Gocovri is a drug owned by Supernus Pharmaceuticals Inc. It is protected by 19 US drug patents filed from 2017 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 23, 2038. Details of Gocovri'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). | |||
| US11065213 | Amantadine compositions and preparations thereof |
Aug, 2038
(13 years from now) | Active |
| US11077073 | Methods of using amantadine compositions |
Aug, 2038
(13 years from now) | Active |
| US10154971 | Methods of administering amantadine |
Dec, 2034
(10 years from now) | Active |
| US11903908 | Methods of administering amantadine |
Jun, 2034
(9 years from now) | Active |
| US10646456 | Methods of administering amantadine |
Jun, 2034
(9 years from now) | Active |
| US9877933 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US8741343 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US9867792 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US9867791 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US9867793 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US11197835 | Method of administering amantadine prior to a sleep period |
Dec, 2030
(6 years from now) | Active |
| US8389578 | Composition and method for treating neurological disease |
Jan, 2028
(3 years from now) | Active |
| US8895614 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8895615 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8895616 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8796337 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8895617 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8895618 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days from now) | Active |
| US8889740 | Composition and method for treating neurological disease |
Nov, 2025
(1 year, 7 days 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 Gocovri's patents.
Latest Legal Activities on Gocovri's Patents
Given below is the list of recent legal activities going on the following patents of Gocovri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent eGrant | 20 Feb, 2024 | US11903908 |
| Mail Patent eGrant Notification | 20 Feb, 2024 | US11903908 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Feb, 2024 | US11903908 |
| Recordation of Patent Grant Mailed Critical | 20 Feb, 2024 | US11903908 |
| Email Notification Critical | 20 Feb, 2024 | US11903908 |
| Patent eGrant Notification | 20 Feb, 2024 | US11903908 |
| Email Notification Critical | 01 Feb, 2024 | US11903908 |
| Issue Notification Mailed Critical | 31 Jan, 2024 | US11903908 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Jan, 2024 | US11903908 |
| Email Notification Critical | 18 Jan, 2024 | US11903908 |
FDA has granted several exclusivities to Gocovri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gocovri, 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 Gocovri.
Exclusivity Information
Gocovri holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Gocovri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-769) | Aug 24, 2020 |
| New Product(NP) | Aug 24, 2020 |
| Orphan Drug Exclusivity(ODE) | Aug 24, 2024 |
| Orphan Drug Exclusivity(ODE-153) | Aug 24, 2024 |
Several oppositions have been filed on Gocovri'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 Gocovri's generic, the next section provides detailed information on ongoing and past EP oppositions related to Gocovri patents.
Gocovri's Oppositions Filed in EPO
Gocovri has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 20, 2017, by Ahrens, Gabriele. This opposition was filed on patent number EP10835150A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10835150A | Apr, 2017 | Ahrens, Gabriele | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Gocovri 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 Gocovri's family patents as well as insights into ongoing legal events on those patents.
Gocovri's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gocovri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 23, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gocovri Generic API suppliers:
Amantadine Hydrochloride is the generic name for the brand Gocovri. 30 different companies have already filed for the generic of Gocovri, with Strides Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gocovri's generic
How can I launch a generic of Gocovri before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gocovri's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gocovri'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 Gocovri -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 137 mg | 16 Jan, 2018 | 1 | 02 Dec, 2030 | ||
| 68.5 mg | 30 Apr, 2020 | 1 | 04 Dec, 2034 |
Alternative Brands for Gocovri
Gocovri which is used for managing motor complications in patients with Parkinson's disease receiving levodopa-based therapy., has several other brand drugs using the same active ingredient (Amantadine 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 | |
|---|---|---|
| Supernus Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Amantadine Hydrochloride, Gocovri's active ingredient. Check the complete list of approved generic manufacturers for Gocovri
About Gocovri
Gocovri is a drug owned by Supernus Pharmaceuticals Inc. It is used for managing motor complications in patients with Parkinson's disease receiving levodopa-based therapy. Gocovri uses Amantadine Hydrochloride as an active ingredient. Gocovri was launched by Supernus Pharms in 2017.
Can you believe Gocovri received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Gocovri was approved by FDA for market use on 24 August, 2017.
Active Ingredient:
Gocovri uses Amantadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Amantadine Hydrochloride ingredient
Treatment:
Gocovri is used for managing motor complications in patients with Parkinson's disease receiving levodopa-based therapy.
Dosage:
Gocovri is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 68.5MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| EQ 137MG BASE | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |