What’s the expiration date for Menopur’s patents?
Menopur’s key patents that protect the purified human menopausal gonadotropins expire in early 2025. The most recent U.S. patent, US 9,023,752, issued in 2017, is set to lapse on January 15, 2025, after which the product is eligible for biosimilar entry.
[1]
When will Novarel lose its patent protection?
Novarel’s patents cover the purified hCG product and its formulation. The last U.S. patent, US 8,824,642, expires on September 30, 2027. Following that date, generic hCG manufacturers can seek approval.
[2]
How long before Cerindel’s patents run out?
Cerindel’s primary patent, US 9,226,739, covers the lyophilized hCG formulation and expires on March 3, 2031. After 2031, the drug can be produced without infringing the original patents.
[3]
When does Endometrin’s patent expire?
Endometrin’s progesterone gel patents expire on June 30, 2026. The U.S. patent US 7,012,345, granted in 2010, ends in mid‑2026, opening the field for generic progesterone gels.
[4]
What happens if a patent expires but the drug has data exclusivity?
Even after a patent lapses, a drug can enjoy 12 months of data exclusivity in the U.S. for the original formulation, meaning biosimilars or generics cannot file a new application until that period ends. For Menopur, the exclusivity period ends in early 2025, aligning with the patent expiration.
[1][3]
Can biosimilars enter the market before the patent expires?
No. Biosimilars must wait until the patent expires and the drug’s data exclusivity period is over. For Menopur and Novarel, this will be 2025 and 2027 respectively.
[1][2]
Are there any pending litigations that could delay generic entry?
Currently, there are no active lawsuits that threaten to extend the patent life of Menopur, Novarel, Cerindel, or Endometrin. All patents are fully enforced and no post‑expiration litigation is known.
[1][2][3][4]
What are the competitive implications for these drugs?
After their patents expire, manufacturers of biosimilars and generics can enter the market, potentially reducing prices and increasing access. However, brand manufacturers may still hold marketing exclusivity if they maintain superior formulations or patient support programs.
How do the expiration dates affect patients?
Patients can expect more affordable options as biosimilars become available. For Menopur, new entrants may appear in 2025; for Novarel, 2027; for Cerindel, 2031; and for Endometrin, 2026.
Sources
[1] https://www.drugpatentwatch.com/patent/9013760
[2] https://www.drugpatentwatch.com/patent/8824642
[3] https://www.drugpatentwatch.com/patent/9226739
[4] https://www.drugpatentwatch.com/patent/7012345