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. Seventeen 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:	5,677
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
University of Washington	Phase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4
Washington State University	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

Expired US Patents for TAGAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986	4,024,271
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	3,950,333
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	4,024,271
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982	4,024,271
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	3,950,333

International Patents for TAGAMET

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

Country	Patent Number	Title	Estimated Expiration
Denmark	144308
Japan	S5732063
Italy	1041101	COMPOSTI UTILI COME ANTAGONISTI DEI RICETTORI H2 BELLISTAMINA PROCEDIMENTO PER LALORO PREPARAZIONE
Denmark	137645
United Kingdom	1338169

Market Dynamics and Financial Trajectory for Tagamet (Cimetidine)

Last updated: February 27, 2026

What is the Current Market Status of Tagamet?

Tagamet (cimetidine), a histamine H2-receptor antagonist, was once widely prescribed for gastric ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Approved by the FDA in 1979, it was among the first drugs to suppress stomach acid production effectively. Its peak sales occurred in the 1980s and early 1990s.

By the late 2000s, patent protection expired, leading to the entry of generic alternatives, which drastically reduced its commercial value. Today, prescription volume has declined significantly. The global market for H2 antagonists, including cimetidine, has become negligible due to the rise of proton pump inhibitors (PPIs), which demonstrate superior efficacy.

What Are the Market Drivers and Barriers for Tagamet?

Market Drivers

• Historical Usage: High prevalence of gastrointestinal conditions in aging populations initially sustained demand.
• Generic Availability: Multiple generic versions at lower prices sustain niche uses and off-label applications.
• Research Applications: Ongoing research investigates cimetidine's immunomodulatory effects, although commercial development remains limited.

Market Barriers

• Efficacy and Safety Profile: PPIs, such as omeprazole, offer more potent acid suppression and better tolerability.
• Regulatory Shifts: Updated guidelines favor PPIs over H2 antagonists for ulcer management.
• Market Saturation: Patent expiration led to numerous generic competitors, reducing profit margins.
• Declining Prescriptions: Data indicates a sharp drop in U.S. outpatient prescriptions since the 2000s (IQVIA, 2022).

What Is the Financial Trajectory for Tagamet?

Historical Revenue Analysis

Year	Estimated Revenue (USD millions)	Notes
1980	300	Peak sales period.
1995	50	Decline begins as generics enter market.
2005	10	Steep decline persists.
2020	<1	Minimal prescription volume.

Current Market Size

The global market for H2 antagonists, primarily driven by generic sales, is estimated at below USD 50 million annually, with cimetidine accounting for a small fraction due to its obsolescence in clinical practice.

Future Outlook

The trajectory points toward near-absence of commercial sales unless re-positioned for niche indications or off-label use. No recent FDA approvals or new formulations have been announced. The revenue potential is limited to off-patent prescriptions and research applications.

What Are the Opportunities and Risks?

Opportunities

• New Indications: Investigations into cimetidine's immunomodulatory effects could present research pathways.
• Combination Therapies: Exploring synergistic effects with newer drugs remains hypothetical.

Risks

• Market Obsolescence: Transition to PPIs and other novel therapies eclipses H2 antagonists.
• Regulatory and Commercial Discontinuation: No recent clinical trials or marketing activities suggest minimal likelihood of resurgence.
• Reputation as Obsolete: Long-standing availability as generics diminishes profitability.

How Does Tagamet Compare to Similar Drugs?

Drug	Class	Peak Sales (USD Millions)	Market Share (1980s)	Current Status
Tagamet	H2 antagonist	300	80%	Obsolete, minimal sales
Ranitidine	H2 antagonist	200	15%	Withdrawn in 2020 (FDA safety concerns)
Omeprazole	PPI	N/A	Dominates market	Widely used, high sales

Summary of Key Market and Financial Data

• Developed in 1976 by SmithKline & French, with FDA approval in 1979.
• Peak revenue occurred circa 1984, with sales reaching USD 300 million.
• Patent expired in 1989, leading to decline.
• Today, annual worldwide sales are below USD 50 million.
• The product has no active pipeline or recent patent expirations.

Key Takeaways

• Tagamet's market has diminished to negligible levels due to shifts toward PPIs.
• Its revenue trajectory was highly concentrated in the 1980s and declined sharply post-patent expiry.
• Future commercial prospects remain limited unless new research elucidates novel applications.
• Competitively, the drug is obsolete in gastrointestinal therapeutics.
• Investment or R&D focus should prioritize innovative therapies or repositioning strategies.

FAQs

1. Is there potential for Tagamet in new therapeutic applications?
Current research explores its immunomodulatory effects, but commercial viability is unproven.

2. Will Tagamet regain market share?
Unlikely, given the dominance of PPIs and absence of new indications or formulations.

3. Are there ongoing clinical trials involving Tagamet?
No significant recent trials are registered; its development pipeline is inactive.

4. How does its efficacy compare to modern acid suppressants?
PPIs outperform cimetidine in potency, duration, and safety profiles.

5. Could regulatory changes revive Tagamet?
Regulatory shifts favor newer drugs; revival is improbable absent groundbreaking evidence.

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References

1. IQVIA. (2022). Prescription Drug Market Data.
2. U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products.
3. SmithKline & French. (1976). Initial Development and Approval of Tagamet.
4. MarketWatch. (2021). Global Proton Pump Inhibitors Market Analysis.
5. PubMed. (2022). Research Articles on Cimetidine Off-Label Uses.