List of Excipients in Branded Drug CIMETIDINE 200

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Generic Drugs Containing CIMETIDINE 200

Company	Ingredient	NDC	Excipient
Walgreen Company	cimetidine	0363-0022	CELLULOSE, MICROCRYSTALLINE
Walgreen Company	cimetidine	0363-0022	HYPROMELLOSE
Walgreen Company	cimetidine	0363-0022	MAGNESIUM STEARATE
Walgreen Company	cimetidine	0363-0022	POLYETHYLENE GLYCOL
Walgreen Company	cimetidine	0363-0022	POLYSORBATE 80
Walgreen Company	cimetidine	0363-0022	POVIDONE

What are the Most Frequently-Used Excipients in CIMETIDINE 200?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	HYPROMELLOSE
1	MAGNESIUM STEARATE
1	POLYETHYLENE GLYCOL
1	POLYSORBATE 80
1	POVIDONE

Cimetidine 200 mg Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 30, 2026

Cimetidine 200 mg is a mature immediate-release H2-receptor antagonist with limited active-ingredient patent protection and substantial generic competition. Commercial value is concentrated in formulation execution, private-label distribution, differentiated dosage forms, packaging, and low-cost manufacturing. The strongest opportunities are chewable, orally disintegrating, liquid, and adherence-oriented products that remain within the FDA’s OTC acid-reducer framework.

What is the commercial profile of cimetidine 200 mg?

Cimetidine is an H2-receptor antagonist that reduces gastric acid secretion by blocking histamine H2 receptors in gastric parietal cells. A 200 mg strength is used in over-the-counter and prescription products for heartburn, acid indigestion, and related acid-reflux symptoms.

Commercial attribute	Cimetidine 200 mg assessment
Active ingredient	Cimetidine
Principal dosage form	Immediate-release tablet
Typical OTC strength	200 mg
Therapeutic class	H2-receptor antagonist
Primary OTC use	Heartburn and acid indigestion relief
FDA status	Approved prescription drug; OTC marketing permitted under applicable FDA requirements
Reference brand	Tagamet HB 200
Main competitors	Famotidine, calcium carbonate antacids, alginate products, proton-pump inhibitors
Biologic exposure	None
Biosimilar risk	Not applicable
Core patent position	Legacy, generally expired composition-of-matter protection
Main commercial barrier	Price competition and consumer preference for famotidine and combination antacid products

FDA labeling for OTC cimetidine generally limits self-treatment to consumers aged 12 years and older and restricts continuous self-treatment to 14 days unless directed by a physician. Product labeling must address drug interactions, renal impairment, and use with other acid-reducing medicines. [1,2]

What excipients are used in cimetidine 200 mg tablets?

Commercial cimetidine 200 mg tablets commonly use conventional direct-compression or wet-granulation excipients. The precise composition varies by manufacturer and regulatory filing.

Typical excipient classes include:

Excipient function	Candidate materials	Commercial purpose
Filler and compression aid	Microcrystalline cellulose, lactose, dibasic calcium phosphate	Tablet weight, hardness, manufacturability
Binder	Hydroxypropyl cellulose, povidone, pregelatinized starch	Granule strength and tablet integrity
Disintegrant	Sodium starch glycolate, crospovidone, croscarmellose sodium	Rapid tablet breakup
Lubricant	Magnesium stearate, stearic acid	Ejection and tooling protection
Glidant	Colloidal silicon dioxide, talc	Powder flow
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, talc	Appearance, swallowability, moisture protection
Sweetener and flavor	Sucralose, aspartame, mannitol, fruit flavors	Chewable or orally disintegrating products
Suspension vehicle	Glycerin, sorbitol, cellulose derivatives, xanthan gum	Liquid-dose uniformity and viscosity
Preservative	Sodium benzoate, potassium sorbate, or other permitted systems	Multidose liquid microbiological control

Tagamet HB 200 labeling identifies a conventional tablet excipient system that includes cellulose-based materials, starch-derived disintegrants, magnesium stearate, coating components, and other standard solid-dose excipients. Generic products may use materially different excipient systems while maintaining the same active ingredient, strength, dosage form, and performance specifications. [2]

Which excipients are most important for immediate-release performance?

The highest-value excipient decisions are disintegrant selection, lubricant concentration, compression force, and coating permeability. Cimetidine 200 mg is a relatively low-dose solid product compared with many tablets, so the formulation must distribute the active ingredient uniformly through a larger tablet matrix.

A robust immediate-release design should target:

• Rapid disintegration without excessive friability.
• Consistent assay and content uniformity.
• Acceptable tablet hardness during high-speed compression.
• Low sticking and picking during manufacture.
• Dissolution performance that remains stable after packaging and storage.
• Minimal excipient-related interaction with cimetidine or the analytical method.

A high lubricant level can slow wetting and dissolution. Excessive hydrophobic coating can create a similar problem. Crospovidone or croscarmellose sodium may support rapid breakup, while microcrystalline cellulose can improve compression and tablet robustness.

What formulation opportunities exist for cimetidine 200 mg?

The main opportunities are differentiated delivery formats rather than new pharmacology.

Chewable cimetidine 200 mg

A chewable tablet can compete in the self-care channel by eliminating the need for water. The formulation challenge is taste. Cimetidine can require strong flavor masking and a high-intensity sweetener system.

A viable chewable platform may combine:

• Mannitol or isomalt for mouthfeel.
• Microcrystalline cellulose or compressible sugar for structure.
• Crospovidone for rapid dispersion.
• Sucralose, acesulfame potassium, or another permitted sweetener.
• Fruit, mint, or cooling flavor systems.
• Polymer coating or granulation technology for taste masking.

The product should be evaluated for chewability, residual bitterness, tablet friability, moisture sensitivity, and dissolution after chewing.

Orally disintegrating tablet

An orally disintegrating tablet can target consumers who have difficulty swallowing conventional tablets. The commercial benefit is convenience rather than faster pharmacologic action.

Key formulation risks include:

• Mechanical fragility during packaging and transport.
• Moisture uptake.
• Cimetidine taste.
• Dose loss from powdering or handling.
• Requirement for specialized blister packaging.

A high-porosity tablet may provide rapid disintegration but can be difficult to package in bottles. Unit-dose aluminum or high-barrier blister packaging can protect the product and support premium positioning.

Oral solution or suspension

A liquid product can target pediatric prescription use, patients with swallowing difficulties, and institutional markets. The principal challenges are chemical stability, microbial control, taste, sedimentation, and dosing-device accuracy.

A multidose suspension requires:

• Uniform redispersion after storage.
• A calibrated oral syringe or dosing cup.
• A suitable suspending system.
• Preservative effectiveness testing.
• Child-resistant packaging where required.
• Labeling that controls dosing errors.

A ready-to-use solution may have a simpler consumer experience, but the formulation must address cimetidine solubility, pH, flavor, and shelf life. A powder-for-reconstitution product may reduce shipping weight and improve stability but adds preparation risk.

Combination products

Cimetidine could be combined with an antacid or alginate system to provide separate mechanisms: acid suppression plus rapid neutralization or reflux-barrier activity. Combination products have greater regulatory and clinical complexity than single-ingredient tablets.

Potential advantages include:

• Faster perceived relief from the antacid component.
• Longer acid suppression from cimetidine.
• Differentiation from low-price generic tablets.

Risks include chemical compatibility, altered dissolution, increased label complexity, and the need to establish the compatibility and performance of the combination. A combination should not be treated as a simple line extension.

What regulatory pathway applies to cimetidine 200 mg products?

A conventional cimetidine 200 mg tablet may be eligible for an abbreviated pathway if it meets the applicable FDA requirements for an approved reference product and demonstrates pharmaceutical equivalence and bioequivalence. OTC marketing must also comply with the relevant FDA monograph and Drug Facts labeling requirements. [1,3]

Conventional generic tablet

A conventional tablet generally has the clearest path where the sponsor can match the reference product’s active ingredient, strength, dosage form, route, and applicable performance requirements. The principal development work is analytical, bioequivalence-related, manufacturing, and stability-focused.

Novel OTC dosage form

A chewable, orally disintegrating, liquid, or combination product may require a different regulatory strategy depending on the formulation and proposed labeling. A novel product may require an ANDA, a 505(b)(2) application, or another FDA route rather than relying entirely on monograph compliance.

The commercial decision should compare:

Route	Advantage	Primary risk
Conventional tablet	Lowest technical and regulatory risk	Severe price competition
Chewable tablet	Better consumer differentiation	Taste masking and monograph fit
Orally disintegrating tablet	Convenience and possible premium pricing	Fragility, moisture, packaging
Liquid product	Access for swallowing-limited patients	Stability and preservative burden
Combination product	Stronger product differentiation	Clinical and regulatory complexity

What patents protect cimetidine 200 mg products?

The original cimetidine composition-of-matter and basic therapeutic patent estate is historical and does not provide a meaningful current barrier to ordinary generic entry. Cimetidine was introduced in the late 1970s, and the commercial product has been available for decades.

IP category	Current commercial relevance
Cimetidine molecule	Historical protection; no practical barrier to generic development
200 mg tablet formulation	Potentially protected only by product-specific patents, if any remain active
Method-of-use claims	Limited value for ordinary OTC heartburn indications
Chewable formulation	Possible protection for taste masking, excipient ratios, or manufacturing process
Orally disintegrating formulation	Possible protection for porous structure, packaging, or disintegration technology
Liquid formulation	Possible protection for stability, pH control, or preservative system
Manufacturing process	Possible protection where process parameters are novel and non-obvious
Trade dress and trademarks	Potentially relevant for brand differentiation, but not generic entry prevention

A sponsor should not assume that a novel excipient combination creates enforceable patent protection. Patent strength depends on claim scope, written description, enablement, prosecution history, prior art, and freedom-to-operate analysis.

What is the Orange Book status of cimetidine 200 mg?

The Orange Book identifies FDA-approved products and certain patent and exclusivity information. A legacy generic cimetidine 200 mg tablet is unlikely to face a meaningful active-ingredient patent barrier. Any current filing analysis must distinguish:

1. The reference listed drug.
2. Active patents listed for that specific product.
3. Pediatric or regulatory exclusivity.
4. Product-specific formulation or method-of-use claims.
5. Patents owned by parties other than the original innovator.

Because a patent may protect a branded formulation without blocking a conventional generic, Orange Book review must be performed at the product level rather than inferred from the drug’s historical patent estate. [4]

Are Paragraph IV challenges relevant to cimetidine 200 mg?

Paragraph IV litigation risk is low for a conventional cimetidine 200 mg tablet because the foundational patents are expired or commercially immaterial. A Paragraph IV filing could still arise against a later-listed formulation patent, but that would be a product-specific dispute rather than a challenge to cimetidine itself.

The more realistic legal issues are:

• Whether a proposed formulation infringes a surviving formulation patent.
• Whether a product falls within an OTC monograph.
• Whether labeling creates an induced-infringement issue for a method-of-use claim.
• Whether trade dress or trademark rights are being confused with patent rights.
• Whether a private-label product relies on a licensed branded formulation.

What manufacturing and IP barriers affect cimetidine 200 mg?

The active pharmaceutical ingredient is commercially mature, and manufacturing barriers are generally manageable. The main barriers are quality, cost, supply reliability, and regulatory execution.

Critical manufacturing controls include:

• API particle-size distribution.
• Blend uniformity.
• Segregation control.
• Tablet weight and hardness.
• Lubrication time.
• Coating uniformity.
• Dissolution after accelerated stability.
• Packaging moisture protection.
• Cleaning validation and cross-contamination control.

For chewable or orally disintegrating products, taste masking and mechanical robustness are the most defensible technical capabilities. For liquids, stability and microbial control create the greatest development burden.

The strongest patentable areas are likely to involve a specific technical solution, such as a validated taste-masking matrix, a stable low-water liquid system, or a manufacturing process that produces a defined disintegration and dissolution profile. Broad claims covering cimetidine plus ordinary fillers or lubricants would face substantial prior-art risk.

How does cimetidine compare with famotidine and proton-pump inhibitors?

Famotidine has a stronger current consumer position in the H2-antagonist category. Proton-pump inhibitors compete for longer-duration acid suppression, while calcium carbonate and alginate products compete for rapid symptom relief.

Attribute	Cimetidine 200 mg	Famotidine	Proton-pump inhibitor
Drug class	H2 antagonist	H2 antagonist	Proton-pump inhibitor
Consumer perception	Legacy product	Current H2 alternative	Longer-duration therapy
Key commercial issue	Drug-interaction profile	Strong brand and generic presence	Delayed onset and longer use cycle
Formulation opportunity	Chewable, ODT, liquid	Similar formats	Delayed-release and combination products
Interaction profile	Significant CYP inhibition	Generally lower interaction burden	Different interaction and long-term-use considerations
IP opportunity	Delivery and taste masking	Delivery and combination products	Enteric coating and release-control systems

Cimetidine’s CYP-mediated interaction profile can reduce its attractiveness relative to famotidine for some consumers and prescribers. A new formulation cannot remove that pharmacology. Labeling accuracy and pharmacist education remain important commercial requirements.

What licensing and commercial opportunities exist?

Cimetidine 200 mg is suitable for business models that rely on manufacturing scale and channel access rather than molecule exclusivity.

The most credible opportunities are:

1. Private-label OTC supply for pharmacies, supermarkets, warehouse clubs, and e-commerce sellers.
2. Contract manufacturing of conventional tablets and chewables.
3. Brand licensing for a differentiated dosage form.
4. Institutional liquid products for hospitals, long-term-care facilities, and specialty pharmacies.
5. Export products in jurisdictions where cimetidine remains commercially accepted.
6. Combination products positioned around rapid relief and acid suppression.
7. Unit-dose and travel packaging for convenience channels.
8. Low-cost products using high-throughput compression and simple packaging.

A conventional tablet is likely to produce the lowest gross margin but also has the shortest development timeline. A taste-masked chewable or moisture-protected orally disintegrating tablet may support higher pricing if the consumer benefit is clear and the product obtains visible retail placement.

What generic launch scenarios exist?

Low-cost conventional generic

This scenario uses a standard immediate-release tablet, bottle packaging, and high-volume manufacturing. It is the fastest route but exposes the sponsor to direct price comparison with existing generics.

Premium convenience product

This scenario uses a chewable or orally disintegrating format, stronger flavor masking, and unit-dose packaging. It can support a higher retail price but requires more development and packaging investment.

Institutional liquid

This scenario targets prescription and institutional demand. The opportunity depends on supply reliability, stability, dosing accuracy, and formulary acceptance rather than consumer branding.

Combination product

This scenario seeks stronger differentiation through rapid antacid relief or reflux-barrier activity. It has the highest regulatory and formulation burden.

How strong is the cimetidine 200 mg patent estate?

The patent estate is weak for the active ingredient and conventional 200 mg tablet. It can be moderate for a genuinely differentiated dosage form if the claims cover a specific formulation architecture, manufacturing process, or stability solution.

IP asset	Relative strength
Historical molecule patent	Expired or commercially irrelevant
Conventional tablet formulation	Low
Basic excipient substitution	Low
Taste-masked chewable	Moderate if technically specific
Orally disintegrating tablet	Moderate if structure and performance are defined
Stable liquid formulation	Moderate if stability is difficult to replicate
Brand and trade dress	Commercially useful but not patent exclusivity
Manufacturing know-how	Potentially valuable as a trade secret

Key Takeaways

• Cimetidine 200 mg is a mature, low-barrier generic drug with limited active-ingredient patent protection.
• The best commercial opportunities are chewable, orally disintegrating, liquid, unit-dose, and combination formats.
• Excipient selection should prioritize rapid disintegration, taste masking, moisture control, tablet robustness, and dissolution consistency.
• Cimetidine’s interaction profile remains a commercial limitation that formulation technology cannot eliminate.
• A conventional tablet is likely to face severe price competition.
• Novel formulations may support premium pricing but require a stronger regulatory and IP strategy.
• Biosimilar risk is irrelevant because cimetidine is a small-molecule drug.
• Formulation patents must claim a specific technical solution rather than routine excipient substitution.
• The most practical commercial model is private-label, contract manufacturing, or differentiated OTC delivery technology.

FAQs

Can cimetidine 200 mg be reformulated as an orally disintegrating tablet?

Yes. The main development issues are taste masking, tablet fragility, moisture sensitivity, packaging, and rapid disintegration.

Which excipient is best for cimetidine 200 mg taste masking?

No single excipient is universally best. A successful system usually combines a taste-masking matrix with sweeteners, flavor, and a mouthfeel modifier such as mannitol or isomalt.

Does cimetidine 200 mg have biosimilar competition?

No. Cimetidine is a small-molecule drug, so competitive products are generics rather than biosimilars.

Can an excipient combination create patent protection for cimetidine?

Yes, but only where the combination produces a patentable technical result and the claims are sufficiently specific. Routine use of standard fillers, binders, lubricants, or disintegrants is unlikely to provide strong protection.

Is a cimetidine 200 mg liquid commercially attractive?

It can be attractive for swallowing-limited patients and institutional use, but stability, microbial control, taste, dosing accuracy, and packaging materially increase development costs.

References

1. U.S. Food and Drug Administration. (n.d.). Over-the-counter monograph for antacid and acid-reducing products.
2. GlaxoSmithKline Consumer Healthcare. (n.d.). Tagamet HB 200: Drug Facts and product labeling.
3. U.S. Food and Drug Administration. (2023). Abbreviated new drug application submissions: Refuse-to-receive standards.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations (Orange Book).