DIACOMIT Drug Patent 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 1 |
| Patent Applications: | 1,225 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for DIACOMIT
US Patents and Regulatory Information for DIACOMIT
DIACOMIT is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DIACOMIT is See Plans and Pricing.
This potential generic entry date is based on INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
FDA Regulatory Exclusivity protecting DIACOMIT
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
Exclusivity Expiration: See Plans and Pricing
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Biocodex Sa | DIACOMIT | stiripentol | FOR SUSPENSION;ORAL | 207223-002 | Aug 20, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Biocodex Sa | DIACOMIT | stiripentol | CAPSULE;ORAL | 206709-002 | Aug 20, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
