AXERT Drug Patent Profile

When do Axert patents expire, and what generic alternatives are available?

Axert is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Axert

A generic version of AXERT was approved as almotriptan malate by TEVA PHARMS USA on July 7^th, 2015.

Summary for AXERT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	388
Drug Prices:	Drug price information for AXERT
What excipients (inactive ingredients) are in AXERT?	AXERT excipients list
DailyMed Link:	AXERT at DailyMed

See drug prices for AXERT

Paragraph IV (Patent) Challenges for AXERT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AXERT	Tablets	almotriptan malate	6.25 mg and 12.5 mg	021001	1	2005-12-08

US Patents and Regulatory Information for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001		DISCN	Yes	No
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001		DISCN	Yes	No

Expired US Patents for AXERT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-001	May 7, 2001
Janssen Pharms	AXERT	almotriptan malate	TABLET;ORAL	021001-002	May 7, 2001

International Patents for AXERT

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	282659	Derivát indolu, způsob jeho přípravy a farmaceutický prostředek, který ho obsahuje (INDOLE DERIVATIVE, PROCESS OF ITS PREPARATION AND PHARMACEUTICAL PREPARATION IN WHICH IT IS COMPRISED)
Poland	174352
New Zealand	254152	NITROGEN RING SUBSTITUTED SULPHONYL INDOLE DERIVATIVES, AND PHARMACEUTICAL COMPOSITIONS THEREOF
China	1087629
World Intellectual Property Organization (WIPO)	9402460
Poland	302917

Supplementary Protection Certificates for AXERT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0605697	C300053	Netherlands		PRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309
0605697	SPC/GB01/008	United Kingdom		PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
0605697	SPC003/2001	Ireland		SPC003/2001: 20041230, EXPIRES: 20141222
0605697	C00605697/01	Switzerland		FORMER OWNER: LABORATORIOS ALMIRALL, S.A., ES
0605697	2001 00005	Denmark		DKCTFF CA 2001 00005, 20010226, EXPIRES: 20150329
0605697	9/2001	Austria		PRODUCT NAME: ALMOTRIPTAN UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE; NAT. REGISTRATION NO/DATE: 1-23957, 1-23958 20010131; FIRST REGISTRATION: ES 62877 19991223