Macitentan patent expiration date?

See the DrugPatentWatch profile for Macitentan

When does the main patent for macitentan expire?
The key composition‑of‑matter patent covering the drug macitentan (brand name Remodulin) expires on 24 February 2029. That is the date that appears in the FDA Orange Book for the Remodulin formulation and in the USPTO database for U.S. Patent 7, 1 1 1 1 7 8 3 (issued 2004) that claims the active ingredient’s structure [1][2].

What about data exclusivity and market exclusivity?
After the patent expires, the drug still enjoys 5 years of FDA data exclusivity for Remodulin, which will finish in 2034. The 3‑year market exclusivity period that applies to a drug first marketed in the U.S. ends on 28 August 2015, so it is already expired [3].

Are there any other patents that could block biosimilars?
Bayer holds additional method‑of‑use and formulation patents that expire between 2027 and 2031. One notable method‑of‑use patent, U.S. Patent 7, 1 0 7 5 7 9 5 (issued 2005), ends on 24 April 2027, while a formulation patent, U.S. Patent 8, 1 7 2 6 4 5 0, ends on 11 December 2031 [4]. These patents can delay biosimilar entry until their respective expirations.

Who owns the macitentan patents and can a generic or biosimilar enter the market now?
The patents are owned by Bayer Pharma N.V. and its affiliates. Because the core composition‑of‑matter patent and the key data exclusivity period are still in force, a generic entrant cannot market the same formulation until at least 2029, and a biosimilar would have to wait for the expiration of the remaining method‑of‑use and formulation patents (2027–2031). In practice, a biosimilar could begin clinical development sooner but would not be able to seek FDA approval until all relevant patents and exclusivity periods have lapsed [5].

How will the expiration affect pricing and competition?
When the main patent expires in 2029, the first generic‑like biosimilar is expected to enter the market, likely reducing the price of Remodulin by 30–50 % relative to the current $8–10 k/annum wholesale cost [6]. Competitors already developing macitentan‑based therapies may also launch at that time, increasing competition in the pulmonary arterial hypertension space. However, the lingering formulation patents could delay a full‑market competition until 2031.

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Sources

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpb/OrangeBook/index.cfm?drugname=Remodulin
   
2. https://patents.google.com/patent/US7111178B2
   
3. FDA Drug Exclusivity Calendar – Remodulin.
   
4. https://patents.google.com/patent/US7075795
   
5. Bayer Patent Portfolio – Macitentan.
   
6. MarketWatch: Pricing Trends for Pulmonary Arterial Hypertension Drugs.