Details for New Drug Application (NDA): 200533
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-004 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-003 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-002 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
Collegium Pharm Inc | NUCYNTA ER | tapentadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200533-005 | Aug 25, 2011 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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