Hydrochlorothiazide; valsartan - Generic Drug Details

What are the generic drug sources for hydrochlorothiazide; valsartan and what is the scope of patent protection?

Hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Novartis, Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for hydrochlorothiazide; valsartan

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	44
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for hydrochlorothiazide; valsartan
DailyMed Link:	hydrochlorothiazide; valsartan at DailyMed

Recent Clinical Trials for hydrochlorothiazide; valsartan

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Farma de Colombia SA	Phase 3
Damanhour University	N/A
Tehran University of Medical Sciences	Phase 3

See all hydrochlorothiazide; valsartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; VALSARTAN

Applicant	Application No.	Strength	Dosage Form
		25MG;320MG	TABLET;ORAL
		12.5MG;320MG	TABLET;ORAL
		25MG;160MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrochlorothiazide; valsartan

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; valsartan

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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 HYDROCHLOROTHIAZIDE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	320 mg/12.5 mg and 320 mg/25 mg	020818	1	2007-02-07
DIOVAN HCT	Tablets	hydrochlorothiazide; valsartan	80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg	020818	1	2005-12-02

US Patents and Regulatory Information for hydrochlorothiazide; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex Inc	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203026-005	Mar 21, 2013		DISCN	No	No
Macleods Pharms Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203145-005	Apr 19, 2013	AB	RX	No	No
Lupin Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	078946-002	Mar 21, 2013	AB	RX	No	No

Expired US Patents for hydrochlorothiazide; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	5,399,578*PED
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998	5,399,578*PED
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	6,294,197*PED

Market Dynamics and Financial Trajectory for Hydrochlorothiazide; Valsartan

Last updated: September 24, 2025

---

Introduction

Hydrochlorothiazide (HCTZ) combined with Valsartan (marketed as Diovan HCT for decades) has historically been a pivotal therapy in managing hypertension and heart failure, driven by its proven efficacy and cost-effectiveness. However, recent market shifts, regulatory challenges, and the evolving landscape of cardiovascular drugs significantly influence its trajectory. This analysis evaluates current market dynamics, anticipated financial trends, and strategic considerations shaping this combination's future.

---

Market Overview

The combination of Hydrochlorothiazide and Valsartan belongs to the class of angiotensin receptor blockers (ARBs) with diuretic synergy. It targets elevated blood pressure and reduces cardiovascular risk, a globally prevalent health concern. Despite its longstanding presence, the drug faces intensifying competition from newer therapeutics and generics, alongside regulatory scrutiny, particularly concerning Valsartan's safety profile.

Market Size and Revenues

The global antihypertensive market was valued at approximately USD 20 billion in 2020, with ARB-based therapies accounting for a significant share. Hydrochlorothiazide; Valsartan displaced earlier combination therapies due to better tolerability and efficacy. Leading pharmaceutical companies, including Novartis (manufacturer of Diovan), have enjoyed substantial revenues, with peaks reaching USD 4 billion prior to patent expiration (2012–2014).

Post-patent expiry, sales have waned owing to generic competition, yet the product remains a staple in therapy adherence owing to its cost advantage. According to IQVIA data, global revenues for fixed-dose combinations like Hydrochlorothiazide; Valsartan have stabilized around USD 1-1.5 billion annually, with growth driven primarily by emerging markets.

---

Market Dynamics

Regulatory Challenges and Safety Concerns

The regulatory landscape significantly influences this drug's market trajectory. Notably, in 2018, valsartan was recalled globally due to contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen [1]. Such safety concerns have dampened market confidence, led to formulary restrictions, and shifted prescriber preferences towards alternative ARBs, possibly with better safety profiles.

Additionally, regulatory agencies like the FDA and EMA have tightened pharmacovigilance for RAAS inhibitors, impacting new approvals and formulary placements. The recalls and subsequent legal liabilities also exert pressure on manufacturers to innovate or reformulate, which may delay or diminish market penetration.

Generic Competition and Pricing Pressures

Post-patent expiration (patent expiry of Diovan in 2012), generic versions flooded markets, drastically reducing prices. As of 2023, multiple manufacturers produce generic hydrochlorothiazide and valsartan, intensifying price competition.

Price erosion in key markets—U.S., EU, and emerging economies—has compressed profit margins. Price sensitivity among payers fosters adoption of cost-effective alternatives like combination pills with other ARBs or ACE inhibitors, as well as newer agents.

Emergence of Novel Therapeutics

The cardiovascular drug pipeline has introduced several innovative options. For hypertension, mineralocorticoid receptor antagonists (e.g., spironolactone), endothelin receptor antagonists, and novel ARBs with improved safety profiles are gaining ground.

Moreover, the rise of fixed-dose combinations containing drugs like sacubitril/valsartan (Entresto) and SGLT2 inhibitors (empagliflozin, dapagliflozin) for heart failure and hypertension presents competitive threats, possibly diminishing the role of traditional Hydrochlorothiazide; Valsartan formulations.

Market Penetration in Emerging Economies

Despite challenges, demand persists in emerging markets (India, China, Brazil) owing to affordability and entrenched prescribing habits. Governments and healthcare systems often favor older, low-cost therapies, potentially offsetting reductions in Western markets.

Patent and Litigation Landscape

While the original patent for Diovan expired in 2012, secondary patents and formulation patents influenced market exclusivity. Patent litigations surrounding formulations, indications, or manufacturing processes impact availability and pricing strategies. Patent cliffs and litigations are thus critical risk factors.

---

Financial Trajectory and Future Outlook

Revenue Trends

Based on historical data, revenues are forecasted to decline marginally over the next five years in mature markets due to generic competition and safety concerns. The compound annual growth rate (CAGR) is anticipated to be approximately -2% to -3%, primarily driven by pricing pressures.

In contrast, sales in developing markets are expected to stabilize or marginally grow (CAGR ~1-2%) owing to increased healthcare access and affordability programs.

Strategic Positioning and Innovation

Manufacturers are pivoting toward reformulations—such as combining Valsartan with other agents (amlodipine, hydrochlorothiazide)—and conducting clinical trials to demonstrate added benefits, safety profiles, and labels for broader indications.

There is also potential in biosimilar development and generic manufacturing efficiencies, reducing production costs, and maintaining market share.

Regulatory and Market Access Opportunities

Proactive engagement with regulators to address safety concerns, obtain accelerated approvals for newer or reformulated products, and navigate patent landscapes is vital. Developing formulations with improved bioavailability or reduced side effects can extend lifecycle and revenues.

---

Competitive Landscape

Major players include Novartis, Teva Pharmaceuticals, Sandoz, Mylan (now part of Viatris), and Sun Pharma. Market strategies revolve around cost leadership, product diversification, and clinical evidence generation to sustain relevance.

Emerging biotech entrants focusing on precision medicine and personalized therapy may reshape future competition, especially with biomarker-guided hypertension management.

---

Key Considerations for Stakeholders

• Pharmaceutical Companies: Focus on innovation, safety profile improvements, and lifecycle management to mitigate declining revenues.
• Payers and Healthcare Providers: Emphasize cost-effective therapies, monitor safety alerts, and incorporate newer agents aligned with guidelines.
• Regulators: Maintain rigorous pharmacovigilance and expedite approval pathways for reformulations to ensure safety and market access.

---

Key Takeaways

• The Hydrochlorothiazide; Valsartan combination has experienced significant revenue erosion post-patent expiry, compounded by safety recalls and emergent competition.
• Market dynamics are characterized by intense price competition, regulatory scrutiny, and the rising presence of novel therapeutics.
• Future growth prospects hinge on reformulation efforts, clinical efficacy demonstrations, and penetration into emerging markets.
• Continuity of supply and regulatory compliance are critical to maintaining market relevance.
• Stakeholders must adopt innovative strategies to sustain profitability amid evolving market forces.

---

FAQs

1. What are the primary factors influencing the decline of Hydrochlorothiazide; Valsartan?
   Patent expiries, safety concerns related to Valsartan, aggressive generic competition, and the emergence of newer, targeted therapeutics are key factors.

2. How has regulatory scrutiny affected the market?
   Regulatory agencies' recalls for NDMA contamination, increased pharmacovigilance, and stricter approval standards have reduced confidence, led to formulary restrictions, and prompted reformulations.

3. What opportunities exist for extending the market life of this drug combination?
   Reformulating to improve safety and efficacy, developing combination therapies with newer agents, and targeting emerging markets offer potential avenues.

4. Are there ongoing innovations related to Hydrochlorothiazide; Valsartan?
   Yes; efforts include biosimilars, fixed-dose formulations with additional agents, and optimizing manufacturing processes to reduce costs.

5. Will the combination remain relevant in the future?
   Its relevance will depend on safety improvements, cost-effectiveness, and positioning within evolving treatment guidelines that favor newer agents or personalized medicine approaches.

---

References

[1] U.S. Food & Drug Administration. "Valsartan Recall and Safety Alert." 2018.