TAGAMET Drug Patent Profile

When do Tagamet patents expire, and what generic alternatives are available?

Tagamet is a drug marketed by Glaxosmithkline and Medtech Products and is included in six NDAs.

The generic ingredient in TAGAMET is cimetidine. There are twenty-five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cimetidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tagamet

A generic version of TAGAMET was approved as cimetidine by CHARTWELL MOLECULES on May 17^th, 1994.

Summary for TAGAMET

US Patents:	0
Applicants:	2
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	6,037
Drug Prices:	Drug price information for TAGAMET
What excipients (inactive ingredients) are in TAGAMET?	TAGAMET excipients list
DailyMed Link:	TAGAMET at DailyMed

See drug prices for TAGAMET

Recent Clinical Trials for TAGAMET

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
University of Washington	Phase 4
National Institutes of Health (NIH)	Early Phase 1

See all TAGAMET clinical trials

US Patents and Regulatory Information for TAGAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Medtech Products	TAGAMET HB	cimetidine	TABLET;ORAL	020238-001	Jun 19, 1995		DISCN	Yes	No
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Medtech Products	TAGAMET HB	cimetidine	TABLET;ORAL	020238-002	Aug 21, 1996		OTC	Yes	Yes
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for TAGAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983

International Patents for TAGAMET

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

Country	Patent Number	Title	Estimated Expiration
Ireland	36050	UREAS THIOUREAS AND GUANIDINES
Sweden	402288	FORFARANDE FOR FRAMSTELLNING AV FORENINGAR VILKA ER ANTAGONISTER MOT VISSA VERKNINGAR AV HISTAMIN
Kenya	2625	UREAS, THOUREAS AND GUANIDINES
Japan	S53119867	PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS
Singapore	28576
Belgium	779775

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: TAGAMET

Introduction
Tagamet, the brand name for the pharmaceutical drug cimetidine, represents a significant chapter in the history of gastroenterology therapeutics. Developed in the 1970s by Johnson & Johnson, Tagamet was among the first histamine H2 receptor antagonists (H2 blockers), revolutionizing the treatment of acid-related gastrointestinal conditions. Its market dynamics and financial trajectory offer vital insights into drug lifecycle evolution, competitive forces in the pharmaceutical industry, and the impact of therapeutic innovation. This analysis explores the factors influencing Tagamet’s market presence from inception through current relevance, emphasizing the therapeutic landscape, competitive challenges, patent considerations, and future outlook.

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Market Introduction and Early Success

Historical Context
Launched in 1976, Tagamet was the pioneer in suppressing gastric acid secretion via H2 receptor antagonism, addressing conditions such as peptic ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease (GERD). Its introduction marked a medical breakthrough, replacing older, less targeted treatments like antacids and surgical interventions.

Market Penetration and Financial Impact
Within years, Tagamet captured a substantial share of the gastrointestinal therapeutics market. Its clinical efficacy and safety profile led to rapid adoption, with sales peaking in the 1980s—estimated at over $1.2 billion annually in the U.S. alone. (Source: Johnson & Johnson annual reports, 1980s). The drug’s patent expiry in 1989 catalyzed a surge in generic competition, setting a precedent for subsequent drug market dynamics.

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Competitive Landscape and Market Erosion

Introduction of Rivals
Post-patent expiration, numerous generic manufacturers launched competing H2 blockers, notably ranitidine (Zantac), famotidine (Pepcid), and nizatidine (Axid). These alternatives offered comparable efficacy at reduced costs, exerting downward pressure on Tagamet’s pricing and sales volume.

Generic Market Impact
The proliferation of generics rapidly eroded Tagamet's market share, with sales declining by approximately 60% during the 1990s. Despite declining revenue, Tagamet retained residual market utility, especially in markets with limited generic penetration or specialized indications.

Shift towards Proton Pump Inhibitors (PPIs)
The late 1990s and early 2000s saw the advent of PPIs, such as omeprazole and lansoprazole, which demonstrated superior efficacy in reducing gastric acid production. This shift decreased demand for H2 blockers, further diminishing Tagamet’s market prominence.

Regulatory and Patent Challenges
While the original patent expired early, Johnson & Johnson sought additional formulations and indications, but regulatory hurdles and patent protections for subsequent formulations limited new competition. Additionally, the emergence of adverse effect concerns, particularly with N-nitroso compounds linked to N-nitrosoguanidine impurities in early formulations, affected the drug's reputation and usage.

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Current Market Dynamics

Market Status
Today, Tagamet’s sales are primarily driven by legacy prescriptions or markets with limited access to newer drugs. Major pharmaceutical companies have phased out large-scale marketing for Tagamet, focusing instead on patent-protected or newer therapies.

Generic Presence and Pricing
Generic versions remain available, but their contribution to overall gastrointestinal therapy sales is modest compared to the burgeoning PPI market. The price elasticity associated with generics sustains some residual revenue, yet margins are low.

Safety Concerns and Regulatory Changes
In recent years, safety warnings concerning drug interactions, particularly with blood thinners and certain antifungals, have influenced prescribing practices. Regulatory agencies, such as the FDA, have issued advisories throughout the years about potential carcinogenic impurities in ranitidine, indirectly impacting the entire class of H2 blockers, including Tagamet.

Technological Innovations and Market Shifts
Advances in GERD management, including the development of more effective PPIs and novel drug delivery systems, continue to override the H2 blocker niche. Nonetheless, some specific indications—such as Zollinger-Ellison syndrome—still see use of cimetidine.

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Financial Trajectory and Business Implications

Revenue Trends
Since peaking in the late 1980s, Tagamet’s market revenue has declined sharply. By 2010, annual sales significantly diminished, with estimates placing global sales below $50 million, mostly driven by legacy markets. (Source: IQVIA sales data, 2010s).

Portfolio Strategy and Lifecycle Management
Johnson & Johnson, the original patent holder, phased out direct marketing of Tagamet in favor of newer drugs and therapeutics. This reflects typical lifecycle management as drugs age and face generic competition; many pharmaceutical companies withdraw or reduce marketing investments for mature products.

Current Licensing and Generic Market Dynamics
Generic manufacturers continue to supply Tagamet at a fraction of the original price. The commoditization of older drugs often reduces profitability but sustains modest revenue streams, especially in emerging markets or for narrow indications.

Investment Outlook
The outlook for Tagamet as a revenue-generating product remains subdued. The broader market shift toward PPIs and novel therapies suggests limited future growth or reinvestment. Nonetheless, the drug retains value as a legacy compound with niche clinical utility and as a research tool for understanding histamine receptor pharmacology.

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Future Outlook

Market Evolution and Unmet Needs
While newer therapies dominate, segment-specific needs—such as unique pharmacokinetics, lower drug interaction profiles, or specific indications—may sustain limited demand for cimetidine-like drugs.

Research and Development
Emerging research exploring histamine receptor modulation may potentially carve new therapeutic niches. However, the dominant driver remains the overall decline of H2 blockers in favor of PPIs, with minimal prospects for resurgence of Tagamet's market position.

Legal and Patent Strategies
Patent expirations facilitated generic entry; current strategies focus on formulation improvements or combination therapies but are unlikely to revive Tagamet's market dominance.

Regulatory Environment
Ongoing safety assessments and regulatory updates continue to shape prescribing habits and market viability. As safety profiles are clarified, prescribing patterns may further decline or stabilize for legacy drugs like Tagamet.

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Key Takeaways

• Early Innovation & Market Leadership: Tagamet pioneered acid suppression therapy, experiencing rapid adoption and peak sales in the late 1970s and 1980s, with sales exceeding $1 billion annually at its height.
• Patent Expiry & Competitive Pressures: Post-patent expiration, generic competitors and the emergence of PPIs significantly eroded Tagamet’s market share, underscoring the importance of lifecycle management and innovation.
• Market Decline & Niche Persistence: Today, Tagamet's sales are marginal, with use confined primarily to niche indications or legacy markets, facing continued competition from more advanced therapies.
• Financial Trajectory: The drug’s revenue trajectory exemplifies typical pharmaceutical lifecycle progression—initial high sales followed by decline due to generic competition and therapeutic obsolescence.
• Future Outlook: The outlook remains limited unless novel therapeutic indications or formulations emerge, as current trends favor newer, more effective agents with better safety profiles.

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FAQs

1. What factors contributed to the decline of Tagamet's market share?
The patent expiration in 1989 triggered extensive generic competition, compounded by the advent of proton pump inhibitors offering superior efficacy and safety, leading to diminished demand for Tagamet.

2. Are there any current therapeutic uses of Tagamet?
Yes. In select cases, especially for Zollinger-Ellison syndrome and certain hypersecretory conditions, cimetidine remains used, but generally, newer therapies have replaced it for typical gastroesophageal reflux disease (GERD).

3. How do regulatory concerns affect Tagamet's market longevity?
Safety warnings related to impurities, drug interactions, and carcinogenic potential have limited broader prescribing and contributed to its decline, although regulatory agencies still approve its use for specific indications.

4. What is the role of generics in Tagamet's current market?
Generic versions continue to be supplied at low cost, maintaining residual utility but with limited revenue potential, largely replacing branded sales since patent expiry.

5. Can innovation revitalize Tagamet’s market position?
Unlikely under current market conditions. Future improvements would require breakthrough formulations or novel indications, neither of which seems imminent given current research focuses.

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References
[1] Johnson & Johnson annual reports, 1980s.
[2] IQVIA sales data, 2010s.
[3] FDA safety advisories, 2010s.
[4] Market analysis reports on H2 antagonists and PPIs.
[5] Clinical guidelines on gastrointestinal therapies.