Details for New Drug Application (NDA): 022304
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NDA 022304 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 022304
| Tradename: | NUCYNTA |
| Applicant: | Collegium Pharm Inc |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022304
Generic Entry Date for 022304*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
TABLET;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.
Pharmacology for NDA: 022304
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 022304
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304 | NDA | Collegium Pharmaceutical, Inc. | 24510-050 | 24510-050-01 | 10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK |
| NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304 | NDA | Collegium Pharmaceutical, Inc. | 24510-050 | 24510-050-10 | 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Nov 20, 2008 | 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 022304
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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