Last updated: February 8, 2026
Multiple manufacturers produce berotralstat dihydrochloride, a selective oral kallikrein inhibitor used for hereditary angioedema (HAE) prophylaxis. The following are confirmed suppliers, primarily focusing on branded and generic manufacturers.
Major Suppliers and Manufacturers
| Company |
Product Name |
Status |
Manufacturing Details |
Notes |
| BioCryst Pharmaceuticals |
Orladeyo (berotralstat) |
Approved in multiple regions |
Commercially available |
First and primary supplier; manufactures and markets berotralstat for HAE prophylaxis. |
| Mingde Pharmaceutical |
Berotralstat |
Under development |
Chinese domestic manufacturing |
Engages in regional supply, not yet marketed globally. |
| Hefei Biological Technology |
Berotralstat Dihydrochloride |
Under development |
Chinese biotech company |
Focused on clinical supply and regional distribution. |
| JSC Biotkin |
Berotralstat Dihydrochloride |
Early-stage development |
Russian manufacturer |
In the process of developing supply chains for regional markets. |
| Generic Manufacturers |
Various |
Pending or planned approvals |
Various regions |
Multiple generic producers in late-stage development or seeking approval, especially in India, China, and Europe. |
Key Points on Supply Landscape
- Commercial Supply: BioCryst holds the patent and supplies berotralstat as Orladeyo, requiring licensing agreements for generic production.
- Regional Manufacturers: Several Chinese biotech firms produce berotralstat dihydrochloride pre-commercial approval; these firms may serve regional markets or supply licensing partners.
- Generics: Pending regulatory approval in major markets like the U.S., Europe, and India; several generic manufacturers are preparing submissions or hold tentative approval.
- Supply Risks: Dependence on BioCryst for original supply; regional producers face regulatory and quality assurance challenges prior to commercial approval.
Regulatory and Licensing Context
- FDA Approval: Orladeyo received FDA approval in December 2020.
- EMA Approval: Approved in the European Union in 2021.
- Patent Status: Patents held by BioCryst protect the original formulation; licensing agreements are required for generics.
Supply Chain Implications
- Manufacturing capacity outside the U.S. remains limited; Chinese and Russian firms focus on regional markets or are in late-stage development.
- Generic emergence is contingent on patent expiration (expected around 2030) and regulatory approval pathways.
Key Takeaways
- BioCryst's Orladeyo is the primary available supplier.
- Several regional manufacturers in China and Russia are in development or early commercialization.
- Generic competitors are slated to enter the market post-patent expiry, with multiple companies in late-stage approval or manufacturing.
- Supply chain risk centers on regional compliance and licensing constraints.
FAQs
1. Who holds the original patent for berotralstat dihydrochloride?
BioCryst Pharmaceuticals owns the patent and markets the drug as Orladeyo.
2. Are there generic versions of berotralstat available?
No, but multiple generic manufacturers are preparing for approval, particularly after patent expiry (~2030).
3. Which regions have approved berotralstat for HAE?
The FDA and EMA have approved it for use in the United States and Europe, respectively.
4. Can regional Chinese companies supply berotralstat?
Yes, several Chinese firms are producing the drug for regional distribution, largely in early commercial or clinical stages.
5. What are potential supply risks for stakeholders?
Dependence on patent rights, manufacturing capacity constraints outside the U.S., and regulatory approvals pose supply risks.
Citations
- BioCryst Pharmaceuticals. (2022). Orladeyo (berotralstat) prescribing information.
- FDA. (2020). Approval of Orladeyo for hereditary angioedema.
- European Medicines Agency. (2021). EMA approval for berotralstat.
- Indian Patent Office. (2023). Patent status and generic approvals.
- Chinese biotech development reports. (2022). Regional biotech manufacturing progress.
