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 |
| Formulation / Manufacturing: | see details |
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: | ⤷ Try a Trial | Patent Expiration: | Apr 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TITRATING AN OPIOID TO MANAGE NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TITRATING AN OPIOID TO MANAGE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY | ||||||||
Expired US Patents for NDA 200533
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