Details for New Drug Application (NDA): 200533
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NDA 200533 describes NUCYNTA ER, which is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NUCYNTA ER profile page.
The generic ingredient in NUCYNTA ER 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 ER 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 200533
| Tradename: | NUCYNTA ER |
| Applicant: | Collegium Pharm Inc |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 200533
Generic Entry Date for 200533*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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: 200533
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 200533
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | NDA | Collegium Pharmaceutical, Inc. | 24510-058 | 24510-058-01 | 10 BLISTER PACK in 1 CARTON (24510-058-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533 | NDA | Collegium Pharmaceutical, Inc. | 24510-058 | 24510-058-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-058-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Aug 25, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 11,344,512*PED | Patent Expiration: | Oct 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 7,994,364*PED | Patent Expiration: | Dec 27, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,114,383 | Patent Expiration: | Oct 10, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
Expired US Patents for NDA 200533
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | 8,309,060 | ⤷ Subscribe |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | 8,075,872 | ⤷ Subscribe |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | 8,309,060 | ⤷ Subscribe |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | 8,309,060 | ⤷ Subscribe |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | 8,420,056 | ⤷ Subscribe |
| Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-001 | Aug 25, 2011 | 11,007,156 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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