ASPRUZYO SPRINKLE Drug Patent Profile

Which patents cover Aspruzyo Sprinkle, and what generic alternatives are available?

Aspruzyo Sprinkle is a drug marketed by Spil and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aspruzyo Sprinkle

A generic version of ASPRUZYO SPRINKLE was approved as ranolazine by CHARTWELL RX on July 29^th, 2013.

Summary for ASPRUZYO SPRINKLE

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ASPRUZYO SPRINKLE
What excipients (inactive ingredients) are in ASPRUZYO SPRINKLE?	ASPRUZYO SPRINKLE excipients list
DailyMed Link:	ASPRUZYO SPRINKLE at DailyMed

See drug prices for ASPRUZYO SPRINKLE

Pharmacology for ASPRUZYO SPRINKLE

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 ASPRUZYO SPRINKLE

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

US Patents and Regulatory Information for ASPRUZYO SPRINKLE

ASPRUZYO SPRINKLE is protected by two US patents.

Patents protecting ASPRUZYO SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		RX	Yes	Yes			Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		RX	Yes	Yes			Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-001	Feb 28, 2022		RX	Yes	No			Y

EU/EMA Drug Approvals for ASPRUZYO SPRINKLE

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 ASPRUZYO SPRINKLE

See the table below for patents covering ASPRUZYO SPRINKLE around the world.

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

Supplementary Protection Certificates for ASPRUZYO SPRINKLE

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