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

Drug patent expirations by year for DIOVAN

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

See all DIOVAN clinical trials

Pharmacology for DIOVAN

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DIOVAN

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for DIOVAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN	Tablets	valsartan	40 mg, 80 mg, 160 mg and 320 mg	021283	1	2004-12-28

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

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Glossary

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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

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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.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	524346	Solid oral dosage forms of valsartan	⤷ Try a Trial
Cyprus	1978	Acyl compounds	⤷ Try a Trial
South Korea	101161283		⤷ Try a Trial
Taiwan	473394		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DIOVAN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	SPC/GB97/009	United Kingdom	⤷ Try a Trial	PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016
1467728	SPC/GB16/025	United Kingdom	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/15/1058(NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
1948158	132016000051118	Italy	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL/VALSARTAN, COME SACUBITRIL VALSARTAN COMPLESSO DI SALE SODICO (TRISODIO (3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOSSICARBONIL-1-BUTILCARBAMMOIL)PROPIONATO-(S)-3'-METIL-2'-(PENTANOIL(2"-(TETRAZOL-5-ILATO)BIFENIL-4'-ILMETIL)AMMINO)BUTIRRATO) EMIPENTAIDRATO)(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058, 20151123
1467728	1690021-9	Sweden	⤷ Try a Trial	PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description