RANOLAZINE - Generic Drug Details

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What are the generic sources for ranolazine and what is the scope of freedom to operate?

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:	3,504
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
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 3
Polish Medical Research Agency	Phase 3
RenJi Hospital	Phase 4

See all RANOLAZINE clinical trials

Generic filers with tentative approvals for RANOLAZINE

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

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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
Ajanta Pharma Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	210054-001	May 28, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211707-002	May 28, 2019	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Piramal	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	213085-002	Jul 25, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211707-001	May 28, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211082-001	Jul 5, 2019	AB	RX	No	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 RANOLAZINE

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

EU/EMA Drug Approvals for RANOLAZINE

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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 RANOLAZINE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3409273	FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RANOLAZINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	SPC/GB08/058	United Kingdom	⤷ Sign Up	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
1109558	2008/034	Ireland	⤷ Sign Up	PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558	09C0001	France	⤷ Sign Up	PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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