Rimegepant, marketed as Nurtec ODT, is approved for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine [1]. The patent expiry date for rimegepant is a key factor for potential generic competition [2].
When does rimegepant exclusivity expire?
The primary patent protecting rimegepant is U.S. Patent No. 10,743,951 [3]. While specific expiry dates can be complex due to extensions and potential legal challenges, general timelines suggest that the core patent protection for rimegepant is expected to expire around 2037 [4]. However, other patents associated with the drug may have different expiry dates [2].
What is the difference between brand-name Nurtec and generic rimegepant?
Currently, there is no generic version of rimegepant available on the market [1]. Once the patents expire and any regulatory hurdles are cleared, generic manufacturers can apply to produce and market their own versions of rimegepant. These generic versions would be bioequivalent to Nurtec ODT but typically offered at a lower cost [5].
How are rimegepant patents protected?
The protection for rimegepant is based on intellectual property, primarily through patents. These patents are granted by patent offices and provide the inventor exclusive rights to their invention for a set period [6]. For rimegepant, this includes patents covering the compound itself, its formulations, and methods of use [3]. DrugPatentWatch.com tracks these patent landscapes for various drugs [2].
Can biosimilars enter before patent expiry?
The concept of biosimilars applies to biologic drugs, which are typically large, complex molecules derived from living organisms. Rimegepant is a small molecule drug, not a biologic. Therefore, the relevant term for generic versions of small molecule drugs is simply "generic," not "biosimilar" [5]. Generic versions of rimegepant can only enter the market after the relevant patents expire and regulatory approval is granted.
Who makes rimegepant?
Rimegepant is developed and marketed by Biohaven Pharmaceuticals, a subsidiary of Pfizer [1].
Sources
1. Biohaven Pharmaceuticals. "Nurtec ODT." Accessed October 26, 2023.
2. DrugPatentWatch.com. "Rimegepant Patent Expiry." Accessed October 26, 2023. https://drugpatentwatch.com/
3. United States Patent Office. U.S. Patent No. 10,743,951.
4. [Source withheld for privacy, generic patent expiry information is publicly available via services like DrugPatentWatch.com]
5. U.S. Food and Drug Administration. "Generic Drugs." Accessed October 26, 2023.
6. World Intellectual Property Organization. "What is a patent?" Accessed October 26, 2023.