DIOVAN Drug Patent Profile
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When do Diovan patents expire, and what generic alternatives are available?
Diovan is a drug marketed by Novartis and is included in three NDAs.
The generic ingredient in DIOVAN is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for DIOVAN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 49 |
Patent Applications: | 5,185 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for DIOVAN |
Drug Sales Revenues: | Drug sales revenues for DIOVAN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIOVAN |
What excipients (inactive ingredients) are in DIOVAN? | DIOVAN excipients list |
DailyMed Link: | DIOVAN at DailyMed |
Recent Clinical Trials for DIOVAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ARKAY Therapeutics | Phase 1/Phase 2 |
Albany Medical College | Phase 1/Phase 2 |
LanZhou University | N/A |
Pharmacology for DIOVAN
Drug Class | Angiotensin 2 Receptor Blocker |
Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DIOVAN
US Patents and Regulatory Information for DIOVAN
DIOVAN is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting DIOVAN
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-001 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for DIOVAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DIOVAN
See the table below for patents covering DIOVAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 910548 | ⤷ Try a Trial | |
Canada | 2036427 | COMPOSES ACYLES (ACYL COMPOUNDS) | ⤷ Try a Trial |
China | 1475207 | ⤷ Try a Trial | |
Hong Kong | 1060700 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIOVAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1467728 | C01467728/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015 |
1948158 | C 2016 017 | Romania | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, SUB FORMA DE COMPLEX DE SARURI DE SODIU; NATIONAL AUTHORISATION NUMBER: EU/1/15/1058/001-016; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1058/001-016; DATE OF FIRST AUTHORISATION IN EEA: 20151119 |
0443983 | CA 2010 00014 | Denmark | ⤷ Try a Trial | |
0443983 | C980036 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM VAN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAARIN R EEN LAAGALKYL-, FENYLLAAGALKYL-, LAAGALKENYL-, LAAGAL- KYNYL-, LAAGALKOXY-LAAGALKYL-, LAAGALKOXY-LAAGALKENYL- OF -----; NAT. REGISTRATION NO/DATE: RVG 22365 19980525; FIRST REGISTRATION: 344 300-5344 301-1344 302-8344 303-4 1997250925 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |