Par Pharmaceuticals and Barr Labs began shipping generic Zofran ODT (ondansetron orally disintegrating tablets) 4 mg and 8 mg doses immediately following FDA's Dec. 26 ANDA approval, Par told "The Pink Sheet" DAILY Dec. 28.

The agency also approved the 16 mg and 24 mg doses of the antiemetic.

Barr will market the generic 5-HT3 antagonist through its subsidiary Pliva, which gained rights to ondansetron per an agreement with Par's subsidiary Kali Laboratories. Kali will manufacture ondansetron.

FDA also approved Dr. Reddy's ANDA for ondansetron immediate-release tablets 4 mg, 8 mg, 16 mg and 24 mg Dec. 26. Dr. Reddy's said Dec. 27 that it will begin shipping the product shortly and that it holds 180-day exclusivity.

Additionally, Roxane's 4 mg/mL ondansetron oral solution was approved Dec. 26. The firm has 180-day exclusivity on that formulation.

The approvals follow the agency's Nov. 22 clearance of the injectable formulation, which Teva markets (¹ Also see "Teva Gains First Generic Zofran Injection Approval" - Pink Sheet, 22 November, 2006.). Sandoz markets authorized generics of the injectable formulation.

IMS Health estimates brand ODT sales for the 4 mg and 8 mg doses at $300 million for the 12 months ended in September and $639 million in brand sales for the immediate release formulation for the 12 months ended in June. GSK recorded U.S. sales for the Zofran franchise of £549 million ($1.04 billion) for the nine months ending in September.

Roche's 5-HT3 antagonist Kytril (granisetron) will likely be the next antiemetic to see generic competition. Several tentative ANDA approvals are pending.

Teva's granisetron ANDA is expected to be approved Dec. 29, 2007 following expiration of Roche's patent No. 4,886,808, covering use of the product for treatment of emesis.

Roche did not file suit against Teva when it submitted a Paragraph IV certification on Roche's patent No. 6,294,548 for multi-dose vial formulations, expiring in May 2019. In its approval letter for Teva's ANDA, FDA said the firm was not seeking to market the product for post-operative nausea and vomiting, covered by patent No. 5,952,340, which expires in September 2016.

- Christopher Hollis (c.hollis@elsevier.com)

Par Launches Generic Zofran ODT Following FDA Clearance

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