Details for New Drug Application (NDA): 219776
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NDA 219776 describes ORLADEYO, which is a drug marketed by Biocryst and is included in two NDAs. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ORLADEYO profile page.
The generic ingredient in ORLADEYO is berotralstat dihydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the berotralstat dihydrochloride profile page.
The generic ingredient in ORLADEYO is berotralstat dihydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the berotralstat dihydrochloride profile page.
Summary for 219776
| Tradename: | ORLADEYO |
| Applicant: | Biocryst |
| Ingredient: | berotralstat dihydrochloride |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219776
Generic Entry Date for 219776*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 219776
Suppliers and Packaging for NDA: 219776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORLADEYO | berotralstat dihydrochloride | PELLETS;ORAL | 219776 | NDA | BioCryst Pharmaceuticals, Inc. | 72769-111 | 72769-111-02 | 4 DOSE PACK in 1 CARTON (72769-111-02) / 7 PACKET in 1 DOSE PACK / 12 PELLET in 1 PACKET |
| ORLADEYO | berotralstat dihydrochloride | PELLETS;ORAL | 219776 | NDA | BioCryst Pharmaceuticals, Inc. | 72769-112 | 72769-112-02 | 4 DOSE PACK in 1 CARTON (72769-112-02) / 7 PACKET in 1 DOSE PACK / 16 PELLET in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PELLETS;ORAL | Strength | EQ 72MG BASE/PACKET | ||||
| Approval Date: | Dec 11, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 11, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jun 11, 2029 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 7, 2035 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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