The primary patent protecting Orladeyo (vernakalant) is set to expire in 2025 [1].
When Can Generic Versions of Orladeyo Enter the Market?
The exclusivity period for Orladeyo is tied to its patent expiration date. Once the patent expires in 2025, generic manufacturers may be able to seek approval and launch their versions of the drug.
What is Orladeyo Used For?
Orladeyo is a medication used to treat the symptoms of bradykinin-responsive hereditary angioedema (HAE) in adult patients [2]. HAE is a rare genetic disorder that causes swelling in various parts of the body [3].
How Does Orladeyo Work?
Orladeyo is an oral kallikrein inhibitor. It works by inhibiting plasma kallikrein, an enzyme that plays a role in the inflammatory pathway that causes HAE attacks [2].
Who Makes Orladeyo?
Orladeyo is manufactured by BioCryst Pharmaceuticals [2].
What is the Patent Status of Orladeyo?
The key patent for Orladeyo is expected to expire in 2025. DrugPatentWatch.com tracks patent information for many medications, including Orladeyo [1].
Are There Any Other Protections for Orladeyo Besides Patents?
Beyond patent protection, regulatory exclusivity periods can also play a role in market exclusivity. For instance, Orladeyo received 5 years of Orphan Drug Exclusivity (ODE) in the United States upon its approval in December 2020, meaning generic competitors cannot be approved for the same use during this period unless specifically allowed by law [4]. This ODE in the US would expire in December 2025.
What Are the Competitors to Orladeyo?
The market for HAE treatments includes other medications that target bradykinin pathways or use different mechanisms to manage attacks. Some of these include Takhzyro (lanadelumab-flyo) and Cinryze (cledacizumab pegol) [5].
What Are the Potential Risks or Side Effects of Orladeyo?
Common side effects associated with Orladeyo include upper respiratory tract infection, headache, and diarrhea [2]. Patients with HAE should discuss potential risks and benefits with their healthcare provider.
Sources:
[1] DrugPatentWatch.com
[2] BioCryst Pharmaceuticals. (2023). Orladeyo® (berotralstat) U.S. Prescribing Information.
[3] National Institutes of Health. (n.d.). Hereditary Angioedema.
[4] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations and Approvals.
[5] Hereditary Angioedema Association. (n.d.). Treatment Options.