Entereg Patent Expiration

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

(3 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

(10 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.

Given below is the list of recent legal activities going on the following patents of Entereg.

Activity Date Patent Number
Patent litigations
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 13 Jul, 2016 US8112290
Change in Power of Attorney (May Include Associate POA) 13 Jul, 2016 US8112290
Correspondence Address Change 12 Jul, 2016 US8112290
Change in Power of Attorney (May Include Associate POA) 12 Apr, 2012 US8112290
Email Notification 12 Apr, 2012 US8112290
Correspondence Address Change 06 Apr, 2012 US8112290
Patent Issue Date Used in PTA Calculation 07 Feb, 2012 US8112290
Recordation of Patent Grant Mailed 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

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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

Entereg has patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Entereg.

Family Patents

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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