FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE Drug Patent Profile

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When do Famotidine, Calcium Carbonate, And Magnesium Hydroxide patents expire, and when can generic versions of Famotidine, Calcium Carbonate, And Magnesium Hydroxide launch?

Famotidine, Calcium Carbonate, And Magnesium Hydroxide is a drug marketed by Perrigo R And D and is included in two NDAs.

The generic ingredient in FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE is calcium carbonate; famotidine; magnesium hydroxide. There is one drug master file entry for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	20
DailyMed Link:	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE at DailyMed

Pharmacology for FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

Drug Class	Calculi Dissolution Agent Histamine-2 Receptor Antagonist Osmotic Laxative Blood Coagulation Factor Phosphate Binder
Mechanism of Action	Histamine H2 Receptor Antagonists Magnesium Ion Exchange Activity Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion Increased Coagulation Factor Activity

US Patents and Regulatory Information for FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	077355-001	Feb 6, 2008		OTC	No	No
Perrigo R And D	FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE	calcium carbonate; famotidine; magnesium hydroxide	TABLET, CHEWABLE;ORAL	204782-001	Aug 29, 2016		DISCN	No	No

Famotidine, Calcium Carbonate, and Magnesium Hydroxide Market Dynamics, Patent Status, and Financial Outlook

Last updated: November 3, 2026

The famotidine, calcium carbonate, and magnesium hydroxide combination is a mature over-the-counter (OTC) heartburn product category led by Pepcid Complete and private-label equivalents. Famotidine provides acid suppression through H2-receptor antagonism, while calcium carbonate and magnesium hydroxide provide rapid antacid activity. The category has broad FDA regulatory support, low formulation complexity, minimal current patent barriers, and intense retail competition.

The commercial outlook is stable rather than high growth. Revenue depends on brand equity, retail distribution, pricing, advertising, and product-line extensions more than on exclusivity. Kenvue reports Pepcid within broader self-care or digestive-health categories, not as a separately disclosed product, so standalone revenue and margin data are not publicly reported. [1]

What is the famotidine, calcium carbonate, and magnesium hydroxide product?

The combination is marketed primarily as a chewable tablet for relief of heartburn and acid indigestion.

Component	Primary function	Commercial role
Famotidine	Reduces gastric acid secretion through H2-receptor blockade	Longer-duration acid control
Calcium carbonate	Neutralizes existing gastric acid	Rapid symptom relief
Magnesium hydroxide	Neutralizes gastric acid	Rapid relief and balances calcium-related gastrointestinal effects
Typical product format	Chewable tablet	Convenient OTC administration

Pepcid Complete is the best-known branded product in the category. U.S. labeling identifies the product as an OTC heartburn reliever containing famotidine, calcium carbonate, and magnesium hydroxide. The product is generally used for relief of heartburn associated with acid indigestion and for prevention of heartburn when taken before a meal. [2]

The product differs from standalone Pepcid tablets, which contain famotidine without antacid ingredients. It also differs from traditional calcium carbonate or magnesium hydroxide antacids because it combines immediate neutralization with H2-mediated acid suppression.

How large is the market for this combination?

The combination competes within the broader U.S. digestive-health and heartburn-relief market, which includes H2 blockers, proton-pump inhibitors, antacids, alginate products, and combination products.

Public company filings do not isolate sales for the specific three-ingredient combination. Kenvue reports brand and category performance at a level that generally combines multiple products or markets. As a result, the following commercial metrics are more reliable than unsupported product-level revenue estimates:

Metric	Assessment
Market maturity	Mature OTC category
Principal branded product	Pepcid Complete
Principal manufacturer	Kenvue Inc.
Generic competition	High
Prescription dependence	None for OTC versions
Patent dependence	Low
Retail concentration	High in mass retail, drugstores, grocery, club, and e-commerce
Revenue transparency	Limited at individual SKU level
Growth driver	Pricing, distribution, private-label conversion, and digestive-health demand

The category benefits from persistent demand for episodic heartburn relief, increased consumer self-treatment, and broad availability. It faces pressure from generic famotidine, low-cost antacid products, proton-pump inhibitors, and retailer-owned brands.

What is the financial trajectory for Pepcid Complete and equivalent products?

The financial trajectory is likely to follow a mature-brand pattern:

1. Stable underlying demand from recurring heartburn episodes.
2. Moderate price growth during periods of inflation.
3. Unit pressure from private-label products and generic substitution.
4. Margin protection through brand pricing, pack-size changes, and manufacturing scale.
5. Periodic volume gains from advertising, new flavors, and channel expansion.

Kenvue’s public filings identify Pepcid as one of its major consumer-health brands, but they do not provide a separate income statement for Pepcid Complete. [1] The appropriate financial analysis therefore focuses on category economics rather than a precise product-level revenue forecast.

Revenue exposure for Kenvue

Pepcid contributes to Kenvue’s self-care portfolio alongside brands such as Tylenol, Motrin, Zyrtec, Benadryl, Nicorette, and other consumer-health products. The company’s consolidated results are influenced by portfolio-wide factors, including retailer inventory management, currency movements, input costs, advertising spending, and litigation or regulatory expenses.

Pepcid has strategic value beyond its direct sales because it gives Kenvue exposure to the digestive-health category and supports a branded alternative to generic H2 blockers. The principal financial risk is erosion of price premium, not loss of patent exclusivity.

Generic and private-label economics

The active ingredients are inexpensive and widely available. A retailer can market a substantially similar product using the same active ingredients, subject to applicable FDA requirements and labeling controls.

Private-label products generally compete through:

• Lower shelf prices.
• Larger count sizes.
• Retailer loyalty programs.
• Placement beside branded products.
• E-commerce search visibility.
• Store-brand pharmacy and digestive-health portfolios.

The branded product retains advantages in consumer recognition, advertising, perceived quality, and physician familiarity. Those advantages can support premium pricing but do not prevent substitution.

What FDA regulatory status applies to the combination?

The product is an OTC drug rather than a prescription product. Calcium carbonate and magnesium hydroxide are established antacid active ingredients under FDA OTC antacid regulations. Famotidine is an established OTC acid-reducing active ingredient. FDA OTC requirements address active ingredients, dosage, labeling, warnings, and permitted claims. [3]

Pepcid Complete labeling is governed by the FDA Drug Facts framework and includes directions, warnings, age restrictions, interaction information, and maximum daily-use instructions. [2]

FDA monograph and nonprescription regulatory pathway

The commercial product does not depend on an active new-drug approval in the same manner as a newly developed prescription therapy. OTC monograph compliance, an approved application where applicable, and product-specific regulatory filings provide the relevant pathway.

The OTC monograph reform process under the Coronavirus Aid, Relief, and Economic Security Act changed the legal structure for OTC monograph drugs. FDA now uses administrative orders and monograph procedures rather than the older tentative-final-monograph model. [4]

For mature combination products, regulatory risk is concentrated in:

• Changes to allowable claims.
• Labeling revisions.
• Safety warnings.
• Manufacturing controls.
• Stability and quality testing.
• Ingredient sourcing.
• Combination-product compliance.
• FDA enforcement against nonconforming formulations.

What patents protect famotidine, calcium carbonate, and magnesium hydroxide products?

The core active ingredients are not protected by meaningful current U.S. composition-of-matter exclusivity.

Famotidine’s original small-molecule patent protection expired long ago. Calcium carbonate and magnesium hydroxide are long-established antacid ingredients with no current composition-of-matter exclusivity relevant to this OTC combination.

IP category	Current commercial significance
Famotidine active-ingredient patent	Expired
Calcium carbonate active-ingredient rights	No meaningful current exclusivity
Magnesium hydroxide active-ingredient rights	No meaningful current exclusivity
Combination formulation patents	Potentially relevant historically, but unlikely to block ordinary generic competition today
Packaging and trade dress	Can protect brand presentation, not the active formulation
Trademarks	Important for Pepcid branding
Manufacturing know-how	Relevant to cost, taste, stability, and quality
Regulatory exclusivity	No material exclusivity comparable to a new prescription drug

Historical patents covering famotidine chemistry, formulation, or combination delivery systems do not create a current market barrier where their terms have expired. Patent status must be reviewed by jurisdiction and claim scope, but ordinary U.S. market entry is not dependent on licensing an active ingredient patent.

What is the Orange Book status of famotidine combination products?

Pepcid Complete and comparable OTC products should not be analyzed as conventional Orange Book-protected prescription products.

The FDA Orange Book primarily identifies approved prescription drug products and certain other approved products with therapeutic-equivalence information. An OTC monograph product generally does not receive the same Orange Book patent-listing and Paragraph IV framework as a prescription new drug. [5]

Consequently:

• There is generally no Orange Book patent estate comparable to a branded prescription drug.
• A generic manufacturer typically does not need to file a Paragraph IV certification against an Orange Book-listed formulation patent to market a compliant OTC product.
• Competition usually occurs through OTC regulatory compliance, manufacturing capability, labeling, and retail execution.
• Any product-specific approved application must be evaluated separately from a purely monograph-compliant product.

When does famotidine combination exclusivity expire?

There is no meaningful remaining exclusivity period for the active combination in the United States.

The relevant commercial protection is brand-based rather than patent-based. Pepcid’s value is supported by trademark rights, consumer awareness, retailer relationships, advertising, and product quality. Generic and private-label products can compete without waiting for a future patent expiration date if they meet FDA requirements.

Exclusivity type	Status
New chemical entity exclusivity	Expired
Original famotidine patent term	Expired
Combination-product patent barrier	No apparent current blocking barrier for ordinary OTC competition
Prescription data exclusivity	Not the principal commercial framework
Trademark protection	Ongoing, subject to renewal and use
Trade dress protection	Potentially ongoing, limited to presentation
OTC regulatory compliance	Ongoing requirement for every manufacturer

Are there Paragraph IV challenges or generic litigation?

No major current Paragraph IV litigation dynamic defines this category.

Paragraph IV challenges are generally associated with abbreviated new drug applications against Orange Book-listed patents. OTC combination products marketed under monograph procedures are exposed instead to ordinary competitive entry, FDA compliance review, labeling disputes, trademark claims, false-advertising claims, and manufacturing litigation.

Potential disputes may involve:

• Whether a competing product uses an allowable active ingredient level.
• Whether claims exceed permitted OTC labeling.
• Whether a product is misbranded.
• Whether a private-label product copies protected trade dress.
• Whether manufacturing or supply-chain practices comply with current good manufacturing practice requirements.

The absence of a visible Paragraph IV pipeline does not eliminate commercial competition. It means the competitive mechanism is retail and regulatory rather than patent litigation.

What formulation patents and manufacturing barriers matter?

Formulation know-how can still affect commercial performance even when patent protection is weak.

Formulation factors

Manufacturers compete on:

• Tablet hardness and chewability.
• Taste masking.
• Flavor stability.
• Calcium carbonate particle size.
• Magnesium hydroxide dispersion.
• Famotidine uniformity.
• Moisture control.
• Shelf life.
• Packaging protection.
• Tablet disintegration.
• Consumer tolerability.

A formulation patent may protect a specific composition or manufacturing process, but a competitor can often design around narrow claims using different excipient ratios, flavors, tablet technologies, or production conditions.

Manufacturing and supply risks

The principal operational barriers are quality and scale. Companies need reliable sources for pharmaceutical-grade famotidine, calcium carbonate, and magnesium hydroxide; validated blending and compression processes; stability data; and compliant packaging.

Famotidine supply is more technically demanding than calcium carbonate or magnesium hydroxide because the active ingredient is a synthetic pharmaceutical compound rather than a common antacid mineral. Even so, the supply chain is established and does not create a durable monopoly.

How does the combination compare with competing heartburn drugs?

Product type	Speed of relief	Duration	Competitive position
Famotidine plus calcium carbonate plus magnesium hydroxide	Fast plus sustained	Moderate to long	Differentiated combination
Standalone famotidine	Moderate	Longer than simple antacids	Lower-cost direct substitute
Calcium carbonate antacid	Fast	Shorter	Very low-cost alternative
Magnesium hydroxide antacid	Fast	Shorter	Established generic alternative
Proton-pump inhibitor	Slower onset for episodic relief	Longer acid suppression	Strong alternative for frequent symptoms
Alginate-antacid products	Fast	Variable	Competes on reflux-barrier positioning

The combination’s commercial proposition is convenience: one chewable product combines immediate antacid action with famotidine’s longer acid-suppression effect. That proposition supports brand differentiation but is easy to imitate at the ingredient level.

Which companies are challenging the branded product?

Competition comes from three groups:

1. Generic drug manufacturers selling famotidine or equivalent combination products.
2. Retailers selling private-label heartburn medicines.
3. Branded manufacturers selling alternative acid reducers or antacids.

The most important competitive threat is not a single patent challenger. It is cumulative substitution from store brands, low-cost single-ingredient products, proton-pump inhibitors, and competing branded digestive-health products.

Retailers with strong private-label programs can capture share without incurring the advertising and innovation costs carried by Kenvue. E-commerce also makes price comparison easier, increasing pressure on branded OTC products.

What licensing deals affect the market?

No major current licensing deal is required to commercialize the active ingredients in the standard OTC combination. The commercial rights are principally associated with trademarks, distribution arrangements, contract manufacturing, and retailer supply agreements.

The absence of a required active-ingredient license lowers entry barriers. Companies may still use contract manufacturers or license brand rights, but those arrangements are commercial choices rather than requirements imposed by active patent ownership.

What generic launch scenarios exist?

The most likely market-entry scenarios are:

Scenario	Market effect
Additional private-label launches	Accelerated price competition and lower branded unit share
Generic combination launch	Direct pressure on Pepcid Complete pricing
Standalone famotidine price cuts	Substitution away from the combination
Premium reformulation	Potential defense through taste, dosage, packaging, or convenience
Retail distribution expansion	Volume growth without exclusivity
Regulatory label change	Possible redesign costs and claim restrictions

A generic launch would probably affect price before it materially changes total category demand. The category is relatively mature, so market expansion is limited compared with share transfer.

What is the geographic coverage and international outlook?

The United States is the most commercially visible market for this branded combination, but famotidine and antacid combinations are sold in multiple jurisdictions under different brand names and regulatory systems.

Geographic performance depends on:

• Local OTC classification.
• Permitted famotidine dosage.
• Antacid monograph rules.
• Trademark ownership.
• Retail pharmacy structure.
• Reimbursement and self-care norms.
• Local manufacturing and import requirements.

A U.S. OTC strategy does not automatically establish rights or regulatory clearance abroad. Trademark and formulation rights must be assessed country by country. In most markets, ingredient-level patent barriers are low, while regulatory and distribution execution remain the principal constraints.

How strong is the patent estate for the combination?

The patent estate is weak as a current exclusivity platform and moderate as a historical formulation asset.

Dimension	Strength
Active-ingredient exclusivity	Very weak
Current U.S. blocking patents	Low
Trademark protection	Stronger than patent protection
Formulation differentiation	Moderate
Manufacturing know-how	Moderate
Regulatory barriers	Low to moderate
Retail and brand barriers	Moderate
Litigation leverage	Limited relative to prescription brands

The product can generate durable cash flow, but not because of a long patent runway. Its defensibility comes from consumer recognition, shelf position, quality control, marketing, and distribution.

Key Takeaways

• Famotidine, calcium carbonate, and magnesium hydroxide is a mature OTC heartburn combination.
• Pepcid Complete is the leading branded reference product in the United States.
• Kenvue does not separately disclose Pepcid Complete revenue, so product-level financial forecasts cannot be derived from public filings with precision.
• The category has low patent risk and no meaningful current composition-of-matter exclusivity.
• Orange Book and Paragraph IV mechanisms are generally less relevant than they are for prescription products.
• Private-label and generic competition are the main threats to price and unit share.
• The combination’s commercial advantage is immediate antacid relief plus longer famotidine-mediated acid control.
• Revenue stability depends on brand equity, retail execution, pricing, and manufacturing scale.
• Formulation know-how can support differentiation but is unlikely to create a durable market monopoly.
• The financial outlook is stable to moderately pressured, with margin protection more likely than rapid volume growth.

FAQs

Is Pepcid Complete the same as famotidine?

No. Pepcid Complete contains famotidine plus calcium carbonate and magnesium hydroxide. Standard Pepcid tablets may contain famotidine alone.

Can generic manufacturers make famotidine, calcium carbonate, and magnesium hydroxide tablets?

Yes. Manufacturers can market compliant products when they satisfy FDA requirements for formulation, labeling, quality, manufacturing, and applicable regulatory authorization.

Does Pepcid Complete have an active U.S. patent?

The active ingredients do not provide meaningful current composition-of-matter exclusivity. Any surviving rights would need to be evaluated at the level of specific formulation, process, packaging, or branding claims.

Is famotidine, calcium carbonate, and magnesium hydroxide subject to FDA prescription exclusivity?

No. The commercial product is an OTC medicine, and its market position does not depend on current prescription-style new-drug exclusivity.

What is the main investment risk for this product category?

The primary risk is erosion of branded pricing and share from private-label products, generic alternatives, standalone famotidine, antacids, and proton-pump inhibitors.

References

1. Kenvue Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2023.
2. U.S. Food and Drug Administration. (n.d.). Pepcid Complete: Drug Facts label. DailyMed.
3. U.S. Food and Drug Administration. (2024). Antacid products for over-the-counter human use. Code of Federal Regulations, Title 21, Part 331.
4. U.S. Food and Drug Administration. (2023). Over-the-counter monograph drug products.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.