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Pharmaceutical industry

Teva Pharmaceutical Industries Receives FDA Approval for Generic Version of Relafen(R)

Strategic Insights

— 1 min read

Teva Pharmaceutical Industries Ltd., a leading generic pharmaceutical company, has received final approval from the US FDA to manufacture and market Nabumetone 500 mg Tablets, the generic version of the SmithKline Beecham drug Relafen(R), for the treatment of acute and chronic osteoarthritis and rheumatoid arthritis. With 180 days of market exclusivity under the Waxman-Hatch Act, Teva is poised to capture a significant share of the US market, which was valued at approximately $220 million in 1999. The company's ability to launch the product will depend on the outcome of a pending patent infringement case in a US Federal District Court in Massachusetts.

Key Takeaways:

  • Teva Pharmaceutical Industries Ltd. has received final approval from the US FDA to manufacture and market Nabumetone 500 mg Tablets, the generic version of Relafen(R), for the treatment of osteoarthritis and rheumatoid arthritis.
  • With 180 days of market exclusivity, Teva is the first to file a Paragraph IV certification with respect to this product under the Waxman-Hatch Act.
  • The 1999 US sales of the branded product, Relafen(R), were approximately $220 million.
  • A patent infringement case is currently pending in a US Federal District Court in Massachusetts, which may impact Teva's launch plans.
  • Teva is among the top 50 pharmaceutical companies and the largest generic pharmaceutical companies in the world, with over 80% of sales outside of Israel.
  • The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

Statistics:

  • 180 days of market exclusivity for Teva Pharmaceutical Industries Ltd. under the Waxman-Hatch Act.
  • $220 million in 1999 US sales of Relafen(R), the branded version of Nashumetone 500 mg Tablets.
  • Teva Pharmaceutical Industries Ltd. is among the top 50 pharmaceutical companies in the world.
  • Over 80% of Teva's sales are outside of Israel.
  • The company's sales are primarily in the United States and Europe.

Sources:

  • Business Wire. (2000, May 31). Teva Pharmaceutical Industries Ltd. Receives FDA Final Approval to Manufacture and Market Nabumetone 500 mg Tablets.
  • Teva Pharmaceutical Industries Ltd. Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission.

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