You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 15, 2026

Tapentadol - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


Generic filers with tentative approvals for TAPENTADOL
Applicant Application No. Strength Dosage Form
⤷  Start Trial⤷  Start Trial50MGTABLET;ORAL
⤷  Start Trial⤷  Start Trial250MGTABLET, EXTENDED RELEASE;ORAL
⤷  Start Trial⤷  Start Trial200MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for tapentadol

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Humanwell TAPENTADOL HYDROCHLORIDE tapentadol hydrochloride TABLET;ORAL 214378-001 Jan 27, 2026 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride SOLUTION;ORAL 203794-001 Oct 15, 2012 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-004 Aug 25, 2011 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Humanwell TAPENTADOL HYDROCHLORIDE tapentadol hydrochloride TABLET;ORAL 214378-003 Jan 27, 2026 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Subscribe to access the full database, or Start Trial

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

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.

 
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links