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Details for Generic Name: amlodipine besylate

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Amlodipine besylate is the generic ingredient in fifteen branded drugs marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Apotex, Ascent Pharms Inc, Aurobindo Pharma, China Resources, Cipla Ltd, Dr Reddys Labs Ltd, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Hikma Pharms, Invagen Pharms, Lupin, Macleods Pharms Ltd, Mutual Pharma, Mylan, Mylan Pharms Inc, Orchid Hlthcare, Puracap Pharm, Roxane, Sandoz, Sovereign Pharms, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Unichem Labs Ltd, Upsher Smith, Vintage, Vivimed Labs, Watson Labs, Wockhardt, Zydus Pharms Usa, Pfizer, Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Lupin Pharms, Par Pharm, Teva Pharms, Watson Labs Inc, Novartis, Daiichi Sankyo, Lupin Ltd, Torrent Pharms Ltd, Symplmed Pharms Llc, Boehringer Ingelheim, Alembic Pharms Ltd, Novel Labs Inc, Par Pharm Inc, and Teva Pharms Usa, and is included in seventy-four NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has four patent family members in four countries.

There are forty-eight drug master file entries for amlodipine besylate. Twelve suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: amlodipine besylate

Tradenames:15
Patents:12
Applicants:54
NDAs:74
Drug Master File Entries: see list48
Suppliers / Packaging: see list50

Pharmacology for Ingredient: amlodipine besylate

Tentative approvals for AMLODIPINE BESYLATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL2.5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 10MG
<disabled><disabled>CAPSULE; ORAL5MG; 20MG

Clinical Trials for: amlodipine besylate

Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions
Status: Completed Condition: Healthy

Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Status: Recruiting Condition: Chronic Hypertension in Pregnancy

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
Status: Completed Condition: Hypertension

CKD-330 Drug-Drug Interaction Study (Amlodipine)
Status: Completed Condition: Hypertension

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-005Apr 30, 2009RXYes8,101,599<disabled>Y <disabled>
Lupin Ltd
TELMISARTAN AND AMLODIPINE
amlodipine besylate; telmisartan
TABLET;ORAL201586-004Jan 8, 2014RXNo<disabled><disabled>
Teva Pharms Usa
AMLODIPINE BESYLATE AND VALSARTAN
amlodipine besylate; valsartan
TABLET;ORAL091235-002Mar 30, 2015RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: amlodipine besylate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-001Jul 31, 19924,572,909*PED<disabled>
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,572,909*PED<disabled>
Pfizer
NORVASC
amlodipine besylate
TABLET;ORAL019787-003Jul 31, 19924,879,303*PED<disabled>
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International Patent Family for Ingredient: amlodipine besylate

Country Document Number Publication Date
Argentina037565Nov 17, 2004
Australia2002343257Jun 10, 2003
European Patent Office1448197Aug 25, 2004
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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