Allergan Files ANDA for Generic Version of Merck's Noxafil(r)

Strategic Insights -

Allergan plc has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Posaconazole Delayed-Release Tablets, 100mg, a generic version of Merck's antifungal agent Noxafil(r). The filing marks a significant step in Allergan's efforts to develop and market high-quality generic and over-the-counter medicines. With over $143.6 million in global sales for the 12 months ending June 30, 2015, Noxafil(r) presents a substantial market opportunity for Allergan.

Key Takeaways:

  • Allergan has filed an ANDA for Posaconazole Delayed-Release Tablets, 100mg, a generic version of Merck's Noxafil(r).
  • The ANDA filing was made on an unspecified date, and Allergan may be entitled to 180 days of generic market exclusivity if its ANDA is approved.
  • Merck Sharp & Dohme Corp. has filed a lawsuit against Allergan seeking to prevent it from commercializing the generic product prior to the expiration of U.S. Patent No. 5,661,151.
  • The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan's ANDA for up to 30 months.
  • For the 12 months ending June 30, 2015, Noxafil(r) had global sales of approximately $143.6 million, according to IMS Health data.
  • Allergan is a global pharmaceutical company and a leader in a new industry model - Growth Pharma, with a portfolio of best-in-class products that provide valuable treatments for various therapeutic categories.
  • Allergan operates the world's third-largest global generics business and is committed to working with physicians, healthcare providers, and patients to deliver innovative and meaningful treatments.

Statistics:

  • $143.6 million: Global sales of Noxafil(r) for the 12 months ending June 30, 2015 (IMS Health data).
  • 5,661,151: U.S. Patent No. related to Merck's Noxafil(r).
  • 180 days: Potential generic market exclusivity for Allergan if its ANDA is approved.
  • 30 months: Potential stay of final FDA approval of Allergan's ANDA due to Merck's lawsuit.

Sources:

  • Allergan plc, press release, date unknown, referenced from the original text.
  • IMS Health data, referenced in the press release, date unknown.
  • U.S. Patent No. 5,661,151, referenced in the press release, date unknown.
  • Hatch-Waxman Act, referenced in the press release, date unknown.
  • Merck Sharp & Dohme Corp., lawsuit against Allergan, filed August 6, 2015, in the U.S. District Court for the District of New Jersey.