When does BioCryst's Orladeyo patent expire?
The primary patent for Orladeyo (berotralstat), developed by BioCryst Pharmaceuticals, is set to expire in 2036 [1]. This patent covers the composition of matter for berotralstat [1].
What is the legal status of Orladeyo's patents?
In 2023, BioCryst filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services [2]. This action was in response to the FDA's tentative approval of a generic version of Orladeyo, which BioCryst argued infringes on its patents [2]. BioCryst asserted that the FDA's approval prematurely allowed a generic competitor onto the market, violating the Hatch-Waxman Act [2].
What happens if the patent is successfully challenged?
If BioCryst's lawsuit is unsuccessful or if its patents are invalidated or circumvented, it could lead to earlier market entry for generic versions of Orladeyo [1]. This would likely result in a decrease in Orladeyo's market share and revenue for BioCryst, as generic drugs typically command lower prices [1].
How does Orladeyo work for hereditary angioedema?
Orladeyo is a once-daily oral therapy designed to treat hereditary angioedema (HAE) [3]. It functions by inhibiting the enzyme plasma kallikrein, which plays a key role in the inflammatory pathways that cause HAE attacks [3]. By blocking plasma kallikrein, Orladeyo helps to reduce the frequency of these attacks [3].
What is the difference between Orladeyo and other HAE treatments?
Orladeyo is notable for being the first and only oral therapy for HAE, offering a convenient daily dosing option [3]. Many other HAE treatments are administered via injection or infusion, and may be used for on-demand treatment of acute attacks [4].
Who are BioCryst's competitors in the HAE market?
BioCryst faces competition from other pharmaceutical companies with approved treatments for HAE. These include drugs like Takhzyro (lanadelumab) from Takeda, Cinryze (C1 esterase inhibitor human) from CSL Behring, and Haegarda (C1 esterase inhibitor subcutaneous) also from CSL Behring [4].
What is the patient outlook for Orladeyo?
For patients with HAE, Orladeyo offers a new oral treatment option aimed at reducing attack frequency. Its oral administration may improve adherence and quality of life compared to injectable therapies [3].
Where can I find more information on drug patents?
Information regarding drug patents, including expiration dates and legal challenges, can be found on DrugPatentWatch.com [1].
---
This information is based on data from DrugPatentWatch.com and other publicly available sources. Patent litigation and timelines can be complex and are subject to change.
Sources
[1] https://drugpatentwatch.com/
[2] BioCryst Pharmaceuticals, Inc. v. United States Food and Drug Administration, et al., Case No. 1:23-cv-02776 (D.D.C. 2023)
[3] BioCryst Pharmaceuticals. (n.d.). Orladeyo. Retrieved from [BioCryst Pharmaceuticals website]
[4] Hereditary Angioedema. (n.d.). National Organization for Rare Disorders. Retrieved from [National Organization for Rare Disorders website]