AMPYRA Drug Patent Profile
✉ Email this page to a colleague
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 |
Hospital for Special Surgery, New York | Phase 1 |
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 | ⤷ 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 |
---|---|---|---|
European Patent Office | 2422782 | Utilisation de compositions d'aminopyridine à libération soutenue (Methods of Using Sustained Release Aminopyridine Compositions) | ⤷ Try a Trial |
Spain | 2406604 | ⤷ Try a Trial | |
Poland | 1732548 | ⤷ Try a Trial | |
Poland | 2377536 | ⤷ 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 | 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 |
0484186 | C300503 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDINE EN DERIVATEN DAARVAN; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 |
1732548 | PA2012001,C1732548 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
1732548 | 122011100058 | Germany | ⤷ Try a Trial | 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 |