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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Questions you can ask:
- What is the 5 year forecast for SEZABY?
- What are the global sales for SEZABY?
- What is Average Wholesale Price for SEZABY?
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 |
![SEZABY drug patent expirations Drug patent expirations by year for SEZABY](/p/graph/s/t/SEZABY-patent-expirations.png)
![Drug Prices for SEZABY](/p/graph/drug-price/SEZABY.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SEZABY
Generic Entry Date for SEZABY*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS NDA:
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.
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 ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING NEONATAL SEIZURES
FDA Regulatory Exclusivity protecting SEZABY
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Sun Pharm Inds Inc | SEZABY | phenobarbital sodium | POWDER;INTRAVENOUS | 215910-001 | Nov 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2023281441 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2023175542 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |