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, Dexcel, Sun Pharm, Wyeth Pharms, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Baxter Hlthcare Corp, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, 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, Sun Pharm Inds Ltd, Teva, Torrent Pharms, and Wockhardt Bio Ag, and is included in forty-one 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-one 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:	37
NDAs:	41
Drug Master File Entries:	48
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	7,225
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
Knack	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	214680-001	May 19, 2022	AP	RX	No	No
Wyeth Pharms	PROTONIX	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	020987-001	Feb 2, 2000	AB	RX	Yes	Yes
Hangzhou Zhongmei	PANTOPRAZOLE SODIUM	pantoprazole sodium	INJECTABLE;INTRAVENOUS	209524-001	Aug 30, 2021	AP	RX	No	No
Sun Pharm	PANTOPRAZOLE SODIUM	pantoprazole sodium	FOR SUSPENSION, DELAYED RELEASE;ORAL	213725-001	Jun 30, 2020	AB	RX	No	No
Fresenius Kabi Usa	PANTOPRAZOLE SODIUM	pantoprazole sodium	POWDER;INTRAVENOUS	216021-001	Aug 1, 2024	AP	RX	No	No

Expired US Patents for PANTOPRAZOLE SODIUM

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

International Patents for PANTOPRAZOLE SODIUM

Country	Patent Number	Title	Estimated Expiration
Spain	2529570
Brazil	PI0415014	formulações em multipartìculas de pantoprazol, cápsula e embalagem que as compreendem, método de produção das formulações, uso e composição
South Korea	101141508
European Patent Office	1667660	PREPARATIONS MULTIPARTICULAIRES DE PANTOPRAZOLE (PANTOPRAZOLE MULTIPARTICULATE FORMULATIONS)
Norway	20061471

Supplementary Protection Certificates for PANTOPRAZOLE SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0166287	96C0032	Belgium		PRODUCT NAME: PANTOPRAZOL. NATR. SESQUIHYDRAS PANTOPRAZOLE; NAT. REGISTRATION NO/DATE: 127 IS 98 F 3 19960222; FIRST REGISTRATION: SE 12131 19940506

PANTOPRAZOLE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Pantoprazole Sodium

Introduction

Pantoprazole sodium, a proton pump inhibitor (PPI), is widely used to treat various gastrointestinal conditions, including gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome. Here, we delve into the market dynamics and financial trajectory of pantoprazole sodium, exploring its current status, future projections, and key influencing factors.

Market Size and Growth

The global pantoprazole sodium market is experiencing significant growth. As of 2023, the market size was substantial, and it is projected to continue growing at a notable compound annual growth rate (CAGR) from 2024 to 2031[1][3].

Historical and Forecast Periods

The market analysis covers historical data from 2019 to 2023 and provides forecasts from 2024 to 2031. This period helps in understanding the trends and growth patterns of the pantoprazole sodium market[1][3].

Regional Analysis

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. The Asia-Pacific region is expected to be one of the fastest-growing segments due to the increasing incidence of gastroenterology-related diseases. However, North America remains a dominant sector in terms of market value[1][5].

Market Segmentation

By Type

Pantoprazole sodium is available in both generic and branded forms, with the generic version expected to hold a larger market share. The branded version is marketed under the name Protonix[5].

By Dosage

The drug is available in 20 mg and 40 mg oral tablets, with the 20 mg tablet segment anticipated to have a larger share due to its efficacy in treating GERD and other conditions[5].

By Route of Administration

The market is bifurcated into oral and intravenous administration. Oral administration dominates the market due to its accessibility, cost-effectiveness, and widespread use in treating gastro-based diseases. Intravenous administration is used as a temporary treatment, particularly for GERD[5].

By Application

Pantoprazole sodium is primarily used to treat GERD, erosive esophagitis, and Zollinger-Ellison syndrome. GERD is the largest application segment, making pantoprazole a first-line treatment for this condition[5].

Financial Aspects

Cost and Pricing

The cost of pantoprazole sodium can vary based on factors such as treatment plan, insurance coverage, and pharmacy. The retail price of pantoprazole sodium can be around $158, but savings programs and insurance can significantly reduce this cost. There is typically no major cost difference between the 20 mg and 40 mg tablets or between pantoprazole and other PPIs like omeprazole[2].

Revenue and Market Share

The global pantoprazole sodium market is expected to generate substantial revenue during the forecast period. Key companies such as Pfizer, Dr. Reddy's Laboratories, Takeda GmbH, Teva Pharmaceutical, and others are profiled in market reports, highlighting their market share and competitive landscape[1][3].

Drivers and Opportunities

Increasing Prevalence of Gastrointestinal Diseases

The rising incidence of GERD, erosive esophagitis, and other gastroenterology-related diseases drives the demand for pantoprazole sodium. This trend is particularly pronounced in the Asia-Pacific region, contributing to the market's growth[5].

Advances in Drug Formulations

The availability of pantoprazole sodium in various forms, including delayed-release tablets and intravenous solutions, enhances its market appeal. These formulations cater to different patient needs and treatment scenarios, expanding the drug's market reach[4].

Cost-Effectiveness

Generic versions of pantoprazole sodium are cost-effective, making the drug more accessible to a broader patient population. This cost-effectiveness is a significant driver of market growth[5].

Restraints and Challenges

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can impact the market dynamics of pantoprazole sodium. Compliance with regulatory requirements is crucial for market players[1].

Competition from Other PPIs

Pantoprazole sodium faces competition from other proton pump inhibitors, such as omeprazole. The competitive landscape can affect market share and pricing strategies[2].

Side Effects and Safety Concerns

Like all medications, pantoprazole sodium has potential side effects and safety concerns. Long-term use of PPIs has been associated with various health risks, which can influence prescribing patterns and patient adherence[4].

Technological and ESG Trends

Technological Advancements

Advances in drug delivery systems and formulations are expected to enhance the efficacy and safety of pantoprazole sodium. These technological trends can drive innovation and growth in the market[1].

Environmental, Social, and Governance (ESG) Analysis

ESG factors are increasingly important in the pharmaceutical industry. Companies that prioritize ESG considerations may have a competitive advantage in the market, influencing investor confidence and consumer trust[1].

Competitive Landscape

The pantoprazole sodium market is characterized by a competitive landscape with several key players. These companies engage in various strategies such as product differentiation, pricing, and market expansion to maintain their market share. The competitive analysis includes profiling companies like Pfizer, Dr. Reddy's Laboratories, and Teva Pharmaceutical, among others[1][3].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the pantoprazole sodium market. Factors such as patient awareness, treatment preferences, and adherence to medication regimens influence market dynamics. The analysis of consumer behavior helps in understanding the demand patterns and preferences, which can guide marketing and sales strategies[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry. While it presented challenges in terms of supply chain disruptions and reduced hospital visits, it also accelerated the adoption of telemedicine and online pharmacy services. The pantoprazole sodium market has been resilient, with continued demand for essential medications like PPIs[1].

Key Takeaways

• The global pantoprazole sodium market is projected to grow significantly from 2024 to 2031.
• The Asia-Pacific region is expected to be a key growth driver due to the increasing incidence of gastroenterology-related diseases.
• Generic versions of pantoprazole sodium dominate the market due to their cost-effectiveness.
• The drug is available in various forms, including oral and intravenous administration, catering to different patient needs.
• Regulatory environment, competition from other PPIs, and safety concerns are key challenges facing the market.

FAQs

What are the primary uses of pantoprazole sodium?

Pantoprazole sodium is primarily used to treat gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome.

How does the cost of pantoprazole sodium vary?

The cost of pantoprazole sodium can vary based on factors such as treatment plan, insurance coverage, and pharmacy. Savings programs and insurance can significantly reduce the retail price.

What are the different forms of pantoprazole sodium available?

Pantoprazole sodium is available in 20 mg and 40 mg oral tablets, as well as in intravenous form for temporary treatment.

Which region is expected to drive the growth of the pantoprazole sodium market?

The Asia-Pacific region is expected to be a key growth driver due to the increasing incidence of gastroenterology-related diseases.

What are the major challenges facing the pantoprazole sodium market?

The market faces challenges such as regulatory environment changes, competition from other PPIs, and safety concerns associated with long-term use of PPIs.

Sources

1. Global Pantoprazole Sodium Market Report 2024 Edition - Cognitivemarketresearch.com
2. Pantoprazole cost 2024: Coupons and more - MedicalNewsToday
3. Global Pantoprazole Sodium Market Size And Forecast - MarketResearchIntellect.com
4. Preformulation Studies of Pantoprazole - Saudijournals.com
5. Global Pantoprazole API Market Analysis - GlobalMarketEstimates.com