Valsartan - Generic Drug Details

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

Valsartan is the generic ingredient in three branded drugs marketed by Novartis, Carmel Biosciences, Novitium Pharma, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Ryan Labs, Sciegen Pharms Inc, Square Pharms, Torrent, Unichem, Watson Labs Inc, and Zydus Lifesciences, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for valsartan. Thirty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for valsartan

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	24
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	385
Patent Applications:	8,236
Drug Prices:	Drug price trends for valsartan
Drug Sales Revenues:	Drug sales revenues for valsartan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valsartan
What excipients (inactive ingredients) are in valsartan?	valsartan excipients list
DailyMed Link:	valsartan at DailyMed

See drug prices for valsartan

See drug sales revenues for valsartan

Recent Clinical Trials for valsartan

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

Sponsor	Phase
International Bio service	Phase 1
Dr. Reddy's Laboratories (Thailand) Limited	Phase 1
Rede de Investigação em Saúde	Phase 4

See all valsartan clinical trials

Generic filers with tentative approvals for VALSARTAN

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

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

Medical Subject Heading (MeSH) Categories for valsartan

Angiotensin II Type 1 Receptor Blockers

Antihypertensive Agents

Anatomical Therapeutic Chemical (ATC) Classes for valsartan

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 VALSARTAN

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 valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	VALSARTAN	valsartan	TABLET;ORAL	205536-002	Mar 12, 2019	AB	RX	No	No
Square Pharms	VALSARTAN	valsartan	TABLET;ORAL	205347-002	Apr 9, 2018	AB	RX	No	No
Ryan Labs	VALSARTAN	valsartan	TABLET;ORAL	218169-004	Aug 5, 2024	AB	RX	No	No
Sciegen Pharms Inc	VALSARTAN	valsartan	TABLET;ORAL	204038-004	Oct 27, 2021	AB	RX	No	No
Alkem Labs Ltd	VALSARTAN	valsartan	TABLET;ORAL	205536-001	Mar 12, 2019	AB	RX	No	No

Expired US Patents for valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001	5,972,990*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-003	Jul 18, 2001	6,294,197*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-004	Aug 14, 2002	6,294,197*PED
Novartis	DIOVAN	valsartan	TABLET;ORAL	021283-002	Jul 18, 2001	5,399,578*PED
Novartis	DIOVAN	valsartan	CAPSULE;ORAL	020665-001	Dec 23, 1996	5,399,578*PED

Valsartan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Valsartan

Introduction

Valsartan, a widely used angiotensin II receptor antagonist, has been a cornerstone in the treatment of hypertension and heart failure. Recent market trends and financial data indicate significant shifts in the drug's pricing, demand, and overall market dynamics.

Global Demand and Pricing Trends

In April 2024, Valsartan prices experienced a notable surge globally, driven by increasing demand and supply constraints. This upward trend is attributed to robust sales in key therapeutic segments such as cardiovascular, dermatology, anti-infectives, and anti-diabetic medications[1].

Indian Pharmaceutical Sector

The Indian pharmaceutical sector, a major player in the global Valsartan market, saw a rebound in April 2024 after a slight contraction in the previous month. The sector witnessed a 9.2% year-on-year growth, largely due to strategic pricing increases and the introduction of new products. This growth contributed to heightened demand for pharmaceuticals, including Valsartan, leading to increased prices[1].

Chinese Market Dynamics

In China, the manufacturing Purchasing Managers' Index (PMI) remained above the expansion threshold, indicating sustained industrial recovery. This ongoing growth in manufacturing, coupled with escalating domestic production costs, resulted in tightened supply conditions for Valsartan. Manufacturers adjusted prices to ensure profitability, contributing to the global price surge[1].

Supply Chain and Regulatory Factors

Supply Chain Disruptions

Supply chain disruptions, particularly in the USA, have significantly impacted the pharmaceutical market. The drug shortage crisis highlighted by the American Society of Health-System Pharmacists (ASHP) has constrained the production capacity of generic drug manufacturers, including those producing Valsartan. This has reverberated throughout the industry, prompting global generic manufacturers to reassess their strategies[1].

Regulatory Influences

Regulatory actions, such as those by the National Pharmaceutical Pricing Authority (NPPA) in India, have also played a crucial role. Starting April 1, 2024, new pricing guidelines led pharmaceutical companies to adjust their pricing strategies, contributing to an overall escalation in medication costs, including Valsartan[1].

Economic and Financial Projections

Market Size and Growth

The global Valsartan market was estimated to be worth $589 million in 2023 and is forecasted to reach $866.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[4].

Cost-Effectiveness and Value Assessments

Studies have shown that Valsartan, particularly when combined with sacubitril, offers high economic value for patients with reduced and mildly reduced ejection fractions. The incremental cost-effectiveness ratio (ICER) for sacubitril-valsartan compared to renin-angiotensin system inhibitors (RASis) is consistent with high economic value, especially at lower ejection fraction ranges[2].

Key Players and Market Competition

The Valsartan market is dominated by several key players, including Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, and others. These companies are instrumental in shaping the market dynamics through their production capacities, pricing strategies, and distribution networks[4].

Regional Market Trends

Eurozone and Germany

The rebound in the Eurozone economy, led by Germany, has resulted in increased consumer spending, driving up demand for commodities like Valsartan and subsequently increasing prices. This trend is expected to continue as economic conditions improve[1].

USA

In the USA, the increasing use of sacubitril-valsartan, as observed in Medicare and Medicaid data, has led to significant spending on this medication. The number of Medicare beneficiaries prescribed sacubitril-valsartan increased by 156% from 2016 to 2017, with corresponding increases in spending[5].

Future Outlook

Price Forecast

Based on current trends, it is anticipated that Valsartan prices will continue their upward trajectory in the forthcoming months, driven by sustained demand and supply constraints. Potential rate cuts by central banks in developed economies could further stimulate demand, instilling optimism within the market[1].

Market Expansion

The forecasted growth of the Valsartan market to $866.2 million by 2030 indicates a robust future for this drug. The increasing prevalence of hypertension and heart failure, coupled with the cost-effectiveness of Valsartan, especially in combination with sacubitril, will likely drive market expansion[4].

Impact on Healthcare and Patients

Access and Affordability

Despite the cost-effectiveness of Valsartan, the increasing prices pose challenges for patient access and affordability. Ongoing efforts are needed to promote high-value care while improving affordability and access to established and emerging heart failure therapies[5].

Quality of Life

The economic evaluation of sacubitril-valsartan highlights its ability to increase quality-adjusted life-years (QALYs) at an incremental cost-effectiveness ratio that is consistent with high economic value. This underscores the drug's significant impact on improving patient outcomes and quality of life[2].

Key Takeaways

• Global Price Surge: Valsartan prices have surged globally due to rising demand and supply constraints.
• Market Growth: The global Valsartan market is projected to grow to $866.2 million by 2030.
• Cost-Effectiveness: Valsartan, especially in combination with sacubitril, offers high economic value for patients with reduced ejection fractions.
• Supply Chain Challenges: Supply chain disruptions and regulatory actions are influencing market dynamics.
• Future Outlook: Prices are expected to continue rising, driven by sustained demand and potential economic stimuli.

FAQs

What are the primary factors driving the surge in Valsartan prices?

The primary factors include rising demand in the healthcare and pharmaceutical sectors, supply constraints, and strategic pricing adjustments by manufacturers.

How does the combination of sacubitril and Valsartan impact patient outcomes?

The combination of sacubitril and Valsartan has been shown to increase quality-adjusted life-years (QALYs) at an incremental cost-effectiveness ratio consistent with high economic value, particularly for patients with reduced and mildly reduced ejection fractions.

Which regions are experiencing significant growth in Valsartan demand?

Regions such as India, China, and the Eurozone, particularly Germany, are experiencing significant growth in Valsartan demand due to improving economic conditions and increased consumer spending.

What are the key challenges in the Valsartan market?

Key challenges include supply chain disruptions, regulatory influences, and the need to balance cost-effectiveness with patient access and affordability.

Who are the major players in the Valsartan market?

Major players include Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, and several other pharmaceutical companies.

Sources

1. ChemAnalyst: Valsartan Prices Surge Globally, Driven by Rising Demand and Supply Constraints.
2. JAMA Cardiology: Health and Economic Evaluation of Sacubitril-Valsartan for Heart Failure.
3. ChemAnalyst: Valsartan Price Trend and Forecast.
4. Valuates Reports: Valsartan Drug - Market Size.
5. JAMA Cardiology: Medicare and Medicaid Utilization and Associated Spending on Sacubitril/Valsartan.