Nucynta is a drug owned by Collegium Pharmaceutical Inc. It is protected by 4 US drug patents filed from 2013 to 2024. Out of these, 2 drug patents are active and 2 have expired. Nucynta's patents will be open to challenges from 03 January, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 03, 2027. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7994364 | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
Jun, 2025
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7994364 (Pediatric) | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
Dec, 2025
(7 months from now) | Active |
| USRE39593 | 1-phenyl-3-dimethylaminopropane compounds with a pharmacological effects |
Aug, 2022
(2 years ago) |
Expired
|
| 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) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nucynta's patents.
Latest Legal Activities on Nucynta's Patents
Given below is the list of recent legal activities going on the following patents of Nucynta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jan, 2023 | US7994364 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Jan, 2019 | US7994364 (Litigated) |
| Request for Trial Denied Critical | 18 Jul, 2016 | US7994364 (Litigated) |
| Petition Requesting Trial | 15 Jan, 2016 | US7994364 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 09 Aug, 2011 | US7994364 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 09 Aug, 2011 | US7994364 (Litigated) |
| Issue Notification Mailed Critical | 20 Jul, 2011 | US7994364 (Litigated) |
| Dispatch to FDC | 13 Jul, 2011 | US7994364 (Litigated) |
| Application Is Considered Ready for Issue Critical | 07 Jul, 2011 | US7994364 (Litigated) |
| Issue Fee Payment Received Critical | 29 Jun, 2011 | US7994364 (Litigated) |
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 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 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 |
|---|---|---|---|---|
 | ||||
| US7994364 | January, 2016 |
Terminated-Denied
(18 Jul, 2016) | 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 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. 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 |
| Pediatric Exclusivity(PED) | Jan 03, 2027 |
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
Explore Our Curated Drug Screens
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 Jan 03, 2027 (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 |
Alternative Brands for Nucynta
Nucynta which is used for managing moderate to severe acute pain and providing relief for moderate to severe acute pain., has several other brand drugs using the same active ingredient (Tapentadol Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Collegium Pharm Inc |
|
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.
Approval Date:
Nucynta was approved by FDA for market use on 20 November, 2008.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Nucynta is 20 November, 2008, its NCE-1 date is estimated to be 03 January, 2026.
Active Ingredient:
Nucynta uses Tapentadol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tapentadol Hydrochloride ingredient
Treatment:
Nucynta is used for managing moderate to severe acute pain and providing relief for moderate to severe acute pain.
Dosage:
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 50MG BASE | TABLET | Prescription | ORAL |
| EQ 75MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |