AMPYRA Drug Patent Profile
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Which patents cover Ampyra, 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.
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 |
---|---|---|---|
Greece | 3032769 | ⤷ Try a Trial | |
Slovenia | 2377536 | ⤷ Try a Trial | |
Japan | H04273820 | MIXTURE AND USE THEREOF IN TREATMENT OF NERVOUS DISEASE | ⤷ Try a Trial |
Japan | 2012188427 | METHOD OF USING SUSTAINED-RELEASE AMINOPYRIDINE COMPOSITION | ⤷ Try a Trial |
Luxembourg | 91933 | ⤷ Try a Trial | |
Slovenia | 1732548 | ⤷ 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 | C300612 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: 4-AMINOPYRIDINE, DAN WEL EEN DERIVAAT DAARVAN, IN HET BIJZONDER EEN ZOUT, SOLVAAT OF PRODRUG; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720 |
2377536 | 13C0033 | France | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110725 |
2377536 | CR 2013 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDIN ELLER ET SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/11/699/001-002 20110725 |
1732548 | C20120002 00051 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011 |
1732548 | PA2012001 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: EU/1/11/699/001 - EU/1/11/699/002 20110720 |
2377536 | 132013902176892 | Italy | ⤷ Try a Trial | PRODUCT NAME: FAMPRIDINA(FAMPYRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/699/001-002, 20110720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |