UNIRETIC Drug Patent Profile

When do Uniretic patents expire, and when can generic versions of Uniretic launch?

Uniretic is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in UNIRETIC is hydrochlorothiazide; moexipril hydrochloride. There is one drug master file entry for this compound. Additional details are available on the hydrochlorothiazide; moexipril hydrochloride profile page.

Summary for UNIRETIC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	3
Patent Applications:	7,400
Drug Prices:	Drug price information for UNIRETIC
DailyMed Link:	UNIRETIC at DailyMed

See drug prices for UNIRETIC

Recent Clinical Trials for UNIRETIC

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1
Paddock Laboratories, Inc.	Phase 1

See all UNIRETIC clinical trials

Paragraph IV (Patent) Challenges for UNIRETIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UNIRETIC	Tablets	hydrochlorothiazide; moexipril hydrochloride	7.5mg/12.5mg, 15 mg/25 mg and 15 mg/12.5 mg	020729	1	2004-01-15

US Patents and Regulatory Information for UNIRETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997		DISCN	No	No
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-003	Feb 14, 2002		DISCN	No	No
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997		DISCN	No	No

Expired US Patents for UNIRETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-003	Feb 14, 2002
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997

International Patents for UNIRETIC

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

Country	Patent Number	Title	Estimated Expiration
Austria	25974
Austria	26120
Australia	5299186
Australia	551239
Australia	563683

Supplementary Protection Certificates for UNIRETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413
0096157	SPC/GB95/011	United Kingdom		SPC/GB95/011:, EXPIRES: 20060930
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419

UNIRETIC market dynamics and financial trajectory: pricing, demand drivers, payer and competitive forces, and genericization risk

Last updated: July 9, 2026

UNIRETIC (quinapril + hydrochlorothiazide) is a long-cycle, off-patent combination product in most developed markets. Its financial trajectory is dominated by (1) generic penetration, (2) payer step-edits and formulary preferences for ACE inhibitor/thiazide pairs, (3) utilization stability for hypertension, and (4) price compression tied to low-margin multi-source supply. Profit pools have shifted from originator exclusivity to generic scale economics, with commercial outcomes largely determined by who owns the highest-coverage generic SKU set and who can defend wholesaler and pharmacy channel access.

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Is UNIRETIC off-patent and what market exclusivity gaps shape its revenue path?

Answer: UNIRETIC’s long-term revenue trajectory is constrained by generic competition. In the US, the specific-tablet combination has been widely available as multi-source generic quinapril/HCTZ for years, so exclusivity is not the primary determinant of revenue today; branded share loss and ongoing price erosion are.

Brand-to-generic transition dynamics (typical for this combination)

• Condition of use: chronic essential hypertension, where payers prefer lowest net cost for first-line agents.
• Substitution behavior: ACE inhibitor plus thiazide regimens are therapeutically substitutable at the class level and at the combination level.
• Regulatory pathway effect: once combination or formulation exclusivity ends, generic entry follows quickly where bioequivalence standards are straightforward for solid oral tablets.

US-centric exclusivity mechanics that matter to UNIRETIC

• Orange Book-driven reality: for a branded combination product, revenue is usually determined by the last relevant listed patent expiration(s) and any FDA exclusivity. After those end, generic entry tends to be fast and durable.
• Switching friction is low: pharmacies and PBMs can switch to AB-rated therapeutics without prescriber authorization in many formularies.
• Net price compression: branded pricing power collapses as multiple generics undercut wholesale acquisition cost.

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How do generic quinapril/hydrochlorothiazide dynamics determine UNIRETIC pricing and volume?

Answer: UNIRETIC’s unit economics typically trend toward stable-to-declining net pricing with volume growth or stability driven by total hypertension prevalence rather than by differentiated clinical value.

Market structure for ACE inhibitor + thiazide combinations

• High multi-source intensity: once generic quinapril/HCTZ combinations are established, competition becomes largely price-led.
• Therapeutic interchangeability: prescribers select by tolerability and historical control, but payer policy steers toward lowest net cost.
• Channel competition: wholesalers and retail pharmacy distribution favor SKUs with stronger purchasing agreements and consistent supply.

What this means for financial trajectory

• Revenue CAGR: usually tracks slower than hypertension drug class growth due to net price erosion.
• Margin profile: branded margins compress first; surviving business tends to come from (a) generic manufacturing scale, (b) brand-specific contracts in select accounts, or (c) remaining reference product presence where payer substitution is delayed.

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What demand drivers keep UNIRETIC utilization stable even as pricing falls?

Answer: Hypertension incidence and treatment persistence support baseline utilization, but growth is capped by generic competition and by prescribing that shifts among ACEi plus thiazide options.

Core demand pillars for quinapril/HCTZ

• Chronic adherence: patients remain on a tolerable regimen for long periods, which stabilizes demand.
• Step-therapy patterns: PBMs may allow ACEi/HCTZ combinations after initial monotherapy failures, sustaining prescriptions.
• Renal and cardiovascular risk management: ACE inhibitor combinations remain entrenched in clinical pathways, particularly when clinicians need dual blockade of volume and RAAS.

Counterweights that can reduce growth

• Shift to alternative combos: ARB/HCTZ, ACEi/CCB, and single-pill triple-therapy strategies can redirect patients.
• Tolerability and lab monitoring burden: ACEi therapy carries monitoring needs (renal function, potassium), which can influence adherence and regimen changes.

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How does payer formulary positioning affect UNIRETIC net sales?

Answer: Payer contracting and formulary tier placement are the highest-leverage determinants of UNIRETIC net sales in a generic-saturated environment.

Practical payer mechanisms

• Tiering and prior authorization: UNIRETIC is typically not the preferred tier once multiple AB-rated generics exist.
• Substitution rules: PBM edits can force switching to specific lower-cost SKUs.
• Rebates and contract concentration: net pricing increasingly reflects rebate schedules rather than list price.

Financial implications

• Net revenue depends on contract wins: branded distributors and generic manufacturers with favored accounts capture higher script share.
• Wholesaler fill rates and supply reliability matter: for solid oral tablets, supply continuity affects capture of pharmacy demand.

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Which competitors most directly pressure UNIRETIC shares in ACE inhibitor/thiazide combination therapy?

Answer: Direct pressure comes from generic quinapril/HCTZ products and from therapeutically similar ACEi or ARB-based combination therapies that PBMs prefer on net cost.

Competitor categories

1. Generic quinapril/HCTZ tablets (AB-substitution)
2. Other ACE inhibitor + thiazide fixed-dose combinations
3. ARB + thiazide fixed-dose combinations
4. ACEi + CCB and other multi-pill or single-pill strategies used in guideline-based sequencing

Competitive outcome drivers

• Net price and rebate levels
• Dose strength coverage (how many strengths are offered at preferred pricing)
• Manufacturing scale and regulatory compliance
• Payer and pharmacy formulary management

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When do generics typically erode UNIRETIC revenue most sharply?

Answer: The revenue erosion peak occurs at generic first-launch for the exact branded presentation or strength, followed by a slower ongoing decline as competition expands and prices reset.

Typical phases in a branded combination’s life cycle

• Pre-generic: higher net price, stable share
• Initial generic entry: rapid share loss to multi-source equivalents
• Consolidation: script share shifts to the cheapest favored SKUs and to manufacturers with best contracting
• Long tail: revenue becomes mainly utilization-driven, with modest changes from local payer formulary updates

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What is the regulatory and substitution environment for UNIRETIC in the US?

Answer: UNIRETIC operates in an FDA-approved oral solid combination framework where AB-rated generics enable pharmacy-level substitution under typical state and plan rules.

FDA labeling and substitution implications

• Bioequivalence compatibility: quinapril/HCTZ generics can be approved through standard bioequivalence pathways for solid oral tablets.
• Interchangeability at the class/combination level: while not identical molecule-by-molecule, substitution is supported by therapeutic equivalence in payer decisioning.

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What does a financial trajectory usually look like for off-patent ACEi/HCTZ brands like UNIRETIC?

Answer: Expect a pattern of declining branded net sales followed by low-growth multi-source market dynamics; the company owning branded inventory typically faces sustained margin pressure.

Revenue mechanics by line item (how the money moves)

• Units: tends to be resilient due to adherence and chronic indication
• Net pricing: tends to fall as new competitors enter and contracts reset
• Mix: strength mix changes as certain doses become cheaper or more favored by formularies
• Trade terms: changes with wholesaler contract renegotiations as the branded product loses share

Business outcomes that differentiate winners and losers

• Winners: manufacturers with broad SKU coverage, strong pricing leverage, and reliable supply capture incremental share from pharmacy substitution
• Losers: branded incumbents with weaker contract access or limited strength availability lose incremental scripts first

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Market outlook: what financial risks and opportunities dominate UNIRETIC over the next 3–5 years?

Answer: The dominant risk is continued price compression and formulary displacement. The opportunity set is limited to account wins and strength coverage, plus any region where branded presence remains advantaged versus generics.

Key risks

• Further net price pressure: continued generic entry or increased discounting
• Formulary narrowing: PBMs can tighten combination lists, pushing patients to a specific set of preferred AB SKUs
• Therapy switching: ARB/HCTZ and newer fixed-dose combinations can take share even within the same hypertension segment

Potential levers

• Contracted preferred status: favorable PBM pharmacy benefit placement can stabilize unit share
• Manufacturing continuity: consistent supply supports rebate eligibility and reduces pharmacy fill loss
• Regional persistence of brand premium: in markets where generic adoption is slower, branded revenues can persist longer, though long-term convergence is typical

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Key Takeaways

• UNIRETIC’s financial trajectory is primarily driven by genericization, payer contracting, and ongoing net price compression rather than by exclusivity.
• Hypertension demand supports utilization, but revenue growth is constrained by AB-substitution and therapeutically similar alternatives.
• The competitive edge shifts toward manufacturers with the strongest formulary coverage, rebate economics, and broad strength supply.
• Over the next 3–5 years, the main forecast risk is further price erosion; the main upside is stabilized share through preferred PBM contracts and reliable supply.

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FAQs

1) Why do ACE inhibitor/thiazide combination generics usually undercut branded UNIRETIC pricing so quickly?
Because pharmacy substitution to AB-rated multisource products is straightforward and PBMs push lowest net cost within chronic hypertension regimens.

2) Does UNIRETIC volume decline when net price drops?
Volume often stabilizes because hypertension therapy is chronic and patients persist on a tolerated regimen, but unit growth can lag while share shifts to cheaper favored SKUs.

3) Which payer levers most affect UNIRETIC reimbursement in the US?
Formulary tiering, preferred brand-to-generic or generic-to-generic selection via contracts, and pharmacy substitution rules that enforce AB choices.

4) How do competitors like ARB/HCTZ combinations affect UNIRETIC market share?
They can divert new starts and regimen switches, especially when PBMs prefer specific net-cost combinations across RAAS drug classes.

5) What is the biggest financial KPI for UNIRETIC in a generic-saturated market?
Net sales per unit (net price) and contract-driven script share, not list price or marketing spend, since differentiation is limited.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. IQVIA. Global use and market dynamics for cardiovascular and hypertension medicines (data series). IQVIA. (Access via subscription).