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 two suppliers. There are two 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. Three suppliers are 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. Three suppliers are 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: | 0 |
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 AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-0942 | 0054-0942-25 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25) |
| NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304 | NDA AUTHORIZED GENERIC | Hikma Pharmaceuticals USA Inc. | 0054-0943 | 0054-0943-25 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0943-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Nov 20, 2008 | TE: | AB | 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 | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Nov 20, 2008 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Jul 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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 | 022304-001 | Nov 20, 2008 | 6,071,970 | ⤷ Get Started Free |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | 6,071,970 | ⤷ Get Started Free |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-002 | Nov 20, 2008 | RE39593 | ⤷ Get Started Free |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-001 | Nov 20, 2008 | RE39593 | ⤷ Get Started Free |
| Collegium Pharm Inc | NUCYNTA | tapentadol hydrochloride | TABLET;ORAL | 022304-003 | Nov 20, 2008 | 6,071,970 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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