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Profile for Tradename: EXFORGE

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Exforge is a drug marketed by Novartis and is included in two NDAs. It is available from four suppliers. There are four patents protecting this drug and six Paragraph IV challenges.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are forty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for Tradename: EXFORGE

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list16

Clinical Trials for: EXFORGE

A Bioequivalence Study of Amlodipine / Valsartan From Amlodipine/Valsartan 10/160 Tablets (Pharmacare, Palestine) and Exforge Tablets (Novartis Pharma, USA)
Status: Completed Condition: Healthy

Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
Status: Completed Condition: Healthy

Phase Ⅰ Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg Tablet and Novartis Exforge 10/160mg Tablet
Status: Completed Condition: Healthy

A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Status: Completed Condition: Healthy Male Volunteer

A Phase I Clinical Trial to Investigate the Pharmacokinetic Interactions and Safety Between Exforge Tab. and Crestor Tab. in Healthy Male Subjects
Status: Not yet recruiting Condition: Healthy

Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Status: Completed Condition: Hypertension

Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
Status: Recruiting Condition: Healthy Male Subjects

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Status: Completed Condition: Hypertension

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.
Status: Completed Condition: Hypertension

One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
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
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 2007RXNo6,395,728<disabled>Y <disabled>
Novartis
EXFORGE HCT
amlodipine besylate; hydrochlorothiazide; valsartan
TABLET;ORAL022314-004Apr 30, 2009RXNo8,101,599<disabled>Y <disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 2007RXYes6,395,728<disabled>Y <disabled>
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Expired Patents for Tradename: EXFORGE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-005Jun 20, 20075,399,578*PED<disabled>
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 20075,399,578*PED<disabled>
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Paragraph IV activity for: EXFORGE

Drugname Dosage Strength RLD Submissiondate
amlodipine, hydrochlorothiazide and valsartanTablets10 mg/12.5 mg/160 mgExforge HCT10/22/2009
amlodipine, hydrochlorothiazide and valsartanTablets5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mExforge HCT9/14/2009
amlodipine besylate and valsartanTablets5 mg/320 mgExforge11/26/2007
amlodipine besylate and valsartanTablets10 mg/320 mgExforge11/9/2007
amlodipine besylate and valsartanTablets5 mg/160 mgExforge10/22/2007
amlodipine besylate and valsartanTablets10 mg/160 mgExforge10/1/2007

Non-Orange Book Patents for Tradename: EXFORGE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,204,281 Method of treatment and pharmaceutical composition<disabled in preview>
6,485,745 Solid oral dosage forms of valsartan<disabled in preview>
6,858,228 Solid oral dosage forms of valsartan<disabled in preview>
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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.

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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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