Cimetidine hydrochloride - Generic Drug Details

What are the generic drug sources for cimetidine hydrochloride and what is the scope of patent protection?

Cimetidine hydrochloride is the generic ingredient in four branded drugs marketed by Cosette, Endo Operations, Hospira, Luitpold, Teva Parenteral, Glaxosmithkline, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for cimetidine hydrochloride. One supplier is listed for this compound.

Summary for cimetidine hydrochloride

US Patents:	0
Tradenames:	4
Applicants:	13
NDAs:	24
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	65
Patent Applications:	1,305
What excipients (inactive ingredients) are in cimetidine hydrochloride?	cimetidine hydrochloride excipients list
DailyMed Link:	cimetidine hydrochloride at DailyMed

Recent Clinical Trials for cimetidine hydrochloride

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
Wollo University	Phase 4

See all cimetidine hydrochloride clinical trials

Pharmacology for cimetidine hydrochloride

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for cimetidine hydrochloride

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for cimetidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	074468-001	Dec 29, 1994		DISCN	No	No
Hospira	CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	074468-004	Dec 29, 1994		DISCN	No	No
Hospira	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	INJECTABLE;INJECTION	074344-001	Jan 31, 1995		DISCN	No	No
Ani Pharms	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	075110-001	Jun 18, 1998		DISCN	No	No
Hospira	CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	074468-003	Dec 29, 1994		DISCN	No	No
Pharm Assoc	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074553-001	Jan 27, 1997		DISCN	No	No

Expired US Patents for cimetidine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	INJECTABLE;INJECTION	017939-002	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET	cimetidine hydrochloride	SOLUTION;ORAL	017924-001	Approved Prior to Jan 1, 1982
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985
Glaxosmithkline	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	INJECTABLE;INJECTION	019434-001	Oct 31, 1985

Cimetidine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cimetidine Hydrochloride

Introduction

Cimetidine hydrochloride, marketed under the brand name Tagamet among others, is a histamine H2 receptor antagonist that has been a significant player in the pharmaceutical market since its introduction in the late 1970s. Here, we will explore the market dynamics and financial trajectory of this drug.

Historical Context and Approval

Cimetidine was developed in 1971 and first approved in the United Kingdom in 1976. It was later approved in the United States by the FDA in 1979. This early approval marked the beginning of a new era in the treatment of peptic ulcer disease and other gastrointestinal conditions[1][2].

Market Impact and Sales

Upon its introduction, cimetidine quickly gained popularity due to its effectiveness in reducing gastric acid production. It became the first blockbuster drug, with sales exceeding $1 billion in 1986, just a few years after its market debut. This milestone was unprecedented at the time and set a new standard for pharmaceutical sales[4].

Economic Impact on Ulcer Disease

The introduction of cimetidine had a significant economic impact on the management of ulcer disease. In Sweden, for example, the drug was introduced in 1978 and rapidly expanded its use. While it was expected to reduce the number of elective ulcer operations and associated medical care costs, retrospective calculations showed that cimetidine actually increased the direct costs of medical care. However, it also reduced indirect costs related to short- and long-term illness[3].

Competition and Market Shift

With the development of proton pump inhibitors (PPIs) like omeprazole, the market dynamics for cimetidine began to shift. PPIs offered more potent and longer-lasting acid suppression, leading to a decline in the prescription use of H2 receptor antagonists like cimetidine. However, cimetidine remained available as an over-the-counter formulation for preventing heartburn and acid indigestion, maintaining a presence in the consumer market[1][2].

Financial Performance Over Time

Cimetidine's financial performance was remarkable during its peak. As the first blockbuster drug, it generated billions of dollars in revenue. However, as PPIs gained market share, the revenue from cimetidine prescriptions decreased. Despite this, its availability as an over-the-counter medication ensured continued sales, albeit at a lower level than during its peak.

Off-Label and Emerging Uses

In addition to its primary indications, cimetidine has been explored for various off-label uses, including dermatological conditions such as warts and porphyria. These emerging uses have helped maintain interest in the drug and potentially expanded its market, although the financial impact of these uses is relatively minor compared to its primary indications[2].

Pharmacokinetic Interactions and Safety Concerns

Cimetidine's role as a potent inhibitor of several cytochrome P450 enzymes has significant implications for its use and market dynamics. The potential for pharmacokinetic interactions with other drugs can limit its prescription use, especially in patients taking multiple medications. This has led to a more cautious approach in prescribing cimetidine, further affecting its market share[1][2].

Regulatory and Safety Monitoring

The FDA has categorized cimetidine as a Category B drug in pregnant females, indicating no significant teratogenic risks based on animal studies. However, the need for careful monitoring, especially in patients with renal impairment or those at risk of mental status changes, adds to the complexity of its market dynamics. Regular monitoring of renal function and potential adverse effects like gynecomastia and impotence also influence prescribing decisions[2].

Current Market Status

Today, cimetidine remains a widely recognized brand, although its market dominance has waned with the advent of more advanced treatments like PPIs. Its availability over-the-counter ensures it remains a consumer choice for managing heartburn and acid indigestion. However, its prescription use is largely limited to specific cases where H2 receptor antagonists are preferred over PPIs.

Key Takeaways

• Historical Significance: Cimetidine was the first blockbuster drug, achieving sales of over $1 billion in the late 1980s.
• Market Shift: The introduction of PPIs significantly reduced cimetidine's prescription market share.
• Off-Label Uses: Cimetidine has been explored for various off-label uses, including dermatological conditions.
• Pharmacokinetic Interactions: Its role as a CYP enzyme inhibitor affects its use and market dynamics.
• Safety Monitoring: Regular monitoring is necessary due to potential adverse effects and interactions.

FAQs

What was the historical significance of cimetidine in the pharmaceutical market?

Cimetidine was the first blockbuster drug, achieving sales of over $1 billion in the late 1980s, setting a new standard for pharmaceutical sales.

How did the introduction of proton pump inhibitors (PPIs) affect cimetidine's market share?

The introduction of PPIs significantly reduced cimetidine's prescription market share due to their more potent and longer-lasting acid suppression.

What are some of the off-label uses of cimetidine?

Cimetidine has been used off-label for dermatological conditions such as warts and porphyria, and it has immunomodulatory properties that may be beneficial in these conditions.

Why is cimetidine a concern in terms of pharmacokinetic interactions?

Cimetidine is a potent inhibitor of several cytochrome P450 enzymes, which can lead to significant pharmacokinetic interactions with other drugs, potentially increasing the risk of toxicity.

What are the safety concerns associated with cimetidine?

Cimetidine can cause gynecomastia, impotence, and other endocrine-related adverse effects, especially at high doses. It also requires careful monitoring of renal function and potential mental status changes.

References

1. Wikipedia: Cimetidine.
2. NCBI Bookshelf: Cimetidine - StatPearls.
3. PubMed: The effects of cimetidine on the cost of ulcer disease in Sweden.
4. Oxford University Press: Beginning of an Era The First Blockbuster Drug, Tagamet.