AMPYRA Drug Patent Profile

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 23^rd, 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

See drug prices for AMPYRA

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

See all AMPYRA clinical trials

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

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
Acorda	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010

International Patents for AMPYRA

See the table below for patents covering AMPYRA around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1111754
Austria	E511841
Japan	2012188427	METHOD OF USING SUSTAINED-RELEASE AMINOPYRIDINE COMPOSITION
Ireland	82916	FORMULATIONS AND THEIR USE IN THE TREATMENT OF NEUROLOGICAL DISEASES
Mexico	370434	MÉTODOS PARA UTILIZAR COMPOSICIONES DE LIBERACION SOSTENIDA DE AMINOPIRIDINA. (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS.)

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2377536	1390026-1	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250412 - 20260724
2377536	C300612	Netherlands		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	C02377536/01	Switzerland		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019
2377536	SPC/GB13/050	United Kingdom		PRODUCT NAME: 4-AMINOPYRIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/699/001-004 20110725
0484186	CA 2011 00031	Denmark