HYZAAR Drug Patent Profile

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

Hyzaar is a drug marketed by Organon and is included in one NDA.

The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for HYZAAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	16
Patent Applications:	10
Drug Prices:	Drug price information for HYZAAR
Drug Sales Revenues:	Drug sales revenues for HYZAAR
What excipients (inactive ingredients) are in HYZAAR?	HYZAAR excipients list
DailyMed Link:	HYZAAR at DailyMed

See drug prices for HYZAAR

See drug sales revenues for HYZAAR

Recent Clinical Trials for HYZAAR

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

Sponsor	Phase
EMS	Phase 3
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
Azidus Brasil	Phase 1

See all HYZAAR clinical trials

Pharmacology for HYZAAR

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

Paragraph IV (Patent) Challenges for HYZAAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	100 mg/12.5 mg	020387	1	2006-04-04
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	50 mg/12.5 mg and 100 mg/25 mg	020387	1	2004-05-24

US Patents and Regulatory Information for HYZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	AB	RX	Yes	No

Expired US Patents for HYZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998

International Patents for HYZAAR

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

Country	Patent Number	Title	Estimated Expiration
Austria	113276
Austria	134368
Austria	146076
Austria	151755
Austria	164520

Supplementary Protection Certificates for HYZAAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
0253310	96C0020	Belgium		PRODUCT NAME: KALII LOSARTAN; NAT. REGISTRATION NO/DATE: 922 IS 169 F3 19960130; FIRST REGISTRATION: SE 12209 19940902
0253310	C950009	Netherlands		PRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
0733366	SPC/GB98/031	United Kingdom		PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412
0733366	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215

Last updated: July 12, 2026

HYZAAR (losartan potassium/hydrochlorothiazide) market dynamics and financial trajectory

HYZAAR (losartan potassium/hydrochlorothiazide, HCTZ) is a long-established U.S. ARB/HCTZ fixed-dose combination with mature branded competition. Its financial trajectory is driven by: (1) ongoing generic substitution for the underlying combination and component monotherapies, (2) payer formulary placement versus other ARB/HCTZ and ARB/CCB regimens, and (3) seasonal and geographic variation in hypertension and diuretic demand. In the absence of any brand-specific exclusivity tail in the U.S., category share and pricing discipline typically determine revenue outcomes.

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What drives HYZAAR market dynamics in the US hypertension market?

Primary demand drivers

• Hypertension prevalence and guideline adherence for combination therapy.
• Prescriber switching between ARB/HCTZ fixed-dose combinations to improve pill burden versus taking agents separately.
• Payer pressure toward lowest net cost and higher-tier alternatives only when clinical differentiation supports a formulary position.

Key supply and substitution forces

• Generic entry risk accelerates brand erosion once Orange Book-protected formulation or method-of-use assets are no longer enforceable.
• Incremental demand shifts can occur when competitors face supply issues or when preferred generics consolidate via contracting.

Price and contracting mechanics

• Branded ARB/HCTZ products typically face rebate pressure as they age.
• Revenue stability is more likely when HYZAAR retains a defined payer position (preferred tier or lower prior authorization friction) compared with clinically “equivalent” fixed-dose generics.

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How has HYZAAR revenue trended as generics replaced branded ARB/HCTZ combinations?

Expected lifecycle pattern for HYZAAR

• Early-stage growth occurred when ARB/HCTZ fixed-dose therapy captured switching from ACE inhibitor regimens and monotherapy.
• Mid-to-late lifecycle is characterized by:
  • steady declines in branded unit share as generic combination products scale,
  • shift from “new starts” to “holdouts” (patients stable on HYZAAR, prescribers anchored by historical practice, or payer-specific coverage),
  • residual revenue resilience through contracting and patient persistence rather than new prescription growth.

Financial trajectory variables that move the needle

• Net pricing: branded net price versus list price.
• Share: TRx share versus equivalent strengths (losartan/HCTZ).
• Mix: higher-dose strengths can generate different net sales per prescription even when overall TRx declines.
• Class volatility: ARB class demand can shift with competing agents (e.g., ARB/CCB fixed-dose products) and tolerability-driven prescriber preferences.

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What patents protect HYZAAR and how does that affect exclusivity?

Core point HYZAAR is a combination of known actives (losartan potassium and HCTZ). For a mature combination product, branded exclusivity typically ends long before today, leaving only expiring or no longer enforceable patents (if any) to delay generic substitution.

How patent estate typically shapes market outcomes

• Before generic entry: brand controls fixed-dose combination use through combination-specific patents and regulatory exclusivity.
• After generic entry: revenue becomes a function of contracting strategy and formulary access, not patent life.

Practical consequence For HYZAAR, the market outcome after generic availability is usually driven less by the legal estate at this point and more by payer contracting, patient persistence, and relative net cost versus generic ARB/HCTZ strengths.

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What is the Orange Book status of HYZAAR?

General status pattern

• Long-market ARB/HCTZ combinations generally show extensive generic penetration with Orange Book listings for approved products and associated exclusivity status.
• For HYZAAR specifically, the operational significance tends to be: whether any listed patents still show enforceability dates that would block specific generic versions or formulations.

Impact on competitive launch timing

• If HYZAAR has no currently enforceable active patents, generic entry risk is “open,” leading to ongoing substitution rather than episodic launch waves tied to Paragraph IV.

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Which companies sell competing ARB/HCTZ fixed-dose combinations to HYZAAR?

Competitive set

• Generic manufacturers of losartan/HCTZ combinations are the primary competitive threat in most channels.
• Brand-to-brand competition is usually limited because fixed-dose ARB/HCTZ combos have become commoditized, with most competitors operating as generics.

Where differentiation survives

• Strength availability and packaging formats.
• Rebates and contracting terms.
• Supply reliability.

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What generic entry risks exist for HYZAAR formulations?

Risk profile

• For fixed-dose combination drugs with entrenched generics, “risk” is less about a single discrete Paragraph IV event and more about:
  • ongoing erosion through incremental generic entrants,
  • price compression across strengths,
  • channel substitution as pharmacy benefit contracts renew.

Formulation nuance Even when actives are the same, differences in strength (e.g., losartan dose and HCTZ dose combinations) can influence:

• which generic is preferred by payers,
• which NDCs are most heavily contracted,
• local formulary controls and prior authorization rules.

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When does HYZAAR lose exclusivity, and what does that mean for launch timing?

How to interpret “loss of exclusivity” for a mature product

• Generic competition generally begins once relevant patents and regulatory exclusivities are no longer a barrier.
• After exclusivity/patent expiration, the practical launch timeline for generics is defined by:
  • ANDA readiness,
  • regulatory approvals,
  • contracted pharmacy supply and PBM formulary inclusion cycles.

Outcome For HYZAAR, “loss of exclusivity” typically manifests as persistent share declines and net price compression rather than a single step-change revenue event.

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What biosimilar risk applies to HYZAAR?

No biosimilar risk. HYZAAR is a small-molecule combination (losartan potassium/HCTZ), not a biologic.

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How does HYZAAR compare with alternative fixed-dose hypertension regimens (ARB/CCB, ACEi/HCTZ)?

Market substitution logic

• Patients and prescribers often move between classes for tolerability and BP control, with fixed-dose ARB/CCB combinations frequently preferred when efficacy needs exceed ARB/HCTZ.
• ARB/HCTZ remains common when cost and tolerability align.

Competitive trade-off

• ARB/HCTZ tends to be favored on affordability and diuretic synergy.
• ARB/CCB can capture higher BP reductions and convenient dosing in some patient subsets, affecting share at the margin.

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What FDA pathway and regulatory status matters for generic HYZAAR?

Regulatory pathway

• Generic ARB/HCTZ products typically use ANDAs.
• The key issues for entry are equivalence, labeling, and any remaining listed patent barriers in the Orange Book (if applicable).

Operational effect If no enforceable Orange Book barriers remain, generics can enter as approvals complete and PBM contracting rolls through.

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How does payer formulary management influence HYZAAR’s financial trajectory?

Formulary placement

• Branded HYZAAR generally faces pressure to maintain preferred status or at least a “covered” tier amid a wide generic field.
• Net sales depend on:
  • tier position (preferred vs non-preferred),
  • utilization management (prior authorization, step therapy),
  • rebate rates demanded by PBMs.

Channel dynamics

• Retail pharmacy: stronger generic substitution pressure.
• Mail order: stronger contract-driven substitution.
• Hospital/clinic: can be less sensitive, depending on local formularies.

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How strong is the HYZAAR patent estate compared with other hypertension fixed-dose combos?

For mature small-molecule fixed-dose combinations, patent estates generally do not prevent long-term erosion once active combination patents expire. Relative strength comparisons typically reduce to whether:

• any enforceable patents remain on method-of-use, formulations, or device-related aspects (rare for a standard tablet),
• any data exclusivity or non-obvious combination-specific protections persisted longer than competitors.

In most markets, HYZAAR’s patent strength impact is limited compared with ongoing PBM contracting power and generic availability.

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What patent litigation affects HYZAAR competition?

For HYZAAR, any litigation impact would historically influence early generic entry timing. In a long-established commoditized combination, the observable market effect is usually reflected in:

• delayed generic entries in earlier periods,
• reduced litigation tail once most ANDAs are approved and products become interchangeable.

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Timeline: how a mature ARB/HCTZ fixed-dose brand typically transitions from patent protection to commoditization

Typical phases

1. Launch and early growth under combination-related exclusivity and patents.
2. First generic approvals as barriers are challenged or patents expire.
3. Sustained erosion as multiple ANDAs launch and PBMs place preferred generics.
4. Ongoing revenue compression driven by net pricing and contracted share.

This lifecycle shape applies to HYZAAR as a mature fixed-dose losartan/HCTZ product, with financial performance increasingly driven by contracting and persistence rather than IP.

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Business impact: what HYZAAR’s market dynamics imply for R&D, licensing, and investment decisions

If evaluating licensing or portfolio strategy

• The primary economic question becomes whether a differentiated formulation, dosing convenience, or payer program can counter commoditization.
• Copycat entry risk is high once relevant IP is weak or expired.

If assessing litigation or patent targeting

• For mature combinations, the ROI focus is usually on:
  • late-cycle formulation claims that are harder to design around,
  • method-of-use claims tied to specific therapeutic subpopulations (if any exist and are enforceable),
  • brand-specific manufacturing or impurity control patents (often narrow).

If assessing revenue exposure

• HYZAAR revenue exposure is predominantly “managed decline,” not “event-driven” by a single remaining patent.

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Key takeaways

• HYZAAR is in a commoditized small-molecule fixed-dose ARB/HCTZ segment where generic substitution and payer contracting dominate financial outcomes.
• Patent and exclusivity effects historically shaped entry timing; current dynamics are largely share and net price driven.
• The product’s competitive reality is dominated by generic equivalents across strengths, with differentiation limited to contracting, persistence, and packaging availability.
• No biosimilar risk applies because HYZAAR is not a biologic.

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FAQs

Is HYZAAR still used as first-line therapy for hypertension?

It is generally used as part of combination regimens when patients need BP control beyond monotherapy. First-line use depends on guideline interpretation and payer coverage.

Do ARB/HCTZ fixed-dose combinations face ongoing pricing pressure from generics?

Yes. Once multiple generic equivalents exist, price compression and formulary preference for lower net cost products typically persist.

Which factors most influence HYZAAR prescriptions at retail pharmacies?

PBM formulary tiers, patient copays after rebates, prior authorization requirements, and prescriber switching behavior toward preferred generics.

Are different HYZAAR strengths treated differently by payers?

Often yes. Contracting can prioritize specific NDCs and strengths, influencing share distribution even when total class demand is stable.

What would most likely change HYZAAR’s market position in the near term?

A meaningful shift would come from payer formulary changes, a competitive disruption (supply or contracting), or a clinically differentiated alternative capturing fixed-dose combination share.

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References

(No sources were provided in the prompt, and no external bibliographic data was included.)

DrugChatter Q&A for HYZAAR

Does medicare cover hyzaar?