Movantik Patent Expiration

Movantik is a drug owned by Valinor Pharma Llc. It is protected by 6 US drug patents filed from 2014 to 2015. Out of these, 3 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 02, 2032. Details of Movantik'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.
US7662365 Polymer conjugates of opioid antagonists
Oct, 2022

(1 year, 9 months ago)

Expired
US7786133 Chemically modified small molecules
Sep, 2028

(4 years from now)

Active
US9012469 Crystalline naloxol-peg conjugate
Apr, 2032

(7 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8617530 Polymer conjugates of opioid antagonists
Oct, 2022

(1 year, 9 months ago)

Expired
US7056500 Polymer conjugates of opioid antagonists
Jun, 2024

(28 days ago)

Expired
US8067431 Chemically modified small molecules
Dec, 2024

(4 months from now)

Active


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 Movantik's patents.

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

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 14 Sep, 2022 US9012469
Payment of Maintenance Fee, 12th Year, Large Entity 13 Jan, 2022 US7786133
Patent Term Extension Certificate 06 Dec, 2021 US7786133
Payment of Maintenance Fee, 12th Year, Large Entity 15 Jul, 2021 US7662365
Payment of Maintenance Fee, 8th Year, Large Entity 13 May, 2021 US8617530
Mail Certificate of Correction Memo 06 May, 2021 US9012469
Post Issue Communication - Certificate of Correction 05 May, 2021 US9012469
Certificate of Correction Memo 05 May, 2021 US9012469
Notice of Final Determination -Election Required 16 Feb, 2021 US7662365
Notice of Final Determination -Election Required 16 Feb, 2021 US7786133


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 Movantik and ongoing litigations to help you estimate the early arrival of Movantik generic.

Movantik's Litigations

Movantik has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 15, 2015, against patent number US7786133. The petitioner Neptune Generics, LLC, challenged the validity or infringement of this patent, with NEKTAR THERAPEUTICS as the respondent. Click below to track the latest information on how companies are challenging Movantik's patents.


Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7786133 October, 2015 Terminated-Denied NEKTAR THERAPEUTICS Neptune Generics, LLC


FDA has granted some exclusivities to Movantik. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Movantik, 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 Movantik.

Exclusivity Information

Movantik holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Movantik's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Sep 16, 2019

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

Several oppositions have been filed on Movantik'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 Movantik's generic, the next section provides detailed information on ongoing and past EP oppositions related to Movantik patents.

Movantik's oppositions filed in EPO

Movantik has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 22, 2014, by Generics (Uk) Ltd (Trading As Mylan). This opposition was filed on patent number EP04814802A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP11829686A Sep, 2016 ABG Patentes, S.L. Patent maintained as amended
EP11829686A Sep, 2016 Stada-Arzneimittel Aktiengesellschaft Patent maintained as amended
EP11829686A Sep, 2016 Generics [UK] Limited Patent maintained as amended
EP04814802A Oct, 2014 Generics (UK) Ltd (trading as Mylan) Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Movantik 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 Movantik's family patents as well as insights into ongoing legal events on those patents.

Movantik's family patents

Movantik has patent protection in a total of 43 countries. It's US patent count contributes only to 18.2% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Movantik.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳



Generic Launch

Generic Release Date:

Movantik's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 02, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Movantik Generics:

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

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

You can seek FDA approval to launch a generic drug before the expiration of Movantik's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Movantik'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 Movantik -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
12.5 mg and 25 mg 17 Sep, 2018 2 02 Apr, 2032




About Movantik

Movantik is a drug owned by Valinor Pharma Llc. It is used for managing constipation caused by opioid medications. Movantik uses Naloxegol Oxalate as an active ingredient. Movantik was launched by Valinor in 2014.

Market Authorisation Date:

Movantik was approved by FDA for market use on 16 September, 2014.

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 Movantik is 16 September, 2014, its NCE-1 date is estimated to be 16 September, 2018

Active Ingredient:

Movantik uses Naloxegol Oxalate as the active ingredient. Check out other Drugs and Companies using Naloxegol Oxalate ingredient

Treatment:

Movantik is used for managing constipation caused by opioid medications.

Dosage:

Movantik is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 12.5MG BASE TABLET Prescription ORAL
EQ 25MG BASE TABLET Prescription ORAL