Nucynta Er is a drug owned by Collegium Pharmaceutical Inc. It is protected by 13 US drug patents filed from 2013 to 2024. Out of these, 6 drug patents are active and 7 have expired. Nucynta Er's patents have been open to challenges since 20 November, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 22, 2029. Details of Nucynta Er'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
(6 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8536130 (Pediatric) | Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain |
Mar, 2029
(4 years from now) | Active |
|
US11344512 (Pediatric) | Titration of tapentadol |
Oct, 2028
(3 years from now) | Active |
| US8536130 | Use of 1 phenyl-3-dimethylamino-propane compounds for treating neuropathic pain |
Sep, 2028
(3 years from now) | Active |
| US11344512 | Titration of tapentadol |
Apr, 2028
(3 years from now) | Active |
|
US7994364 (Pediatric) | Crystalline forms of (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride |
Dec, 2025
(1 year, 4 days from now) | Active |
| US8114383 | Abuse-proofed dosage form |
Oct, 2024
(2 months ago) |
Expired
|
| US8420056 | Abuse-proofed dosage form |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US8075872 | Abuse-proofed dosage form |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US8309060 | Abuse-proofed dosage form |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US11007156 | Prolonged release pharmaceutical composition containing 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol |
Oct, 2022
(2 years ago) |
Expired
|
| 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 Er's patents.
Latest Legal Activities on Nucynta Er's Patents
Given below is the list of recent legal activities going on the following patents of Nucynta Er.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US8309060 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Aug, 2023 | US8114383 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 May, 2023 | US8075872 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jan, 2023 | US7994364 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 31 May, 2022 | US11344512 |
| Recordation of Patent Grant Mailed Critical | 31 May, 2022 | US11344512 |
| Email Notification Critical | 12 May, 2022 | US11344512 |
| Issue Notification Mailed Critical | 11 May, 2022 | US11344512 |
| Dispatch to FDC | 26 Apr, 2022 | US11344512 |
| Application Is Considered Ready for Issue Critical | 26 Apr, 2022 | US11344512 |
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 Er and ongoing litigations to help you estimate the early arrival of Nucynta Er generic.
Nucynta Er's Litigations
Nucynta Er 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 Er'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 Er. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nucynta Er, 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 Er.
Exclusivity Information
Nucynta Er holds 3 exclusivities. All of its exclusivities have expired in 2015. Details of Nucynta Er's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 20, 2013 |
| New Dosage Form(NDF) | Aug 25, 2014 |
| New Indication(I-656) | Aug 28, 2015 |
Several oppositions have been filed on Nucynta Er's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Nucynta Er's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nucynta Er patents.
Nucynta Er's Oppositions Filed in EPO
Nucynta Er has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 14, 2007, by Purdue Pharma Lp. This opposition was filed on patent number EP04763834A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP06706682A | Dec, 2017 | G. L. Pharma GmbH | Revoked |
| EP08749016A | Aug, 2012 | Generics [UK] Limited | Revoked |
| EP2005006983W | Oct, 2009 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP2005006983W | Oct, 2009 | Ypsomed AG | Patent maintained as amended |
| EP04763833A | Mar, 2008 | Purdue Pharma LP | Opposition rejected |
| EP04763834A | Dec, 2007 | Purdue Pharma LP | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Nucynta Er 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 Er's family patents as well as insights into ongoing legal events on those patents.
Nucynta Er's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nucynta Er's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 22, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nucynta Er Generics:
There are no approved generic versions for Nucynta Er as of now.
How can I launch a generic of Nucynta Er before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nucynta Er's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nucynta Er'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 Er -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg | 20 Nov, 2012 | 2 | 27 Jun, 2025 |
Alternative Brands for Nucynta Er
Nucynta Er which is used for managing severe chronic pain, including neuropathic pain associated with diabetic peripheral neuropathy, when other treatment options are inadequate., 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 Er
Nucynta Er is a drug owned by Collegium Pharmaceutical Inc. It is used for managing severe chronic pain, including neuropathic pain associated with diabetic peripheral neuropathy, when other treatment options are inadequate. Nucynta Er uses Tapentadol Hydrochloride as an active ingredient. Nucynta Er was launched by Collegium Pharm Inc in 2011.
Approval Date:
Nucynta Er was approved by FDA for market use on 25 August, 2011.
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 Er is 25 August, 2011, its NCE-1 date is estimated to be 20 November, 2012.
Active Ingredient:
Nucynta Er uses Tapentadol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tapentadol Hydrochloride ingredient
Treatment:
Nucynta Er is used for managing severe chronic pain, including neuropathic pain associated with diabetic peripheral neuropathy, when other treatment options are inadequate.
Dosage:
Nucynta Er is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 250MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 200MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 150MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 100MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |