DIOVAN HCT Drug Patent Profile

When do Diovan Hct patents expire, and what generic alternatives are available?

Diovan Hct is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in DIOVAN HCT 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 HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	49
Patent Applications:	219
Drug Prices:	Drug price information for DIOVAN HCT
Drug Sales Revenues:	Drug sales revenues for DIOVAN HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIOVAN HCT
What excipients (inactive ingredients) are in DIOVAN HCT?	DIOVAN HCT excipients list
DailyMed Link:	DIOVAN HCT at DailyMed

See drug prices for DIOVAN HCT

See drug sales revenues for DIOVAN HCT

Recent Clinical Trials for DIOVAN HCT

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 HCT clinical trials

Pharmacology for DIOVAN HCT

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

Paragraph IV (Patent) Challenges for DIOVAN HCT

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 DIOVAN HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-002	Mar 6, 1998	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-004	Apr 28, 2006	AB	RX	Yes	No
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006	AB	RX	Yes	Yes

Expired US Patents for DIOVAN HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-004	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-005	Apr 28, 2006
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-001	Mar 6, 1998
Novartis	DIOVAN HCT	hydrochlorothiazide; valsartan	TABLET;ORAL	020818-003	Jan 17, 2002

International Patents for DIOVAN HCT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20050092054
Peru	87498	FORMAS SOLIDAS DE DOSIFICACION ORAL
Spain	2231873
China	1133427
Australia	724998

Supplementary Protection Certificates for DIOVAN HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
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
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0443983	98C004	Belgium		PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925

DIOVAN HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diovan HCT

Introduction to Diovan HCT

Diovan HCT is a combination medication consisting of valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide (HCTZ), a diuretic. It is primarily used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions[4].

Market Size and Growth

The global market for valsartan hydrochlorothiazide preparations, which includes Diovan HCT, has been experiencing steady growth. As of 2023, the market size was valued at USD 0.21 billion and is projected to reach USD 0.30 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 4.5%[1].

Driving Factors

Several factors are driving the growth of the valsartan hydrochlorothiazide preparation market:

• Prevalence of Cardiovascular Diseases: The increasing incidence of hypertension and other cardiovascular diseases globally is a significant driver. Hypertension is a major risk factor for heart disease, stroke, and kidney disease, making effective treatments like Diovan HCT crucial.
• Advancements in Pharmaceutical Formulations: Continuous improvements in drug formulations and delivery systems enhance the efficacy and patient compliance of medications like Diovan HCT[1].

Market Segmentation

The market for valsartan hydrochlorothiazide preparations is segmented based on type and application:

• Type: The market includes tablets and powders. Tablets are the most common form, given their ease of administration and widespread acceptance.
• Application: The primary applications are in hospitals, clinics, and other healthcare settings. The demand from hospitals and clinics is particularly high due to the need for controlled blood pressure management in these settings[1].

Financial Performance of Key Players

Companies like Novartis, the manufacturer of Diovan HCT, have shown strong financial performance in recent years, which is partly attributed to the success of their pharmaceutical products.

Novartis Financial Highlights

• In the past, Novartis has reported significant growth in net sales and operating income. For instance, in the second quarter of 2010, Novartis saw a 37% increase in operating income to USD 6.5 billion, driven by volume expansion and favorable currency movements[5].
• The company's core operating income, which excludes exceptional items and amortization of intangible assets, has also shown robust growth. This indicates a strong financial foundation that supports the development and marketing of drugs like Diovan HCT.

Impact of Generic Entries

The pharmaceutical market is heavily influenced by the entry of generic drugs. For Diovan HCT, the expiration of patents can lead to generic competition, which can impact sales. However, the transition period from brand to generic can be lucrative for the original manufacturer. For example, in the 21 months following the patent expiry of Diovan (valsartan), sales totaled USD 3.8 billion before generic entry[3].

Pricing and Revenue Dynamics

The pricing of branded pharmaceuticals like Diovan HCT is subject to various factors, including healthcare cost-containment measures and competition from generics. Despite these challenges, branded products often maintain their market share through discounts and rebates. For instance, in 2014, the average invoice price growth for branded products was 13.5%, but this was reduced to 7-8% after accounting for off-invoice discounts and rebates[3].

Clinical and Therapeutic Benefits

Diovan HCT offers significant clinical benefits, particularly in managing hypertension. It can be used as monotherapy or in combination with other antihypertensive agents. The combination of valsartan and hydrochlorothiazide has been shown to be more effective in achieving blood pressure goals compared to monotherapy with either component alone[4].

Efficacy in Blood Pressure Management

• Studies have demonstrated that Diovan HCT significantly increases the likelihood of achieving target blood pressure levels. For example, patients with a baseline blood pressure of 160/100 mmHg have a higher likelihood of achieving systolic and diastolic blood pressure goals with Diovan HCT compared to monotherapy with either valsartan or hydrochlorothiazide[4].

Regulatory and Safety Considerations

The FDA plays a crucial role in the approval and monitoring of pharmaceuticals, including Diovan HCT. Safety concerns and regulatory actions can impact the market dynamics. For instance, safety concerns led to the FDA revoking Ranbaxy’s exclusive right to market a generic version of Nexium in 2015, highlighting the importance of regulatory oversight[3].

Market Competition

The market for antihypertensive medications is highly competitive, with various classes of drugs available, including ARBs, ACE inhibitors, and diuretics. Diovan HCT competes with other combination therapies and monotherapies in this space. The competitive landscape is further complicated by the entry of generic and biosimilar products[4].

Future Outlook

Given the increasing prevalence of hypertension and the ongoing advancements in pharmaceutical formulations, the market for valsartan hydrochlorothiazide preparations, including Diovan HCT, is expected to continue growing. However, the market will need to navigate challenges such as generic competition, regulatory changes, and evolving healthcare policies.

Innovative Strategies

To maintain market share, manufacturers may focus on innovative strategies such as developing new formulations, enhancing patient compliance programs, and investing in clinical trials to demonstrate additional benefits of their products.

Key Takeaways

• The valsartan hydrochlorothiazide preparation market, including Diovan HCT, is projected to grow to USD 0.30 billion by 2032.
• The market is driven by the prevalence of cardiovascular diseases and advancements in pharmaceutical formulations.
• Diovan HCT offers significant clinical benefits in managing hypertension.
• The market faces challenges from generic entries and regulatory changes.
• Innovative strategies and strong financial performance by key players are crucial for market success.

Frequently Asked Questions

What is the expected market size of valsartan hydrochlorothiazide preparations by 2032?

The global valsartan hydrochlorothiazide preparation market is expected to reach USD 0.30 billion by 2032[1].

What is the CAGR of the valsartan hydrochlorothiazide preparation market?

The valsartan hydrochlorothiazide preparation market is expected to exhibit a CAGR of 4.5% by 2032[1].

What are the primary applications of Diovan HCT?

The primary applications of Diovan HCT are in hospitals, clinics, and other healthcare settings[1].

How does Diovan HCT compare to monotherapy in blood pressure management?

Diovan HCT has been shown to be more effective in achieving blood pressure goals compared to monotherapy with either valsartan or hydrochlorothiazide alone[4].

What are the key factors driving the growth of the valsartan hydrochlorothiazide preparation market?

The key factors driving the growth include the prevalence of cardiovascular diseases and advancements in pharmaceutical formulations[1].

Cited Sources:

1. Business Research Insights - Valsartan Hydrochlorothiazide Preparation Market Size 2032
2. FierceBiotech - Novartis achieves strong third quarter financial performance and pipeline progress
3. IQVIA - Medicines Use and Spending Shifts in the US in 2014
4. DailyMed - DIOVAN HCT- valsartan and hydrochlorothiazide tablet, film coated
5. FiercePharma - Novartis delivers strong financial performance in second quarter