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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 two patents protecting this drug.

This drug has thirty-six 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:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Patent Applications:	22
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DAYBUE

Generic Entry Date for DAYBUE^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER NDA: 217026 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 two US patents and two FDA Regulatory Exclusivities.

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

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.

Patents protecting DAYBUE

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF RETT SYNDROME OR A SYMPTOM THEREOF

FDA Regulatory Exclusivity protecting DAYBUE

TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026-001	Mar 10, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20220059479	트로피네타이드의 조성물	⤷ Try a Trial
Australia	2012209466	Treatment of Autism Spectrum Disorderes using Glycyl-L-2-Methylprolyl-L-Glutamic Acid	⤷ Try a Trial
Japan	6640275		⤷ Try a Trial
Colombia	2022002616	Composiciones de trofinetida	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for DAYBUE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAYBUE

Patents protecting DAYBUE

FDA Regulatory Exclusivity protecting DAYBUE

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DAYBUE