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 Acorda 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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Questions you can ask:
- What is the 5 year forecast for AMPYRA?
- What are the global sales for AMPYRA?
- What is Average Wholesale Price for AMPYRA?
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: | 2,943 |
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 |
Weill Medical College of Cornell University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acorda | 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 |
---|---|---|---|---|---|---|---|
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Acorda | 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 |
---|---|---|---|
Slovenia | 1732548 | ⤷ Sign Up | |
Ireland | 903952 | ⤷ Sign Up | |
Hong Kong | 1162971 | METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS | ⤷ Sign Up |
Japan | 5736100 | ⤷ Sign Up | |
Mexico | 370434 | MÉTODOS PARA UTILIZAR COMPOSICIONES DE LIBERACION SOSTENIDA DE AMINOPIRIDINA. (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS.) | ⤷ Sign Up |
Finland | 1732548 | ⤷ Sign Up | |
Czechoslovakia | 9103313 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AMPYRA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
0484186 | 1190033-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: 4-AMINOPYRIDIN ELLER ETT SALT DAERAV; REG. NO/DATE: EU/1/11/699/001 20110720 |
2377536 | 132013902176892 | Italy | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINA(FAMPYRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/699/001-002, 20110720 |
2377536 | C02377536/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019 |
2377536 | C 2013 021 | Romania | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/699/001-002; DATE OF NATIONAL AUTHORISATION: 20110720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/699/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110720 |
1732548 | PA2012001 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
1732548 | 122011100058 | Germany | ⤷ Sign Up | PRODUCT NAME: FAMPYRA - ZUSAMMENSETZUNG UMFASSEND FAMPRIDIN SOWIE SALZE ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |