ZANTAC 300 Drug Patent Profile

When do Zantac 300 patents expire, and when can generic versions of Zantac 300 launch?

Zantac 300 is a drug marketed by Glaxosmithkline and Glaxo Grp Ltd and is included in two NDAs.

The generic ingredient in ZANTAC 300 is ranitidine hydrochloride. There are forty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ranitidine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zantac 300

A generic version of ZANTAC 300 was approved as ranitidine hydrochloride by SANDOZ on August 29^th, 1997.

Summary for ZANTAC 300

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	22
Patent Applications:	2,331
DailyMed Link:	ZANTAC 300 at DailyMed

Recent Clinical Trials for ZANTAC 300

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

Sponsor	Phase
Spaulding Clinical Research LLC	Phase 1
Food and Drug Administration (FDA)	Phase 1
Nova Scotia Health Authority	Phase 4

See all ZANTAC 300 clinical trials

US Patents and Regulatory Information for ZANTAC 300

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 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985		DISCN	Yes	No
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994		DISCN	Yes	No

Expired US Patents for ZANTAC 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	5,028,432*PED
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	4,128,658
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	4,128,658
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	4,880,636*PED
Glaxo Grp Ltd	ZANTAC 300	ranitidine hydrochloride	TABLET;ORAL	018703-002	Dec 9, 1985	4,521,431*PED
Glaxosmithkline	ZANTAC 300	ranitidine hydrochloride	CAPSULE;ORAL	020095-002	Mar 8, 1994	4,521,431*PED

International Patents for ZANTAC 300

See the table below for patents covering ZANTAC 300 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	407956
Hungary	185001	PROCESS FOR PREPARING PHARMACEUTICALLY ACTIVE AMINO-ALKYL-FURANE DERIVATIVES
Israel	63968	FORM 2 RANITIDINE HYDROCHLORIDE,ITS PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT
Netherlands	192819
Philippines	13540	AMINOALKYL FURAN DERIVATIVES
Sweden	453500	RANITIDIN-HYDROKLORID FORM 2, FORFARANDE FOR FRAMSTELLNING DERAV SAMT FARMACEUTISK KOMPOSITION INNEHALLANDE NEMNDA FORENING MED HISTAMIN-H?712-BLOCKERANDE VERKAN

Market Dynamics and Financial Trajectory for Zantac 300

Introduction

Zantac, known generically as ranitidine, has been a staple in the treatment of various gastrointestinal conditions, including heartburn, gastric and duodenal ulcers, and gastroesophageal reflux disease (GERD). However, the market dynamics and financial trajectory of Zantac 300 have been significantly impacted by recent developments.

Historical Market Performance

Market Size and Growth

As of 2017, the global ranitidine market was valued at US$ 412.4 million and was expected to grow at a Compound Annual Growth Rate (CAGR) of 1.8% from 2018 to 2026[1].

Segmentation

The market is segmented by strength (75 mg, 150 mg, and 300 mg), form (tablets, syrup, and injection), and route of administration (oral and intravenous). Zantac 300 mg, being one of the higher strengths, was a significant contributor to the market[1].

Regulatory Challenges

FDA Recall

In April 2020, the U.S. Food and Drug Administration (FDA) requested the removal of all prescription and over-the-counter (OTC) ranitidine products, including Zantac, from the market due to the presence of N-Nitrosodimethylamine (NDMA), a contaminant linked to cancer. This decision was based on findings that NDMA levels in ranitidine products increase over time and with higher storage temperatures[4].

International Regulatory Issues

In addition to the FDA recall, other regulatory bodies have also taken action. For instance, in 2018, South Korea's Ministry of Food and Drug Safety banned the import of 150 mg Zantac tablets supplied by GlaxoSmithKline (GSK) due to non-compliance with approved specifications[1].

Impact on Sales and Revenue

Immediate Market Withdrawal

The FDA's request for the immediate withdrawal of ranitidine products from the market has drastically reduced sales and revenue for Zantac 300. This move has effectively halted new and existing prescriptions and OTC sales in the U.S.[4].

Decline in Market Share

Prior to the recall, Zantac was one of the top 10 antacid tablet brands in the U.S., with significant sales. However, the recall and subsequent market withdrawal have led to a substantial decline in market share and revenue[5].

Litigation and Legal Implications

Cancer Link and Lawsuits

Numerous studies have linked NDMA in Zantac to various types of cancer, leading to a surge in lawsuits against the manufacturers. These lawsuits allege that the companies concealed the cancer link from consumers, which has further damaged the brand's reputation and financial standing[5].

Financial Trajectory of GSK

Overall Performance

Despite the challenges faced by Zantac, GSK's overall financial performance has been robust, driven by strong sales in other segments such as vaccines and specialty medicines. In 2023, GSK reported total sales of £30.3 billion, with a 5% increase and a 14% increase excluding COVID-19 solutions[2].

Impact on General Medicines Segment

The general medicines segment, which includes Zantac, saw a decline. However, this decline was offset by the strong performance in other areas, such as vaccines and specialty medicines. GSK's HIV business, respiratory treatments, and other specialty medicines have contributed significantly to the company's growth[3].

Future Outlook

GSK's Strategic Focus

GSK has shifted its strategic focus towards vaccines and specialty medicines, which are driving the company's growth. The successful launch of vaccines like Arexvy and strong sales of Shingrix have contributed to GSK's upgraded growth outlooks for 2026 and 2031[3].

Absence of Zantac in Future Projections

Given the market withdrawal and legal issues surrounding Zantac, it is unlikely that this product will contribute to GSK's future growth projections. Instead, the company is focusing on new product launches and pipeline development in other therapeutic areas[3].

Research and Development

Ongoing R&D in Ranitidine

Despite the current challenges, research and development on ranitidine continue, with various studies aimed at improving its efficacy and comparing it with other proton pump inhibitors. However, these efforts are overshadowed by the regulatory and legal issues[1].

Consumer Impact

Alternative Treatments

The withdrawal of Zantac has led consumers to seek alternative treatments for gastrointestinal conditions. This shift has benefited other antacid and proton pump inhibitor brands, which have seen an increase in sales and market share[5].

Key Takeaways

• The global ranitidine market, including Zantac 300, faced significant challenges due to regulatory actions and contamination issues.
• The FDA's recall of all ranitidine products has halted sales and revenue for Zantac 300 in the U.S.
• GSK's financial performance has been resilient due to strong sales in other segments like vaccines and specialty medicines.
• The company has shifted its focus away from general medicines, including Zantac, towards more promising therapeutic areas.
• Ongoing litigation and the link between NDMA and cancer have further impacted the brand's reputation and financial trajectory.

FAQs

What led to the FDA's recall of Zantac?

The FDA recalled Zantac due to the presence of N-Nitrosodimethylamine (NDMA), a contaminant linked to cancer, which increases over time and with higher storage temperatures[4].

How has the recall affected GSK's financial performance?

While the recall has negatively impacted the sales of Zantac, GSK's overall financial performance has remained strong due to robust sales in other segments such as vaccines and specialty medicines[2][3].

What are the alternative treatments available for conditions previously treated with Zantac?

Consumers have shifted to other antacid and proton pump inhibitor brands, which have seen an increase in sales and market share following the withdrawal of Zantac[5].

Is GSK continuing research on ranitidine?

Yes, despite the current challenges, various government and private research organizations are engaged in research and development studies to improve the efficacy of ranitidine[1].

What is the current legal status of Zantac-related lawsuits?

Numerous lawsuits have been filed alleging that the manufacturers concealed the cancer link associated with NDMA in Zantac. These lawsuits continue to impact the brand's reputation and financial standing[5].

Sources

1. Coherent Market Insights Analysis (2018) - Ranitidine Market - Share, Size and Industry Analysis.
2. GSK - Q4 2023 Announcement.
3. GSK - Annual Report 2023.
4. FDA - FDA Requests Removal of All Ranitidine Products (Zantac) from the Market.
5. Wisner Baum - Zantac Lawsuit Update December 2024.