Nucynta Patent Expiration

Nucynta is a drug owned by Collegium Pharmaceutical Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 03, 2026. Details of Nucynta's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7994364 Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride
Jun, 2025

(11 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6071970 Compounds active at a novel site on receptor-operated calcium channels useful for treatment of neurological disorders and diseases
Jun, 2017

(7 years ago)

USRE39593 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects
Aug, 2022

(1 year, 11 months ago)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Nucynta and ongoing litigations to help you estimate the early arrival of Nucynta generic.

Nucynta's Litigations

Nucynta has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 15, 2016, against patent number US7994364. The petitioner Rosellini Scientific, LLC, challenged the validity or infringement of this patent, with Gruenenthal GmbH as the respondent. Click below to track the latest information on how companies are challenging Nucynta's patents.

Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7994364 January, 2016 Terminated-Denied Gruenenthal GmbH Rosellini Scientific, LLC

FDA has granted some exclusivities to Nucynta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nucynta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Nucynta.

Exclusivity Information

Nucynta holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Nucynta's exclusivity codes and their expiration dates are given below.

Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 20, 2013
New Patient Population(NPP) Jul 03, 2026

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US patents provide insights into the exclusivity only within the United States, but Nucynta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nucynta's family patents as well as insights into ongoing legal events on those patents.

Nucynta's family patents

Nucynta has patent protection in a total of 26 countries. It's US patent count contributes only to 27.8% of its total global patent coverage. Click below to unlock the full patent family tree for Nucynta.

Family Patents

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Generic Launch

Generic Release Date:

Nucynta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 03, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Nucynta Generics:

There are no approved generic versions for Nucynta as of now.

How can I launch a generic of Nucynta before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Nucynta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nucynta's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Nucynta -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
50 mg, 75 mg, and 100 mg 20 Nov, 2012 4 27 Jun, 2025
20 mg/mL 20 Dec, 2013 1 27 Jun, 2025

About Nucynta

Nucynta is a drug owned by Collegium Pharmaceutical Inc. It is used for managing moderate to severe acute pain and providing relief for moderate to severe acute pain. Nucynta uses Tapentadol Hydrochloride as an active ingredient. Nucynta was launched by Collegium Pharm Inc in 2008.

Market Authorisation Date:

Nucynta was approved by FDA for market use on 20 November, 2008.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Nucynta is 20 November, 2008, its NCE-1 date is estimated to be 20 November, 2012

Active Ingredient:

Nucynta uses Tapentadol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tapentadol Hydrochloride ingredient


Nucynta is used for managing moderate to severe acute pain and providing relief for moderate to severe acute pain.


Nucynta is available in the following dosage forms - tablet form for oral use, solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 100MG BASE TABLET Prescription ORAL