AMPYRA Drug Patent Profile
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When do Ampyra patents expire, and when can generic versions of Ampyra launch?
Ampyra is a drug marketed by Merz Pharms and is included in one NDA.
The generic ingredient in AMPYRA is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ampyra
A generic version of AMPYRA was approved as dalfampridine by ACTAVIS LABS FL INC on January 23rd, 2017.
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Summary for AMPYRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 163 |
| Clinical Trials: | 21 |
| Patent Applications: | 3,018 |
| Drug Prices: | Drug price information for AMPYRA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AMPYRA |
| What excipients (inactive ingredients) are in AMPYRA? | AMPYRA excipients list |
| DailyMed Link: | AMPYRA at DailyMed |
Recent Clinical Trials for AMPYRA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MGH Institute of Health Professions | Phase 4 |
| Milton S. Hershey Medical Center | Phase 2/Phase 3 |
| Hospital for Special Surgery, New York | Phase 1 |
Pharmacology for AMPYRA
| Drug Class | Potassium Channel Blocker |
| Mechanism of Action | Potassium Channel Antagonists |
Paragraph IV (Patent) Challenges for AMPYRA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AMPYRA | Extended-release Tablets | dalfampridine | 10 mg | 022250 | 8 | 2014-01-22 |
US Patents and Regulatory Information for AMPYRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Merz Pharms | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AMPYRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merz Pharms | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Merz Pharms | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMPYRA
See the table below for patents covering AMPYRA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5736100 | ⤷ Sign Up | |
| Croatia | P20130424 | ⤷ Sign Up | |
| Slovenia | 1732548 | ⤷ Sign Up | |
| Luxembourg | 92275 | ⤷ Sign Up | |
| European Patent Office | 0484186 | Formulations et leur utilisation dans le traitement de maladies neurologiques (Formulations and their use in the treatment of neurological diseases) | ⤷ Sign Up |
| Denmark | 1732548 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMPYRA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1732548 | C20120002 00051 | Estonia | ⤷ Sign Up | PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011 |
| 2377536 | C02377536/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019 |
| 2377536 | 2013/024 | Ireland | ⤷ Sign Up | PRODUCT NAME: 4-AMINOPYRIDINE (FAMPRIDINE) OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/11/699/001-EU/1/22/699-002 20110720 |
| 2377536 | CR 2013 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: FAMPRIDIN ELLER ET SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/11/699/001-002 20110725 |
| 2377536 | 1390026-1 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20250412 - 20260724 |
| 2377536 | 92275 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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