DIOVAN Drug Patent Profile
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Which patents cover Diovan, and when can generic versions of Diovan launch?
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. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
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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: | 4,295 |
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 |
US Patents and Regulatory Information for DIOVAN
DIOVAN is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting DIOVAN
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Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-001 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | Jul 18, 2001 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | DIOVAN HCT | hydrochlorothiazide; valsartan | TABLET;ORAL | 020818-002 | Mar 6, 1998 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-002 | Dec 23, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | 021283-003 | Jul 18, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-001 | Dec 23, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Hungary | 229134 | Process of forming a compressed solid oral dosage form comprising valsartan | ⤷ Sign Up |
Germany | 122010000024 | ⤷ Sign Up | |
Norway | 331739 | ⤷ Sign Up | |
Japan | 2000506540 | ⤷ Sign Up | |
China | 1232394 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DIOVAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | C00443983/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009 |
1948158 | 2016C/026 | Belgium | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
1948158 | PA2016017,C1948158 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
0443983 | C980036 | Netherlands | ⤷ Sign Up | 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 |
2340828 | 2/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/VALSARTAN ALS SACUBITRIL-VALSARTAN-NATRIUMSALZ-KOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA3 ? X H2O, WOBEI X FUER 0 BIS 3 STEHT; REGISTRATION NO/DATE: EU/1/15/1058 (MITTEILUNG) 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |