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 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 214094
| Tradename: | ORLADEYO |
| Applicant: | Biocryst |
| Ingredient: | berotralstat dihydrochloride |
| Patents: | 16 |
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 dihydrochloride | 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 dihydrochloride | 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: | 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 7, 2035 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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