Details for New Drug Application (NDA): 214094
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NDA 214094 describes ORLADEYO, which is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ORLADEYO profile page.
The generic ingredient in ORLADEYO is berotralstat hydrochloride. One supplier is listed for this compound. Additional details are available on the berotralstat hydrochloride profile page.
The generic ingredient in ORLADEYO is berotralstat hydrochloride. One supplier is listed for this compound. Additional details are available on the berotralstat hydrochloride profile page.
Summary for 214094
| Tradename: | ORLADEYO |
| Applicant: | Biocryst |
| Ingredient: | berotralstat hydrochloride |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214094
Generic Entry Date for 214094*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 214094
Suppliers and Packaging for NDA: 214094
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094 | NDA | BioCryst Pharmaceuticals Inc. | 72769-101 | 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 |
| ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094 | NDA | BioCryst Pharmaceuticals Inc. | 72769-102 | 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 110MG BASE | ||||
| Approval Date: | Dec 3, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 3, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 3, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 3, 2027 | ||||||||
| Regulatory Exclusivity Use: | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
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