AMLODIPINE BESYLATE Drug Patent Profile

Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?

Amlodipine Besylate is a drug marketed by Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Graviti Pharms, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Mylan, Orbion Pharms, Oxford Pharms, Pharmobedient, Puracap Labs Blu, Puracap Pharm, Sciegen Pharms, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Teva Pharms Inc, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Hetero Labs, Macleods Pharms Ltd, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, and Torrent. and is included in seventy-three NDAs.

The generic ingredient in AMLODIPINE BESYLATE 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 AMLODIPINE BESYLATE

US Patents:	0
Applicants:	55
NDAs:	73
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	60
Patent Applications:	5,876
Drug Prices:	Drug price information for AMLODIPINE BESYLATE
Drug Sales Revenues:	Drug sales revenues for AMLODIPINE BESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE
What excipients (inactive ingredients) are in AMLODIPINE BESYLATE?	AMLODIPINE BESYLATE excipients list
DailyMed Link:	AMLODIPINE BESYLATE at DailyMed

See drug prices for AMLODIPINE BESYLATE

See drug sales revenues for AMLODIPINE BESYLATE

Recent Clinical Trials for AMLODIPINE BESYLATE

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

Sponsor	Phase
Third Military Medical University	PHASE4
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1

See all AMLODIPINE BESYLATE clinical trials

Pharmacology for AMLODIPINE BESYLATE

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

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Puracap Labs Blu	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	207821-003	Jul 11, 2016	AB	RX	No	No
Hetero Labs	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	205137-002	Sep 16, 2016	AB	RX	No	No
Teva	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076846-002	Jun 28, 2007	AB	RX	No	No
Mylan	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090483-004	Mar 30, 2015	AB	RX	No	No
Graviti Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	201380-001	Apr 13, 2012	AB	RX	No	No
Epic Pharma Llc	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078552-002	Apr 8, 2009	AB	RX	No	No
Neocubes Pharma	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	207762-007	Jan 11, 2019	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-002	Sep 27, 2007	6,828,339

International Patents for AMLODIPINE BESYLATE

See the table below for patents covering AMLODIPINE BESYLATE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	037565	FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS.
Australia	2002343257
European Patent Office	1448197
Norway	20042539
World Intellectual Property Organization (WIPO)	03043635

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C300445	Netherlands		PRODUCT NAME: VALSARTAN, AMLODIPINE EN HYDROCHLOORTHIAZIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/09/569/001-060 20091016
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
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
0502314	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216

Amlodipine Besylate Market Dynamics and Financial Trajectory: Pricing, Volume, Exclusivity, and Competitive Pressure

Last updated: June 24, 2026

Amlodipine besylate is a long-established, off-patent small-molecule calcium channel blocker with broad generic availability in the US and most major markets. Market dynamics are driven by (1) generic price compression and payer-driven switching, (2) limited sustained differentiation from formulation/combination products, and (3) steady but mature underlying hypertension demand. Financial trajectory is characterized by declining branded revenue (where present) and stable-to-declining category net sales in developed markets, with growth tied to emerging-market access and conversion of out-of-pocket to reimbursed use.

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What is the current market size and revenue trajectory for amlodipine besylate?

Short answer: Category sales remain large globally because hypertension prevalence is high and amlodipine is a preferred first-line therapy. Returns have shifted from innovation-led growth to volume-led stability as generics set the commercial ceiling.

Where does revenue come from?

• Primary use: hypertension and chronic stable angina (with dosing and prescribing patterns that keep utilization steady).
• Commercial mix: generic monotherapy tablets and combination products (most importantly with atorvastatin in some geographies via fixed-dose combinations).

Typical financial trajectory profile

• Branded-to-generic transition: once innovator exclusivity ends, branded unit pricing falls fast, while category volumes can hold up.
• Generic equilibrium: pricing settles at a low band tied to manufacturing cost curves, distribution contracts, and payer formularies.
• Category growth drivers: demographic aging, diagnosis and treatment rates, and uptake in less saturated markets.

Competitive landscape impact on category pricing

• Multiple ANDA filers in the US and multiple suppliers globally force:
  • high competition at the same dose strengths (2.5 mg, 5 mg, 10 mg),
  • short tender cycles by wholesalers and large payers,
  • limited pricing power for individual manufacturers.

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How do generic amlodipine prices and payer formularies shape market dynamics?

Short answer: Generic pricing is constrained by tendering, rebate dynamics, and rapid substitution at the pharmacy level, which caps durable margins.

US payer behavior

• Formulary position: amlodipine generics usually sit on tiered formularies with frequent interchange.
• Utilization control: managed care plans push toward lowest net cost generics.
• Switching: pharmacy substitution and therapeutic substitution reinforce price competition.

Tendering and wholesaler dynamics

• Large group purchasing organizations and pharmacy benefit managers influence net prices through:
  • contracted reimbursement rates,
  • distribution leverage,
  • volume commitments that reward cost leadership.

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When does amlodipine lose exclusivity, and what does that mean for revenue?

Short answer: Amlodipine besylate’s innovator exclusivity has long expired; remaining value is protected mostly by process, formulation, and combination patents in niche areas, not by broad molecule-level exclusivity.

Exclusivity channels that historically mattered

• Regulatory exclusivity (US): innovator periods for the reference product have already run their course for this drug class.
• Patent estate (typical for legacy drugs): residual protection often persists through:
  • polymorph and solid-state claims,
  • manufacturing/process claims,
  • specific dosage forms,
  • combination products (fixed-dose combinations with other actives).

Commercial implication

• Revenues today are dominated by generic manufacturers.
• Brand-associated revenue (if any remains via legacy contracts or limited channels) tends to be smaller and increasingly dependent on price discipline and channel mix rather than IP exclusivity.

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What patents protect amlodipine besylate today, and how much do they matter commercially?

Short answer: For the base drug, the dominant outcome is off-patent status with generic freedom. Patents that remain relevant typically cover specific formulations, manufacturing methods, or combination FDCs rather than the core API.

Patent families that can still matter

• Solid state and polymorph patents: claims related to crystalline forms, particle size distributions, and stability.
• Manufacturing process patents: scale-up steps, milling/granulation methods, or drying parameters.
• Formulation patents: controlled release or specific excipient systems (less common for immediate-release amlodipine).
• Fixed-dose combinations: patents tied to co-formulation with another active or to specific dose regimens.

How this shows up in competition

• If a remaining patent blocks a particular generic approach, the market can see:
  • delayed entry of certain ANDA products,
  • limited assortment by dose strengths and packaging configurations,
  • market segmentation by product-level differentiation rather than molecule exclusivity.

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What is the Orange Book status of amlodipine besylate in the US?

Short answer: Amlodipine besylate is largely represented by generic ANDA listings, with very limited or no remaining reference-listed innovator exclusivity for the foundational immediate-release tablet.

How to read the status for business impact

• Orange Book “active” listings drive:
  • Paragraph IV opportunities for generic applicants (if any listed patents remain),
  • settlement and entry scheduling.
• For widely available legacy drugs, the functional outcome is typically:
  • multiple generics are already on the market,
  • new entrants focus on cost and supply reliability rather than exclusivity workarounds.

(Orange Book listing details are the gating data for a precise “patents-in-force” map; market impact conclusions above reflect the established off-patent nature of the base drug.)

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How many Paragraph IV challenges exist for amlodipine besylate, and what are the typical outcomes?

Short answer: For legacy off-patent molecules like amlodipine, the bulk of the competitive entry occurred years ago. Current Paragraph IV challenges, if present, are more likely to cluster around residual formulation/process patents or combination products rather than the base API itself.

Typical litigation settlement pattern for mature drugs

• When late-stage claims still exist at the formulation or method level:
  • settlements often include delayed launch dates,
  • supply/at-risk entry can be limited to particular strengths or packaging.

Current market effect

• For a drug with broad established generic availability:
  • the financial impact of any one Paragraph IV settlement is smaller than for later-expiring pipeline drugs,
  • the dominant financial variable is ongoing price erosion and margin compression across multiple suppliers.

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How does amlodipine compare with competing antihypertensives on market power and margins?

Short answer: Amlodipine’s competitive position is strong on clinical familiarity and prescriber habit but weak on IP-driven margins versus newer branded agents. Margin outcomes align with generic class economics.

Relative market dynamics by class

• Compared with newer branded combinations: amlodipine has lower price points and limited brand premium.
• Compared with other generics: pricing competition is similar, but amlodipine’s utilization base can be more resilient due to entrenched guideline roles and broad prescriber adoption.

Key differentiators that affect demand

• Dosing convenience: once-daily regimens support adherence and sustained switching.
• Safety/tolerability: class familiarity can reduce prescriber friction even when net prices fall.

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What formulations and dosage strengths drive commercial performance for amlodipine?

Short answer: Immediate-release tablets at standard strengths dominate. Package and strength mix matter for contracting and tender eligibility more than formulation IP.

Commercially important product attributes

• Strength availability: 2.5 mg, 5 mg, 10 mg drive broad treatment alignment.
• Tablet vs other dosage forms: immediate-release tablets usually dominate category volume.
• Bioequivalence and supply reliability: generic acceptance depends on consistent manufacturing and distribution.

Where niche differentiation can appear

• Combination products (FDC) and select branded re-packaging can temporarily stabilize revenue for particular channels, but do not change the long-run category economics of off-patent immediate-release tablets.

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Which companies sell amlodipine besylate, and how does supplier concentration affect financial outcomes?

Short answer: The market is served by multiple generic manufacturers and distributors; supplier concentration influences liquidity, supply continuity, and price floor behavior.

How competition affects manufacturer financials

• High number of suppliers pushes:
  • low gross margins,
  • volatile net pricing due to tender cycles,
  • frequent rationalization decisions (some suppliers exit or consolidate production lines).
• Manufacturing scale and procurement of API intermediates often define who wins.

Business-relevant signals

• Contract wins with PBMs or large retail chains can shift unit volumes quickly.
• Supply disruptions can temporarily lift pricing, but market normalization typically follows once production ramps.

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What FDA regulatory pathways matter for new generic entry of amlodipine?

Short answer: New entrants typically use Abbreviated New Drug Application frameworks for generic amlodipine tablets where bioequivalence is established and IP barriers are addressed.

Business impact of regulatory status

• Bioequivalence determines speed-to-market for generic substitutable products.
• Patent listing clearance (via Orange Book and Paragraph IV strategy) determines legal readiness to launch.
• Manufacturing quality is decisive in a mature market where prescribers and patients rarely switch unless reimbursement or formulary incentives require it.

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How do manufacturing and IP barriers affect supply and profitability in amlodipine?

Short answer: The largest constraints are manufacturing scale, batch consistency, and any residual IP around specific processes or solid-state characteristics for particular product attributes.

Typical bottlenecks

• Quality systems and compliance track record (FDA inspections and batch failures).
• API and excipient procurement cost.
• Capacity and line changeover schedules across multiple strengths.

Financial consequence

• When capacity is tight or a plant exits, pricing can spike briefly, but long-term supply additions compress pricing again.

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What is the outlook for amlodipine besylate revenue through 2028 and beyond?

Short answer: Category revenue growth is likely to be modest in developed markets, led by volume stability and patient population growth, while unit net prices remain under persistent downward pressure.

Key drivers

• Positive: persistent hypertension prevalence, continued guideline use, and replacement of patients switching from other therapies.
• Negative: periodic generic price resets, payer tightening, and manufacturing competition.

Scenario behavior for a legacy generic

• Base case: stable volumes, gradual margin compression.
• Upside: supply constraints, fewer competing bids in key tenders, or incremental growth from combination product mix.
• Downside: intensified price competition, additional supply from new entrants, or regional reimbursement cuts.

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Key takeaways

• Amlodipine besylate is a mature, off-patent antihypertensive where financial trajectory is governed by generic price compression and payer-driven switching, not by molecule-level exclusivity.
• Market dynamics favor manufacturers with low cost of goods, reliable supply, and contract execution in PBM and wholesaler channels.
• Residual value, where present, comes from product-level differentiation such as specific formulations or fixed-dose combinations, not from core API protection.
• Near-to-mid term revenue behavior is expected to be stable-to-modestly growing by volume with persistent downward pressure on net prices.

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FAQs

1) What fixed-dose combination products with amlodipine can influence revenue beyond generic monotherapy?

Fixed-dose combinations that pair amlodipine with complementary actives can shift revenue through different prescribing patterns and formulary positions, especially where combination therapy is incentivized by payers.

2) How do wholesaler and PBM contract cycles change amlodipine net pricing?

Contract renewals and tender awards can cause rapid step-changes in net prices; manufacturers with better contract placement typically see volume gains despite lower per-unit margins.

3) Are there still any material patent restrictions on certain amlodipine generic strengths or products?

Restrictions, where they exist, tend to be product- and process-specific rather than blocking the entire molecule, meaning risk is confined to particular product configurations.

4) Does supply disruption meaningfully lift amlodipine profitability?

Short-term it can, but sustained profitability usually requires structural supply limitations, since multiple manufacturers can re-enter or increase production once constraints ease.

5) What is the main determinant of long-run market share among amlodipine generics?

Contracting plus manufacturing continuity: steady supply, consistently meeting specifications, and winning pharmacy/PBM formulary placements drive share more than brand-like differentiation.

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References

(No specific sources were cited because the provided prompt contains no jurisdiction-specific Orange Book or litigation dataset to support an accurate patent-by-patent or Orange Book status map.)