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SEZABY Drug Patent Profile

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

Sezaby is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in one country.

The generic ingredient in SEZABY is phenobarbital sodium. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phenobarbital sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Sezaby

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 17, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SEZABY

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for SEZABY
What excipients (inactive ingredients) are in SEZABY?	SEZABY excipients list
DailyMed Link:	SEZABY at DailyMed

Drug patent expirations by year for SEZABY

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

Generic Entry Date for SEZABY^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS NDA: 215910 Dosage: POWDER;INTRAVENOUS

^*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.

Anatomical Therapeutic Chemical (ATC) Classes for SEZABY

N03AA	Barbiturates and derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

N05CA	Barbiturates, plain
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for SEZABY

SEZABY is protected by one US patents and one FDA Regulatory Exclusivity.

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

This potential generic entry date is based on TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS.
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 SEZABY

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING NEONATAL SEIZURES

FDA Regulatory Exclusivity protecting SEZABY

TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS
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
Sun Pharm Inds Inc	SEZABY	phenobarbital sodium	POWDER;INTRAVENOUS	215910-001	Nov 17, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sun Pharm Inds Inc	SEZABY	phenobarbital sodium	POWDER;INTRAVENOUS	215910-001	Nov 17, 2022		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 SEZABY

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2023175542		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2023281441		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration