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Last Updated: December 30, 2024

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DAYBUE Drug Patent Profile


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When do Daybue patents expire, and when can generic versions of Daybue launch?

Daybue is a drug marketed by Acadia Pharms Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in DAYBUE is trofinetide. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.

DrugPatentWatch® Generic Entry Outlook for Daybue

Daybue will be eligible for patent challenges on March 10, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DAYBUE
International Patents:48
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 26
Patent Applications: 23
Drug Prices: Drug price information for DAYBUE
What excipients (inactive ingredients) are in DAYBUE?DAYBUE excipients list
DailyMed Link:DAYBUE at DailyMed
Drug patent expirations by year for DAYBUE
Drug Prices for DAYBUE

See drug prices for DAYBUE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAYBUE
Generic Entry Date for DAYBUE*:
Constraining patent/regulatory exclusivity:
TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER
NDA:
Dosage:
SOLUTION;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 DAYBUE

DAYBUE is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAYBUE is ⤷  Subscribe.

This potential generic entry date is based on TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Acadia Pharms Inc DAYBUE trofinetide SOLUTION;ORAL 217026-001 Mar 10, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acadia Pharms Inc DAYBUE trofinetide SOLUTION;ORAL 217026-001 Mar 10, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Acadia Pharms Inc DAYBUE trofinetide SOLUTION;ORAL 217026-001 Mar 10, 2023 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

International Patents for DAYBUE

See the table below for patents covering DAYBUE around the world.

CountryPatent NumberTitleEstimated Expiration
Colombia 2023017186 Formas cristalinas de trofinetida ⤷  Subscribe
European Patent Office 4369934 FORMES CRISTALLINES DE TROFINÉTIDE (CRYSTALLINE FORMS OF TROFINETIDE) ⤷  Subscribe
Japan 2016210808 グリシル−L−2−メチルプロピル−L−グルタミン酸を用いる自閉症スペクトラム障害の治療 (TREATMENT OF AUTISM SPECTRUM DISORDERS USING GLYCYL-L-2-METHYLPROPYL-L-GLUTAMIC ACID) ⤷  Subscribe
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

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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.