DIOVAN Drug Patent Profile

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. Sixteen 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:	114
Clinical Trials:	49
Patent Applications:	2,123
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

See drug prices for DIOVAN

See drug sales revenues 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

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
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-002	Dec 23, 1996		DISCN	No	No
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	AB	RX	Yes	No
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	AB	RX	Yes	Yes

Expired US Patents for DIOVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001	5,972,990*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	5,399,578*PED
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996	5,399,578*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001	6,294,197*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	5,972,990*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001	5,399,578*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-001	Jul 18, 2001	5,399,578*PED

International Patents for DIOVAN

See the table below for patents covering DIOVAN around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	100618038
Norway	910630
Cyprus	2553	Solid oral dosage forms of valsartan
South Korea	20110063587
Japan	2014012747	SOLID ORAL DOSAGE FORMS OF VALSARTAN
Canada	2232775	COMPOSES ACYLES (ACYL COMPOUNDS)
European Patent Office	0914119	PROCEDE DE PREPARATION DE FORMES SOLIDES DE VALSARTAN ADMINISTREES PAR VOIE ORALE (PROCESS FOR FORMING SOLID ORAL DOSAGE FORMS OF VALSARTAN)

Supplementary Protection Certificates for DIOVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C970001	Netherlands		PRODUCT NAME: VALSARTANUM, DESGEWENST IN DE VORM VAN EEN ZOUT OF IN DE VORM V AN EEN ESTER MET EEN HYDROXYVERBINDING MET DE FORMULE R-OH, WAA RIN R EEN LAAGALKYL-, FENYLLAAGALKYL-,LAAGALKENYL-,LAAGALKYNYL- ,LAAGALKOXY-LAAGALKYL-,LAAGALKOXY-LAAGALKENYL-OF LAAGALKOXY-LAA; NAT. REGISTRATION NO/DATE: RVG 20667, RVG 20668 19961104; FIRST REGISTRATION: 36983.00.00, 36983.01.00 19960513
1948158	CA 2016 00023	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
2340828	PA2021502,C2340828	Lithuania		PRODUCT NAME: SAKUBITRILAS/VALSARTANAS, KAIP SAKUBITRILO VALSARTANO NATRIO DRUSKOS KOMPLEKSAS, T.Y. (((S)-N-VALERIL-N-((2'-(1H-TETRAZOL-5-IL)-BIFENIL-4-IL)-METIL)-VALINAS)((2R,4S)-5-BIFENIL-4-IL-4-(3-KARBOKSI-PROPIONILAMINO)-2-METIL-PENTANO RUGSTIES ETILO ESTERIS)NA3 - X H2O, KUR X YRA 0 - 3; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2340828	CA 2021 00001	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN, SOM SACUBITRILVALSARTAN-NATRIUMSALTKOMPLEKS, DVS. ...; REG. NO/DATE: EU/1/15/1058 20151123
0443983	C00443983/02	Switzerland		PRODUCT NAME: VALSARTAN UND AMLODIPIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57771 22.12.2006
2340828	2/2021	Austria		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
1467728	C01467728/01	Switzerland		PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015

Market Dynamics and Financial Trajectory for DIOVAN (Valsartan)

Last updated: November 18, 2025

Introduction

DIOVAN, generically known as valsartan, represents a pivotal player in the hypertensive and cardiovascular therapeutic landscape. Since its approval, DIOVAN has experienced significant shifts driven by regulatory, clinical, and market forces. This report provides a comprehensive analysis of the current market dynamics and forecasts the financial trajectory of DIOVAN within the broader pharmaceutical sector.

Historical Context and Product Overview

DIOVAN was first approved by the FDA in 1996, developed by Novartis. It is classified as an angiotensin II receptor blocker (ARB), primarily indicated for hypertension and heart failure. Its mechanism involves blocking the vasoconstrictive effects of angiotensin II, leading to lowered blood pressure and reduced cardiovascular risk.

Initially, DIOVAN enjoyed robust market penetration due to its efficacy and favorable safety profile compared to ACE inhibitors. However, recent legal challenges and regulatory scrutiny have influenced its market performance.

Market Dynamics

Regulatory and Legal Challenges

One of the most profound market influences has been the 2018 recall of certain batches of valsartan contaminated with carcinogenic N-nitrosodimethylamine (NDMA). This incident significantly affected consumer confidence and sales, particularly in the U.S. and European markets [1].

Furthermore, numerous class-action litigations alleging contamination and safety concerns have led to substantial settlement expenses for manufacturers. These legal issues have prompted tighter quality controls and increased manufacturing costs, influencing the product's marketability and pricing strategies [2].

Competitive Landscape

DIOVAN's primary competitors include other ARBs such as losartan, olmesartan, and telmisartan. The competition is intense, often driven by pricing, patent status, and clinical outcomes.

• Generic Entry: Patent expirations for DIOVAN and related ARBs have generally led to a proliferation of generic alternatives, exerting downward pressure on prices. Generics now hold a predominant share in many markets, with brand DIOVAN retaining a premium segment due to brand loyalty and perception.

• Biosimilars: While biosimilars are less relevant for small-molecule drugs like valsartan, the emergence of alternative therapy combinations and new ARBs influences market share.

Pricing and Reimbursement Dynamics

Pricing strategies have evolved with increased generic competition. In regions where payers emphasize cost-effectiveness, DIOVAN faces reimbursement constraints, limiting price premiums.

Contrastingly, in emerging markets, demand remains resilient due to higher prevalence of hypertension and limited access to alternative therapies. Reimbursement policies vary significantly, influencing regional sales patterns.

Patent and Regulatory Environment

Patent landscapes around DIOVAN have been highly active, with Novartis defending its patent rights internationally until roughly 2019, after which generic manufacturers gained leverage [3].

The regulatory environment has tightened, especially concerning manufacturing quality, due to past contamination episodes. Companies are investing heavily in compliance, impacting production costs and timelines.

Market Penetration and Adoption Trends

In developed countries, DIOVAN's market share stabilizes as generics dominate. Adoption rates are influenced by clinical guidelines, prescriber preferences, and insurance formulary placements.

In emerging economies, growth persists due to increasing hypertension prevalence and expanding healthcare access, although affordability remains a core factor.

Financial Trajectory

Revenue Trends

Pre-2018, DIOVAN generated substantial revenues, with global sales reaching approximately $2.3 billion in 2017 [4]. Post-2018, revenues declined by nearly 35% in the subsequent year, primarily driven by regulatory recalls and legal issues.

Despite the decline, some markets exhibit recovery, particularly where brand loyalty persists and generics are less entrenched.

Impact of Patent Expiry and Generics

The expiration of key patents around 2019 facilitated a surge in generic versions, reducing DIOVAN's market share and profit margins.

Novartis and other stakeholders have responded with:

• Price reductions to maintain volume.
• Product repositioning emphasizing quality and compliance.
• Diversification into combination therapies and new formulations.

Future Revenue Projections

Market analysts project that global valsartan sales could stabilize at roughly $800 million to $1 billion annually over the next five years, assuming:

• Effective management of legal and regulatory challenges.
• Strategic engagement in emerging markets.
• Innovation in formulation and delivery systems.

Conversely, if legal liabilities intensify or generic competition intensifies, revenues could decline further, potentially stabilizing at or below the current levels.

Cost Factors and Investment Trends

Increasing manufacturing costs due to enhanced quality control and litigation settlement expenses are anticipated to pressure profit margins.

Investments in R&D for new formulations, combination drugs, and biomarker-driven therapies may offer future growth avenues but do not significantly impact immediate revenues.

Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Focus on compliance, effective patent management, and market-specific strategies.
• Payers and Policymakers: Emphasize access, affordability, and quality assurance.
• Investors: Monitor legal, regulatory, and competitive developments that influence revenue stability.

Conclusion

DIOVAN's market and financial landscape epitomizes the complexities of the global pharmaceutical industry, where safety concerns, regulatory hurdles, and competitive pressures intertwine. While current revenues face headwinds, strategic adaptation and emerging market opportunities could underpin a stabilized or modestly growing trajectory.

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Key Takeaways

• Regulatory and Safety Controversies: Past contamination issues and legal challenges have transiently suppressed DIOVAN’s market performance, emphasizing the importance of rigorous quality control.

• Generics and Competition: Patent expirations have shifted the landscape toward price-sensitive generic markets, reducing DIOVAN’s revenue but expanding global access.

• Market Expansion in Emerging Economies: Despite challenges, rising hypertension prevalence continues to offer growth prospects, especially where affordability and healthcare infrastructure improve.

• Innovation as a Growth Driver: Development of novel formulations and combination therapies can rejuvenate DIOVAN's relevance, provided regulatory and safety standards are upheld.

• Financial Outlook: While short-term revenues are subdued, strategic positioning and geographic expansion could offer moderate growth, contingent on navigating legal, regulatory, and market dynamics.

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FAQs

1. What factors most significantly impacted DIOVAN’s market share in recent years?
Legal issues surrounding contamination, patent expirations leading to generic competition, and regulatory recalls have collectively diminished its market share, particularly in developed markets.

2. How have patent expirations influenced DIOVAN’s pricing and profitability?
Patent expirations facilitated the entry of cheaper generics, exerting downward pressure on prices and profits. Companies have responded with cost adjustments and strategic marketing to sustain revenues.

3. What are the growth prospects for DIOVAN in emerging markets?
Strong growth potential exists due to rising hypertension prevalence, increasing healthcare infrastructure, and limited access to alternative therapies, although affordability remains a barrier.

4. What strategic moves could improve DIOVAN’s financial trajectory?
Enhancing compliance and quality control, developing combination therapies, exploring new delivery systems, and expanding into new geographic markets are pivotal strategies.

5. How does the competitive landscape affect DIOVAN’s future?
Intense competition from other ARBs and generics necessitates differentiation through quality, efficacy, and marketing. Cross-innovation in drug formulation can also provide competitive advantages.

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References

[1] U.S. Food and Drug Administration (FDA). “Valsartan Recall Announcements.” 2018.
[2] Legal Proceedings. “Class Actions on NDMA Contamination in ARBs.” 2019.
[3] Patent Landscape Reports. “Novartis’ Patent Filings for Valsartan.” 2019.
[4] Market Intelligence Reports. “Global Valsartan Sales and Market Share Data.” 2017-2022.