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. Seventeen 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

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
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001

International Patents for DIOVAN

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

Country	Patent Number	Title	Estimated Expiration
Portugal	914119
Hong Kong	219996	Acyl compounds
Slovakia	178498	SOLID ORAL DOSAGE FORMS OF VALSARTAN
Greece	3019155
Netherlands	980036

Supplementary Protection Certificates for DIOVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1948158	300810	Netherlands		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
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
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	CA 2016 00022	Denmark		PRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
1467728	SPC/GB16/025	United Kingdom		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

Market Dynamics and Financial Trajectory for DIOVAN (Valsartan)

Last updated: December 16, 2025

Executive Summary

DIOVAN (valsartan) is a widely prescribed angiotensin II receptor blocker (ARB) used primarily for hypertension and heart failure management. Its market trajectory has been influenced by regulatory impacts, patent statuses, competitive landscape, and evolving healthcare policies. Post-2018, DIOVAN's financial revenue was significantly affected by a major recall linked to contamination with carcinogenic nitrosamines, notably N-nitrosodimethylamine (NDMA), leading to substantial revenue decline. However, strategic modifications such as formulation changes, market diversification, and generic penetration are shaping its future. This analysis examines the key market dynamics, revenue trends, competitive environment, regulatory considerations, and future outlook for DIOVAN from a business perspective.

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1. Introduction: DIOVAN’s Therapeutic and Market Position

Attribute	Details
Generic Name	Valsartan
Therapeutic Area	Hypertension, Heart Failure, Kidney Protection
Manufacturer	Historically: Novartis; Post-2018: Multiple generics & branded competitors
Market Launch	1996 (origin, Novartis), Post-2018 generic proliferation
Market Size (2022)	Estimated global sales: ~$1.3 billion (pre-recall); with decline post-2018

DIOVAN dominated initial markets with patent protections and healthcare provider adoption. Its primary mechanism is antagonism of angiotensin II receptors, reducing blood pressure and cardiac stress. It is prescribed across multiple markets globally, with the US, Europe, and Asia as key regions.

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2. Market Dynamics: Factors Shaping DIOVAN’s Trajectory

2.1 Patent Life and Exclusivity

Milestones	Details
Patent Expiry	US patent expired in 2012; EU patent expired around 2011-2012
Impact	Surge in generic entry leading to price erosion and increased competition

2.2 Regulatory Events and Recall Impact

Event	Date	Impact
Contamination Recall	July 2018	Voluntary recall of certain batches due to NDMA contamination; significant revenue impact
Regulatory Responses	FDA, EMA	Pose restrictions, require reformulation, trigger market exit for some manufacturers

2.3 Competitive Landscape

Type	Key Players	Market Shares (2022, Estimated)	Notes
Branded	Novartis (DIOVAN), others	~45%	DIOVAN still retains brand equity in certain markets
Generic	Multiple manufacturers	~55%	Post-patent expiration, rapid proliferation; dominance in generics

2.4 Market Penetration and Adoption Trends

Trend	Details
Generic Uptake	Rapid; led to price decreases (~80-90%) post-2012
Physician Preferences	Shift toward generics; some indication-based prescription persists for branded versions
Pricing Trends	Steady decline, increased access but squeezed margins

2.5 Emerging Therapies Impact

Treatments	Description	Potential Impact
SGLT2 Inhibitors	e.g., empagliflozin, canagliflozin	Increased use for diabetic nephropathy; a complement rather than substitute
ARNI (Angiotensin Receptor-Neprilysin Inhibitors)	e.g., sacubitril/valsartan	Direct competitor; may cannibalize DIOVAN markets in heart failure

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3. Financial Trajectory: Revenue Trends & Forecasts

3.1 Historical Revenue Analysis

Year	Global Revenue (USD)	Commentary
2011	~$2.2 billion	Peak, driven by patent exclusivity
2012	~$1.9 billion	Slight decline due to emergence of generics
2015	~$1.6 billion	Continued erosion, increased generics
2018	~$1.3 billion	Pre-recall; stable with market saturation
2018 (Q3-Q4)	Sharp decline post-recall	Revenue drops approximately 50% in affected regions
2019-2022	<$500 million	Continued decline; some recovery in certain markets

3.2 Impact of the 2018 NDMA Recall

• The recall resulted in over $100 million in lost revenue for Novartis alone.
• Many generic manufacturers exited the market, reducing supply and price competition temporarily.
• In affected markets, DIOVAN's sales plummeted by 50-70%, depending on region.

3.3 Competitive Rebound and Strategic Response

• Reformulation efforts, including low-NDMA formulations.
• Licensing agreements allowing generic manufacturers to produce NDMA-free versions.
• Entry into emerging markets with lower-cost formulations.

3.4 Future Revenue Projections (2023-2027)

Scenario	Assumptions	Projected Revenue (USD)	Comments
Conservative	Continued generic competition, slow recovery	<$300 million annually by 2025	Markets stabilizing with high generic penetration
Optimistic	Successful reformulation, new markets, and brand loyalty	~$500 million by 2025	Niche segments and developed markets sustain branded sales
Upside	Combination of new indications, hybrid formulations	Up to $700 million by 2027	Potential expansion into combination therapies or new formulations

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4. Regulatory and Policy Landscape

4.1 Regulatory Constraints and Opportunities

Regulation	Details	Impact
FDA/EMA NDMA Limits	96 ng/day (FDA), 100 ng/day (EMA)	Stringent limits led to reformulation necessity
Market Withdrawal Policies	Countries with strict nitrosamine limits prompting early withdrawal	Revenue decline, brand repositioning
Labeling and Safety Updates	Ongoing updates affecting prescribing habits	Slight revenue stabilization as trust rebuilds

4.2 Generic Drug Approval Trends

Trends	Details	Impacts
Accelerated Pathways	Post-recall, faster approvals for NDMA-free generics	Increased market share for compliant generics
Patent and Data Exclusivity	No patent protection post-2012; regulatory exclusivities vary	Market saturation by multiple generic players

4.3 Healthcare Policy Changes Influencing Market

Policy	Relevance	Implication
Price Controls	In countries like India and parts of Europe	Lowered revenue potential for premium-priced formulations
Reimbursement Policies	Favor generic substitutions	Accelerate generic market share gains

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5. Competitive Landscape: Key Players & Strategies

Player	Market Share (2022)	Strategies	Strengths/Weaknesses
Novartis (DIOVAN)	Estimated ~45% (brands)	Reformulation, market diversification	Strong brand presence; impacted by recall
Teva, Mylan, Sandoz (Generics)	Estimated ~40%	Price competition, NDMA-free formulations	High volume, low margins, recall impacts
Others (regional players)	Estimated ~15%	Focused on emerging markets	Niche presence, lower R&D investment

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6. Future Outlook and Strategic Considerations

6.1 Growth Opportunities

• Formulation innovations: Low-NDMA or alternative delivery systems.
• Market diversification: Expansion into emerging markets with high hypertensive populations.
• Combination therapies: Fixed-dose combinations (e.g., valsartan + amlodipine).

6.2 Challenges to Address

• Regulatory hurdles: Ensuring compliance with nitrosamine limits.
• Pricing pressures: Particularly in price-sensitive regions.
• Market cannibalization: With newer ARBs, ACE inhibitors, and ARNI agents.

6.3 Strategic Recommendations

Action Point	Rationale	Expected Outcome
Invest in reformulation	Mitigate NDMA risks	Extend market life
Expand into emerging markets	High hypertensive burden	Revenue growth
Pursue partnership/licensing	Cost-sharing for reformulation	Accelerated market entry
Diversify portfolio	Adjunct indications and formulations	Revenue stability

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7. Key Takeaways

• DIOVAN faced a sharp revenue decline post-2018 due to NDMA contamination issues, leading to reformulation efforts and market exits.
• The patent expiry precipitated a wave of generic competition, reducing prices and profit margins significantly.
• The competitive landscape is dominated by low-cost generics; brand retention relies on reformulation and market positioning.
• Regulatory policies, especially regarding nitrosamines, will continue to influence product formulations and market stability.
• Future growth depends on innovation, market expansion, and strategic partnerships to offset ongoing price pressures.

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8. Frequently Asked Questions (FAQs)

Q1: Will DIOVAN regain its previous market dominance?
A: Unlikely in the short term due to sustained generic competition and regulatory challenges. Success depends on reformulation, market expansion, and brand differentiation.

Q2: How significant was the NDMA recall on DIOVAN’s revenues?
A: The recall caused a revenue decline of approximately 50-70% in affected markets, equating to over $500 million lost in recent years across global operations.

Q3: What are the main competitive advantages for DIOVAN post-recall?
A: Its established brand recognition in certain regions and its potential reformulation for compliance may enable niche recovery. Nonetheless, price competition remains fierce.

Q4: Are there new indications or formulations planned for DIOVAN?
A: Currently, no significant new indications are announced; reformulation to address regulatory concerns is ongoing.

Q5: Which regions are the most promising for DIOVAN’s future growth?
A: Emerging markets such as India, Southeast Asia, and parts of Latin America, where hypertension prevalence is high and generic adoption is rapid.

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References

[1] Novartis Annual Reports and Financial Statements, 2012-2022.
[2] FDA and EMA regulatory guidelines on nitrosamines, 2018-2022.
[3] Market research reports from IQVIA and GlobalData, 2022.
[4] Industry news articles on DIOVAN recall and reformulations, 2018-2022.
[5] Scientific publications on ARBs and nitrosamine contamination, peer-reviewed journals.

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