Ampyra Drug Patent Profile
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When do Ampyra patents expire, and what generic alternatives are available?
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.
Summary for Ampyra
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 163 |
Clinical Trials: | 20 |
Patent Applications: | 2,922 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Milton S. Hershey Medical Center | Phase 2/Phase 3 |
Weill Medical College of Cornell University | Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Acorda | AMPYRA | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 022250-001 | Jan 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Austria | 511841 | ⤷ Try a Trial | |
South Africa | 9108711 | ⤷ Try a Trial | |
Ireland | 903952 | ⤷ Try a Trial | |
Spain | 2141706 | ⤷ Try a Trial | |
Slovenia | 1732548 | ⤷ Try a Trial | |
Canada | 2870734 | UTILISATION DE COMPOSITIONS D'AMINOPYRIDINE A LIBERATION SOUTENUE (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Ampyra
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2377536 | 122013000046 | Germany | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDIN ODER EIN DERIVAT DAVON, INSBESONDERE EIN SALZ, EIN SOLVAT ODER EINE PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 |
2377536 | 92275 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720 |
2377536 | PA2013015 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
0484186 | 11C0049 | France | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720 |
0484186 | SPC/GB11/055 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720 |
2377536 | 2013/024 | Ireland | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |