RANEXA Drug Patent Profile

Which patents cover Ranexa, and what generic alternatives are available?

Ranexa is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ranexa

A generic version of RANEXA was approved as ranolazine by LUPIN LTD on July 29^th, 2013.

Summary for RANEXA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	46
Patent Applications:	2,345
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RANEXA
Drug Sales Revenues:	Drug sales revenues for RANEXA
What excipients (inactive ingredients) are in RANEXA?	RANEXA excipients list
DailyMed Link:	RANEXA at DailyMed

See drug prices for RANEXA

See drug sales revenues for RANEXA

Recent Clinical Trials for RANEXA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 4
Policlinico Universitario Agostino Gemelli	Phase 4
IRCCS San Raffaele	Phase 2

See all RANEXA clinical trials

Pharmacology for RANEXA

Drug Class	Anti-anginal
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RANEXA

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for RANEXA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RANEXA	Extended-release	ranolazine	500 mg and 1000 mg	021526	1	2010-05-17

US Patents and Regulatory Information for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007		DISCN	Yes	No
Gilead	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006		DISCN	Yes	No

Expired US Patents for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007
Gilead	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Gilead	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007

EU/EMA Drug Approvals for RANEXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A. (MIOL)	Ranexa (previously Latixa)	ranolazine	EMEA/H/C/000805 Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,	Authorised	no	no	no	2008-07-08

International Patents for RANEXA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2008069159	SUSTAINED RELEASE RANOLAZINE FORMULATION
Czech Republic	20010879
China	1321088

Supplementary Protection Certificates for RANEXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	PA2008017,C1109558	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558	122008000065	Germany		PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709