PANTOPRAZOLE SODIUM - Generic Drug Details

What are the generic drug sources for pantoprazole sodium and what is the scope of patent protection?

Pantoprazole sodium is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dexcel, Sun Pharm, Wyeth Pharms, Alembic, Aspiro, Be Pharms, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Baxter Hlthcare Corp, Actavis Totowa, Amneal Pharms, Dr Reddys Labs Ltd, Granules, Graviti Pharms, Hetero Labs Ltd V, Ingenus Pharms Llc, Jubilant Generics, L Perrigo Co, Lannett Co Inc, Macleods Pharms Ltd, Mankind Pharma, Mylan Pharms Inc, Orbion Pharms, Rubicon Research, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt Bio Ag, and is included in forty-six NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pantoprazole sodium has thirty-five patent family members in twenty-eight countries.

There are forty-eight drug master file entries for pantoprazole sodium. Seventy suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for PANTOPRAZOLE SODIUM

International Patents:	35
US Patents:	4
Tradenames:	4
Applicants:	41
NDAs:	46
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	70
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	7,136
Drug Prices:	Drug price trends for PANTOPRAZOLE SODIUM
Drug Sales Revenues:	Drug sales revenues for PANTOPRAZOLE SODIUM
What excipients (inactive ingredients) are in PANTOPRAZOLE SODIUM?	PANTOPRAZOLE SODIUM excipients list
DailyMed Link:	PANTOPRAZOLE SODIUM at DailyMed

See drug prices for PANTOPRAZOLE SODIUM

See drug sales revenues for PANTOPRAZOLE SODIUM

Recent Clinical Trials for PANTOPRAZOLE SODIUM

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

Sponsor	Phase
Alexandria University	Phase 3
Mansoura University	Phase 1/Phase 2
Federal University of São Paulo	Phase 4

See all PANTOPRAZOLE SODIUM clinical trials

Generic filers with tentative approvals for PANTOPRAZOLE SODIUM

Applicant	Application No.	Strength	Dosage Form
		40MG	INJECTABLE; INJECTION
		EQ 40MG BASE/VIAL	POWDER;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PANTOPRAZOLE SODIUM

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PANTOPRAZOLE SODIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for PANTOPRAZOLE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PROTONIX	for Delayed-release Oral Suspension	pantoprazole sodium	40 mg	022020	1	2019-09-13
PROTONIX IV	For Injection	pantoprazole sodium	40 mg/vial	020988	1	2005-04-07
PROTONIX	Delayed-release Tablets	pantoprazole sodium	20 mg and 40 mg	020987		2004-02-02

US Patents and Regulatory Information for PANTOPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	200821-002	Feb 16, 2012		DISCN	No	No
Sun Pharm	PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	213725-001	Jun 30, 2020	AB	RX	No	No
Sun Pharm	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	077674-001	Aug 19, 2019		DISCN	No	No
Jubilant Generics	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090901-002	Aug 30, 2011		DISCN	No	No
Mylan Pharms Inc	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090970-002	Jan 19, 2011	AB	RX	No	No

Expired US Patents for PANTOPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX IV	pantoprazole sodium	INJECTABLE;INTRAVENOUS	020988-001	Mar 22, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-002	Jun 12, 2001
Wyeth Pharms	PROTONIX	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022020-001	Nov 14, 2007
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000

International Patents for PANTOPRAZOLE SODIUM

Country	Patent Number	Title	Estimated Expiration
Canada	2539982	PREPARATIONS MULTIPARTICULAIRES DE PANTOPRAZOLE (PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS)
Mexico	266708	FORMULACIONES DE MICROPARTICULAS DE PANTOPRAZOL.
Russian Federation	2361574	СОСТАВЫ ПАНТОПРАЗОЛА, СОСТОЯЩИЕ ИЗ МНОЖЕСТВА ЧАСТИЦ (PANTOPRAZOLE COMPOUNDS CONSISTING OF SET OF PARTICLES)
Australia	2004278037	Pantoprazole multiparticulate formulations
New Zealand	581267	Pantoprazole multiparticulate formulations

Supplementary Protection Certificates for PANTOPRAZOLE SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0166287	96C0032	Belgium		PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506
0166287	SPC/GB96/056	United Kingdom		PRODUCT NAME: PANTOPRAZOLE AND ITS SALTS, HYDRATES AND HYDRATES OF ITS SALTS; REGISTERED: SE SE12131 19940506; UK 04889/0010 19960604

Market Dynamics and Financial Trajectory for Pantoprazole Sodium

Last updated: July 27, 2025

Introduction

Pantoprazole sodium, a proton pump inhibitor (PPI), is extensively prescribed for acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and peptic ulcers. Its mechanism involves irreversibly binding to gastric H+/K+ ATPase enzymes, suppressing gastric acid production. The drug's high efficacy and favorable safety profile have cemented its position within both prescription and over-the-counter (OTC) markets. Analyzing market dynamics and financial trajectories entails evaluating demand drivers, competitive landscape, patent considerations, and emerging trends.

Market Overview

The global pantoprazole sodium market exhibits robust growth, driven by the increasing prevalence of acid-related diseases, expanding aging populations, and the rising incidence of obesity, which correlates with GERD [1]. As of 2022, the compound’s market valuation was estimated at approximately USD 2.5 billion, with projections reaching USD 4 billion by 2030, reflecting a CAGR of around 6.4%. The dominant share belongs to North America, followed by Europe and Asia-Pacific, with emerging markets displaying accelerated growth potential.

Key Market Drivers

• Rising Prevalence of Acid-Related Disorders: The global burden of GERD and peptic ulcer disease fuels demand. Urbanization, dietary habits, and obesity contribute significantly to this trend.
• Expanding Aging Population: Older adults are more susceptible to gastrointestinal conditions, propelling sales.
• Generic Entry & Price Competitiveness: Patent expirations, notably in the U.S. and Europe, have fostered a surge in generic pantoprazole sales, reducing treatment costs and expanding access.

Regulatory & Patent Landscape

Initially patented in the early 2000s, pantoprazole sodium faced expiration of exclusive rights around 2010-2015 in key markets, leading to widespread generic manufacturing. This transition intensified price competition and altered profit margins for original developers like Takeda and pharma majors.

Market Dynamics Analysis

Competitive Landscape

The market is highly fragmented post-patent expiry, with numerous pharmaceutical companies producing generics. Leading manufacturers include Teva, Sandoz, Mylan, and Hikma. Major branded products, such as Protonix (Pfizer), reduced market share after patent loss, but remain relevant in specific markets due to brand loyalty and formulations.

Innovation and Formulation Developments: While traditional formulations dominate, there is a growing focus on enhanced delivery systems, including disintegrating tablets and IV formulations, to cater to hospitalized or geriatric patients.

Pricing and Reimbursement Policies

Reimbursement frameworks heavily influence market penetration. In mature markets like the U.S., insurance coverage and formulary placements dictate sales volume. Price reductions owing to generic competition have significant implications for profit margins, with average prices decreasing approximately 30-50% post-patent expiry.

Supply Chain Considerations

Robust global supply chains underpin market stability. However, recent geopolitical tensions, raw material shortages, and manufacturing disruptions have temporarily affected supply, emphasizing the need for resilient logistics and diversified manufacturing bases.

Emerging Trends

• OTC Market Expansion: Over-the-counter availability in multiple markets enhances accessibility but exerts downward pressure on pricing.
• Dose and Formulation Innovation: Efforts to optimize bioavailability and reduce side effects could sustain competitive edge.
• Concerns Over Long-term Use: Growing awareness of PPI-associated risks, including deficiencies and renal complications, influence prescribing practices and market growth.

Financial Trajectory Projections

Revenue Forecasts

Post-patent expiration catalyzed a revenue decline for branded versions, but the generics segment experienced exponential growth. The market is expected to sustain moderate expansion driven by emerging markets and increased OTC sales.

• 2023-2030 Revenue Outlook: Estimated compound annual growth rate of approximately 5-7%. Market analysts project the overall market to reach USD 4 billion by 2030, with the OTC segment accounting for nearly 40% of this figure.

Profitability Trends

Profit margins for original manufacturers have diminished, often below 20%, due to intense price competition. Conversely, generic manufacturers capitalize on high-volume, low-margin sales. Investment in formulation improvements and niche indications might bolster margins for innovator companies.

Investment and R&D Outlook

Pharmaceutical companies are channeling R&D efforts into developing novel PPIs with enhanced pharmacokinetics, and into combination therapies targeting Helicobacter pylori eradication, creating avenues for differentiated products.

Potential Risks and Opportunities

• Regulatory Risks: Stringent guidelines or safety warnings could impact sales.
• Market Saturation: High generic penetration challenges profitability.
• Biosimilar and Alternative Therapies: Emerging biologics and non-PPI alternatives may threaten market share.
• Market Expansion: Drawn-out patent litigations and approvals in emerging markets offer growth opportunities.

Conclusion

Pantoprazole sodium's market is characterized by significant shifts post-patent expiry, intense competition, and evolving consumer and regulatory preferences. While branded revenues have declined, the overall market maintains growth due to rising global gastrointestinal disease burdens and market expansion into OTC and emerging regions. Companies investing in formulation innovation, focused branding, and strategic supply chain management are poised to capitalize on future opportunities. Careful navigation of regulatory landscapes and safety concerns will remain critical to capturing sustained financial gains.

Key Takeaways

• The global pantoprazole sodium market is projected to grow steadily, reaching USD 4 billion by 2030.
• Patent expirations prompted a surge in generics, intensifying price competition but expanding market access.
• Pricing strategies and reimbursement policies significantly influence revenue trajectories across geographies.
• Innovation in formulations and combination therapies present avenues for differentiation and higher margins.
• Market risks include safety concerns, biosimilar threats, and regulatory challenges, underscoring the need for strategic agility.

FAQs

1. How have patent expirations impacted Pantoprazole sodium’s market profitability?
Patent expirations led to a surge in generic manufacturing, significantly reducing prices and profit margins for original developers. While revenues for branded versions declined, the overall market growth accelerated through increased generic sales and OTC availability.

2. What are the primary drivers of demand for Pantoprazole sodium?
Rising prevalence of acid-related gastrointestinal conditions, aging populations, and increased obesity rates are primary demand drivers. Expanding OTC accessibility further fuels consumption.

3. How does the competitive landscape influence market innovation for Pantoprazole sodium?
Intense price competition encourages companies to innovate in delivery mechanisms, formulations, and combination therapies to differentiate their products and sustain profit margins.

4. What risks threaten Pantoprazole sodium’s market stability?
Safety concerns related to long-term PPI use, emerging biosimilars or alternative therapies, regulatory restrictions, and supply chain disruptions pose risks to stability.

5. What emerging trends could shape the future financial trajectory of Pantoprazole sodium?
Development of novel formulations, expansion into emerging markets, OTC growth, and strategic R&D investments in combination therapies are key trends shaping future prospects.

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References

[1] MarketWatch. “Proton Pump Inhibitors Market Analysis.” 2022.