DIOVAN Drug Patent Profile
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When do Diovan patents expire, 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
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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 | |||
| >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 |
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-003 | Jul 18, 2001 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novartis | DIOVAN | valsartan | TABLET;ORAL | 021283-002 | 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 |
|---|---|---|---|
| European Patent Office | 1774967 | ⤷ Try a Trial | |
| Turkey | 9802698 | ⤷ Try a Trial | |
| Germany | 19675036 | ⤷ Try a Trial | |
| Japan | 2003231634 | SOLID ORAL DOSAGE FORM OF VALSARTAN | ⤷ Try a Trial |
| South Africa | 9101179 | ⤷ Try a Trial | |
| South Korea | 100618038 | ⤷ 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 |
|---|---|---|---|---|
| 0443983 | 97C0039 | Belgium | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513 |
| 2340828 | 2021C/502 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
| 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 | CA 2016 00023 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123 |
| 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 | PA2016017 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
| >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
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