DIOVAN Drug Patent Profile
✉ Email this page to a colleague
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. 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 | |||
| Novartis | DIOVAN | valsartan | CAPSULE;ORAL | 020665-002 | Dec 23, 1996 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-004 | Aug 14, 2002 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | AB | RX | Yes | Yes | ⤷ 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 |
| 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 |
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-001 | 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 |
| >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 |
|---|---|---|---|
| Norway | 910630 | ⤷ Try a Trial | |
| Japan | 2000506540 | ⤷ Try a Trial | |
| Denmark | 1767206 | ⤷ Try a Trial | |
| Malaysia | 146868 | SOLID ORAL DOSAGE FORMS OF VALSARTAN | ⤷ Try a Trial |
| Brazil | 9709956 | ⤷ Try a Trial | |
| Portugal | 1767206 | ⤷ Try a Trial | |
| Hong Kong | 1019858 | ⤷ 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 | 340 5007-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| 1948158 | 122016000038 | Germany | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
| 0443983 | 98C004 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925 |
| 0443983 | 97C0050 | France | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513 |
| 1948158 | PA2016017,C1948158 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
| 0443983 | 2007C/043 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222 |
| 1948158 | 300810 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
