Cimetidine - Generic Drug Details

What are the generic sources for cimetidine and what is the scope of freedom to operate?

Cimetidine is the generic ingredient in seven branded drugs marketed by Glaxosmithkline, Apotex, Chartwell Molecules, Chartwell Rx, Contract Pharmacal, Cycle, Hikma, Ivax Sub Teva Pharms, L Perrigo Co, Mylan, Novitium Pharma, Perrigo, Pliva, Sandoz, Teva, Upsher Smith Labs, Watson Labs Inc, Watson Labs Teva, Medtech Products, Cosette, Endo Operations, Hospira, Luitpold, Teva Parenteral, Ani Pharms, Chartwell Molecular, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for cimetidine. Eighteen suppliers are listed for this compound.

Summary for cimetidine

US Patents:	0
Tradenames:	7
Applicants:	30
NDAs:	55
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	177
Clinical Trials:	65
Patent Applications:	6,543
Drug Prices:	Drug price trends for cimetidine
What excipients (inactive ingredients) are in cimetidine?	cimetidine excipients list
DailyMed Link:	cimetidine at DailyMed

See drug prices for cimetidine

Recent Clinical Trials for cimetidine

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
Wollo University	Phase 4

See all cimetidine clinical trials

Pharmacology for cimetidine

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

Medical Subject Heading (MeSH) Categories for cimetidine

Anti-Ulcer Agents

Cytochrome P-450 CYP1A2 Inhibitors

Histamine H2 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for cimetidine

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cycle	CIMETIDINE	cimetidine	TABLET;ORAL	074361-002	Dec 23, 1994		DISCN	No	No
Ani Pharms	CIMETIDINE HYDROCHLORIDE	cimetidine hydrochloride	SOLUTION;ORAL	074859-001	Jul 9, 1998		DISCN	No	No
Medtech Products	TAGAMET HB	cimetidine	TABLET;ORAL	020238-002	Aug 21, 1996		OTC	Yes	Yes
Watson Labs Teva	CIMETIDINE	cimetidine	TABLET;ORAL	075425-001	Jul 29, 1999		DISCN	No	No

Expired US Patents for cimetidine

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

Cimetidine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cimetidine

Introduction

Cimetidine, marketed under the brand name Tagamet among others, is a histamine H2 receptor antagonist that has been a cornerstone in the treatment of various gastrointestinal conditions since its introduction in the late 1970s. Here, we delve into the market dynamics and financial trajectory of cimetidine, exploring its current status, future projections, and the factors influencing its market performance.

Historical Context

Cimetidine was developed in 1971 and came into commercial use in 1977, following approvals in the UK in 1976 and the US in 1979. It was the first drug of its kind to inhibit stomach acid production and was a significant innovation in the treatment of duodenal ulcers, gastric ulcers, and gastroesophageal reflux disease (GERD)[5].

Medical Uses and Indications

Cimetidine is indicated for a range of conditions, including duodenal ulcers, gastric ulcers, GERD, and pathological hypersecretory conditions. It is also used to relieve or prevent heartburn and acid indigestion. Its efficacy in reducing stomach acid production has made it a staple in gastrointestinal medicine[5].

Market Players

The global cimetidine market is populated by several key players, including Shanghai Qingping Pharmaceutical Co., Ltd., Guangxi Xiu Xiu Pharmaceutical Co., Ltd., Jiangxi Renqi Pharmaceutical Co., Ltd., Changzhou Kangpu Pharmaceutical Co., Ltd., and international companies like Mylan, AdvaCare Pharma, and Teva Pharmaceuticals USA[1].

Pricing and Cost Analysis

The cost of cimetidine varies based on the dosage and form of the medication. For example, a supply of 10 cimetidine 400 mg oral tablets can cost around $16, depending on the pharmacy. The prices range from $0.78 to $1.63 per unit, depending on the quantity purchased[2].

Oral Liquid and Tablet Prices

• Oral Liquid: A 237 milliliter supply of cimetidine oral liquid can cost around $519.50, with a per-unit price of $2.19[2].
• Oral Tablets: Prices for oral tablets range from $14.08 for 30 tablets of 200 mg to $136.40 for 90 tablets of 800 mg[2].

Market Size and Growth Projections

The global cimetidine market is expected to grow significantly over the coming years. Projections indicate that the market will expand from 2022 to 2029, with a notable compound annual growth rate (CAGR). This growth is driven by increasing demand for effective treatments for gastrointestinal disorders and the availability of cimetidine in both prescription and over-the-counter formulations[1][4].

Impact on Healthcare Expenditures

Studies have shown that the introduction of cimetidine has led to significant reductions in healthcare expenditures. For instance, a study using data from the Texas Medicaid program found that total healthcare expenditures for patients with duodenal ulcers were 40% to 63% lower, and days hospitalized were 15% to 33% lower, when treated with cimetidine compared to other treatments[3].

Competitive Landscape

The competitive landscape for cimetidine has evolved with the introduction of proton pump inhibitors (PPIs) like omeprazole, which have similar indications but may offer different efficacy and safety profiles. Despite this, cimetidine remains a viable option due to its long-standing presence in the market and its availability as an over-the-counter medication[5].

Financial Benefits and Cost Savings

The financial benefits of cimetidine are multifaceted. It not only reduces direct healthcare costs by decreasing the need for hospitalizations and other treatments but also provides social benefits through improved health outcomes. A study estimated a reduction of $645 million in healthcare costs for duodenal ulcers at an 80% penetration rate of cimetidine usage[3].

Challenges and Future Outlook

While cimetidine continues to be a valuable treatment option, its market is influenced by several factors, including the availability of alternative treatments like PPIs and the potential for side effects, such as gynecomastia and sexual dysfunction, especially at high doses[5].

Side Effects and Safety Profile

Cimetidine's safety profile includes potential side effects such as gynecomastia, erectile dysfunction, and oligospermia, particularly at higher doses. These side effects can impact its market appeal and usage rates[5].

Regulatory Environment

Cimetidine's regulatory status has evolved over the years. Initially approved as a prescription medication, it is now available in many regions as an over-the-counter drug, which has expanded its market reach and accessibility[5].

Key Takeaways

• Market Growth: The global cimetidine market is projected to grow significantly from 2022 to 2029.
• Cost Savings: Cimetidine reduces healthcare expenditures by decreasing hospitalizations and other treatment costs.
• Competitive Landscape: Despite competition from PPIs, cimetidine remains a viable treatment option.
• Pricing: The cost of cimetidine varies based on dosage and form, with discounts available through various programs.
• Regulatory Status: Available as both prescription and over-the-counter medication.

FAQs

What is cimetidine used for?

Cimetidine is used for the treatment of duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), and pathological hypersecretory conditions. It is also used to relieve or prevent heartburn and acid indigestion[5].

How much does cimetidine cost?

The cost of cimetidine varies based on the dosage and form. For example, a supply of 10 cimetidine 400 mg oral tablets can cost around $16, depending on the pharmacy[2].

What are the potential side effects of cimetidine?

Potential side effects include gynecomastia, erectile dysfunction, oligospermia, and other hormonal changes, particularly at higher doses[5].

How does cimetidine impact healthcare expenditures?

Cimetidine reduces healthcare expenditures by decreasing the need for hospitalizations and other treatments, resulting in significant cost savings[3].

Is cimetidine available over-the-counter?

Yes, cimetidine is available in many regions as an over-the-counter medication, expanding its market reach and accessibility[5].

Sources

1. Global Cimetidine Tablets Market Research Report 2023 - Valuates Reports
2. Cimetidine Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com
3. The Case of a New Drug - Institute for Research on Poverty
4. Cimetidine Market Size | Share | Scope | Trend & Forecast to 2031 - Market Research Intellect
5. Cimetidine - Wikipedia