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Last Updated: October 2, 2022

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 two suppliers. There are nine 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. Two suppliers are 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:9
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:Aug 25, 2011TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Oct 22, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
Patent:See Plans and PricingPatent Expiration:Oct 22, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
Patent:See Plans and PricingPatent Expiration:Apr 21, 2028Product 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

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 200533-005 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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