LOTREL Drug Patent Profile

When do Lotrel patents expire, and when can generic versions of Lotrel launch?

Lotrel is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotrel

A generic version of LOTREL was approved as amlodipine besylate; benazepril hydrochloride by LUPIN PHARMS on February 5^th, 2010.

Summary for LOTREL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	9
Patent Applications:	4,296
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LOTREL
What excipients (inactive ingredients) are in LOTREL?	LOTREL excipients list
DailyMed Link:	LOTREL at DailyMed

See drug prices for LOTREL

See drug sales revenues for LOTREL

Recent Clinical Trials for LOTREL

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Teva Pharmaceuticals USA	Phase 1
Dr. Reddy's Laboratories Limited	Phase 1

See all LOTREL clinical trials

Pharmacology for LOTREL

Drug Class	Angiotensin Converting Enzyme Inhibitor Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Decreased Blood Pressure

Anatomical Therapeutic Chemical (ATC) Classes for LOTREL

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for LOTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	5 mg/40 mg and 10 mg/40 mg	020364	1	2006-11-17
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg	020364	1	2004-06-09

US Patents and Regulatory Information for LOTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-007	Apr 11, 2006	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995	AB	RX	Yes	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-006	Apr 11, 2006	AB	RX	Yes	Yes
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002	AB	RX	Yes	No

Expired US Patents for LOTREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995

International Patents for LOTREL

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

Country	Patent Number	Title	Estimated Expiration
Argentina	240807	PROCEDIMIENTO PARA OBTENER DERIVADOS DE BENZAZEPIN-2-ONA Y SUS SALES
Argentina	241222	PROCEDIMIENTO PARA ELABORAR NUEVOS ACIDOS 3-AMINO- (1) BENZAZEPIN-2-ALCANOICOS Y SUS SALES. (BENZAZEPIN-2-ONES, PROCESS FOR THEIR PREPARATION, PHARMACEUTICAL PREPARATIONS CONTAINING THESE COMPOUNDS AND THEIR THERAPEUTICAL USE)
Spain	526887
Norway	830847
Norway	166232
Austria	18397

Supplementary Protection Certificates for LOTREL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216