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Last Updated: April 10, 2021

DrugPatentWatch Database Preview

ORLADEYO Drug Profile

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Which patents cover Orladeyo, and what generic alternatives are available?

Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-eight patent family members in twenty-one countries.

The generic ingredient in ORLADEYO is berotralstat hydrochloride. Additional details are available on the berotralstat hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Orladeyo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ORLADEYO
International Patents:28
US Patents:4
Applicants:1
NDAs:1
What excipients (inactive ingredients) are in ORLADEYO?ORLADEYO excipients list
DailyMed Link:ORLADEYO at DailyMed
Drug patent expirations by year for ORLADEYO
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ORLADEYO
Generic Entry Date for ORLADEYO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for ORLADEYO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Express Scripts
Colorcon
Medtronic

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.