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. Movantik's patents have been open to challenges since 16 September, 2018. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9012469 | Crystalline naloxol-peg conjugate |
Apr, 2032
(7 years from now) | Active |
| US7786133 | Chemically modified small molecules |
Sep, 2028
(3 years from now) | Active |
| US7662365 | Polymer conjugates of opioid antagonists |
Oct, 2022
(2 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8067431 | Chemically modified small molecules |
Dec, 2024
(23 days from now) | Active |
| US7056500 | Polymer conjugates of opioid antagonists |
Jun, 2024
(4 months ago) |
Expired
|
| US8617530 | Polymer conjugates of opioid antagonists |
Oct, 2022
(2 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 Movantik's patents.
Latest Legal Activities on Movantik's Patents
Given below is the list of recent legal activities going on the following patents of Movantik.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 Critical | 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 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 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 |
|---|---|---|---|---|
 | ||||
| US7786133 | October, 2015 |
Terminated-Denied
(27 Apr, 2016) | 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 |
Alternative Brands for Movantik
Movantik which is used for managing constipation caused by opioid medications., has several other brand drugs in the same treatment category . 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.
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.
Approval Date:
Movantik was approved by FDA for market use on 16 September, 2014.
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 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 |