ZANTAC Drug Patent Profile

Which patents cover Zantac, and when can generic versions of Zantac launch?

Zantac is a drug marketed by Pai Holdings Pharm, Glaxo Grp Ltd, Glaxosmithkline, and Chattem Sanofi. and is included in nine NDAs.

The generic ingredient in ZANTAC 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

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

Summary for ZANTAC

US Patents:	0
Applicants:	4
NDAs:	9
Raw Ingredient (Bulk) Api Vendors:	212
Clinical Trials:	22
Patent Applications:	4,046
Drug Prices:	Drug price information for ZANTAC
What excipients (inactive ingredients) are in ZANTAC?	ZANTAC excipients list
DailyMed Link:	ZANTAC at DailyMed

See drug prices for ZANTAC

See drug sales revenues for ZANTAC

Recent Clinical Trials for ZANTAC

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

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

See all ZANTAC clinical trials

US Patents and Regulatory Information for ZANTAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984		DISCN	Yes	No
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-002	Mar 13, 2007		DISCN	Yes	No
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994		DISCN	No	No

Expired US Patents for ZANTAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988
Pai Holdings Pharm	ZANTAC	ranitidine hydrochloride	INJECTABLE;INJECTION	019090-001	Oct 19, 1984
Glaxo Grp Ltd	ZANTAC	ranitidine hydrochloride	SYRUP;ORAL	019675-001	Dec 30, 1988

International Patents for ZANTAC

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2198352	PHARMACEUTICAL COMPOSITIONS CONTAINING RANITIDINE
Spain	505951
United Kingdom	2142820	AQUEOUS COMPOSITIONS OF RANITIDINE

ZANTAC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zantac

Introduction

Zantac, a widely recognized heartburn medication, has had a tumultuous journey from its inception to the present day. Originally introduced in the 1980s, it quickly became one of the best-selling drugs globally. However, recent years have seen a significant shift in its market dynamics and financial trajectory due to various factors, including litigation and regulatory actions.

Historical Success of Zantac

Zantac, first sold in the US in 1983, was a groundbreaking medication that quickly gained popularity for its effectiveness in treating heartburn and ulcers. It was developed by Glaxo Holdings, now part of GlaxoSmithKline (GSK), and became the world’s top-selling drug by 1988. The drug was also marketed by other pharmaceutical giants such as Sanofi, Pfizer, and Boehringer Ingelheim, further expanding its reach[3].

Market Expansion and Segmentation

The market for Zantac was segmented based on various factors, including the type of formulation (capsules, oral tablets, injectable solutions, and oral syrups) and the distribution channels (hospital pharmacies, retail pharmacies, and online pharmacies). This segmentation allowed for a comprehensive analysis of market trends and consumer behavior across different regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Decline and Regulatory Issues

The fortunes of Zantac began to decline significantly in 2020 following reports that its main active ingredient, ranitidine, could potentially turn into a carcinogen, N-nitrosodimethylamine (NDMA), under certain storage conditions. This led to a series of recalls by regulatory bodies such as the US Food and Drug Administration (FDA), as well as voluntary recalls by manufacturers in the UK, Australia, and the European Union[3].

Litigation and Settlements

The allegations that Zantac could cause cancer led to a massive wave of litigation against its manufacturers. Approximately 80,000 cases were filed in US state courts, with a significant portion consolidated into a Multi-District Litigation (MDL) in the Southern District of Florida. Although the MDL was dismissed in December 2022 due to lack of sound scientific evidence, the plaintiffs plan to appeal, and many cases are still pending in Delaware[4].

In a recent development, GSK agreed to pay up to $2.2 billion to settle the majority of these lawsuits, covering around 93% of the pending cases. This settlement also includes a $70 million "Qui Tam" settlement to resolve a whistleblower complaint filed by Valisure, which alleged that GSK hid the potential cancer risks associated with Zantac[2][3][5].

Financial Impact

The settlement of the Zantac lawsuits has significant financial implications for GSK. The company will recognize an incremental charge of approximately $2.3 billion in its Q3 2024 financial results to cover the settlement costs. Despite this substantial charge, GSK has emphasized that the settlements are in the best long-term interests of the company and its shareholders, as they remove significant financial uncertainty and risk associated with ongoing litigation[2][3][5].

Market Dynamics and Growth Projections

Despite the current challenges, the Ranitidine (Zantac) market is still expected to show some growth, albeit not as robust as in its heyday. The market dynamics are influenced by drivers such as the ongoing demand for heartburn medications, restraints like the regulatory issues and litigation, and opportunities in emerging markets. However, the growth projections are tempered by the recent controversies and the discontinuation of Zantac by many manufacturers[1].

Consumer Behavior and Market Trends

Consumer behavior has been significantly impacted by the safety concerns surrounding Zantac. The decline in sales and the shift towards alternative heartburn medications reflect the changing consumer preferences and increased awareness of potential health risks. Market trends now focus on safer alternatives and more stringent regulatory compliance[3].

Impact on Pharmaceutical Companies and Insurers

The Zantac litigation highlights broader trends in the pharmaceutical industry, where companies often opt for large settlements to avoid prolonged litigation and reputational damage, even in the absence of conclusive scientific evidence. This approach is seen in other high-profile cases, such as the Johnson & Johnson talc litigation. Insurers and distributors are also likely to be affected as companies seek coverage and contributions to mitigate the financial impact of such settlements[4].

Conclusion

The market dynamics and financial trajectory of Zantac have been dramatically altered by recent events. From its peak as a global best-seller to its current status marred by litigation and regulatory issues, Zantac's story serves as a cautionary tale for pharmaceutical companies. The settlements and financial charges underscore the importance of addressing consumer and regulatory concerns promptly to maintain long-term viability.

Key Takeaways

• Zantac was a highly successful heartburn medication until safety concerns arose.
• Regulatory recalls and litigation have significantly impacted its market.
• GSK has settled the majority of Zantac-related lawsuits for up to $2.2 billion.
• The settlements aim to remove financial uncertainty and risk for GSK.
• The pharmaceutical industry is seeing a trend towards settling lawsuits to avoid reputational damage.
• Consumer behavior has shifted towards safer alternatives.

FAQs

What led to the decline of Zantac?

Zantac's decline was primarily due to reports that its active ingredient, ranitidine, could potentially turn into a carcinogen, N-nitrosodimethylamine (NDMA), under certain storage conditions, leading to regulatory recalls and widespread litigation.

How much did GSK agree to pay to settle the Zantac lawsuits?

GSK agreed to pay up to $2.2 billion to settle the majority of the Zantac-related lawsuits, along with an additional $70 million for a "Qui Tam" settlement.

What is the current status of the Zantac litigation?

The majority of the cases have been settled, but some cases are still pending in Delaware, and the plaintiffs from the dismissed MDL in Florida plan to appeal.

How has the settlement affected GSK's financials?

GSK will recognize an incremental charge of approximately $2.3 billion in its Q3 2024 financial results to cover the settlement costs, but this will not affect its growth or R&D investment plans.

What are the broader implications of the Zantac litigation for the pharmaceutical industry?

The litigation highlights the trend of pharmaceutical companies opting for large settlements to avoid prolonged litigation and reputational damage, even in the absence of conclusive scientific evidence, and the potential exposure for insurers and distributors.

Sources

1. Market Research Intellect, "Ranitidine (Zantac) Market Size, Scope And Forecast Report".
2. Morningstar, "GSK: Zantac Settlement Was Big, But Removes Uncertainty".
3. Euronews, "GSK shares leap after drug firm settles US Zantac cancer claim lawsuit".
4. Clyde & Co, "Zantac Exposure: Uncharted Waters".
5. BioSpace, "GSK Settles Zantac Lawsuits for $2.2B, Analysts Now Shift Focus to Vaccines".