➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Merck
McKesson
Baxter
Moodys
Colorcon

Last Updated: February 26, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022304

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 022304 describes NUCYNTA, which is a drug marketed by Collegium Pharm Inc and is included in three NDAs. It is available from one supplier. There are seven 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. One supplier is 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:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022304
Generic Entry Date for 022304*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 022304
Mechanism of ActionOpioid 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 Collegium Pharmaceutical, Inc. 24510-050 24510-050-01 10 BLISTER PACK in 1 CARTON (24510-050-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK
NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304 NDA Collegium Pharmaceutical, Inc. 24510-050 24510-050-10 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)
Paragraph IV (Patent) Challenges for 022304
Tradename Dosage Ingredient NDA Submissiondate
NUCYNTA TABLET;ORAL tapentadol hydrochloride 022304 2012-11-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN
Patent:  Start TrialPatent Expiration:Aug 5, 2022Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 75MG BASE
Approval Date:Nov 20, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 27, 2025Product Flag?YSubstance Flag?YDelist Request?
Patented Use:RELIEF OF MODERATE TO SEVERE ACUTE PAIN

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   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008   Start Trial   Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
AstraZeneca
Medtronic
Boehringer Ingelheim
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.