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, 4 drug patents are active and 2 have 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
(30 days from now) | Active |
| US9918973 | Sustained release aminopyridine composition |
Dec, 2024
(5 days ago) |
Expired
|
| 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 20 Mar, 2018 | US9918973 |
| Recordation of Patent Grant Mailed Critical | 20 Mar, 2018 | US9918973 |
| Issue Notification Mailed Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 |