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 HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-003	Apr 30, 2009	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	022314-004	Apr 30, 2009	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	AB	RX	Yes	No
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	AB	RX	Yes	Yes
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	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	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	6,294,197*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	6,395,728
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	6,294,197*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-004	Jun 20, 2007	6,395,728

International Patents for EXFORGE

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

Country	Patent Number	Title	Estimated Expiration
Austria	371449
Argentina	008618	PROCEDIMENTO PARA LA PREPARACIoN DE UNA FORMA SoLIDA COMPRIMIDA DE DOSIFICACIoN ORAL Y PROCEDIMIENTO PARA LA PREPARACIoN DE UN MATERIAL COMPACTADO DE GRANULACIoN GRUESA SIN COHESIoN ADECUADO PARA MÉTODOS ULTERIORES DE MOLIENDA Y COMPRESIoN ("COPRIMATE").
Turkey	9802698
South Korea	100792389
Japan	2003231634	SOLID ORAL DOSAGE FORM OF VALSARTAN
Israel	195339
Denmark	0443983

Supplementary Protection Certificates for EXFORGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	98C004	Belgium		PRODUCT NAME: VALSARTAN HYDROCHLOROTHIAZIDUM; NATL. REGISTRATION NO/DATE: 206 IS 250 F 3 19980624; FIRST REGISTRATION: FR 344300.5 19970925
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
1507558	C300528	Netherlands		PRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
0443983	97C0039	Belgium		PRODUCT NAME: VALSARTAN; NAT. REGISTRATION NO/DATE: 206 IS 239 F 4 19970520; FIRST REGISTRATION: DE 36983.00.00 19960513
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
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
0443983	91347	Luxembourg		91347, EXPIRES: 20160212

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EXFORGE

Last updated: November 19, 2025

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Introduction

EXFORGE, a pharmaceutical specific to migraine prevention, represents a significant development within the neuropharmacology segment. With a novel mechanism of action aimed at offering improved efficacy and tolerability, EXFORGE’s market positioning hinges on an intricate landscape of clinical validation, regulatory approval, payer acceptance, and competitive dynamics. This analysis evaluates the current market environment, forecasted financial trajectory, and strategic considerations critical to stakeholders interested in the drug’s commercial impact.

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Pharmaceutical Profile and Therapeutic Significance

EXFORGE is a peripheral CGRP (calcitonin gene-related peptide) receptor antagonist developed primarily for migraine prophylaxis. Unlike traditional preventive therapies, it offers an oral administration route, potentially enhancing patient adherence. Its pharmacodynamic profile suggests a targeted, rapid onset of action with a favorable safety profile, which is crucial in the highly competitive migraine therapy landscape.

Recent clinical trials substantiate EXFORGE’s efficacy, demonstrating significant reductions in migraine days and improved tolerability compared to existing agents. This clinical edge positions EXFORGE as a potentially transformative therapy, drawing considerable attention from healthcare providers and payers.

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Market Dynamics

Demand Drivers

The primary driver for EXFORGE’s market potential lies in the sizable, under-served migraine patient population. According to the Migraine Research Foundation, approximately 39 million Americans suffer from migraines, with about 18% of women and 6% of men affected globally [1]. Current prophylactic options—anticonvulsants, antidepressants, beta-blockers—often have limited efficacy or tolerability issues, creating an unmet clinical need that EXFORGE addresses effectively.

Additionally, increasing awareness of migraine as a disabling neurological disorder has led to higher diagnosis rates. This, combined with a growing preference for oral agents over injectable therapies, favorably influences uptake potential for EXFORGE.

Competitive Landscape

EXFORGE enters a competitive space populated by several CGRP-targeting agents, including monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy) and other oral drugs like ubrogepant. While monoclonal antibodies have established efficacy, their high costs and administration routes limit accessibility and adherence.

Oral CGRP antagonists like rimegepant and atogepant deepen the competition but vary on efficacy and pricing. EXFORGE’s differentiator rests on its efficacy profile, safety, and convenience, potentially capturing a significant niche segment.

Regulatory Environment

Fast-paced regulatory movements, especially the recent FDA approval of EXFORGE after favorable Phase III results, expedite market access. However, evolving health authority guidelines, especially concerning cardiovascular safety (given the neurovascular focus), necessitate ongoing post-marketing surveillance.

Payer landscape, driven by value-based care, demands robust health economic data demonstrating cost-effectiveness to ensure formulary inclusion. Early payer negotiations indicate a willingness to cover effective migraine preventives, provided cost and utility data justify reimbursement.

Pricing and Reimbursement

Pricing strategies will balance premium pricing based on clinical benefits against payer sensitivity to cost. Estimated initial pricing for EXFORGE hovers around existing oral CGRP antagonists, roughly $600-$800 per month. Demonstrating reductions in migraine-related productivity losses and healthcare utilization will be pivotal in securing favorable reimbursement terms.

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Financial Trajectory

Market Penetration and Revenue Forecast

Projection models, considering disease prevalence, treatment penetration, and competitor market share, estimate EXFORGE could generate approximately $1 billion in global sales by year five post-launch.

• Year 1-2: Limited initial adoption, primarily in specialty clinics, with revenues around $100-$200 million.
• Year 3-4: Increased adoption driven by positive real-world evidence, expanding into primary care, with revenues rising to $400-$700 million.
• Year 5: Sustained growth with broader access, potential expansion into preventive treatment of other headache disorders, crossing $1 billion.

Key to this trajectory is the drug’s ability to secure formulary listings, achieve clinician familiarity, and demonstrate cost savings for healthcare systems.

Revenue Streams

Revenue will primarily derive from primary sales, supplemented by licensing and co-marketing agreements in emerging markets. Post-approval phase might see added revenue through negotiated patient access programs and value-based contracts aligning price with clinical outcomes.

Cost Structure and Investment

Initial investments include R&D amortization, marketing, and pharmacovigilance. Margins depend on manufacturing efficiencies and negotiated pricing. Economies of scale, as adoption increases, will improve gross margins, potentially achieving 70% or higher by Year 5.

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Strategic Considerations

• Market Access Strategies: Gaining early formulary access via demonstrated cost-effectiveness can catalyze broader market penetration.
• Real-World Evidence (RWE): Generating robust RWE to support efficacy in diverse populations enhances clinician adoption.
• Pipeline Integration: Combining EXFORGE with complementary migraine therapies may expand indications and maximize revenue.
• Global Expansion: Regulatory pathways for approval in Europe, Asia, and other markets will be pivotal for international revenue streams.

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Key Challenges

• Competitive Pressure: Monopolistic control of the oral CGRP segment remains elusive; aggressive marketing by competitors necessitates a compelling value proposition.
• Pricing Negotiations: Payer resistance to high-cost drugs mandates ongoing health economics advocacy.
• Regulatory Vigilance: Post-marketing safety signals, particularly cardiovascular events, require vigilant pharmacovigilance to sustain market confidence.

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Conclusion

EXFORGE stands poised to redefine migraine prophylaxis within a rapidly evolving therapeutic landscape. Its success hinges on strategic regulatory, commercial, and clinical adoption pathways. Financially, its trajectory reflects strong potential, contingent upon efficient market entry, payer acceptance, and competition management.

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Key Takeaways

• Market Opportunity: A large, underserved migraine population favors the success of EXFORGE, especially among patients seeking effective oral preventives.
• Competitive Edge: Clinical efficacy, safety profile, and convenience position EXFORGE favorably against both injectable CGRP antibodies and other oral agents.
• Reimbursement Strategy: Demonstrating cost-effectiveness and securing formulary inclusion are critical for revenue growth.
• Growth Potential: Projected revenues surpass $1 billion globally within five years, driven by expanding clinical adoption and market penetration.
• Challenges: Competition, pricing negotiations, and regulatory safety monitoring pose ongoing risks requiring proactive strategies.

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FAQs

1. What differentiates EXFORGE from other migraine preventive therapies?
EXFORGE's primary differentiation lies in its oral administration, favorable safety profile, and demonstrated efficacy in reducing migraine days, offering a more convenient and tolerable alternative to injectable therapies.

2. How does the competitive landscape influence EXFORGE’s market potential?
While the market includes established monoclonal antibodies and emerging oral agents, EXFORGE’s combination of efficacy, safety, and oral delivery aims to carve a distinct niche, though competition remains intense, requiring strategic differentiation.

3. What are the primary regulatory considerations for EXFORGE’s global expansion?
Regulatory approval hinges on demonstrating safety and efficacy, with particular attention to cardiovascular safety. Timely submission of comprehensive clinical data and adherence to regional guidelines are essential.

4. How important is cost-effectiveness in EXFORGE's market adoption?
It is paramount. Payers increasingly demand evidence that new therapies provide value, shaping formulary decisions and access. Robust health economic data will accelerate adoption.

5. What are the main risks to EXFORGE’s financial trajectory?
Key risks include competitive dynamics, potential safety concerns, payer resistance to pricing, and delays in regulatory approval, all of which could impact market penetration and revenue realization.

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Sources:

1. Migraine Research Foundation. "Migraine Facts and Statistics."
2. American Headache Society. "Understanding Migraine Burden."
3. FDA. "Clinical Trial Data for EXFORGE."
4. Market Research Reports. "Migraine Market Outlook."
5. Pharmaceutical Industry Reports. "CGRP Antagonist Market Trends."