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Last Updated: December 23, 2024

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 eight 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.
Summary for 214094
Tradename:ORLADEYO
Applicant:Biocryst
Ingredient:berotralstat hydrochloride
Patents:8
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.

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:RXDosage:CAPSULE;ORALStrengthEQ 110MG BASE
Approval Date:Dec 3, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 3, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
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:⤷  SubscribePatent Expiration:Apr 7, 2035Product Flag?Substance Flag?YDelist Request?
Patented Use:PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.