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, Dexcel, Sun Pharm, Aspiro, Be Pharms, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Hangzhou Zhongmei, Knack, Meitheal, Norvium Bioscience, Sandoz, Fresenius Kabi Usa, Hikma, Actavis Totowa, Amneal Pharms, Aurobindo Pharma Ltd, 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, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Wockhardt Bio Ag, and Baxter Hlthcare Corp. and is included in thirty-nine NDAs.

The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-nine 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 DR REDDYS LABS LTD on January 19^th, 2011.

Summary for PANTOPRAZOLE SODIUM

US Patents:	0
Applicants:	37
NDAs:	39
Finished Product Suppliers / Packagers:	67
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	23
Patent Applications:	4,759
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
Federal University of 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
Sun Pharm	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	077058-002	Sep 10, 2007		DISCN	No	No
Orbion Pharms	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	202052-002	Dec 2, 2014	AB	RX	No	No
Ingenus Pharms Llc	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	211368-001	Mar 1, 2019		DISCN	No	No
Mankind Pharma	PANTOPRAZOLE SODIUM	pantoprazole sodium	TABLET, DELAYED RELEASE;ORAL	215880-001	Jul 26, 2022	AB	RX	No	No
Baxter Hlthcare Corp	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	pantoprazole sodium	SOLUTION;INTRAVENOUS	217512-003	Feb 14, 2024		RX	Yes	Yes

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