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DIACOMIT Drug Profile
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When do Diacomit patents expire, and when can generic versions of Diacomit launch?
Diacomit is a drug marketed by Biocodex Sa and is included in two NDAs.
The generic ingredient in DIACOMIT is stiripentol. One supplier is listed for this compound. Additional details are available on the stiripentol profile page.
Summary for DIACOMIT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 53 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,066 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DIACOMIT |
| What excipients (inactive ingredients) are in DIACOMIT? | DIACOMIT excipients list |
| DailyMed Link: | DIACOMIT at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for DIACOMIT
Generic Entry Dates for DIACOMIT*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for DIACOMIT*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM NDA:
Dosage:
FOR SUSPENSION;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.
Recent Clinical Trials for DIACOMIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Biocodex | Phase 2 |
US Patents and Regulatory Information for DIACOMIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-001 | Aug 20, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-001 | Aug 20, 2018 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
