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DIOVAN Drug Profile
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This drug has eighty-eight patent family members in thirty-three countries.
The generic ingredient in DIOVAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for Tradename: DIOVAN
| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: see list | 11 |
| Drug Prices: : | see details |
Pharmacology for Tradename: DIOVAN
| Drug Class | Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Clinical Trials for: DIOVAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | DISCN | No | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | Jul 18, 2001 | RX | No | 5,972,990*PED | Apr 26, 2017 | Y | |||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | RX | No | 6,294,197*PED | Dec 18, 2017 | Y | |||||||||||||||||||
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Expired Patents for Tradename: DIOVAN
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | 5,399,578*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: DIOVAN
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| valsartan and hydrochlorothiazide | Tablets | 320 mg/12.5 mg and 320 mg/25 mg | Diovan HCT | 2/7/2007 |
| valsartan and hydrochlorothiazide | Tablets | 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg | Diovan HCT | 12/2/2005 |
| valsartan | Tablets | 40 mg, 80 mg,160 mg | Diovan | 12/28/2004 |
Non-Orange Book Patents for Tradename: DIOVAN
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5,952,305 | Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims | <disabled in preview> | |||||||||||||||||||||||||||
| 6,858,228 | Solid oral dosage forms of valsartan | <disabled in preview> | |||||||||||||||||||||||||||
| 6,485,745 | Solid oral dosage forms of valsartan | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Tradename: DIOVAN
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Malaysia | 146868 | <disabled in preview> | |||||||||||||||||||||||||||
| South Africa | 9705673 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 1475207 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: DIOVAN
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 074 | Luxembourg | <disabled> | PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123 | ||||||||||||||||||||||||||
| 0443983/03 | Switzerland | <disabled> | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 | ||||||||||||||||||||||||||
| C004 | Belgium | <disabled> | PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925 | ||||||||||||||||||||||||||
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