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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 seven 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: | 2 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 203794
Generic Entry Date for 203794*:
Constraining patent/regulatory exclusivity:
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.
Paragraph IV (Patent) Challenges for 203794
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUCYNTA | SOLUTION;ORAL | tapentadol hydrochloride | 203794 | 2013-12-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/ML | ||||
| Approval Date: | Oct 15, 2012 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jun 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 5, 2022 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN | ||||||||
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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