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Amlodipine besylate; benazepril hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for amlodipine besylate; benazepril hydrochloride?

Amlodipine besylate; benazepril hydrochloride is the generic ingredient in two branded drugs marketed by Apotex Inc, Aurobindo Pharma Ltd, Mylan, Dr Reddys Labs Inc, Watson Labs Inc, Novartis, Lupin Pharms, Teva Pharms, Par Pharm, and Watson Labs, and is included in twelve NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for amlodipine besylate; benazepril hydrochloride. Twenty-five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate; benazepril hydrochloride

Tradenames:2
Patents:2
Applicants:10
NDAs:12
Drug Master File Entries: see list49
Suppliers / Packagers: see list25
Clinical Trials: see list1,128
Drug Prices:see low prices
DailyMed Link:amlodipine besylate; benazepril hydrochloride at DailyMed

Pharmacology for Ingredient: amlodipine besylate; benazepril hydrochloride

Tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE; ORAL2.5MG; 10MG
► Subscribe► SubscribeCAPSULE; ORAL5MG; 10MG
► Subscribe► SubscribeCAPSULE; ORAL5MG; 20MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-006Jul 5, 2011RXNoNo► Subscribe► Subscribe
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-002Feb 5, 2010RXNoNo► Subscribe► Subscribe
Watson Labs
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL077890-002Oct 14, 2010RXNoNo► Subscribe► Subscribe
Lupin Pharms
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL078466-005Jul 5, 2011RXNoNo► Subscribe► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-003Mar 3, 1995RXYesNo6,162,802► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate; benazepril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-005Jun 20, 20024,572,909► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-002Mar 3, 19954,410,520*PED► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-007Apr 11, 20064,879,303► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-005Jun 20, 20024,879,303► Subscribe
Novartis
LOTREL
amlodipine besylate; benazepril hydrochloride
CAPSULE;ORAL020364-003Mar 3, 19954,879,303► Subscribe
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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 verifification 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.

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