List of Excipients in Branded Drug MOEXIPRIL HYDROCHLORIDE

Generic Drugs Containing MOEXIPRIL HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	moexipril hydrochloride	0093-0017	CROSPOVIDONE
Teva Pharmaceuticals USA Inc	moexipril hydrochloride	0093-0017	FERRIC OXIDE RED
Teva Pharmaceuticals USA Inc	moexipril hydrochloride	0093-0017	HYPROMELLOSE 2910
Teva Pharmaceuticals USA Inc	moexipril hydrochloride	0093-0017	LACTOSE MONOHYDRATE
Teva Pharmaceuticals USA Inc	moexipril hydrochloride	0093-0017	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in MOEXIPRIL HYDROCHLORIDE?

# Of NDCs	Excipient
1	COPOVIDONE
5	CROSPOVIDONE
4	FERRIC OXIDE RED
1	FERRIC OXIDE YELLOW
1	FERROSOFERRIC OXIDE

Moexipril Hydrochloride Excipient Strategy and Commercial Opportunities

Last updated: August 9, 2026

Moexipril hydrochloride is an off-patent, orally administered angiotensin-converting enzyme inhibitor marketed historically as Univasc. Its commercial value now depends on formulation execution rather than active-ingredient exclusivity. The strongest opportunities are low-cost immediate-release tablets, differentiated pediatric or geriatric presentations, and potentially fixed-dose cardiovascular combinations. A new product would face limited patent barriers but substantial market-size and regulatory-economics constraints.

What is the regulatory and commercial status of moexipril hydrochloride?

Moexipril hydrochloride is the hydrochloride salt of moexipril, a prodrug converted to the active ACE inhibitor moexiprilat. It was approved in the United States for hypertension, including use alone or with thiazide diuretics.[1]

Attribute	Moexipril hydrochloride
Drug class	ACE inhibitor
Historical brand	Univasc
Original U.S. sponsor	Schwarz Pharma
Dosage form	Immediate-release film-coated tablet
Historical strengths	7.5 mg and 15 mg
Primary indication	Hypertension
FDA pathway for a new generic tablet	ANDA
Current U.S. exclusivity	None identified
Core patent position	Expired
Biosimilar relevance	None; moexipril is a small molecule
Main commercial constraint	Small and mature market

The FDA labeling history identifies moexipril tablets in 7.5-mg and 15-mg strengths. The product is administered once or twice daily, depending on the clinical regimen, and food can reduce systemic exposure to moexiprilat. The label recommends administration at least one hour before meals when consistent absorption is required.[1]

The original brand’s commercial position has eroded because ACE inhibitors such as lisinopril, enalapril, ramipril and perindopril are widely available at low cost. Moexipril does not have the prescription volume or guideline prominence of the leading ACE inhibitors.

What patents protect moexipril hydrochloride?

The principal composition-of-matter and early development patents for moexipril hydrochloride have expired. No current U.S. patent estate appears to create a meaningful barrier to a conventional immediate-release generic tablet.

The relevant patent position is best analyzed by category:

Patent category	Current relevance
Moexipril compound and salt patents	Expired
Immediate-release tablet patents	Expired or commercially non-blocking
Manufacturing-process patents	Any surviving rights would require product-specific freedom-to-operate review
Method-of-use patents	No meaningful barrier to standard hypertension labeling
Formulation patents	No known active U.S. barrier that would block a conventional generic tablet
Pediatric formulation patents	Potentially available for a new product, subject to claim drafting and prior-art review
Fixed-dose combination patents	Possible only for a particular combination, dosage ratio or formulation

The historic innovator patent family included patents directed to ACE-inhibitor compounds and related pharmaceutical compositions. Because the relevant terms ran decades from filing, the core rights are no longer enforceable in the United States. A current applicant should focus its intellectual-property strategy on formulation, manufacturing, packaging and combination-product claims rather than the moexipril molecule.

When does moexipril lose exclusivity?

Moexipril has already lost regulatory and patent exclusivity in the United States.

The original product’s market protection ended after expiration of the relevant small-molecule patents and regulatory exclusivity periods. FDA’s Orange Book framework lists patent and exclusivity information for approved drug products, but the commercial question is whether an active listed patent or regulatory exclusivity period remains. For moexipril, the relevant exclusivity window is historical rather than prospective.[2]

Exclusivity issue	Assessment
New chemical entity exclusivity	Expired
Pediatric exclusivity	No current commercial relevance
Orphan exclusivity	Not applicable
Patent term extension	No current barrier
Paragraph IV risk	Low for the base product because core patents are expired
Generic launch timing	Dependent mainly on ANDA approval, supply economics and market demand

What is the Orange Book status of moexipril hydrochloride?

Moexipril hydrochloride is an FDA-approved small-molecule product historically listed in the Orange Book under immediate-release tablet products. Orange Book status should be checked by applicant, strength and marketing status because older products may be listed as discontinued even when the active ingredient remains approved in the regulatory record.[2]

A discontinued listing does not automatically establish a safety or efficacy withdrawal. FDA’s discontinued-drug databases distinguish commercial discontinuation from withdrawal for safety or effectiveness reasons.[3] For commercial planning, the critical questions are:

1. Whether an approved reference listed drug remains available for an ANDA reference strategy.
2. Whether FDA identifies a current reference product or requires a suitability or 505(b)(2) approach.
3. Whether the proposed strength and dosage form match an approved reference.
4. Whether the applicant can demonstrate bioequivalence using the applicable product-specific guidance.

A sponsor should not assume that the historic Univasc label alone provides a readily marketable current reference product.

What excipients were used in historical moexipril tablets?

Historical moexipril hydrochloride tablets used conventional immediate-release excipients. Public labeling identifies excipients including lactose, crospovidone, povidone and magnesium stearate, with film-coating components used to provide color, protection and swallowability.[1,4]

The exact inactive-ingredient declaration should be confirmed against the applicable product label and FDA Inactive Ingredient Database before development. For a generic program, the historical formulation is a useful starting point but does not need to be copied if the new formulation meets quality, bioequivalence and safety requirements.

Functional role of the likely excipient system

Excipient function	Candidate materials	Formulation purpose
Diluent	Lactose monohydrate, microcrystalline cellulose, mannitol	Tablet mass and compressibility
Superdisintegrant	Crospovidone, croscarmellose sodium, sodium starch glycolate	Rapid tablet breakup
Binder	Povidone, hydroxypropyl cellulose	Granule and tablet strength
Lubricant	Magnesium stearate, sodium stearyl fumarate	Ejection and manufacturing efficiency
Glidant	Colloidal silicon dioxide	Powder flow
Film former	Hypromellose	Surface protection and appearance
Plasticizer	Polyethylene glycol	Film flexibility
Opacifier	Titanium dioxide	Light protection and color
Colorant	Iron oxides or approved color systems	Product differentiation

The formulation should avoid unnecessary complexity. Moexipril’s commercial profile does not justify an expensive multiparticulate or advanced delivery platform unless the product targets a defined patient or reimbursement segment.

How should excipients be selected for moexipril hydrochloride?

The base formulation should prioritize rapid, reproducible dissolution and chemical stability. A direct-compression platform is commercially attractive if the active pharmaceutical ingredient has adequate flow, content uniformity and compactability. Wet granulation may be preferable if low-dose uniformity, segregation or tablet strength is problematic.

Recommended development priorities

1. Use a robust immediate-release platform.
   Crospovidone or croscarmellose sodium can support rapid disintegration. The final choice should follow dissolution profiling across pH conditions and manufacturing-scale compression studies.

2. Control lubricant exposure.
   Excess magnesium stearate can reduce wetting and slow dissolution. Blend time and lubricant concentration should be controlled as critical process parameters.

3. Evaluate lactose compatibility.
   Lactose is commercially efficient and historically relevant, but reducing sugars can create compatibility concerns with certain amine-containing compounds. The sponsor should assess assay, degradation products and solid-state behavior under accelerated conditions.

4. Consider microcrystalline cellulose for a lactose-free platform.
   Microcrystalline cellulose may improve tablet robustness and provide a differentiated label for patients avoiding lactose. It can also support direct compression, although its moisture behavior and mouthfeel require evaluation.

5. Use a protective film coat.
   A thin hypromellose-based coating can improve swallowability, reduce handling loss and support product identification without materially increasing cost.

6. Screen pH-modifying excipients carefully.
   Acidifiers, alkalizers and buffering systems may alter dissolution, salt behavior or stability. They should not be included without a demonstrated formulation need.

7. Avoid unnecessary modified release.
   A sustained-release moexipril product would create a new clinical and regulatory program. The mature market is unlikely to support that investment without evidence of a meaningful dosing or adherence advantage.

What formulation patents could protect a new moexipril product?

A new sponsor could seek protection for a specific formulation, but patentability would depend on unexpected technical results rather than routine excipient substitution.

Potential claim areas include:

• A low-impurity tablet with defined degradation-product limits.
• A moisture-controlled formulation with improved stability.
• A lactose-free composition with superior dissolution and content uniformity.
• A pediatric liquid or dispersible tablet with acceptable taste and chemical stability.
• A fixed-dose combination with a diuretic or calcium-channel blocker.
• A manufacturing process that reduces degradation or improves low-dose uniformity.
• A package formulation that extends shelf life under high humidity.

Routine claims covering “moexipril plus a conventional binder and disintegrant” would face substantial obviousness risk. Stronger claims would require comparative data showing a measurable improvement over the known tablet formulation.

What commercial opportunities exist for moexipril hydrochloride?

1. Low-cost generic tablets

The most practical opportunity is a conventional 7.5-mg and 15-mg immediate-release tablet. The formulation can use low-cost, widely accepted excipients and standard blister or high-density polyethylene bottle packaging.

The weakness is market size. Lisinopril, enalapril and ramipril are entrenched, and many hypertension patients receive generic products with extensive pharmacy substitution. A moexipril launch would need low manufacturing cost, reliable supply and a focused distribution strategy.

2. Pediatric oral liquid

A liquid could address patients who cannot swallow tablets, although the commercial population is limited. Key development problems include:

• Moexipril hydrochloride solubility and pH-dependent stability.
• Taste masking.
• Uniform dosing after shaking.
• Preservative compatibility.
• In-use stability.
• Container-closure performance.
• Appropriate measuring device design.

A ready-to-use liquid may have a clearer clinical use case than a novel tablet, but it would likely require a 505(b)(2) or other non-ANDA strategy if no suitable reference liquid exists.

3. Dispersible or orally disintegrating tablet

A dispersible tablet could serve geriatric patients and patients with dysphagia. Mannitol, crospovidone, low-substituted hydroxypropyl cellulose and taste-masking coatings are possible excipient tools.

The main technical risk is palatability. ACE inhibitors can have a bitter taste, and a rapidly disintegrating dosage form increases oral exposure to the active ingredients. A taste-masked ODT would need dissolution, mechanical-strength and stability data that justify its added cost.

4. Fixed-dose combinations

Moexipril was historically used with thiazide diuretics. A fixed-dose combination with hydrochlorothiazide could improve pill burden, but the market is crowded with established ACE-inhibitor/thiazide products.

A combination with amlodipine or another antihypertensive could provide a stronger commercial position only if the product offers a clear dosing or adherence benefit. Combination development would require compatibility studies, dose-selection work and combination-product bioequivalence.

5. Contract manufacturing and regional supply

Moexipril may have more value in selected international markets than in the United States. Opportunities may exist where:

• The product remains listed in national formularies.
• Local generic competition is limited.
• The sponsor has an established cardiovascular sales channel.
• Existing tablet equipment can produce the product at low incremental cost.
• The active ingredient is available from qualified suppliers.

Geographic freedom to operate must be assessed separately. U.S. patent expiration does not establish freedom to market in Europe, Japan, China, India or other jurisdictions.

How strong is the moexipril patent estate?

The base moexipril patent estate is weak for new U.S. entry because the principal molecule and historical tablet rights have expired. The remaining strategic value lies in implementation rights.

Estate component	Strength for a new entrant
Active ingredient	Low
Standard tablet	Low
New excipient combination	Low to moderate
Stability-improved formulation	Moderate if supported by data
Pediatric dosage form	Moderate
Fixed-dose combination	Moderate, product-specific
Manufacturing process	Moderate where technically distinctive
Trade secrets and know-how	Potentially meaningful
Brand differentiation	Limited

A formulation patent can delay direct copying only if it claims a commercially important and technically non-obvious product. Trade secrets covering granulation endpoints, impurity control and scale-up parameters may have more practical value than a narrow composition patent.

Which companies are challenging moexipril?

The historic generic market included multiple manufacturers of moexipril tablets, but current commercial participation should be verified through FDA marketing-status records, wholesaler listings and national-market databases. No major active Paragraph IV dispute is central to the current U.S. moexipril market because the original patent barriers have expired.

The competitive set is broader than moexipril manufacturers. It includes generic suppliers of:

• Lisinopril
• Enalapril
• Ramipril
• Perindopril
• Benazepril
• Losartan and other angiotensin-receptor blockers
• Fixed-dose antihypertensive combinations

These products constrain pricing and make a me-too moexipril launch difficult without a differentiated dosage form or a low-cost regional strategy.

What generic entry risks exist for moexipril hydrochloride?

The principal risks are commercial and regulatory rather than patent-related.

Regulatory risks

• Lack of a clearly available reference listed drug.
• Need for a 505(b)(2) pathway for a novel dosage form.
• Bioequivalence failure caused by food effects or dissolution differences.
• Inadequate control of degradation products.
• Strength-specific manufacturing problems.
• Failure to match inactive-ingredient limits or route-specific safety precedents.

Manufacturing risks

• Low-dose content-uniformity failures.
• Segregation during direct compression.
• Over-lubrication and slow dissolution.
• Moisture-driven degradation.
• Tablet friability after film coating.
• API supply variability.

Commercial risks

• Low prescription demand.
• Generic substitution by established ACE inhibitors.
• Limited reimbursement differentiation.
• Minimum-order quantities that exceed market demand.
• Pharmacy and wholesaler reluctance to add a low-volume product.

What licensing deals could support a moexipril program?

A licensing transaction would make sense only if it brings one of four assets:

1. A differentiated pediatric or dysphagia-friendly dosage form.
2. A validated fixed-dose combination.
3. A low-cost, qualified API source.
4. Access to a regional market where moexipril remains commercially relevant.

A license covering only expired moexipril composition patents would have little value. A stronger transaction would combine formulation know-how, regulatory documentation, manufacturing capacity and established cardiovascular distribution.

How does moexipril compare with competing ACE inhibitors?

Factor	Moexipril	Lisinopril	Enalapril	Ramipril
Patent status	Expired	Expired	Expired	Expired
Market maturity	Mature, smaller	Very high	High	High
Prodrug	Yes	No	Yes	Yes
Once-daily use	Possible	Common	Common	Common
Food-related formulation consideration	Relevant	Less central	Relevant	Relevant
Generic competition	Limited to moderate	Very high	High	High
Differentiation potential	Dosage form or combination	Low	Low	Low
Commercial launch attractiveness	Niche	Scale-driven	Scale-driven	Scale-driven

Moexipril’s prodrug design and historical food-administration instruction create formulation considerations, but they do not create a durable commercial advantage by themselves.

What is the likely revenue exposure?

Revenue potential is difficult to support without current prescription, price and market-share data. The product should be treated as a niche generic opportunity rather than a major U.S. revenue platform.

A practical commercial model is:

• Base case: low-volume generic tablet supplied through selected channels.
• Upside case: differentiated pediatric, dispersible or fixed-dose product with limited competition.
• Downside case: no launch because manufacturing, regulatory and distribution costs exceed achievable net sales.

The product’s low active-ingredient cost does not eliminate commercial risk. Stability studies, analytical method validation, bioequivalence work, registration fees and ongoing pharmacovigilance can exceed the value of a small mature market.

Key Takeaways

• Moexipril hydrochloride is an off-patent ACE inhibitor with no meaningful current U.S. molecule-level exclusivity.
• The best generic strategy is a conventional immediate-release tablet using a robust disintegrant, controlled lubrication and a protective film coat.
• Historical excipients included lactose, crospovidone, povidone and magnesium stearate, with standard film-coating materials.
• Formulation patents could protect a new product only if they claim a technically distinctive result, such as improved stability, pediatric usability or a validated combination.
• A pediatric liquid, dispersible tablet or fixed-dose combination offers more differentiation than another standard tablet.
• The principal barriers are market size, reference-product strategy, bioequivalence and manufacturing economics.
• A U.S. launch should be evaluated as a niche generic program, while selected international markets may provide better commercial potential.
• No biosimilar pathway applies because moexipril is a small molecule.
• Licensing value lies in formulation know-how, API supply, regional rights and distribution, not in expired core patents.

FAQs

Is moexipril hydrochloride still marketed in the United States?

The original Univasc product has been commercially discontinued, and current availability depends on the status of individual generic applicants and distributors.

Can moexipril hydrochloride be developed as an ANDA?

A matching immediate-release tablet may qualify for an ANDA if FDA identifies an appropriate reference listed drug and the applicant satisfies pharmaceutical-equivalence and bioequivalence requirements. A new liquid or ODT may require a 505(b)(2) pathway.

Does moexipril hydrochloride need a biosimilar application?

No. Moexipril hydrochloride is a chemically synthesized small molecule and follows generic-drug pathways rather than the biologic biosimilar pathway.

Which excipient is most important for moexipril tablet performance?

The superdisintegrant and lubricant system is critical. Crospovidone or croscarmellose sodium can support rapid breakup, while excessive magnesium stearate may impair wetting and dissolution.

Is a moexipril hydrochloride fixed-dose combination commercially attractive?

It may be attractive in a targeted regional market, particularly with hydrochlorothiazide, but the U.S. market is crowded with established ACE-inhibitor combinations. The product would need a clear adherence, dosing or supply advantage.

References

1. U.S. Food and Drug Administration. (2008). Univasc (moexipril hydrochloride) tablets prescribing information. FDA/DailyMed labeling archive.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. Orange Book.

3. U.S. Food and Drug Administration. (2024). Discontinued drug product list. FDA.

4. National Library of Medicine. (2024). DailyMed: Moexipril hydrochloride tablet labeling and inactive ingredients. DailyMed.