EXFORGE Drug Patent Profile

Which patents cover Exforge, and what generic alternatives are available?

Exforge is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in EXFORGE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for EXFORGE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	15
Drug Prices:	Drug price information for EXFORGE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXFORGE
What excipients (inactive ingredients) are in EXFORGE?	EXFORGE excipients list
DailyMed Link:	EXFORGE at DailyMed

See drug prices for EXFORGE

See drug sales revenues for EXFORGE

Recent Clinical Trials for EXFORGE

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

Sponsor	Phase
International Bio service	Phase 1
Novartis Pharmaceuticals	Phase 4
Hanlim Pharm. Co., Ltd.	Phase 1

See all EXFORGE clinical trials

Pharmacology for EXFORGE

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Paragraph IV (Patent) Challenges for EXFORGE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/320 mg	021990	1	2007-11-26
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/320 mg	021990	1	2007-11-09
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/160 mg	021990	1	2007-10-22
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/160 mg	021990	1	2007-10-01

US Patents and Regulatory Information for EXFORGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	AB	RX	Yes	Yes
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	AB	RX	Yes	No

Expired US Patents for EXFORGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007

International Patents for EXFORGE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2055301
Hong Kong	219996	Acyl compounds
Russian Federation	2294743	ТВЕРДЫЕ ОРАЛЬНЫЕ ДОЗИРУМЫЕ ФОРМЫ НА ОСНОВЕ ВАЛЬСАРТАНА (VALSARTAN-BASE SOLID ORAL DOSING FORMULATIONS)
South Africa	9101179

Supplementary Protection Certificates for EXFORGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	91347	Luxembourg		91347, EXPIRES: 20160212
1915993	92315	Luxembourg		PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
0443983	SPC/GB97/009	United Kingdom		PRODUCT NAME: VALSARTAN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: DE 36983.00.00 19960513; DE 36983.01.00 19960513; UK 00001/0218 19961016; UK 00001/0219 19961016; UK 00001/0225 19961016

Market Dynamics and Financial Trajectory for EXFORGE

Introduction

EXFORGE, a combination drug consisting of amlodipine and valsartan, is a significant player in the antihypertensive market. Developed and marketed by Novartis, this drug has been designed to provide effective blood pressure control, particularly for patients who are not adequately managed on monotherapy.

Market Need and Target Audience

Hypertension is a silent but pervasive disease that poses significant health risks, including strokes and myocardial infarctions. The need for effective antihypertensive drugs is high, and EXFORGE has been positioned to meet this demand. The target audience includes patients whose hypertension is not adequately controlled by single-agent therapies, making it an attractive option for both physicians and patients seeking better blood pressure management[3][4].

Product Profile

EXFORGE combines a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (valsartan). This combination is effective in lowering blood pressure and reducing the risk of cardiovascular events. The drug is available in various dosages, such as EXFORGE 5/160, which contains 5mg of amlodipine and 160mg of valsartan[3][4].

Clinical Efficacy

Clinical trials have demonstrated that EXFORGE provides powerful blood pressure control. For instance, patients with a baseline blood pressure of 160/100 mmHg have a higher likelihood of achieving blood pressure goals with EXFORGE compared to monotherapy with either amlodipine or valsartan alone. The likelihood of achieving systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg is significantly higher with EXFORGE[3].

Market Launch and Reception

EXFORGE was approved by the FDA on June 20, 2007, and was released to the market on August 1, 2007. Prior to its launch, about a quarter of physicians intended to prescribe it as first-line therapy, while the majority envisioned its use in second- or third-line positions. The marketing campaign emphasized EXFORGE as the best option for patients needing a significant reduction in blood pressure[4].

Market Performance

The antihypertensive market, particularly the segment involving angiotensin II antagonists, has seen steady growth. In the years leading up to EXFORGE's launch, US sales of angiotensin II antagonists increased from $2.7 billion in 2002 to $5.8 billion in 2006. EXFORGE has contributed to this growth, although specific sales figures for the drug are not detailed in the available sources. However, it is noted that EXFORGE has displaced other antihypertensive agents, such as ACE inhibitors and ARBs, in many treatment regimens[4].

Financial Impact on Novartis

Novartis's financial performance has been influenced by the sales of EXFORGE, among other products. In the second quarter of 2024, Novartis reported significant financial gains, including a core operating income of $5.0 billion, a 17% increase from the previous year. While the specific financial contribution of EXFORGE is not isolated in these reports, the overall performance of Novartis's antihypertensive portfolio, which includes EXFORGE, has been a key factor in these positive financial results[2].

Competitive Landscape

The antihypertensive market is highly competitive, with various drugs and combinations available. However, EXFORGE's unique combination of amlodipine and valsartan positions it favorably. As of the last available data, there were no competitor compounds in Phase III or pre-registration in the US, giving EXFORGE a competitive edge in the market[4].

Marketing Strategy

The marketing strategy for EXFORGE has focused on both professional and consumer promotion. Integrated Communications has handled professional promotion, while Deutsch has been engaged for consumer marketing. The campaign theme emphasizes EXFORGE as the best drug for patients needing a significant drop in blood pressure, highlighting its clinical efficacy and the silent nature of hypertension[4].

Physician and Patient Adoption

Physician adoption of EXFORGE has been significant, with many prescribing it as a second- or third-line treatment. Patient education has also been a key component, given the silent nature of hypertension and the need for effective blood pressure management. The drug's efficacy and the comprehensive marketing campaign have contributed to its adoption among both physicians and patients[4].

Future Outlook

Given the ongoing need for effective antihypertensive treatments and the competitive positioning of EXFORGE, the drug is likely to continue playing a significant role in the market. Novartis's continued investment in research and development, as well as its strong marketing efforts, will likely support the sustained growth of EXFORGE in the antihypertensive market.

Key Takeaways

• EXFORGE is a combination drug of amlodipine and valsartan, designed for effective blood pressure control.
• It is particularly useful for patients not adequately controlled on monotherapy.
• Clinical trials have shown EXFORGE to be highly effective in achieving blood pressure goals.
• The drug was launched in 2007 and has been well-received by physicians and patients.
• EXFORGE has contributed to Novartis's positive financial performance.
• The competitive landscape favors EXFORGE due to its unique combination and lack of direct competitors in late-stage development.

FAQs

What is EXFORGE used for?

EXFORGE is used for the treatment of hypertension, particularly in patients whose blood pressure is not adequately controlled on monotherapy or who are likely to need multiple drugs to achieve their blood pressure goals[3].

How does EXFORGE work?

EXFORGE combines a calcium channel blocker (amlodipine) and an angiotensin II receptor blocker (valsartan), which work together to lower blood pressure and reduce the risk of cardiovascular events[3].

What are the benefits of using EXFORGE?

EXFORGE provides powerful blood pressure control, reducing the risk of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions. It also offers a higher likelihood of achieving blood pressure goals compared to monotherapy with either amlodipine or valsartan alone[3].

When was EXFORGE approved and released?

EXFORGE was approved by the FDA on June 20, 2007, and was released to the market on August 1, 2007[4].

How has EXFORGE impacted Novartis's financial performance?

EXFORGE has contributed to Novartis's positive financial performance, although specific figures are not detailed. The overall growth in Novartis's antihypertensive portfolio, which includes EXFORGE, has been a key factor in their financial gains[2].

Sources

1. Antihypertensive Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst
2. Novartis Financial Results Q2 2024 - Novartis
3. EXFORGE® (amlodipine and valsartan) tablets, for oral use - Novartis
4. Exforge 5/160 - MM+M - Medical Marketing and Media
5. 10M24: Net profit exceeds CHF 260 million and net new assets of CHF 7.4 billion - EFG International