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Details for Patent: 6,395,728

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Patent 6,395,728 protects EXFORGE and is included in one NDA. There have been four Paragraph IV challenges on Exforge. There are two tentative approvals for the compound protected by this patent. Additional details are available via the generic ingredient links below.

Summary for Patent: 6,395,728

Title: Method of treatment and pharmaceutical composition
Abstract:The invention relates to a method for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, myocardial infarction and its sequelae, supraventricular and ventricular arrhythmias, atrial fibrillation or atrial flutter, atherosclerosis, angina (whether stable or ustable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetessecondary aldosteronism, primary and secondary pulmonary hyperaldosteronism, primary and pulmonary hypertension, renal failure conditions, such as diabetic nephropathy,glomerulonephritis, scleroderma, glomerular sclerosis, proteinuria of primary renal disease, and also renal vascular hypertension, diabetic retinopathy, the management of other vascular disorders, such as migraine, Raynaud's disease, luminal hyperplasia, cognitive dysfunction (such as Alzheimer's), and stroke, comprising administering a therapeutically effective amount of combination of (i) the AT.sub.1 -antagonists valsartan or a pharmaceutically acceptable salt thereof and (ii) a Calcium channel blocker or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier to a mammal in need of such treatment and to corresponding pharmaceutical combination composition.
Inventor(s): Webb; Randy Lee (Flemington, NJ), de Gasparo; Marc (Es Planches, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:09/757,413
Patent Claim Types:
see list of patent claims
Use; Composition;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-002Jun 20, 2007RXNo6,395,728► subscribeY
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-004Jun 20, 2007RXNo6,395,728► subscribeY
Novartis
EXFORGE
amlodipine besylate; valsartan
TABLET;ORAL021990-003Jun 20, 2007RXYes6,395,728► subscribeY
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Non-Orange Book Patents for Patent: 6,395,728

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► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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