DIOVAN Drug Patent Profile
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Which patents cover Diovan, 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 |
---|---|
Albany Medical College | Phase 1/Phase 2 |
ARKAY Therapeutics | 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 | |||
>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 | 021283-002 | Jul 18, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ 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 |
---|---|---|---|
Japan | 2003231634 | SOLID ORAL DOSAGE FORM OF VALSARTAN | ⤷ Try a Trial |
Slovakia | 285902 | ⤷ Try a Trial | |
Japan | 4969338 | ⤷ 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 |
---|---|---|---|---|
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 |
1948158 | 16C0018 | France | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
0443983 | C00443983/03 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |