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:	4,364
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
Albany Medical College	Phase 1/Phase 2
ARKAY Therapeutics	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

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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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	⤷ 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

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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	⤷ 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	021283-002	Jul 18, 2001	⤷ Sign Up	⤷ Sign Up
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	⤷ 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.

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Country	Patent Number	Title	Estimated Expiration
Slovakia	285902		⤷ Sign Up
United Kingdom	9613470		⤷ Sign Up
Argentina	059324	UNA FORMA SOLIDA DE DOSIFICACION ORAL	⤷ Sign Up
South Korea	20050092054		⤷ Sign Up
Hungary	229134	Process of forming a compressed solid oral dosage form comprising valsartan	⤷ Sign Up
>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	2007C/043	Belgium	⤷ Sign Up	PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
1467728	19/2016	Austria	⤷ Sign Up	PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828	301088	Netherlands	⤷ Sign Up	PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2340828	122021000003	Germany	⤷ Sign Up	PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, 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))NA 3 * X H 2 0, WORIN X 0 BIS 3 IST; REGISTRATION NO/DATE: EU/1/15/1058 20151119
1948158	CA 2016 00023	Denmark	⤷ Sign Up	PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description