ZANTAC 25 Drug Patent Profile

When do Zantac 25 patents expire, and what generic alternatives are available?

Zantac 25 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ZANTAC 25 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zantac 25

A generic version of ZANTAC 25 was approved as ranitidine hydrochloride by SANDOZ on August 29^th, 1997.

Summary for ZANTAC 25

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	22
Patent Applications:	2,331
DailyMed Link:	ZANTAC 25 at DailyMed

Recent Clinical Trials for ZANTAC 25

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Spaulding Clinical Research LLC	Phase 1
Food and Drug Administration (FDA)	Phase 1
Dalhousie University	Phase 4

See all ZANTAC 25 clinical trials

US Patents and Regulatory Information for ZANTAC 25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	ZANTAC 25	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-003	Apr 1, 2004		DISCN	No	No

International Patents for ZANTAC 25

See the table below for patents covering ZANTAC 25 around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	505951
Germany	2734070
Japan	H0443070
Yugoslavia	40088
Sweden	8205533

ZANTAC 25 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zantac

Introduction

Zantac, a brand name for the drug ranitidine, has been a significant player in the pharmaceutical market for decades, particularly in the treatment of heartburn and other gastrointestinal issues. However, recent years have seen a complex interplay of factors affecting its market dynamics and financial trajectory.

Historical Market Performance

Global Market Size and Growth

The global ranitidine market, which includes Zantac, was valued at US$ 412.4 million in 2017 and was expected to grow at a CAGR of 1.8% from 2018 to 2026[1].

Dominance and Competition

Zantac was originally developed by Glaxo Holdings, now part of GlaxoSmithKline (GSK), and gained its first approval in 1983. It became the world’s top-selling drug in 1988. Over the years, several pharmaceutical companies developed generic versions of ranitidine, increasing competition in the market[5].

Regulatory Challenges

FDA Actions and Recalls

In 2020, Zantac and its generic versions were pulled from the market due to the discovery of a probable carcinogen called N-Nitrosodimethylamine (NDMA). This recall significantly impacted the drug's market presence and led to a series of legal and financial repercussions[4].

Compliance Issues

Regulatory bodies have been stringent in their oversight. For instance, in 2018, the Ministry of Food and Drug Safety in South Korea banned the import of 150 mg Zantac tablets supplied by GSK Korea due to non-compliance with approved specifications, such as changes in shape and coatings[1].

Legal and Financial Implications

Litigation and Settlements

The discovery of NDMA in Zantac led to a massive wave of lawsuits alleging that manufacturers concealed the cancer risks associated with the drug. Recent settlements include GSK agreeing to settle 80,000 cases for $2.2 billion and Pfizer settling over 10,000 lawsuits. These settlements have significant financial implications for the companies involved[4][5].

Financial Impact

The $2.2 billion settlement by GSK will be reflected in its third-quarter financials, adding an incremental $2.3 billion charge. However, GSK has stated that these costs will not affect its growth or R&D investment plans[5].

Market Reaction and Investor Sentiment

Stock Performance

The ongoing litigation and settlements have led to a significant drop in the stock prices of companies involved, such as GSK and Sanofi. This is largely due to concerns over the potential liability and financial impact of the Zantac litigation[4].

Research and Development

Ongoing Studies

Despite the challenges, there is ongoing research and development aimed at improving the efficacy of ranitidine. Clinical trials are comparing the efficacy of ranitidine with other proton pump inhibitors to measure gastric acid reduction. These studies could potentially enhance the future scope of the ranitidine market[1].

Market Shifts and Alternatives

Changing Market Dynamics

The recall of Zantac has led to a shift in market dynamics, with patients moving to alternative treatments. For example, in China, sales of Toujeo, another Sanofi product, have increased as patients shift away from Zantac[3].

Competitive Landscape

The absence of Zantac from the market has created opportunities for other heartburn medications. This shift highlights the dynamic nature of the pharmaceutical market, where consumer preferences and regulatory actions can significantly impact market share[3].

Expert Insights and Industry Perspective

CEO Commentary

Paul Hudson, CEO of Sanofi, has emphasized the company's commitment to transforming its portfolio and investing in late-stage pipelines. This strategic focus indicates a broader industry trend towards innovation and development-driven growth[3].

Scientific Consensus

GSK has maintained that there is no consistent or reliable evidence linking ranitidine to an increased risk of cancer. This stance reflects the ongoing debate and the need for further scientific research to clarify the risks associated with the drug[5].

Key Statistics and Figures

• Global Market Value: US$ 412.4 million in 2017[1].
• CAGR: Expected to grow at 1.8% from 2018 to 2026[1].
• Settlement Amount: GSK agreed to settle 80,000 cases for $2.2 billion[4][5].
• Stock Impact: Significant drop in stock prices due to litigation concerns[4].

Future Outlook

The future of Zantac and the broader ranitidine market is uncertain due to the ongoing legal battles and regulatory challenges. However, the pharmaceutical industry's focus on research and development, along with the emergence of new treatments, suggests that the market will continue to evolve.

"The scientific consensus remains that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer," - GSK[5].

Key Takeaways

• Zantac's market presence has been significantly impacted by regulatory actions and litigation.
• The drug's recall due to NDMA contamination has led to substantial financial settlements.
• Ongoing research aims to improve the efficacy of ranitidine.
• Market dynamics are shifting towards alternative treatments.
• The pharmaceutical industry is focusing on innovation and development-driven growth.

FAQs

What was the global market value of ranitidine in 2017?

The global ranitidine market was valued at US$ 412.4 million in 2017[1].

Why was Zantac recalled from the market?

Zantac was recalled due to the discovery of a probable carcinogen called N-Nitrosodimethylamine (NDMA)[4].

How much did GSK agree to settle in Zantac lawsuits?

GSK agreed to settle 80,000 cases for $2.2 billion[4][5].

What is the impact of the Zantac litigation on the stock prices of pharmaceutical companies?

The litigation has led to a significant drop in the stock prices of companies involved, such as GSK and Sanofi, due to concerns over potential liability[4].

Is there ongoing research to improve the efficacy of ranitidine?

Yes, various clinical trials are ongoing to compare the efficacy of ranitidine with other proton pump inhibitors and to improve its treatment regimes[1].

Sources

1. Coherent Market Insights - Ranitidine Market - Share, Size and Industry Analysis.
2. Sanofi - 2021 Half-Year Financial Report.
3. Sanofi - Press Release: Sanofi Q1: robust 7% sales growth driven by ...
4. Miller and Zois - Zantac Cancer Lawsuit Update | December 2024 Settlement News.
5. BioSpace - GSK Settles Zantac Lawsuits for $2.2B, Analysts Now Shift Focus to ...