ZANTAC 150 Drug Patent Profile

When do Zantac 150 patents expire, and when can generic versions of Zantac 150 launch?

Zantac 150 is a drug marketed by Glaxosmithkline, Glaxo Grp Ltd, and Chattem Sanofi. and is included in four NDAs.

The generic ingredient in ZANTAC 150 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 150

A generic version of ZANTAC 150 was approved as ranitidine hydrochloride by SANDOZ on August 29^th, 1997.

Summary for ZANTAC 150

US Patents:	0
Applicants:	3
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	22
Patent Applications:	2,331
What excipients (inactive ingredients) are in ZANTAC 150?	ZANTAC 150 excipients list
DailyMed Link:	ZANTAC 150 at DailyMed

Recent Clinical Trials for ZANTAC 150

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 150 clinical trials

US Patents and Regulatory Information for ZANTAC 150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994		DISCN	Yes	No
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	GRANULE, EFFERVESCENT;ORAL	020251-002	Mar 31, 1994		DISCN	No	No
Chattem Sanofi	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	021698-001	Aug 31, 2004		DISCN	Yes	No

Expired US Patents for ZANTAC 150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZANTAC 150	ranitidine hydrochloride	CAPSULE;ORAL	020095-001	Mar 8, 1994
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET;ORAL	018703-001	Jun 9, 1983
Glaxo Grp Ltd	ZANTAC 150	ranitidine hydrochloride	TABLET, EFFERVESCENT;ORAL	020251-001	Mar 31, 1994

International Patents for ZANTAC 150

See the table below for patents covering ZANTAC 150 around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	33792
Philippines	21761	PHARMACEUTICAL COMPOSITION CONTAINING FORM 2 RANITIDINE HYDROCHLORIDE AND PROCESS OF PREPARATION THEREOF
Sweden	512412	Farmaceutisk komposition i kapselform bestående av ranitidin och en icke-vattenhaltig grundmassa

Market Dynamics and Financial Trajectory for Zantac 150

Introduction to Zantac 150

Zantac 150, a brand name for the drug ranitidine, has been a widely used medication for treating and preventing heartburn, ulcers, and other stomach and throat disorders. Here, we will delve into the market dynamics and financial trajectory of Zantac 150, considering recent developments and historical context.

Historical Context of Zantac 150

Zantac, first introduced in the US in 1983, was one of the best-selling medicines globally, generating over $1 billion in sales annually. It was marketed by several major pharmaceutical companies, including GlaxoSmithKline (GSK), Sanofi, Pfizer, and Boehringer Ingelheim[3].

Market Growth and Drivers

Despite recent challenges, the ranitidine market, including Zantac 150, is expected to show significant growth. Here are some key drivers:

Launch of New Products

The market is expected to grow due to the launch of ranitidine products in key markets by major players. For instance, Strides Pharma Science Limited launched its ranitidine tablets USP, 150 mg, in the US market in February 2018[1].

High Prevalence of Stomach Disorders

The high prevalence of stomach and throat-related disorders is a significant driver. According to the Centers for Disease Control and Prevention, over 25 million Americans will suffer from an ulcer at some point in their lifetime[1].

Regulatory Approvals

Key players are working to gain approvals for new ranitidine products in major regions. For example, Granules India Limited received US FDA approval for its ranitidine tablets USP, 150 mg, in August 2018[1].

Market Segmentation

By Strength

The ranitidine market is segmented by strength, with Zantac 150 mg being one of the primary strengths. Other strengths include 75 mg and 300 mg[1].

By Indication

Ranitidine is used for various indications, including the treatment of peptic ulcers of the stomach and intestines, and the prevention of heartburn[1].

By Geography

The market is analyzed across key regions such as North America, Europe, Asia Pacific, Latin America, Africa, and the Middle East. North America is expected to account for a major market share due to high demand and prevalence of stomach disorders[1].

Challenges and Controversies

Cancer Risk Allegations

One of the significant challenges faced by Zantac 150 is the allegation that its main active ingredient, ranitidine, could potentially turn into a carcinogen, N-nitrosodimethylamine (NDMA), under certain conditions. This led to recalls by the US FDA in 2020 and voluntary recalls by manufacturers in the UK, Australia, and the European Union[3].

Litigation and Settlements

GSK has recently reached settlement agreements to resolve a significant portion of the Zantac product liability cases in the US. The company will pay up to $2.2 billion to settle approximately 80,000 cases and an additional $70 million to resolve a qui tam complaint. Despite these settlements, GSK maintains that there is no consistent evidence linking ranitidine to cancer risk[2][3].

Financial Impact

Settlement Costs

The settlements will result in an incremental charge of £1.8 billion ($2.3 billion) in GSK's Q3 results for 2024. However, these costs will be funded through existing resources and are expected to be partially offset by reduced future legal costs[2][3].

Market Impact

Despite the challenges, the ranitidine market is forecasted to grow with a CAGR of 2.5% from 2020 to 2030, reaching an estimated market size of $562.09 million by 2030[1].

Share Price and Investor Confidence

GSK's shares surged over 6% after the announcement of the settlement agreements, indicating a positive impact on investor confidence and the company's financial stability[3].

Regional Market Dynamics

North America

North America is expected to dominate the market due to high demand and the prevalence of stomach disorders. The region has seen significant activity in terms of product launches and regulatory approvals[1].

Other Regions

Other regions, including Europe, Asia Pacific, Latin America, Africa, and the Middle East, also contribute to the market growth. However, the growth rates and market shares vary based on regional health trends and regulatory environments[1].

Future Outlook

Continued Growth

Despite the recent controversies, the ranitidine market, including Zantac 150, is expected to continue growing driven by the high prevalence of stomach disorders and the launch of new products[1].

Regulatory Vigilance

The future outlook will be influenced by regulatory vigilance, especially regarding the safety and efficacy of ranitidine products. Manufacturers will need to ensure compliance with stringent regulatory standards to maintain market confidence[3].

Key Takeaways

• The ranitidine market, including Zantac 150, is expected to grow with a CAGR of 2.5% from 2020 to 2030.
• High prevalence of stomach and throat disorders drives market demand.
• Recent settlements related to cancer risk allegations have significant financial implications but do not change GSK’s growth agenda.
• North America is expected to dominate the market due to high demand and regulatory activities.
• The market is segmented by strength, indication, and geography.

FAQs

What is the current market size and growth rate of the ranitidine market?

The ranitidine market is estimated to be $562.09 million by 2030 with a CAGR of 2.5% during the forecast period[1].

Why has Zantac 150 faced recalls and litigation?

Zantac 150 faced recalls and litigation due to allegations that its main active ingredient, ranitidine, could potentially turn into a carcinogen, N-nitrosodimethylamine (NDMA), under certain conditions[3].

How much will GSK pay to settle the Zantac product liability cases?

GSK will pay up to $2.2 billion to settle approximately 80,000 Zantac product liability cases and an additional $70 million to resolve a qui tam complaint[2][3].

What is the impact of the settlements on GSK’s financials?

The settlements will result in an incremental charge of £1.8 billion ($2.3 billion) in GSK's Q3 results for 2024, but these costs will be funded through existing resources and are expected to be partially offset by reduced future legal costs[2][3].

Will the settlements affect GSK’s growth agenda and R&D investments?

No, the settlements will not change GSK’s growth agenda or investment plans for R&D[2][3].

Sources

1. Prophecy Market Insights: "Ranitidine Market Size, Trends and Forecast To 2030"
2. GSK: "Statement: Zantac (ranitidine) litigation – settlement agreements reached"
3. Euronews: "GSK shares leap after drug firm settles US Zantac cancer claim lawsuit"
4. GlobeNewswire: "FDA Removal of Zantac (Ranitidine) Products - Market Analysis, Trends, Growth Opportunities, Forecast 2023-2030"