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. Nineteen 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:	152
Clinical Trials:	49
Patent Applications:	5,185
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
ARKAY Therapeutics	Phase 1/Phase 2
Albany Medical College	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.

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

Expired US Patents for DIOVAN

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

International Patents for DIOVAN

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1060700
Slovakia	178498	SOLID ORAL DOSAGE FORMS OF VALSARTAN
South Korea	100792389
China	1475207

Supplementary Protection Certificates for DIOVAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1467728	16C0019	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1058 20151123
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0443983	CA 2010 00014	Denmark
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

DIOVAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Diovan (Valsartan)

Introduction

Diovan, known generically as Valsartan, is a widely used medication for treating high blood pressure, heart failure, and diabetic kidney disease. This article delves into the current market dynamics and financial trajectory of Valsartan, highlighting key factors influencing its market performance.

Global Market Size and Growth

The global Valsartan market is projected to grow at a significant rate. As of 2023, the market was valued at approximately $589 million and is forecasted to reach $866.2 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.4% during the period 2024-2030[4].

Market Drivers

Rising Demand

The demand for Valsartan has been on the rise due to its efficacy in treating cardiovascular conditions. The persistent demand in the healthcare and pharmaceutical sectors, particularly for cardiovascular, dermatology, anti-infectives, and anti-diabetic medications, has driven up the sales of Valsartan[1].

Supply Constraints

Supply chain disruptions and dwindling product supplies across various markets have contributed to the surge in Valsartan prices. Manufacturers and distributors have strategically increased prices to leverage the situation and maintain a bullish market sentiment[1].

Regional Market Performance

India

The Indian pharmaceutical sector has seen a rebound, driven by robust sales in key therapeutic segments. In April 2024, the sector experienced a 9.2% year-on-year growth, largely due to pricing strategies and the introduction of new products. This growth has positively impacted the demand for Valsartan, leading to higher prices[1].

China

China's manufacturing sector, despite a slight dip in the Purchasing Managers' Index (PMI), remains above the expansion threshold, indicating sustained industrial recovery. This ongoing growth in manufacturing has resulted in consistent demand for pharmaceuticals like Valsartan, coupled with escalating domestic production costs, which has tightened supply conditions and prompted price adjustments[1].

USA and Europe

In the USA, the drug shortage crisis, exacerbated by supply chain disruptions and regulatory oversight, has impacted the production capacity of generic drug manufacturers. This has reverberated throughout the industry, affecting global generic manufacturers and contributing to the upward trajectory of Valsartan prices. In Europe, particularly in Germany, improving economic conditions have led to increased consumer spending, driving up demand for commodities like Valsartan[1].

Competitive Landscape

The Valsartan market is highly competitive, with several key players dominating the scene. These include Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, Lupin, Aurobindo Pharma, and others. These companies are continually adapting their strategies to meet the rising demand and navigate supply constraints[4].

Financial Performance of Key Players

Novartis

Novartis, the original developer of Diovan, has seen significant financial performance. In the third quarter of 2023, Novartis reported sales growth driven mainly by ex-US markets. However, the company experienced an operating loss due to costs related to the spinoff of the Sandoz business. Despite this, the core operating income remained substantial, reflecting the company's strong market position[2].

Viatris

Viatris, another major player in the pharmaceutical industry, reported total net sales of $3.83 billion in the fourth quarter of 2023, with operational revenue growth on a divestiture-adjusted basis. The company's adjusted EBITDA and free cash flow also showed positive trends, indicating a stable financial trajectory[5].

Pricing Dynamics

The pricing of Valsartan has undergone significant changes due to regulatory actions and market conditions. In India, directives from the National Pharmaceutical Pricing Authority (NPPA) led to an escalation in medication costs, including Valsartan. Globally, manufacturers have adjusted their pricing strategies to ensure profitability amidst rising demand and supply constraints[1].

Applications and Types

Valsartan is available in various formulations, including 40 mg, 80 mg, 160 mg, and 320 mg tablets. It is used to treat hypertension, heart failure, and heart attack, among other cardiovascular conditions. The versatility of Valsartan in treating different health issues has contributed to its widespread adoption and growing market demand[3][4].

Future Outlook

The future outlook for the Valsartan market appears optimistic. With sustained demand from end-consumers and potential economic stimuli such as rate cuts by central banks, the market is expected to continue its upward trajectory. The global market size is projected to grow, driven by increasing demand and the introduction of new products[1][4].

Challenges and Opportunities

Supply Chain Disruptions

Supply chain disruptions remain a significant challenge for the Valsartan market. These disruptions, compounded by regulatory oversight, have constrained the production capacity of generic drug manufacturers, affecting global supply and prices[1].

Regulatory Environment

Regulatory actions, such as those by the NPPA in India, can significantly impact the pricing dynamics of essential medicines, including Valsartan. Manufacturers must adapt to these changes to maintain market competitiveness[1].

Economic Factors

Improving economic conditions in regions like Europe and the potential for rate cuts by central banks could further stimulate demand for Valsartan, presenting opportunities for growth in the market[1].

"Given China and India's prominence as major exporters of Active Pharmaceutical Ingredients (APIs), including Valsartan, a similar pattern may emerge in countries such as the USA and Germany. Recent data suggests a rebound in the Eurozone economy, with Germany leading the recovery. With improving economic conditions, consumers exhibit greater spending willingness, driving up demand for commodities like Valsartan and subsequently increasing prices."[1]

Key Takeaways

• The global Valsartan market is projected to grow at a CAGR of 6.4% from 2024 to 2030.
• Rising demand and supply constraints are key drivers of the current market dynamics.
• Regulatory actions and economic factors significantly influence the pricing and availability of Valsartan.
• Major players like Novartis, Sun Pharmaceutical, and Viatris are adapting their strategies to navigate market challenges and opportunities.
• The market is expected to continue its upward trajectory driven by sustained demand and potential economic stimuli.

FAQs

What are the primary drivers of the current surge in Valsartan prices?

The primary drivers include rising demand in the healthcare and pharmaceutical sectors, coupled with supply constraints and regulatory actions that have led to price adjustments by manufacturers.

Which regions are experiencing significant growth in the Valsartan market?

India and China are experiencing significant growth, with India's pharmaceutical sector rebounding and China's manufacturing sector sustaining industrial recovery. Europe, particularly Germany, is also seeing increased demand due to improving economic conditions.

What are the main applications of Valsartan?

Valsartan is mainly used for treating hypertension, heart failure, and heart attack, among other cardiovascular conditions.

Who are the key players in the Valsartan market?

Key players include Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, Lupin, Aurobindo Pharma, and others.

What is the projected market size of Valsartan by 2030?

The global Valsartan market is forecasted to reach $866.2 million by 2030, with a CAGR of 6.4% during the period 2024-2030.

Sources

1. ChemAnalyst: "Valsartan Prices Surge Globally, Driven by Rising Demand and Supply Constraints"[1]
2. Novartis Q3 2023 Condensed Interim Financial Report: "Sales in the US were USD 4.7 billion (+13%) and in the rest of the world USD 7.1 billion (+12%, +11% cc)"[2]
3. OpenPR: "Valsartan Market Growth, Competitive Analysis and Forecast"[3]
4. Valuates Reports: "Valsartan Drug - Market Size"[4]
5. Viatris: "Viatris Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides 2024 Financial Guidance"[5]