AMLODIPINE AND OLMESARTAN MEDOXOMIL Drug Patent Profile

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When do Amlodipine And Olmesartan Medoxomil patents expire, and what generic alternatives are available?

Amlodipine And Olmesartan Medoxomil is a drug marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd V, Jubilant Generics, Macleods Pharms, Micro Labs, Sciegen Pharms, Teva Pharms Usa, Torrent, and Zydus Pharms. and is included in fourteen NDAs.

The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for AMLODIPINE AND OLMESARTAN MEDOXOMIL

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	13
Clinical Trials:	14
What excipients (inactive ingredients) are in AMLODIPINE AND OLMESARTAN MEDOXOMIL?	AMLODIPINE AND OLMESARTAN MEDOXOMIL excipients list
DailyMed Link:	AMLODIPINE AND OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for AMLODIPINE AND OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company	Phase 3
Daiichi Sankyo Korea Co., Ltd.	Phase 3
Torrent Pharmaceuticals Limited	Phase 1

See all AMLODIPINE AND OLMESARTAN MEDOXOMIL clinical trials

Pharmacology for AMLODIPINE AND OLMESARTAN MEDOXOMIL

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

US Patents and Regulatory Information for AMLODIPINE AND OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209010-001	Dec 3, 2018	AB	RX	No	No
Jubilant Generics	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207450-004	May 15, 2017		DISCN	No	No
Torrent	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	202933-001	Nov 25, 2016		DISCN	No	No

Amlodipine and Olmesartan Medoxomil Market Dynamics and Financial Trajectory

Last updated: October 14, 2026

Amlodipine and olmesartan medoxomil is a mature fixed-dose antihypertensive combination marketed in the United States as Azor. The product combines a calcium-channel blocker, amlodipine, with an angiotensin II receptor blocker, olmesartan medoxomil. Its commercial trajectory has moved from branded growth to broad generic substitution, with pricing pressure now outweighing volume growth. The combination remains clinically relevant, but it has limited ability to generate premium revenue because both components are longstanding small-molecule therapies and multiple generic manufacturers compete in the market.

What is amlodipine and olmesartan medoxomil?

Amlodipine and olmesartan medoxomil is an oral, once-daily treatment for hypertension in adults. The U.S. product is approved in four strength combinations:

Amlodipine component	Olmesartan medoxomil component
5 mg	20 mg
10 mg	20 mg
5 mg	40 mg
10 mg	40 mg

The product is designed for patients who require more than one antihypertensive agent or who need additional blood-pressure control after monotherapy. Amlodipine produces vasodilation through calcium-channel blockade. Olmesartan blocks the angiotensin II type 1 receptor.

The reference product, Azor, was developed by Daiichi Sankyo and approved by the U.S. Food and Drug Administration in 2007 under NDA 021675. The FDA label identifies hypertension as the indication and permits initial combination therapy in selected patients, as well as substitution or add-on use after inadequate control with either component alone (U.S. Food and Drug Administration [FDA], 2007).

How large is the market for amlodipine and olmesartan medoxomil?

The market is large by patient volume but modest by product-level revenue. Hypertension affects roughly half of U.S. adults under current blood-pressure definitions, creating a broad treatment base. Most revenue in the category is generated by low-cost generic monotherapies and combinations rather than by branded products (Centers for Disease Control and Prevention, 2024).

Amlodipine is one of the most widely used antihypertensive drugs in the United States. Olmesartan is also available as a single agent and in other combinations, including olmesartan/hydrochlorothiazide. The fixed-dose combination competes with:

• Generic amlodipine monotherapy.
• Generic olmesartan monotherapy.
• Generic amlodipine/valsartan.
• Generic amlodipine/benazepril.
• Generic losartan and valsartan combinations.
• Generic olmesartan/hydrochlorothiazide.
• Other calcium-channel blocker and renin-angiotensin-system combinations.

The combination’s principal value proposition is adherence. A two-drug tablet can reduce pill burden and simplify chronic treatment. Its commercial disadvantage is that physicians and payers can achieve similar therapeutic effects by prescribing inexpensive generic components separately.

When did Azor lose exclusivity?

Azor lost practical U.S. market exclusivity after approval of generic amlodipine/olmesartan products. The principal commercial protection associated with the olmesartan franchise did not prevent long-term generic erosion of the combination.

Event	Approximate timing	Commercial effect
Azor U.S. approval	2007	Initiated branded combination sales
Early branded adoption	2007-2011	Growth from combination prescribing and promotion
Olmesartan franchise patent expiry	2016	Removed major protection for the active ingredient franchise
Generic fixed-dose combination entry	Mid-to-late 2010s	Accelerated price and share erosion
Mature generic market	2020s	High substitution and low unit pricing

The key distinction is between loss of protection for olmesartan as an active ingredient and later generic competition against the specific fixed-dose combination. Once generic versions of amlodipine/olmesartan became available, Azor faced direct substitution in addition to indirect competition from separate generic tablets.

What patents protect amlodipine and olmesartan medoxomil?

The historical patent estate relied primarily on olmesartan composition and formulation rights rather than on durable exclusivity for amlodipine. The principal olmesartan compound patent, U.S. Patent No. 5,616,599, was associated with Daiichi Sankyo and had an expiration date in the 2016 period, including applicable pediatric-extension considerations in the U.S. Orange Book framework.

The combination product had additional formulation and fixed-dose claims, but these did not create a long-lived barrier comparable to a new chemical entity patent. Patent protection for a mature small-molecule combination typically has lower commercial strength because:

1. The active ingredients are already widely available.
2. Generic companies can challenge formulation or combination claims.
3. Physicians can substitute separate tablets.
4. Regulatory approval does not require a manufacturer to reproduce the branded commercial formulation in every respect.
5. Payers have strong incentives to prefer the lowest-cost therapeutically equivalent option.

The relevant patent review should distinguish among:

• Olmesartan medoxomil compound patents.
• Fixed-dose combination patents.
• Salt, crystal-form, or polymorph claims.
• Tablet formulation patents.
• Manufacturing-process patents.
• Method-of-use patents.
• Pediatric exclusivity and other regulatory exclusivities.

A patent may remain listed in the Orange Book without preserving meaningful market power if generic applicants can design around it, challenge it under Paragraph IV, or launch after expiration of a different blocking patent.

What is the Orange Book status of Azor?

Azor was approved under an NDA and its generic competitors were approved through abbreviated new drug applications. The Orange Book remains the principal U.S. source for identifying listed patents, therapeutic-equivalence ratings, and product-level approval status (FDA, 2024a).

For commercial analysis, the important Orange Book questions are:

Orange Book issue	Relevance to Azor
Reference-listed drug	Azor
Dosage form	Oral tablet
Active ingredients	Amlodipine besylate and olmesartan medoxomil
Approval route for generics	ANDA
Therapeutic-equivalence objective	AB-rated substitution where applicable
Patent relevance	Determines filing certifications and launch timing
Current market effect	Limited, because generic entry is established

The existence of an Orange Book listing does not establish current commercial exclusivity. The relevant question is whether any listed patent blocks approval or launch. For Azor, the market has already transitioned to generic competition.

How did generic entry change the market?

Generic entry changed the product from a branded-growth asset into a price-sensitive maintenance market. The main effects were:

• Lower average selling prices.
• Increased pharmacy substitution.
• Reduced promotional return on investment.
• Greater use of separate generic components.
• Higher payer leverage.
• More fragmented supplier competition.
• Lower revenue per treated patient.

Generic manufacturers typically compete through pharmacy benefit managers, wholesalers, retail pharmacy contracts, and purchasing groups. The combination has no biologic manufacturing barrier, complex-device requirement, or specialized distribution channel. This makes entry and supply substitution comparatively straightforward.

The product also faces therapeutic substitution. A payer does not need to use amlodipine/olmesartan specifically to capture much of the clinical value. A patient can receive generic amlodipine and generic olmesartan as separate tablets, or a different fixed-dose combination within the same antihypertensive treatment class.

Are there Paragraph IV challenges involving Azor?

Paragraph IV certification is the standard Hatch-Waxman mechanism used by an ANDA applicant to assert that a listed patent is invalid, unenforceable, or not infringed. Historical patent challenges may have affected the timing of generic amlodipine/olmesartan entry, but the current commercial issue is no longer whether the product faces generic risk. It is already exposed to generic competition.

A Paragraph IV case can produce several outcomes:

1. Settlement with a delayed generic launch.
2. Early generic launch after a court decision.
3. Launch at risk before final patent resolution.
4. Patent narrowing or invalidation.
5. Withdrawal or amendment of the ANDA certification.

For mature Azor products, litigation value is generally lower than for a high-revenue protected drug because the branded market has already contracted and separate-component substitution limits the value of delayed entry.

What is the FDA regulatory status?

Azor is an FDA-approved prescription tablet for hypertension. The product is not a biologic and does not require biosimilar regulation. Generic competitors follow the ANDA pathway, which relies on bioequivalence to the reference product rather than independent clinical-outcome trials of the type required for an original NDA.

The regulatory framework creates a relatively low barrier to entry:

• Established active ingredients.
• Conventional oral tablet dosage form.
• Well-characterized pharmacology.
• No cold-chain requirement.
• No complex delivery device.
• No biologic comparability program.
• Standardized bioequivalence expectations.

FDA approval risk still exists at the manufacturing and quality level. Applicants must demonstrate consistent dissolution, content uniformity, stability, impurity control, and bioequivalence. These requirements can delay approval, but they usually do not create a durable market barrier for a technically capable generic manufacturer.

What formulations are protected by Azor-related patents?

The commercially relevant formulation is a fixed-dose immediate-release tablet containing amlodipine and olmesartan medoxomil. Potential formulation claims may cover:

• Specific dose ratios.
• Excipient composition.
• Tablet manufacturing processes.
• Dissolution characteristics.
• Stability and impurity profiles.
• Combination use in hypertension.
• Particular dosage regimens.

Formulation patents are weaker than compound patents when the product can be reproduced through alternative excipient systems or separate tablets. A generic manufacturer may also avoid a claim by using a different manufacturing process or formulation while maintaining bioequivalence.

No major commercial value is associated with a controlled-release, injectable, implantable, or device-enabled version of this combination. The absence of a technically difficult delivery system limits lifecycle-management potential.

How strong is the patent estate for amlodipine and olmesartan?

The patent estate is weak for current commercial protection and moderate in historical defensive value.

Patent-estate factor	Assessment
New chemical entity protection	Expired or commercially exhausted
Fixed-dose combination protection	Historically relevant, now limited
Formulation complexity	Low to moderate
Manufacturing barrier	Low
Generic substitution risk	High
Biosimilar risk	Not applicable
Litigation leverage	Low in the mature market
Lifecycle-extension potential	Limited

The strongest historical asset was olmesartan’s active-ingredient protection. The weakest elements are method-of-use and routine formulation claims that do not prevent prescribing of separate generic components.

What was the financial trajectory of Azor and the olmesartan franchise?

The financial trajectory followed the standard pattern for a primary-care small molecule:

1. Launch and uptake: The combination benefited from Daiichi Sankyo’s established Benicar sales force and the clinical convenience of fixed-dose therapy.
2. Expansion: Revenue increased as combination prescribing broadened and hypertension treatment intensified.
3. Maturity: Sales growth slowed as the product competed with other branded and generic combinations.
4. Patent loss: Generic entry caused a steep reduction in price and branded market share.
5. Post-exclusivity phase: Revenue shifted toward low-margin generic volume rather than branded pricing power.

Daiichi Sankyo’s public reporting historically grouped Azor with the Benicar franchise or broader cardiovascular products. Product-level Azor revenue is therefore not consistently disclosed in company filings. This limits precise standalone calculations for revenue, margin, and lifetime sales. The more reliable financial conclusion is directional: branded revenue declined sharply after generic competition, while the underlying treated population remained large.

Revenue exposure

The commercial exposure is now concentrated in three areas:

• Generic manufacturing volume.
• Portfolio access and contracting.
• Supply reliability and cost control.

A branded owner cannot generally preserve premium pricing through promotion alone once AB-rated generic substitution is available. Revenue recovery would require a differentiated formulation, a new indication, a device-based delivery system, or a separate commercial strategy. None is inherent in the legacy product.

Which companies compete in the market?

The competitive field includes the originator and multiple generic manufacturers. Depending on jurisdiction and time, generic suppliers have included large multinational and specialty-generic companies such as Teva, Mylan/Viatris, Lupin, Torrent Pharmaceuticals, and other FDA-approved ANDA holders.

Competition occurs at two levels:

Direct fixed-dose competition

Manufacturers sell generic tablets containing both active ingredients in the same dosage combinations as Azor.

Therapeutic substitution

Manufacturers supply separate amlodipine and olmesartan tablets, as well as alternative combinations such as amlodipine/valsartan and olmesartan/hydrochlorothiazide.

Therapeutic substitution increases price pressure because a generic manufacturer does not need to win the entire fixed-dose market to reduce Azor’s addressable revenue. Formularies can substitute other low-cost regimens.

What generic launch scenarios exist?

The most likely current scenario is continued generic price erosion with periodic supplier rationalization. The market can develop in several ways:

Scenario	Market outcome
Stable multi-source supply	Low prices and predictable substitution
Supplier consolidation	Temporary price increases or shortages
Aggressive contracting	Further margin compression
Manufacturing disruption	Short-term wholesaler or pharmacy shortages
New formulation entry	Limited premium opportunity unless clinically differentiated
Branded relaunch	Low probability of restoring historical economics

A generic launch does not always produce immediate maximum erosion. Prices may remain temporarily elevated when only one or two suppliers are active. Once several ANDA holders enter, payer and wholesaler bargaining power typically increases.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are modest. The product is a conventional oral solid dose, and both active ingredients have long histories of commercial production. The principal operational risks are:

• API sourcing.
• Impurity and degradation control.
• Batch consistency.
• Dissolution performance.
• Regulatory inspection findings.
• Supply-chain concentration.
• Pricing below sustainable manufacturing cost.

Intellectual-property risk is also modest in the current market. The relevant challenge is less the ability to manufacture a bioequivalent tablet than the ability to do so at a sustainable cost while maintaining FDA compliance.

How does amlodipine/olmesartan compare with competing antihypertensive combinations?

Product class	Generic maturity	Differentiation	Commercial pressure
Amlodipine/olmesartan	Mature	Fixed-dose convenience	High
Amlodipine/valsartan	Mature	Broad physician familiarity	High
Amlodipine/benazepril	Mature	ACE-inhibitor option	High
Olmesartan/hydrochlorothiazide	Mature	Diuretic combination	High
Separate amlodipine plus olmesartan	Very mature	Flexible titration	Very high
Newer branded antihypertensives	Variable	Potential formulation or outcome claims	Depends on exclusivity

Amlodipine/olmesartan can retain clinical use where patients respond well to the combination or prefer one tablet. Its market position is less defensible where payers prioritize the lowest acquisition cost or where clinicians prefer independent dose titration.

What is the outlook for the market?

The market outlook is stable in volume and weak in branded value. Hypertension prevalence, aging populations, and long-term treatment requirements support demand. Those factors do not translate into strong revenue growth for this specific combination because generic competition captures most of the economic benefit.

The principal growth opportunities are outside the legacy branded product:

• Emerging-market volume.
• Generic supply contracts.
• Fixed-dose combination penetration where pill burden remains high.
• Adherence-focused treatment programs.
• Combination products paired with digital adherence monitoring.
• Portfolio sales across several antihypertensive strengths.

Geographic economics vary. In the United States, generic substitution and payer control are strong. In Europe, national reimbursement systems and reference pricing constrain prices. In emerging markets, volume can remain attractive, but local registration, tender pricing, distribution, and manufacturing requirements reduce margins.

Key Takeaways

• Amlodipine/olmesartan medoxomil is a mature oral fixed-dose antihypertensive combination marketed in the United States as Azor.
• The product’s principal commercial advantage is lower pill burden, not pharmacologic exclusivity.
• Olmesartan’s historical compound protection has expired or lost practical commercial force.
• Generic fixed-dose products and separate generic tablets create high substitution risk.
• The product is an FDA-approved small molecule, not a biologic, so biosimilar risk does not apply.
• Formulation and method-of-use patents have limited current ability to preserve premium pricing.
• Product-level Azor revenue is not consistently disclosed separately from the broader olmesartan franchise.
• Future commercial value is concentrated in generic volume, manufacturing efficiency, supply reliability, and geographic expansion.
• The market should be modeled as mature and price-sensitive rather than as a branded growth opportunity.

FAQs

Does amlodipine/olmesartan have biosimilar competition?

No. It is a small-molecule drug. Competition occurs through generic ANDA products, not biosimilars.

Is Azor still commercially protected by patents?

Azor no longer has meaningful protection against generic substitution. Historical patents may remain relevant to specific legal records, but they do not restore branded market exclusivity.

Can generic manufacturers sell separate amlodipine and olmesartan tablets?

Yes. Separate generic tablets provide therapeutic competition even when a fixed-dose combination patent is asserted.

Is amlodipine/olmesartan more valuable than olmesartan monotherapy?

Clinically, the fixed-dose combination can improve convenience for patients requiring dual therapy. Commercially, it is not necessarily more valuable because both components are available at low generic prices.

What is the main investment risk for this product?

The main risk is structural price compression from generic substitution, compounded by payer bargaining power and competition from separate-component therapy.

References

1. Centers for Disease Control and Prevention. (2024). Facts about hypertension. https://www.cdc.gov/high-blood-pressure/data-research/facts-stats/

2. Daiichi Sankyo Co., Ltd. (Various years). Annual reports and securities reports. https://www.daiichisankyo.com/investors/

3. U.S. Food and Drug Administration. (2007). Azor prescribing information. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Food and Drug Administration. (2024b). Generic drugs: Questions and answers. https://www.fda.gov/drugs/questions-answers/generic-drugs

6. U.S. Patent and Trademark Office. (2024). Patent Center and patent term information. https://patentcenter.uspto.gov/