Details for Patent: 11,857,683
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Which drugs does patent 11,857,683 protect, and when does it expire?
Patent 11,857,683 protects SEZABY and is included in one NDA.
This patent has two patent family members in one country.
Summary for Patent: 11,857,683
| Title: | Stabilization of phenobarbital sodium for injection |
| Abstract: | The present invention relates to a lyophilized pharmaceutical composition of hydrolytically unstable pharmaceutical compounds, such as phenobarbital or salts thereof. The present invention also relates to an aqueous solution for injection of phenobarbital or salts thereof that is reconstituted from the lyophilized pharmaceutical composition. The pharmaceutical compositions of the present disclosure have an ethanol content in the range from about 5000 ppm to about 70000 ppm. The composition of the present disclosure, in certain embodiments, is stable following two years of storage, wherein the total impurities do not exceed 0.5%. The pharmaceutical compositions of the present disclosure may be used for the treatment of neonatal seizures. |
| Inventor(s): | Malay Shah, Bhushan Borole, Ravi PATEL, Ajay Jaysingh Khopade |
| Assignee: | Sun Pharma Advanced Research Co Ltd |
| Application Number: | US17/715,491 |
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Patent Claim Types: see list of patent claims | Use; Composition; Formulation; |
Drugs Protected by US Patent 11,857,683
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Inc | SEZABY | phenobarbital sodium | POWDER;INTRAVENOUS | 215910-001 | Nov 17, 2022 | RX | Yes | Yes | 11,857,683 | ⤷ Start Trial | Y | METHOD OF TREATING NEONATAL SEIZURES | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 11,857,683
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2023175542 | ⤷ Start Trial | |||
| World Intellectual Property Organization (WIPO) | 2023281441 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
