Phenobarbital sodium - Generic Drug Details
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What are the generic sources for phenobarbital sodium and what is the scope of patent protection?
Phenobarbital sodium
is the generic ingredient in one branded drug marketed by Sun Pharm Inds Inc and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Phenobarbital sodium has two patent family members in one country.
There are three drug master file entries for phenobarbital sodium. One supplier is listed for this compound.
Summary for phenobarbital sodium
| International Patents: | 2 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 13 |
| Patent Applications: | 2,289 |
| What excipients (inactive ingredients) are in phenobarbital sodium? | phenobarbital sodium excipients list |
| DailyMed Link: | phenobarbital sodium at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for phenobarbital sodium
Generic Entry Date for phenobarbital sodium*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS 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.
Recent Clinical Trials for phenobarbital sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Kingston Health Sciences Centre | Phase 1/Phase 2 |
| Bruyere Research Institute | Phase 1/Phase 2 |
| Ottawa Hospital Research Institute | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for phenobarbital sodium
US Patents and Regulatory Information for phenobarbital sodium
| 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 | ⤷ Sign Up | ||||
| Sun Pharm Inds Inc | SEZABY | phenobarbital sodium | POWDER;INTRAVENOUS | 215910-001 | Nov 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
