RANEXA Drug Patent Profile

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

Ranexa is a drug marketed by Menarini Intl 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-seven 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 CHARTWELL RX on July 29^th, 2013.

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Summary for RANEXA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	46
Patent Applications:	2,163
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

Drug patent expirations by year for RANEXA

Recent Clinical Trials for RANEXA

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

Sponsor	Phase
Policlinico Universitario Agostino Gemelli	Phase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	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

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

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Glossary

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

Expired US Patents for RANEXA

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

EU/EMA Drug Approvals for RANEXA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for RANEXA

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

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Country	Patent Number	Title	Estimated Expiration
Germany	69922964		⤷ Sign Up
European Patent Office	1096937	FORMULATIONS DE RANOLAZINE A LIBERATION LENTE (SUSTAINED RELEASE RANOLAZINE FORMULATIONS)	⤷ Sign Up
Czech Republic	20010880		⤷ Sign Up
Turkey	200101262		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RANEXA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	122008000065	Germany	⤷ Sign Up	PRODUCT NAME: RANOLAZIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558	PA2008017,C1109558	Lithuania	⤷ Sign Up	PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
1109558	C 2008 020	Romania	⤷ Sign Up	PRODUCT NAME: RANOLAZINA SAU O SARE SAU SOLVAT AL ACESTEIA(+/-)-N-(2,6-DIMETILFENIL)-2-[4-[2-HIDROXI-3-(2-METOXIFENOXI)PROPIL]PIPERAZIN-1- IL]ACETAMIDA SAU O SARE SAU SOLVAT ALACESTEIA; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF NATIONAL AUTHORISATION: 20080709; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF FIRST AUTHORISATION IN EEA: 20080709
1109558	2008/034	Ireland	⤷ Sign Up	PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description