Details for New Drug Application (NDA): 203794
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NDA 203794 describes NUCYNTA, which is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. There are four patents protecting this drug and four Paragraph IV challenges. Additional details are available on the NUCYNTA profile page.
The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
The generic ingredient in NUCYNTA is tapentadol hydrochloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 203794
| Tradename: | NUCYNTA |
| Applicant: | Collegium Pharm Inc |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203794
Generic Entry Date for 203794*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SOLUTION;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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 15, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jan 3, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 203794
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | SOLUTION;ORAL | 203794-001 | Oct 15, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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