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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Questions you can ask:
- What is the 5 year forecast for DAYBUE?
- What are the global sales for DAYBUE?
- What is Average Wholesale Price for DAYBUE?
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 |
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.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist 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 |
International Patents for DAYBUE
See the table below for patents covering DAYBUE around the world.
Country | Patent Number | Title | Estimated 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 |