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 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:	3,018
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
Weill Medical College of Cornell University	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	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	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250-001	Jan 22, 2010
Merz Pharms	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
Japan	5736100
Croatia	P20130424
Slovenia	1732548
Luxembourg	92275
European Patent Office	0484186	Formulations et leur utilisation dans le traitement de maladies neurologiques (Formulations and their use in the treatment of neurological diseases)
Denmark	1732548
Australia	2005232732	Methods of using sustained release aminopyridine compositions

Supplementary Protection Certificates for AMPYRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1732548	C20120002 00051	Estonia		PRODUCT NAME: FAMPYRA - FAMPRIDINE;REG NO/DATE: C(2011)5390 FINAL 20.07.2011
2377536	C02377536/01	Switzerland		PRODUCT NAME: FAMPRIDINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67139 22.08.2019
2377536	2013/024	Ireland		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
2377536	CR 2013 00045	Denmark		PRODUCT NAME: FAMPRIDIN ELLER ET SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/11/699/001-002 20110725
2377536	1390026-1	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250412 - 20260724
2377536	92275	Luxembourg		PRODUCT NAME: 4-AMINOPYRIDINE OU UN DERIVE DE CELUI-CI, SPECIALEMENT UN SEL, UN SOLVANT OU UNE PRODROGUE; FIRST REGISTRATION: 20110720
0484186	SPC/GB11/055	United Kingdom		PRODUCT NAME: 4-AMINOPYRIDINE OR A SALT THEREOF; REGISTERED: UK EU/1/11/699/001 20110720; UK EU/1/11/699/002 20110720