Gocovri Patent Expiration

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
US10646456 Methods of administering amantadine
Jun, 2034

(9 years from now)

Active
US11903908 Methods of administering amantadine
Jun, 2034

(9 years from now)

Active
US11197835 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
US9877933 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
US8741343 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
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, 1 month from now)

Active
US8796337 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month from now)

Active
US8895616 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month from now)

Active
US8895617 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month from now)

Active
US8895615 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month from now)

Active
US8895618 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month from now)

Active
US8889740 Composition and method for treating neurological disease
Nov, 2025

(1 year, 1 month 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.

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

Activity Date Patent Number
Patent litigations
Recordation of Patent eGrant 20 Feb, 2024 US11903908
Mail Patent eGrant Notification 20 Feb, 2024 US11903908
Patent Issue Date Used in PTA Calculation 20 Feb, 2024 US11903908
Recordation of Patent Grant Mailed 20 Feb, 2024 US11903908
Email Notification 20 Feb, 2024 US11903908
Patent eGrant Notification 20 Feb, 2024 US11903908
Email Notification 01 Feb, 2024 US11903908
Issue Notification Mailed 31 Jan, 2024 US11903908
Change in Power of Attorney (May Include Associate POA) 18 Jan, 2024 US11903908
Email Notification 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

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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
Patent litigations
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

Gocovri has patent protection in a total of 9 countries. It has a significant patent presence in the US with 70.0% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Gocovri.

Family Patents

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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 Generics:

Amantadine Hydrochloride is the generic name for the brand Gocovri. 29 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
Osmolex Er


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 137MG BASE CAPSULE, EXTENDED RELEASE Prescription ORAL
EQ 68.5MG BASE CAPSULE, EXTENDED RELEASE Prescription ORAL