PANTOPRAZOLE SODIUM Drug Patent Profile

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

Pantoprazole Sodium is a drug marketed by Ajanta Pharma Ltd, Annora Pharma, Aurobindo Pharma Ltd, Cipla, Dexcel, Sun Pharm, Alembic, Aspiro, Be Pharms, Deva Holding As, Epic Pharma Llc, Eugia Pharma, Gland, Hangzhou Zhongmei, Knack, Meitheal, Pharmobedient, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Apotex, 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 Baxter Hlthcare Corp. and is included in forty-three NDAs.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pantoprazole Sodium

A generic version of PANTOPRAZOLE SODIUM was approved as pantoprazole sodium by APOTEX on January 19^th, 2011.

Summary for PANTOPRAZOLE SODIUM

US Patents:	0
Applicants:	40
NDAs:	43
Finished Product Suppliers / Packagers:	64
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	5,506
Drug Prices:	Drug price information 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
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all PANTOPRAZOLE SODIUM clinical trials

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
L Perrigo Co	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	203024-001	May 7, 2014		DISCN	No	No
Granules	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	217282-001	Dec 11, 2023	AB	RX	No	No
Mylan Pharms Inc	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090970-002	Jan 19, 2011	AB	RX	No	No
Torrent Pharms	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	090074-001	Jan 19, 2011	AB	RX	No	No
Macleods Pharms Ltd	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	200821-002	Feb 16, 2012		DISCN	No	No
Orbion Pharms	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	202052-001	Dec 2, 2014	AB	RX	No	No

Market Dynamics and Financial Trajectory for Pantoprazole Sodium

Last updated: February 19, 2026

What is the current market size and growth rate for pantoprazole sodium?

The global proton pump inhibitor (PPI) market, which includes pantoprazole sodium, was valued at approximately USD 13.8 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% from 2022 to 2028. Pantoprazole sodium accounts for roughly 8-10% of this market, driven by its use in GERD, Zollinger-Ellison syndrome, and erosive esophagitis.

How competitive is the pantoprazole sodium market?

Major players include:

• Pfizer Inc. ("Protonix")
• Teva Pharmaceutical Industries Ltd.
• Mylan N.V.
• Sandoz (Novartis)
• Aurobindo Pharma

Pfizer's Protonix remains the leading formulation. Patent expirations for brand-name versions in the U.S. occurred in 2014, opening the market to generics. Generics dominate sales, representing approximately 60% of total pantoprazole sodium revenue globally.

What are the patents and regulatory barriers affecting market entry?

Pfizer's original patents on pantoprazole sodium expired in 2014 in the U.S., but certain formulations gained extended exclusivity through secondary patents and formulation-specific claims until 2020. The expiry of patents in key markets like the U.S. and Europe facilitated generics' entry.

Regulatory approval processes are generally straightforward due to established biosimilar pathways. However, patent litigations may delay generic market entry in some jurisdictions.

What trends influence the financial trajectory?

• Increasing prevalence of GERD and related disorders: Global GERD prevalence is approximately 20%, driving sustained demand.
• Patent expirations: Expected manufactured generic proliferation post-2014, matching sales declines of proprietary brands.
• Price erosion: Entry of generics has reduced average selling prices (ASPs) by 30-50%, affecting revenue.
• Rise of OTC formulations: Moving from prescription-only to OTC status in some regions expands market size, but pressures prices.
• Manufacturing changes: Companies adopting cost-effective APIs and formulations reduce production costs and improve margins.

How do supply chain and manufacturing factors impact the outlook?

Supply chain disruptions, such as raw material shortages (e.g., omeprazole intermediates), can impact production volumes. Companies investing in vertical integration mitigate some risks. API cost reductions from process innovations support competitiveness.

Financial projections: Revenue and profit prospects

Year	Estimated Global Sales (USD billions)	Key Drivers	Comments
2022	2.5 – 2.7	Generics market share expansion	Market stabilization after patent expiry
2024	2.3 – 2.5	Price erosion, competitive intensification	Margin impact from pricing pressures
2026	2.0 – 2.2	Market saturation, OTC shift	Revenue plateau unless new indications emerge

Profitability depends heavily on manufacturing efficiencies and patent litigation outcomes. Companies that innovate or diversify formulation offerings may see improved margins.

Summary of key market drivers and risks

• Market drivers: Rising GERD prevalence, patent expirations, OTC availability.
• Risks: Price erosion, regulatory delays, raw material shortages, increased competition.

Key Takeaways

• The pantoprazole sodium market is mature, with significant generic penetration reducing prices.
• Estimated global sales hover around USD 2.5 billion, with slow growth projected post-2024.
• Patent expirations and OTC conversions will influence supply dynamics.
• Supply chain stability and production innovation are critical for maintaining margins.
• Emerging markets and new indications may present growth opportunities despite market saturation.

FAQs

Q1: How does patent expiry affect pantoprazole sodium's market?

A1: Patent expiry opens markets to generics, increases competition, and drives down prices, leading to revenue declines for branded formulations.

Q2: What are the main drivers for future growth?

A2: Rising prevalence of acid-related disorders and expansion into OTC segments are primary growth drivers.

Q3: How are generic manufacturers impacting the market?

A3: They provide lower-cost alternatives, capturing a majority share of sales, and exert downward pressure on ASPs.

Q4: Are there new indications or formulations expected to influence market size?

A4: Few new indications are projected; however, formulations with improved delivery or combination therapies might offer niche growth.

Q5: What are the primary risks facing companies in this market?

A5: Price erosion due to generics, supply chain disruptions, and regulatory hurdles are significant risks.

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References

1. Grand View Research. (2022). Proton Pump Inhibitors Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com
2. U.S. Food and Drug Administration. (2022). Patent Status of Proton Pump Inhibitors. Retrieved from https://www.fda.gov
3. Statista. (2022). GERD prevalence worldwide. Retrieved from https://www.statista.com