Suppliers and packagers for generic pharmaceutical drug: berotralstat dihydrochloride

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berotralstat dihydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094	NDA	BioCryst Pharmaceuticals Inc.	72769-101-01	4 DOSE PACK in 1 CARTON (72769-101-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK	2020-12-04
Biocryst	ORLADEYO	berotralstat dihydrochloride	CAPSULE;ORAL	214094	NDA	BioCryst Pharmaceuticals Inc.	72769-102-01	4 DOSE PACK in 1 CARTON (72769-102-01) / 1 BLISTER PACK in 1 DOSE PACK / 7 CAPSULE in 1 BLISTER PACK	2020-12-04
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776	NDA	BioCryst Pharmaceuticals Inc.	72769-111-02	4 DOSE PACK in 1 CARTON (72769-111-02) / 7 PACKET in 1 DOSE PACK / 12 PELLET in 1 PACKET	2025-12-12
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776	NDA	BioCryst Pharmaceuticals Inc.	72769-112-02	4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKET	2025-12-12
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776	NDA	BioCryst Pharmaceuticals Inc.	72769-113-02	4 DOSE PACK in 1 CARTON (72769-113-02) / 7 PACKET in 1 DOSE PACK / 18 PELLET in 1 PACKET	2025-12-12
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776	NDA	BioCryst Pharmaceuticals Inc.	72769-114-02	4 DOSE PACK in 1 CARTON (72769-114-02) / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET	2025-12-12
Biocryst	ORLADEYO	berotralstat dihydrochloride	PELLETS;ORAL	219776	NDA	BioCryst Pharmaceuticals Inc.	72769-115-02	4 DOSE PACK in 1 CARTON (72769-115-02) / 7 PACKET in 1 DOSE PACK / 22 PELLET in 1 PACKET	2026-10-15

Suppliers for Berotralstat Dihydrochloride

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.

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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.

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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.

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Citations

1. BioCryst Pharmaceuticals. (2022). Orladeyo (berotralstat) prescribing information.
2. FDA. (2020). Approval of Orladeyo for hereditary angioedema.
3. European Medicines Agency. (2021). EMA approval for berotralstat.
4. Indian Patent Office. (2023). Patent status and generic approvals.
5. Chinese biotech development reports. (2022). Regional biotech manufacturing progress.