ZANTAC IN PLASTIC CONTAINER Drug Patent Profile

When do Zantac In Plastic Container patents expire, and what generic alternatives are available?

Zantac In Plastic Container is a drug marketed by Pai Holdings Pharm and is included in one NDA.

The generic ingredient in ZANTAC IN PLASTIC CONTAINER 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 In Plastic Container

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

Summary for ZANTAC IN PLASTIC CONTAINER

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

Recent Clinical Trials for ZANTAC IN PLASTIC CONTAINER

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 IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for ZANTAC IN PLASTIC CONTAINER

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 IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-002	Sep 27, 1991		DISCN	No	No
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986		DISCN	No	No

Expired US Patents for ZANTAC IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-002	Sep 27, 1991
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-001	Dec 17, 1986
Pai Holdings Pharm	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	INJECTABLE;INJECTION	019593-002	Sep 27, 1991

International Patents for ZANTAC IN PLASTIC CONTAINER

See the table below for patents covering ZANTAC IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	505951
United Kingdom	2142820	AQUEOUS COMPOSITIONS OF RANITIDINE
Germany	2734070
Japan	H0443070
Yugoslavia	40088

ZANTAC IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zantac in Plastic Containers

Introduction

Zantac, a widely used heartburn medication, has been a significant player in the pharmaceutical industry since its introduction in the 1980s. However, its market dynamics and financial trajectory have been heavily impacted by recent controversies and regulatory actions. Here, we delve into the key factors influencing Zantac's market and financial performance, particularly in the context of its packaging in plastic containers.

Historical Market Performance

Zantac, containing the active ingredient ranitidine, was one of the best-selling medicines globally, generating over $1 billion in sales annually[2][4].

• Peak Sales: At its peak, Zantac was sold by several major pharmaceutical companies, including GlaxoSmithKline (GSK), Sanofi, Pfizer, and Boehringer Ingelheim.
• Global Reach: It was widely available in various markets, including the US, UK, Australia, and the European Union.

Regulatory Actions and Market Impact

In recent years, Zantac faced significant regulatory challenges due to concerns over its safety.

FDA Recall and Global Withdrawal

• In 2020, the FDA requested that all manufacturers of ranitidine products, including Zantac, remove their products from the market due to contamination with N-nitrosodimethylamine (NDMA), a potential human carcinogen[3][5].
• Similar recalls were implemented in the UK, Australia, and the European Union.

Market Consequences

• The recall led to a sharp decline in sales and market presence for Zantac.
• The drug's popularity waned significantly as consumers and healthcare providers sought alternative treatments.

Litigation and Financial Implications

The recall and safety concerns triggered a wave of litigation against GSK and other manufacturers.

Settlement Agreements

• GSK reached agreements to settle approximately 93% of the US state court product liability cases related to Zantac for up to $2.2 billion[2][4].
• An additional $70 million settlement was agreed upon to resolve a qui tam complaint filed by Valisure[4].

Financial Charges

• GSK expects to recognize an incremental charge of £1.8 billion ($2.3 billion) in its Q3 2024 results to cover these settlements and remaining litigation costs[4].

Impact on Packaging Industry

The withdrawal of Zantac from the market has implications for the plastic containers used in its packaging.

Reduced Demand for Plastic Containers

• Since Zantac was packaged in plastic containers, the reduction in its sales has led to a decrease in the demand for these containers.
• This decrease is part of a broader trend where pharmaceutical companies are reevaluating their packaging needs in response to changes in product portfolios.

Shift to Sustainable Packaging

• The pharmaceutical industry, like other sectors, is increasingly focusing on sustainable packaging solutions. The decline of Zantac has accelerated this shift, as companies look to bioplastics and recycled plastics to reduce environmental impact[1].

Regional Market Dynamics

North America

• The US market, once a significant contributor to Zantac's sales, saw a drastic decline following the FDA's recall. This has impacted the overall demand for plastic containers in the pharmaceutical sector in North America.

Europe

• Similar to North America, European markets experienced a decline in Zantac sales, affecting the packaging industry's demand for plastic containers.

Asia Pacific and Latin America

• While these regions were less directly impacted by the Zantac recall, the global trend towards sustainable packaging and reduced plastic use is influencing packaging choices across these markets as well.

Consumer and Industry Response

Consumer Preference for Sustainable Packaging

• The increasing consumer preference for environmentally friendly packaging products is driving the demand for sustainable alternatives, such as bioplastics and recycled plastics[1].

Industry Adaptation

• Pharmaceutical companies are adapting by investing in research and development to find safer and more sustainable packaging solutions.

Quotes from Industry Experts

"The shift towards sustainable packaging is not just a trend but a necessity. Companies that adapt quickly will be better positioned for long-term success."[1]

Illustrative Statistics

• Market Size: The global plastic containers market, which includes pharmaceutical packaging, was valued at USD 207.35 billion in 2023 and is projected to grow to USD 344.79 billion by 2032, with a CAGR of 5.9%[1].
• Settlement Costs: GSK's settlement agreements for Zantac-related litigation amount to up to $2.2 billion, plus an additional $70 million for the qui tam complaint[2][4].

Highlight: Regulatory Impact on Market Dynamics

"The FDA decided on April 1, 2020, to ask all manufacturers of products containing ranitidine to remove their products from the market due to contamination with N-nitrosodimethylamine (NDMA), a potential human carcinogen."[5]

Key Takeaways

• Regulatory Actions: The FDA's recall of Zantac due to safety concerns significantly impacted its market presence and financial performance.
• Litigation Costs: GSK and other manufacturers faced substantial financial charges due to litigation settlements.
• Packaging Industry Impact: The decline in Zantac sales reduced demand for plastic containers, accelerating the shift towards sustainable packaging solutions.
• Consumer and Industry Response: There is a growing preference for sustainable packaging, driving innovation and investment in the packaging industry.

FAQs

1. What led to the recall of Zantac from the market?

   • Zantac was recalled due to contamination with N-nitrosodimethylamine (NDMA), a potential human carcinogen[3][5].

2. How much did GSK agree to pay in settlement for Zantac-related litigation?

   • GSK agreed to pay up to $2.2 billion to settle US state court product liability cases and an additional $70 million for a qui tam complaint[2][4].

3. What is the impact of Zantac's recall on the plastic containers market?

   • The recall reduced the demand for plastic containers used in pharmaceutical packaging, contributing to a broader shift towards sustainable packaging solutions[1].

4. How is the pharmaceutical industry responding to the need for sustainable packaging?

   • The industry is investing in research and development to find safer and more sustainable packaging solutions, such as bioplastics and recycled plastics[1].

5. What is the projected growth of the global plastic containers market?

   • The global plastic containers market is projected to grow from USD 218.04 billion in 2024 to USD 344.79 billion by 2032, with a CAGR of 5.9%[1].

Sources

1. Fortune Business Insights - Plastic Containers Market Size, Share | Growth Report [2032].
2. Euronews - GSK shares leap after drug firm settles US Zantac cancer claim lawsuit.
3. Healthcare Packaging - Quick Hits: FDA Finally Pulls the Plug on Zantac.
4. GSK - Statement: Zantac (ranitidine) litigation – settlement agreements reached.
5. MyMatrixx - FDA Calls for Heartburn Drug Zantac to be Pulled from Market.