The U.S. patent for Orladeyo (vernakalant), developed by BioCryst Pharmaceuticals, is set to expire in 2037 [1]. This patent, U.S. Patent No. 9,707,402, covers the drug's composition of matter and its method of use [2].
What is Orladeyo used for?
Orladeyo is a once-daily oral therapy approved for the preventative treatment of hereditary angioedema (HAE) attacks in adult and adolescent patients [3]. HAE is a rare genetic disorder characterized by recurrent, unpredictable swelling episodes [4].
When does Orladeyo's market exclusivity end?
Beyond patent expiration, other forms of market exclusivity can affect a drug's commercial life. For instance, the drug may have received regulatory exclusivities, such as New Chemical Entity (NCE) exclusivity, which can provide additional years of protection from generic competition after FDA approval [5]. Information regarding specific regulatory exclusivities for Orladeyo can be found through patent databases [1].
What happens when Orladeyo's patent expires?
Upon the expiration of its U.S. patent in 2037, generic manufacturers may be able to seek approval from the Food and Drug Administration (FDA) to market biosimilar versions of Orladeyo [6]. This typically leads to increased competition and potentially lower prices for the medication [7].
Can biosimilars be approved before patent expiration?
The pathway for biosimilar approval in the United States, governed by the Biologics Price Competition and Innovation Act (BPCIA), can allow for abbreviated approval processes [8]. However, the earliest a biosimilar can be approved and enter the market is generally after the expiration of a drug's primary patent or other market exclusivities, unless specific patent litigation outcomes or licensing agreements permit earlier entry [9]. For Orladeyo, with a patent expiration date of 2037, generic competition would likely not be expected before this time [1].
Who manufactures Orladeyo?
Orladeyo is developed and manufactured by BioCryst Pharmaceuticals [3].
What are the patent details for Orladeyo?
The key U.S. patent protecting Orladeyo is U.S. Patent No. 9,707,402. This patent provides protection for the drug until its expiration in 2037 [1][2]. DrugPatentWatch.com is a resource that tracks such patent information for pharmaceutical products [1].
How is Orladeyo's patent challenged?
Pharmaceutical patents can sometimes face legal challenges from generic drug manufacturers seeking to introduce their products to the market sooner [10]. These challenges often involve allegations of patent invalidity or non-infringement. Specific details regarding any ongoing or past patent litigation concerning Orladeyo would typically be found in legal dockets or specialized patent litigation databases [1].
What is the cost of Orladeyo?
The cost of Orladeyo can vary significantly depending on factors such as insurance coverage, pharmacy, and geographic location [11]. As a specialty medication for a rare disease, it is generally considered expensive [12]. Pricing information is often available through patient assistance programs or by consulting with healthcare providers and pharmacies [11].
Are there alternative treatments for hereditary angioedema?
Yes, there are other treatments available for hereditary angioedema, including both acute attack treatments and prophylactic therapies [13]. These alternatives may include different classes of drugs that target various pathways involved in HAE pathogenesis [14]. A healthcare provider can discuss the most suitable treatment options based on an individual's HAE type, frequency and severity of attacks, and overall health [4].
Sources:
[1] DrugPatentWatch.com
[2] U.S. Patent No. 9,707,402
[3] BioCryst Pharmaceuticals
[4] National Institute of Allergy and Infectious Diseases
[5] FDA
[6] U.S. Food and Drug Administration
[7] Congressional Research Service
[8] U.S. Congress
[9] The K&L Gates Health Law Blog
[10] American Intellectual Property Law Association
[11] GoodRx
[12] PriceWaterhouseCoopers
[13] HAE Advocacy Groups
[14] Mayo Clinic