List of Excipients in Branded Drug CIMETIDINE

Generic Drugs Containing CIMETIDINE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	cimetidine	0093-8192	CARNAUBA WAX
Teva Pharmaceuticals USA Inc	cimetidine	0093-8192	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA Inc	cimetidine	0093-8192	D&C YELLOW NO. 10 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc	cimetidine	0093-8192	FD&C BLUE NO. 1 ALUMINUM LAKE
Teva Pharmaceuticals USA Inc	cimetidine	0093-8192	FD&C YELLOW NO. 6

What are the Most Frequently-Used Excipients in CIMETIDINE?

# Of NDCs	Excipient
1	ALCOHOL
4	ALUMINUM OXIDE
1	BLUE 1
12	CARNAUBA WAX
16	CELLULOSE, MICROCRYSTALLINE

Cimetidine Excipient Strategy and Commercial Opportunities

Last updated: September 9, 2026

Cimetidine is a mature H2-receptor antagonist with no meaningful U.S. new-drug exclusivity and limited patent-based barriers. Commercial value now depends on formulation execution, supply reliability, dosage-form differentiation, geographic expansion, and targeted products for veterinary, hospital, and specialty markets. The strongest excipient opportunities are taste-masked liquids, orally disintegrating tablets, modified-release systems, low-cost direct-compression tablets, and preservative-controlled multidose liquids.

What is cimetidine and where is it used?

Cimetidine blocks histamine H2 receptors and reduces gastric acid secretion. It is used for peptic ulcer disease, gastroesophageal reflux disease, pathological hypersecretory conditions, and related acid-control indications. FDA-approved dosage forms have included oral tablets, oral solutions, and injectable products. Typical tablet strengths are 200 mg, 300 mg, 400 mg, and 800 mg. [1]

Cimetidine has a relatively short elimination half-life, generally about two hours, and is substantially eliminated through the kidneys. Dose adjustment is relevant in renal impairment. The drug also inhibits several cytochrome P450 enzymes, creating interaction risk with medicines including warfarin, phenytoin, theophylline, and certain benzodiazepines. [1]

The product’s commercial profile differs from newer acid-suppressing agents:

Attribute	Cimetidine	Famotidine	Omeprazole
Class	H2 antagonist	H2 antagonist	Proton-pump inhibitor
Original U.S. approval era	1970s	1980s	1980s
Typical oral dosage	200-800 mg	10-40 mg	10-40 mg
Dose frequency	Often twice daily or at bedtime	Often once or twice daily	Usually once daily
Major differentiation issue	Drug interactions and generic price pressure	Longer use in current H2 market	Stronger acid suppression
Patent-based opportunity	Minimal	Limited for legacy products	Product-specific depending on formulation
Excipient opportunity	High in liquids, ODTs, and low-cost products	Moderate	High in delayed-release systems

Cimetidine’s high dose relative to newer H2 antagonists makes tablet size, swallowability, powder flow, and taste control important formulation variables.

What excipients are used in cimetidine tablets and liquids?

Commercial cimetidine products use conventional excipient systems. The exact composition varies by manufacturer and dosage form. Labeling databases identify excipients such as microcrystalline cellulose, lactose, starch, povidone, croscarmellose sodium, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, hypromellose, titanium dioxide, polyethylene glycol, and coloring agents. [2]

A typical immediate-release tablet may contain:

Formulation function	Suitable excipient classes	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, dibasic calcium phosphate	Controls tablet weight and compression
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Accelerates tablet breakup
Glidant	Colloidal silicon dioxide	Improves powder flow
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces tooling friction
Film former	Hypromellose, polyvinyl alcohol	Improves handling, appearance, and taste
Plasticizer	Polyethylene glycol, propylene glycol	Supports film flexibility
Sweetener	Sucralose, sodium saccharin, sorbitol	Improves liquid and ODT acceptability
Suspending agent	Xanthan gum, sodium carboxymethylcellulose, hypromellose	Maintains liquid uniformity
Preservative	Methylparaben, propylparaben, potassium sorbate, sodium benzoate	Controls microbial growth in multidose liquids

Cimetidine has an unpleasant taste that can limit liquid and orally disintegrating formulations. Taste masking therefore has greater commercial relevance than adding complex release technology to a conventional tablet.

What excipient strategy is strongest for cimetidine?

The highest-value strategy is to match excipients to a specific commercial weakness rather than create an unnecessarily complex formulation.

Immediate-release tablets

Immediate-release tablets are the lowest-risk product. A direct-compression platform using microcrystalline cellulose, a superdisintegrant, colloidal silicon dioxide, and magnesium stearate can reduce manufacturing steps and support low-cost generic production.

The principal development risks are:

• Large tablet size at 400 mg and 800 mg strengths.
• Variable flow caused by high drug loading.
• Compression capping or picking.
• Slow disintegration if excessive binder or lubricant is used.
• Dissolution changes caused by excipient grade or granulation method.

A dry-granulation or roller-compaction process may be preferable where cimetidine has poor flow or insufficient compactability. Wet granulation can improve content uniformity but raises drying and scale-up requirements.

Film-coated tablets

Film coating can improve swallowability, color differentiation, moisture protection, and product identification. Hypromellose-based aqueous coating systems are commercially practical. A coating system can also reduce immediate perception of bitterness, although it does not solve the problem after tablet disintegration.

A differentiated product could use color-coded strengths and a high-contrast imprinting system for older patients taking multiple medicines. These changes have limited regulatory value but can support hospital procurement and medication-error reduction.

Oral liquids

Oral liquid cimetidine is a stronger excipient opportunity than the standard tablet market. Relevant design requirements include:

• Rapid dissolution or stable suspension.
• Acceptable taste after dilution.
• Chemical and microbial stability.
• Low sedimentation and easy redispersion.
• Accurate dosing with an oral syringe.
• Compatibility with commonly used bottle and closure systems.

A solution is preferable if cimetidine remains chemically stable at the target concentration and pH. A suspension may provide better flexibility where solubility, taste, or stability limits a concentrated solution.

Potential commercial formats include:

1. A ready-to-use multidose liquid for pediatric and geriatric use.
2. A powder for reconstitution with longer shelf life before activation.
3. A concentrated liquid supplied with a dosing syringe.
4. A sugar-free product using sorbitol, glycerol, or a suitable polyol system.
5. A preservative-free unit-dose presentation for institutional use.

Preservative selection requires compatibility testing with the pH, container, and surfactant system. Benzyl alcohol is generally unattractive for pediatric products because of safety concerns in vulnerable populations. A unit-dose preservative-free product may command a higher price in hospitals despite greater packaging cost.

Orally disintegrating tablets

An ODT could address swallowing difficulty and nighttime dosing. Cimetidine’s relatively high dose creates a practical constraint: an 800 mg ODT would likely be too large for a commercially acceptable single unit. A 200 mg or 400 mg ODT is more realistic, potentially using multiple units for higher doses.

Suitable excipient approaches include:

• Mannitol for mouthfeel and cooling sensation.
• Crospovidone or croscarmellose sodium for rapid disintegration.
• Low-moisture direct-compression fillers.
• Aspartame, sucralose, or acesulfame potassium for sweetness.
• Flavors selected to suppress sulfurous or bitter notes.
• Coated drug particles or polymeric taste-masking systems.

The key development metrics are disintegration time, friability, moisture uptake, tablet hardness, and in-mouth bitterness. Packaging in alu-alu blisters may be necessary for moisture-sensitive products.

Modified-release formulations

Modified release is technically possible but commercially harder to justify. Cimetidine’s short half-life creates a pharmacologic rationale, but the established low-cost immediate-release market limits pricing power.

Potential systems include:

• Hydrophilic matrix tablets using hypromellose.
• Multiparticulate systems using polymer-coated drug-loaded pellets.
• Bilayer tablets combining immediate and sustained-release portions.
• Gastroretentive systems for prolonged gastric exposure.

These products face higher development and bioequivalence risk. They may be commercially relevant only for a defined adherence problem, a hospital protocol, or a jurisdiction where a differentiated product receives meaningful reimbursement.

What formulation patents protect cimetidine products?

Cimetidine’s original compound and early product patents are historic. The drug was introduced by Smith Kline & French, now part of the GSK corporate lineage, and received FDA approval in 1977 under the Tagamet brand. [3]

The commercial patent position is now primarily a generic-product landscape:

Patent category	Current commercial significance
Original cimetidine compound patents	Expired
Original tablet formulation patents	Expired or commercially obsolete
Original method-of-use patents	Expired
Generic tablet formulation patents	Usually narrow and product-specific
Taste-masking patents	Potentially relevant for new ODT or liquid systems
Modified-release patents	Potentially relevant if a new delivery system is developed
Manufacturing-process patents	Relevant only if they provide measurable cost, purity, or scale advantages
Device and packaging patents	Possible for unit-dose or dosing-system products

No cimetidine product has the type of active compound patent protection associated with a recently launched small molecule. New patent value would have to come from a specific formulation, process, dosage regimen, device, or combination.

A company pursuing a new cimetidine product should focus on claimable technical differences, such as:

• A defined taste-masking coating.
• A stable high-concentration oral solution.
• A preservative-free multidose system.
• A low-dose ODT with rapid disintegration and acceptable taste.
• A controlled-release matrix with demonstrated pharmacokinetic benefit.
• A manufacturing process that materially improves impurity control or yield.

Broad claims covering “cimetidine plus conventional excipients” would face substantial validity and freedom-to-operate pressure because of extensive historical use.

What is the Orange Book and FDA regulatory status of cimetidine?

Cimetidine is an established small-molecule drug with generic approval pathways under abbreviated new drug applications. The FDA Orange Book is relevant for identifying listed patents and regulatory exclusivity associated with approved products. [4]

Cimetidine has no remaining new chemical entity exclusivity. Any current regulatory protection would depend on a specific product, formulation, labeling, pediatric program, or listed patent rather than the active ingredient itself.

For a conventional generic tablet, the principal regulatory requirements are:

• Pharmaceutical equivalence.
• Bioequivalence.
• Adequate stability data.
• Impurity and degradation-product control.
• Dissolution testing.
• Manufacturing-process validation.
• Labeling that reflects renal dosing and interaction warnings.

An oral solution, suspension, ODT, or modified-release product may require additional comparative performance work. The regulatory burden increases when the product changes release rate, concentration, pH, dosing device, or administration conditions.

When does cimetidine lose exclusivity?

Cimetidine lost its core U.S. exclusivity decades ago. Generic competition has been established for many years, and no meaningful compound-level launch barrier remains.

The practical exclusivity timeline is:

Period	Commercial event
1977	FDA approval of Tagamet in the United States [3]
1980s and 1990s	Expansion of generic and alternative H2-antagonist competition
2000s	Mature generic market and declining branded differentiation
Current market	Product-level opportunities based on formulation, packaging, supply, and channel strategy

There is no credible basis for expecting a conventional cimetidine tablet to obtain market exclusivity through the active ingredient. Commercial protection would require a new, patentable product architecture.

Are there Paragraph IV challenges or biosimilar risks for cimetidine?

Paragraph IV litigation risk is low for standard cimetidine products because the active ingredient is old and the principal patents have expired. A new Paragraph IV dispute could arise only if a branded company listed a later formulation or method-of-use patent in the Orange Book.

Biosimilar risk does not apply. Cimetidine is a chemically synthesized small molecule, not a biologic. Competition comes from ANDA-based generics, authorized generics, private-label products, and nonprescription alternatives.

The main competitive risks are price erosion, API availability, manufacturing-site concentration, and substitution by famotidine or proton-pump inhibitors.

Which companies are challenging or competing with cimetidine?

Cimetidine competes across three levels:

Generic manufacturers

Generic manufacturers compete primarily on:

• Tablet and capsule cost.
• FDA supply reliability.
• Contract manufacturing capacity.
• Hospital and wholesaler contracts.
• Shortage avoidance.
• Product availability in multiple strengths.

The market is fragmented by labeler and distributor, and the commercial identity of a product may be less important than dependable supply.

H2-antagonist manufacturers

Famotidine is the most direct pharmacologic competitor. It is generally used at lower doses and has a longer half-life than cimetidine. Famotidine also has a lower interaction burden, which supports physician and pharmacist preference in many settings.

Proton-pump inhibitor manufacturers

Omeprazole, pantoprazole, lansoprazole, and related agents provide stronger and longer acid suppression. Cimetidine can remain relevant where an H2 antagonist is clinically preferred, where low acquisition cost matters, or where a liquid, injectable, or specific hospital presentation is needed.

What commercial opportunities exist for cimetidine excipients?

The strongest opportunities are specialized rather than mass-market.

Opportunity	Excipient strategy	Commercial attractiveness
Pediatric liquid	Sweetener, flavor, suspending agent, preservative or unit-dose system	High if taste and stability are solved
Geriatric product	ODT or small dispersible tablet	Moderate to high
Hospital injectable	Low-particulate, low-sorbitol or compatible parenteral system	Moderate
Veterinary product	Palatable liquid or flavored chewable presentation	Moderate
Premium OTC product	Taste-masked tablet or convenient nighttime dosage	Limited to moderate
Global-market product	Stable, low-cost tablet using locally available excipients	Moderate
Modified-release product	Matrix or multiparticulate technology	Selective, high development risk
Supply-constrained generic	Robust, simplified excipient system	High operational value

Veterinary use may support a separate commercial niche, but regulatory status, species-specific labeling, and clinical demand must be assessed independently. Human and veterinary products should not be treated as interchangeable regulatory categories.

What manufacturing and intellectual-property barriers affect cimetidine?

The largest barriers are operational, not patent-based.

API and manufacturing considerations include:

• Control of related substances and degradation products.
• Consistent particle-size distribution.
• Powder flow at high drug loading.
• Blend uniformity across multiple strengths.
• Moisture control in ODTs and powders for reconstitution.
• Compatibility with plastic bottles, elastomer closures, and blister films.
• Stability of liquid products across the proposed shelf life.
• Reliable supply of pharmacopeial-grade excipients.

A manufacturer can create defensible value through a validated process that reduces batch failure, improves throughput, or supports a differentiated dosage form. Process patents may help, but know-how, supplier qualification, analytical methods, and regulatory history may provide more durable protection in a mature generic market.

How does cimetidine compare with famotidine and omeprazole?

Cimetidine is less attractive for broad primary-care growth because it has more clinically important drug interactions and a larger dose burden. Its advantages are low active-ingredient cost, long regulatory history, availability in multiple dosage forms, and possible utility in targeted institutional or specialty settings.

Criterion	Cimetidine	Famotidine	Omeprazole
Tablet burden	Higher	Lower	Low
Interaction burden	Higher	Lower	Different interaction profile
Formulation complexity	Low for IR; high for taste masking	Low to moderate	High because of acid-labile API
Patent opportunity	New formulation only	New formulation only	Delayed-release and combination products
Best commercial angle	Low-cost niche and differentiated liquid	Mainstream H2 replacement	Broad acid-suppression market
Generic price pressure	Very high	High	High

Key Takeaways

• Cimetidine has no meaningful remaining compound-level exclusivity in the United States.
• Conventional immediate-release tablets are low-margin products with limited patent differentiation.
• Taste-masked oral liquids and low-dose ODTs offer the clearest excipient-led opportunities.
• High-dose tablets create challenges in tablet size, flow, compression, and patient acceptability.
• Modified-release products are technically feasible but face weak pricing power and higher regulatory risk.
• Cimetidine has no biosimilar risk; competition comes from generics, famotidine, and proton-pump inhibitors.
• New patent value would need to arise from formulation, process, packaging, dosing-device, or delivery-system claims.
• Supply reliability, impurity control, and excipient robustness are more important commercial barriers than legacy composition patents.

FAQs

Is cimetidine still commercially viable as a generic drug?

Yes, but mainly as a low-cost supply product or in targeted dosage forms. Conventional tablets have limited pricing power.

Which excipient is best for masking cimetidine taste?

No single excipient is universally best. Polymer-coated drug particles combined with a sweetener-flavor system generally provide a stronger platform than sweetness alone.

Can cimetidine be developed as an orally disintegrating tablet?

Yes. A 200 mg or 400 mg ODT is more practical than an 800 mg unit because of dose loading, tablet size, and taste constraints.

Does cimetidine require a delayed-release coating?

No. Cimetidine is not dependent on enteric protection in the manner of acid-labile proton-pump inhibitors. Immediate release is the conventional approach.

Can a new cimetidine formulation receive patent protection?

Yes, if it has a novel and non-obvious formulation, process, delivery system, device, or clinically meaningful dosing feature. A conventional mixture of cimetidine with routine excipients is unlikely to provide strong protection.

References

1. U.S. Food and Drug Administration. (2017). Cimetidine tablets: Prescribing information. FDA labeling database.

2. National Library of Medicine. (2024). DailyMed: Cimetidine tablet and injection product labeling. U.S. National Library of Medicine.

3. U.S. Food and Drug Administration. (1977). Approval history for Tagamet (cimetidine). FDA drug approval records.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.