharma has launched ketorolac tromethamine ophthalmic solution, 0.5% following a final approval from the US Food and Drug Administration.

Sun Pharma’s ketorolac tromethamine ophthalmic solution, 0.5% is the therapeutic equivalent of Acular marketed by Allergan, Inc.

Sun Pharmaceutical Industries’ Abbreviated New Drug Application (ANDA) for generic  ketorolac tromethamine ophthalmic solution, 0.5% was given approval on the first day following patent expiration Allergan’s patent on Acular.

Ketorolac tromethamine ophthalmic solution, 0.5% is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis.

Ketorolac tromethamine ophthalmic solution is also used in the treatment of post operative inflammation in patients who have undergone cataract extraction.

Ketorolac tromethamine ophthalmic solution has annual sales of approximately USD 40 million in the US, Sun Pharma said in an official release.

Ketorolac tromethamine ophthalmic solution is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use.

Ketorolac tromethamine, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

Ketorolac tromethamine given systemically does not cause pupil constriction.

In October, US FDA granted approval for Sun Pharma’s abbreviated new drug application (ANDA) for caffeine citrate intrvenous solution 30 mg/3 ml strength.

Sun Pharma caffeine citrate is the generic version of Mead Johnson’s Cafcit injection. In January 2008, Bedford Laboratories acquired Cafcit (caffeine citrate) injection and Cafcit oral solution from Mead Johnson & Company. Bedford Laboratories is now the reference listed drug holder.

Sun Pharma and Caraco got US FDA approvals for 79 ANDAs. In the second quarter, ANDAs for 3 products have been filed between Sun Pharma and Caraco. This takes Sun Pharma total ANDA filings to 11, in the first half. During the second quarter, ANDAs for 6 products from Sun Pharma have been approved. ANDAs for 108 products now await USFDA approval, including 10 tentative approvals. This pipeline is expected to build revenues for our US generic business in the years ahead, Sun Pharma said in an official release announcing quarterly results.

Sun Pharma has made a cumulative of 144 DMF / CEP applications, with 84 approved so far.

The total number of patent applications submitted for Sun Pharma now stands at 239 with 76 patents granted so far.

In August, Sun got FDA approval to launch two generics, including a version of Sanofi-Aventis’ cancer drug Eloxatin used to treat colon and rectal cancer, that has annual U.S. sales of about $2.3 billion.

Sun Pharma, India’s No. 1 drugmaker by market value, posted an 11.5% drop in net profit in July-September 2009, largely owing to fall in sales in its US subsidiary Caraco Pharma following seizure of products by US FDA.

Sun Pharma’s profits dropped to 4.54 billion rupees ($96 million) in its fiscal second quarter from 5.13 billion last year.

US FDA seized all medicines made by Sun Pharma’s US subsidiary Caraco’s facilities in Detroit  after regulatory  officials found there had been repeated violations of manufacturing standards, in June.

Caraco signed a consent decree with the U.S. Food and Drug Administration in September, under which it cannot resume manufacturing until it gets a written notification from independent experts and the agency to do so.

Caraco’s sales in the September quarter fell 36 percent to $78.4 million following FDA action and the cessation of manufacturing.