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Last Updated: December 4, 2023

Amlodipine besylate; benazepril hydrochloride - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; benazepril hydrochloride and what is the scope of patent protection?

Amlodipine besylate; benazepril hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Inc, Lupin Pharms, Mylan, Strides Pharma, Teva Pharms, Watson Labs, Watson Labs Inc, and Sandoz, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for amlodipine besylate; benazepril hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	39
DailyMed Link:	amlodipine besylate; benazepril hydrochloride at DailyMed

Recent Clinical Trials for amlodipine besylate; benazepril hydrochloride

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Novartis Pharmaceuticals	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all amlodipine besylate; benazepril hydrochloride clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	10MG; 20MG	CAPSULE; ORAL
⤷ Try a Trial	⤷ Try a Trial	5MG; 20MG	CAPSULE; ORAL
⤷ Try a Trial	⤷ Try a Trial	5MG; 10MG	CAPSULE; 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 amlodipine besylate; benazepril hydrochloride

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 amlodipine besylate; benazepril hydrochloride

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 AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

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 amlodipine besylate; benazepril hydrochloride

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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
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Pharms	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	078466-003	Feb 5, 2010	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	079047-002	Jul 5, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 amlodipine besylate; benazepril hydrochloride

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

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