Ampyra Patent Expiration

Ampyra is a drug owned by Merz Pharmaceuticals Llc A Sub Of Merz Therapeutics Gmbh. It is protected by 6 US drug patents filed from 2013 to 2018. Out of these, 5 drug patents are active and 1 has expired. Ampyra's patents have been open to challenges since 22 January, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be May 26, 2027. Details of Ampyra'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).
US8007826 Sustained release aminopyridine composition
May, 2027

(2 years from now)

Active
US8354437 Method of using sustained release aminopyridine compositions
Dec, 2026

(2 years from now)

Active
US8440703 Methods of using sustained release aminopyridine compositions
Apr, 2025

(3 months from now)

Active
US8663685 Sustained release aminopyridine composition
Jan, 2025

(a month from now)

Active
US9918973 Sustained release aminopyridine composition
Dec, 2024

(2 days from now)

Active
US5540938 Formulations and their use in the treatment of neurological diseases
Jul, 2018

(6 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 Ampyra's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 28 Feb, 2023 US8007826 (Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 20 Sep, 2021 US9918973
Payment of Maintenance Fee, 8th Year, Large Entity 07 Sep, 2021 US8663685
Payment of Maintenance Fee, 8th Year, Large Entity 16 Nov, 2020 US8440703 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 15 Jul, 2020 US8354437 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 28 Feb, 2019 US8007826 (Litigated)
Patent Issue Date Used in PTA Calculation 20 Mar, 2018 US9918973
Recordation of Patent Grant Mailed 20 Mar, 2018 US9918973
Issue Notification Mailed 28 Feb, 2018 US9918973
Review Certificate Mailed 26 Feb, 2018 US8007826 (Litigated)


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

Ampyra's Litigations

Ampyra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 10, 2015, against patent number US8663685. The petitioner Coalition for Affordable Drugs (ADROCA) LLC, challenged the validity of this patent, with Acorda Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Ampyra's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8007826 September, 2015 FWD Entered
(09 Mar, 2017)
Acorda Therapeutics, Inc. Coalition For Affordable Drugs (ADROCA) LLC
US8354437 September, 2015 FWD Entered
(09 Mar, 2017)
Acorda Therapeutics, Inc. Coalition for Affordable Drugs (ADROCA) LLC
US8440703 September, 2015 FWD Entered
(09 Mar, 2017)
Acorda Therapeutics, Inc. Coalition For Affordable Drugs (ADROCA) LLC
US8663685 September, 2015 FWD Entered
(09 Mar, 2017)
Acorda Therapeutics, Inc. Coalition For Affordable Drugs (ADROCA) LLC
US8007826 February, 2015 Terminated-Denied
(24 Aug, 2015)
Acorda Therapeutics, Inc. Coalition for Affordable Drugs (ADROCA) LLC
US8663685 February, 2015 Terminated-Denied
(24 Aug, 2015)
Acorda Therapeutics, Inc. Coalition for Affordable Drugs (ADROCA) LLC


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

Exclusivity Information

Ampyra holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Ampyra's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 22, 2015
Orphan Drug Exclusivity(ODE) Jan 22, 2017

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

Ampyra's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Ampyra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Ampyra Generic API suppliers:

Dalfampridine is the generic name for the brand Ampyra. 8 different companies have already filed for the generic of Ampyra, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ampyra's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg 22 Jan, 2014 8 23 Jan, 2017 26 May, 2027 Eligible





About Ampyra

Ampyra is a drug owned by Merz Pharmaceuticals Llc A Sub Of Merz Therapeutics Gmbh. It is used for improving walking in patients with multiple sclerosis. Ampyra uses Dalfampridine as an active ingredient. Ampyra was launched by Merz Pharms in 2010.

Approval Date:

Ampyra was approved by FDA for market use on 22 January, 2010.

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 Ampyra is 22 January, 2010, its NCE-1 date is estimated to be 22 January, 2014.

Active Ingredient:

Ampyra uses Dalfampridine as the active ingredient. Check out other Drugs and Companies using Dalfampridine ingredient

Treatment:

Ampyra is used for improving walking in patients with multiple sclerosis.

Dosage:

Ampyra is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
10MG TABLET, EXTENDED RELEASE Prescription ORAL