Entereg is a drug owned by Cubist Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2015. Out of these, 3 drug patents are active and 3 have expired. Entereg's patents have been open to challenges since 20 May, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2030. Details of Entereg's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8112290 | Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug |
Jul, 2030
(5 years from now) | Active |
| US8946262 | Methods of preventing and treating gastrointestinal dysfunction |
Feb, 2030
(5 years from now) | Active |
| US8645160 | Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug |
Jun, 2029
(4 years from now) | Active |
| US6469030 | Methods for the treatment and prevention of ileus |
Nov, 2020
(4 years ago) |
Expired
|
| US5250542 | Peripherally selective piperidine carboxylate opioid antagonists |
Mar, 2016
(8 years ago) |
Expired
|
| US5434171 | Preparation of 3,4,4-trisubstituted-piperidinyl-N-alkylcarboxylates and intermediates |
Dec, 2013
(11 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 Entereg's patents.
Latest Legal Activities on Entereg's Patents
Given below is the list of recent legal activities going on the following patents of Entereg.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jul, 2023 | US8112290 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jul, 2019 | US8112290 |
| Email Notification Critical | 13 Jul, 2016 | US8112290 |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Jul, 2016 | US8112290 |
| Correspondence Address Change Critical | 12 Jul, 2016 | US8112290 |
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Apr, 2012 | US8112290 |
| Email Notification Critical | 12 Apr, 2012 | US8112290 |
| Correspondence Address Change Critical | 06 Apr, 2012 | US8112290 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Feb, 2012 | US8112290 |
| Recordation of Patent Grant Mailed Critical | 07 Feb, 2012 | US8112290 |
FDA has granted several exclusivities to Entereg. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Entereg, 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 Entereg.
Exclusivity Information
Entereg holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Entereg's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 20, 2013 |
| M(M-128) | Oct 18, 2016 |
US patents provide insights into the exclusivity only within the United States, but Entereg 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 Entereg's family patents as well as insights into ongoing legal events on those patents.
Entereg's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Entereg's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 31, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Entereg Generic API suppliers:
Alvimopan is the generic name for the brand Entereg. 3 different companies have already filed for the generic of Entereg, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Entereg's generic
How can I launch a generic of Entereg before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Entereg's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Entereg'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 Entereg -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12 mg | 16 Jun, 2017 | 1 | 19 Dec, 2019 | 31 Jul, 2030 | Deferred |
About Entereg
Entereg is a drug owned by Cubist Pharmaceuticals Inc. It is used for accelerating gastrointestinal recovery following bowel resection surgeries. Entereg uses Alvimopan as an active ingredient. Entereg was launched by Cubist Pharms in 2008.
Approval Date:
Entereg was approved by FDA for market use on 20 May, 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 Entereg is 20 May, 2008, its NCE-1 date is estimated to be 20 May, 2012.
Active Ingredient:
Entereg uses Alvimopan as the active ingredient. Check out other Drugs and Companies using Alvimopan ingredient
Treatment:
Entereg is used for accelerating gastrointestinal recovery following bowel resection surgeries.
Dosage:
Entereg is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |