Ranolazine - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for ranolazine and what is the scope of patent protection?

Ranolazine is the generic ingredient in three branded drugs marketed by Spil, Menarini Intl, Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-six NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ranolazine has one patent family member in one country.

There are twenty-three drug master file entries for ranolazine. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ranolazine

International Patents:	1
US Patents:	2
Tradenames:	3
Applicants:	26
NDAs:	26
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	85
Patent Applications:	3,648
Drug Prices:	Drug price trends for ranolazine
What excipients (inactive ingredients) are in ranolazine?	ranolazine excipients list
DailyMed Link:	ranolazine at DailyMed

See drug prices for ranolazine

Recent Clinical Trials for ranolazine

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

Sponsor	Phase
Polish Medical Research Agency	Phase 3
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 3
RenJi Hospital	Phase 4

See all ranolazine clinical trials

Generic filers with tentative approvals for RANOLAZINE

Applicant	Application No.	Strength	Dosage Form
⤷ Subscribe	⤷ Subscribe	1000MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Subscribe	⤷ Subscribe	500MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ranolazine

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

Medical Subject Heading (MeSH) Categories for ranolazine

Cardiovascular Agents
Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for ranolazine

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

Paragraph IV (Patent) Challenges for RANOLAZINE

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 ranolazine

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	209953-001	Nov 30, 2020	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Allied	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	213517-001	Apr 27, 2022	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Chartwell Rx	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	201046-001	Jul 29, 2013	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Ajanta Pharma Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	210054-001	May 28, 2019	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Unichem	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	213083-002	Mar 16, 2023	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Cipla	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211291-002	May 28, 2019		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Rising	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	212889-001	Jan 28, 2021	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 ranolazine

Subscribe to access the full database, or Subscribe
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	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	⤷ Subscribe	⤷ Subscribe
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ranolazine

Subscribe to access the full database, or Subscribe
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 ranolazine

Subscribe to access the full database, or Subscribe
Country	Patent Number	Title	Estimated Expiration
European Patent Office	3409273	FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ranolazine

Subscribe to access the full database, or Subscribe
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	09C0001	France	⤷ Subscribe	PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558	2008/034	Ireland	⤷ Subscribe	PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558	SPC/GB08/058	United Kingdom	⤷ Subscribe	PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.