AMPYRA Drug Patent Profile

When do Ampyra patents expire, and when can generic versions of Ampyra launch?

Ampyra is a drug marketed by Merz Pharms Gmbh 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:	21
Patent Applications:	3,329
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
MGH Institute of Health Professions	Phase 4
Milton S. Hershey Medical Center	Phase 2/Phase 3
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
Merz Pharms Gmbh	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
Merz Pharms Gmbh	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010
Merz Pharms Gmbh	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	1114073
Montenegro	01721	POSTUPCI ZA PRIMJENU KOMPOZICIJA AMINOPIRIDINA SA PRODUŽENIM OSLOBAĐANJEM (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)
European Patent Office	0484186	Formulations et leur utilisation dans le traitement de maladies neurologiques (Formulations and their use in the treatment of neurological diseases)
Japan	2007532578
Spain	2406604
Austria	E511841
Canada	2562277	UTILISATION DE COMPOSITIONS D'AMINOPYRIDINE A LIBERATION SOUTENUE (METHODS OF USING SUSTAINED RELEASE AMINOPYRIDINE COMPOSITIONS)

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2377536	C02377536/01	Switzerland		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019
1732548	C20120002 00051	Estonia		PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
0484186	11C0049	France		PRODUCT NAME: FAMPRIDINE OU L'UN DE SES DERIVES; REGISTRATION NO/DATE: EU/1/11/699/001 20110720
1732548	122011100058	Germany		PRODUCT NAME: FAMPYRA - ZUSAMMENSETZUNG UMFASSEND FAMPRIDIN SOWIE SALZE ODER ESTER DAVON; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720
1732548	CA 2012 00004	Denmark
2377536	C 2013 021	Romania		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
2377536	25/2013	Austria		PRODUCT NAME: 4-AMINOPYRIDIN ODER DESSEN SALZE; REGISTRATION NO/DATE: EU/1/11/699/001-002 20110720