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Last Updated: December 22, 2024

TAGAMET HB Drug Patent Profile


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

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

The generic ingredient in TAGAMET HB 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 Hb

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

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Drug patent expirations by year for TAGAMET HB
Recent Clinical Trials for TAGAMET HB

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SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4
University of WashingtonPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Early Phase 1

See all TAGAMET HB clinical trials

Pharmacology for TAGAMET HB

US Patents and Regulatory Information for TAGAMET HB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medtech Products TAGAMET HB cimetidine TABLET;ORAL 020238-001 Jun 19, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medtech Products TAGAMET HB cimetidine TABLET;ORAL 020238-002 Aug 21, 1996 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline TAGAMET HB 200 cimetidine SUSPENSION;ORAL 020951-001 Jul 9, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TAGAMET HB Market Analysis and Financial Projection Experimental

The Rise and Impact of Tagamet HB: A Pharmaceutical Success Story

Introduction

Tagamet HB, known generically as cimetidine, is a landmark drug in the pharmaceutical industry, particularly notable for its role as the first blockbuster drug. Here, we delve into the market dynamics and financial trajectory of Tagamet HB, exploring its discovery, market impact, and the broader implications for its manufacturer and the industry.

Discovery and Development

Tagamet was discovered by James W. Black and his colleagues at Smith Kline & French’s (SK&F) British subsidiary in Welwyn Garden City. The research began in 1964, but it wasn't until 1977 that the drug was introduced to the market. This delay was due to the lengthy and challenging research process that did not yield immediate results[1].

Market Introduction and Impact

When Tagamet was introduced, it quickly gained traction as an effective treatment for peptic ulcers and heartburn. By 1986, just three years after its market debut, Tagamet's sales exceeded $1 billion, earning it the status of the first blockbuster drug. This success transformed SK&F from a relatively unknown U.S. drug firm into one of the largest pharmaceutical companies in the world[1].

Indications and Mechanism of Action

Tagamet HB is an H2 blocker that reduces the amount of acid produced in the stomach by binding to H2 receptors on the stomach lining. This mechanism makes it effective for the relief and prevention of heartburn, acid indigestion, and sour stomach. It is particularly beneficial for conditions such as gastroesophageal reflux disease (GERD) and peptic ulcers[4][5].

Market Performance and Sales

The financial performance of Tagamet HB was nothing short of phenomenal. Its sales not only exceeded $1 billion but also drove significant growth for SK&F. The drug's success was a key factor in the company's expansion and its eventual merger with Beecham to form SmithKline Beecham, which later merged with GlaxoWellcome to form GlaxoSmithKline (GSK)[1].

Financial Trajectory

The financial impact of Tagamet HB on SK&F was profound. Before Tagamet, SK&F was a modest pharmaceutical company. However, the drug's blockbuster status catapulted the company into the top tier of global pharmaceutical firms. The revenue generated from Tagamet helped SK&F invest in further research and development, expand its product portfolio, and make strategic acquisitions[1].

Market Dynamics

The success of Tagamet HB influenced market dynamics in several ways:

  • Competitive Landscape: Tagamet set a new standard for anti-ulcer medications, prompting other pharmaceutical companies to develop similar H2 blockers. This competition drove innovation and expanded treatment options for patients.
  • Pricing and Accessibility: The introduction of generic versions of cimetidine reduced the cost of treatment, making it more accessible to a wider population. For example, generic cimetidine can cost around $0.50 per day, compared to the brand name version which costs approximately $0.67 per day[4].
  • Regulatory Environment: The approval and success of Tagamet HB highlighted the importance of rigorous clinical trials and regulatory approvals. It also led to stricter guidelines for future drug approvals, ensuring higher safety and efficacy standards[2].

Impact on GSK

The legacy of Tagamet HB continues to influence GSK's strategies. GSK aims to build the best product pipeline in the industry, focusing on developing a focused portfolio strategy that supports the full life cycle of compounds from launch to becoming over-the-counter products where appropriate. The success of Tagamet HB has been a benchmark for GSK's R&D productivity and commercial excellence[3].

Consumer and Market Trends

Tagamet HB remains a popular medication, with approximately 1.3 million prescriptions in the U.S. in 2020. It accounts for about 5% of all prescriptions for medications used to reduce stomach acid and treat conditions like GERD and peptic ulcers. The drug's enduring popularity is a testament to its efficacy and the ongoing demand for effective treatments for gastrointestinal disorders[4].

Challenges and Considerations

Despite its success, Tagamet HB is not without its challenges:

  • Interactions and Contraindications: The drug can interact with other medications such as anticoagulants, phenytoin, and theophylline, necessitating careful patient monitoring[5].
  • Side Effects and Warnings: Patients with renal or hepatic impairment, pregnancy, or nursing mothers need to be cautious when using Tagamet HB. Persistent or worsening symptoms require reevaluation[5].

Key Takeaways

  • Tagamet HB was the first blockbuster drug, achieving $1 billion in sales by 1986.
  • It transformed SK&F into a major pharmaceutical company.
  • The drug is an H2 blocker, effective for heartburn, acid indigestion, and sour stomach.
  • Generic versions have made the treatment more accessible.
  • The success of Tagamet HB has influenced GSK's R&D and commercial strategies.
  • Despite its popularity, the drug has interactions and contraindications that need careful management.

FAQs

What is Tagamet HB used for?

Tagamet HB is used for the prevention and relief of heartburn, acid indigestion, and sour stomach. It is particularly effective for conditions such as gastroesophageal reflux disease (GERD) and peptic ulcers.

Who discovered Tagamet HB?

Tagamet HB was discovered by James W. Black and his colleagues at Smith Kline & French’s (SK&F) British subsidiary.

How did Tagamet HB impact the pharmaceutical industry?

Tagamet HB set a new standard for anti-ulcer medications, drove innovation, and expanded treatment options. It also transformed SK&F into a major pharmaceutical company.

What are the potential interactions of Tagamet HB with other medications?

Tagamet HB can interact with medications such as anticoagulants, phenytoin, theophylline, lidocaine, and triazolam by inhibiting hepatic microsomal enzymes.

Is Tagamet HB available as a generic?

Yes, Tagamet HB is available as a generic version of cimetidine, which is generally cheaper than the brand name version.

What are the contraindications for using Tagamet HB?

Tagamet HB should be used with caution in patients with renal or hepatic impairment, pregnancy, or nursing mothers. It is also contraindicated with certain medications without a doctor's advice.

Sources

  1. Beginning of an Era The First Blockbuster Drug, Tagamet - Academic.oup.com
  2. TAGAMET HB 200 SUSPENSION Generic Name: CIMETIDINE - Accessdata.fda.gov
  3. FORM 20-F GlaxoSmithKline plc - GSK.com
  4. Tagamet vs Tums - Withpower.com
  5. TAGAMET HB Prescription & Dosage Information - eMPR.com

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