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. Eighteen 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:	178
Clinical Trials:	7
Patent Applications:	4,126
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	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	4,024,271
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-002	Approved Prior to Jan 1, 1982	3,950,333
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	3,950,333
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982	3,950,333
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-003	Approved Prior to Jan 1, 1982	3,950,333
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-005	Apr 30, 1986	3,950,333

International Patents for TAGAMET

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	578583
Denmark	349776
Japan	S53119868	PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS
Japan	S5324422
France	2128505
Kenya	2625	UREAS, THOUREAS AND GUANIDINES

TAGAMET Market Analysis and Financial Projection Experimental

The Rise and Impact of Tagamet: Understanding the Market Dynamics and Financial Trajectory

Introduction

Tagamet, also known as cimetidine, marked a significant milestone in the pharmaceutical industry by becoming the first blockbuster drug. Introduced in 1977, it revolutionized the treatment of duodenal ulcers and set a new standard for drug sales. Here, we delve into the market dynamics and financial trajectory of Tagamet, exploring its impact on the industry and the economy.

The Emergence of Tagamet

Tagamet was first introduced to the market in July 1977 by SmithKline & French (now part of GlaxoSmithKline). It was the first H2-receptor antagonist, designed to reduce stomach acid production, providing effective treatment for duodenal ulcers[3][4].

Medical Impact

Tagamet was a game-changer in the medical field. Studies showed that it significantly reduced medical care expenditures associated with duodenal ulcers. For instance, total health care expenditures for patients with duodenal ulcers were found to be 40% to 63% lower, and hospitalization days were reduced by 15% to 33% compared to other treatments[3].

Market Entry and Dominance

When Tagamet entered the market, it enjoyed a monopoly due to patent protection. This allowed it to capture a significant market share without immediate competition. The drug's sales grew rapidly, with Tagamet becoming the first drug to exceed $1 billion in annual sales in 1986, just three years after it reached the market[1][5].

Competitive Landscape

The entry of competitors, particularly Zantac (ranitidine) in July 1983, marked a significant shift in the market dynamics. Zantac, despite having a higher price than Tagamet, quickly gained market share due to its favorable side-effect profile and effective marketing efforts. By January 1988, Zantac had overtaken Tagamet in sales, capturing about 55% of the market share by the end of the observed period in May 1993[4].

Pricing Strategies

The pricing of Tagamet and its competitors played a crucial role in market dynamics. Initially, Tagamet's price was higher than other treatments, but its effectiveness justified the cost. However, with the entry of Zantac and other competitors, pricing strategies became more complex. Tagamet increased its price upon Zantac's entry, a move that was not mirrored by significant price drops from other competitors. By the end of the observed period, the price per day of therapy for Tagamet was around $1.44, compared to $1.41 for Pepcid and $1.80 for Zantac[4].

Marketing and Advertising

Marketing efforts were pivotal in the success of Tagamet and its competitors. Industry-expanding advertising, particularly in the early years of Tagamet's monopoly, significantly boosted sales. However, Zantac's marketing efforts, which highlighted its better side-effect profile, helped it gain substantial market share. The effectiveness of these marketing strategies is evident in the steady growth of H2-antagonist sales, with an average annual growth rate of about 15%[4].

Economic Impact

The success of Tagamet had a profound economic impact, not only on the pharmaceutical industry but also on the local economy. For instance, in Massachusetts, the pharmaceutical industry, including companies like those producing Tagamet, contributed significantly to the state's economy. Between 1995 and 1997, the industry invested $358 million in new capital expenditures, and in 1998, it contributed $1.2 billion in manufacturing value added to the state's economy[2].

Financial Trajectory

Tagamet's financial trajectory was nothing short of spectacular. From its introduction in 1977 to its peak in the mid-1980s, Tagamet's sales grew exponentially. It reached $1 billion in sales in 1986, a milestone that cemented its status as the first blockbuster drug. However, with the entry of competitors, particularly Zantac, Tagamet's sales began to decline. By the end of the observed period in May 1993, Tagamet's monthly sales had dropped to less than half their peak, although it still maintained a significant market share[1][4].

Public Health and Social Benefits

The introduction of Tagamet not only generated significant revenue but also provided substantial social benefits. By reducing the cost and duration of hospital stays and lowering overall medical care expenditures, Tagamet improved health outcomes and reduced the economic burden of duodenal ulcers on the healthcare system[3].

Long-Term Impact on the Pharmaceutical Industry

Tagamet's success paved the way for future blockbuster drugs. It demonstrated the potential for pharmaceuticals to achieve unprecedented sales figures and highlighted the importance of effective marketing, strong research and development, and strategic pricing. The model set by Tagamet has been followed by numerous other drugs, transforming the pharmaceutical industry into one of the most lucrative sectors globally.

Key Takeaways

• First Blockbuster Drug: Tagamet was the first drug to exceed $1 billion in annual sales.
• Medical Impact: It significantly reduced medical care expenditures and hospitalization days for duodenal ulcers.
• Market Dynamics: Tagamet's monopoly was challenged by the entry of Zantac, which eventually overtook it in sales.
• Pricing Strategies: Pricing played a crucial role, with Tagamet increasing its price upon competition.
• Economic Impact: Tagamet contributed significantly to the economy, particularly in regions with strong pharmaceutical industries.
• Financial Trajectory: Tagamet's sales peaked in the mid-1980s but declined with increased competition.

FAQs

What was the significance of Tagamet in the pharmaceutical industry?

Tagamet was the first drug to achieve $1 billion in annual sales, marking it as the first blockbuster drug and setting a new standard for pharmaceutical sales.

How did Tagamet impact the treatment of duodenal ulcers?

Tagamet significantly reduced medical care expenditures and hospitalization days for patients with duodenal ulcers, providing a more effective and cost-efficient treatment option.

What were the key factors in Tagamet's market success?

Effective marketing, strong research and development, and strategic pricing were crucial in Tagamet's success. Industry-expanding advertising during its monopoly period also played a significant role.

How did the entry of competitors affect Tagamet's market share?

The entry of Zantac in 1983 significantly impacted Tagamet's market share. Zantac's favorable side-effect profile and effective marketing efforts allowed it to overtake Tagamet in sales by 1988.

What was the economic impact of Tagamet on local economies?

Tagamet and the broader pharmaceutical industry contributed substantially to local economies, particularly in regions like Massachusetts, through investments in research, clinical trials, and manufacturing.