Sucralfate - Generic Drug Details

What are the generic sources for sucralfate and what is the scope of freedom to operate?

Sucralfate is the generic ingredient in two branded drugs marketed by Abbvie, Abon Pharms Llc, Amneal, Hikma, Mylan, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Nostrum Labs Inc, Teva, and Zydus Lifesciences, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for sucralfate. Forty-three suppliers are listed for this compound.

Summary for sucralfate

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	43
Clinical Trials:	25
Drug Prices:	Drug price trends for sucralfate
Drug Sales Revenues:	Drug sales revenues for sucralfate
What excipients (inactive ingredients) are in sucralfate?	sucralfate excipients list
DailyMed Link:	sucralfate at DailyMed

See drug prices for sucralfate

See drug sales revenues for sucralfate

Recent Clinical Trials for sucralfate

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

Sponsor	Phase
National Cheng-Kung University Hospital	N/A
National Cheng-Kung University Hospital	Phase 1
Memorial Sloan Kettering Cancer Center	Phase 2

See all sucralfate clinical trials

Pharmacology for sucralfate

Drug Class

Aluminum Complex

Medical Subject Heading (MeSH) Categories for sucralfate

Anti-Ulcer Agents

Anatomical Therapeutic Chemical (ATC) Classes for sucralfate

A02BX	Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sucralfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	SUCRALFATE	sucralfate	SUSPENSION;ORAL	212769-001	Jul 23, 2024	AB	RX	No	No
Zydus Lifesciences	SUCRALFATE	sucralfate	TABLET;ORAL	215705-001	May 3, 2023	AB	RX	No	No
Mylan	SUCRALFATE	sucralfate	SUSPENSION;ORAL	212913-001	Sep 12, 2022	AB	RX	No	No

Expired US Patents for sucralfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	CARAFATE	sucralfate	TABLET;ORAL	018333-001	Approved Prior to Jan 1, 1982

Sucralfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sucralfate

Overview of Sucralfate

Sucralfate is a medication widely used to prevent and treat various gastrointestinal disorders, including duodenal ulcers, gastroesophageal reflux disease (GERD), gastritis, peptic ulcer disease, stress ulcers, and dyspepsia. Its mechanism of action involves forming a protective barrier over the ulcer site, shielding it from further irritation and allowing it to heal.

Global Market Size and Growth

The global sucralfate market is projected to experience steady growth over the coming years. As of 2023, the global market for sucralfate was valued at approximately $257.7 million and is forecasted to reach $300.2 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 1.8% during the period from 2024 to 2030[1].

Regional Market Analysis

North America

North America dominates the global sucralfate market, accounting for over 40% of the market share in 2021. The United States is a major market within this region, driven by high healthcare expenditure, the presence of key market players, and an increasing demand for safe and effective ulcer treatments[4].

Europe

Europe is another significant market for sucralfate, driven by the high prevalence of gastrointestinal disorders, a rising geriatric population, and an increasing demand for non-invasive treatments. Countries like Germany, France, and the United Kingdom are key markets due to their well-established healthcare systems and growing preference for generic drugs[4].

Asia Pacific

The Asia Pacific region is expected to witness the fastest growth during the forecast period, driven by the increasing prevalence of gastrointestinal disorders, rising healthcare expenditure, and a growing demand for affordable and accessible treatments. China, India, and Japan are major markets in this region[4].

Middle East, Africa, and Latin America

These regions are expected to see moderate growth, influenced by the increasing prevalence of gastrointestinal disorders and rising healthcare expenditure. However, limited access to healthcare facilities and low awareness about gastrointestinal health may restrain market growth in some areas[4].

Market Segmentation

By Formulation

The tablet segment dominated the market in 2021, accounting for over 70% of the global revenue share due to ease of administration, convenience of storage, and widespread availability[4].

By Indication

The peptic ulcer disease segment held the largest market share in 2021, attributed to the high prevalence of the disease, particularly in developing countries, and the increasing use of sucralfate as a first-line treatment for peptic ulcers[4].

By Distribution Channel

The hospital pharmacy segment accounted for the largest market share in 2021, owing to the increasing number of hospital admissions for gastrointestinal complications and the rising demand for inpatient ulcer treatment[4].

Key Drivers and Constraints

Drivers

• Increasing Prevalence of Gastrointestinal Disorders: Conditions like peptic ulcer disease, GERD, and inflammatory bowel disease (IBD) are driving the growth of the sucralfate market. According to the World Health Organization, the global prevalence of peptic ulcer disease is estimated to be around 10%, and GERD prevalence is between 15-20%[4].
• Rising Geriatric Population: The increasing age of the population contributes to a higher incidence of gastrointestinal disorders.
• Changing Lifestyle Patterns: Factors such as diet, stress, and the increasing consumption of non-steroidal anti-inflammatory drugs (NSAIDs) contribute to the rising prevalence of gastrointestinal disorders.
• Growing Demand for Safe and Effective Treatments: There is a growing preference for non-invasive and effective treatments, particularly in developing countries[4].

Constraints

• Limited Access to Healthcare: In some regions, limited access to healthcare facilities and low awareness about gastrointestinal health can restrain market growth.
• Presence of Counterfeit and Substandard Drugs: This is a significant challenge, especially in certain countries within the Middle East, Africa, and Latin America[4].

Competitive Landscape

The global sucralfate market is highly competitive, with both large multinational companies and small and medium-sized enterprises (SMEs) operating in the space. Key players include:

• Strides Pharma Science: Recently received USFDA approval for Sucralfate Oral Suspension, marking a significant milestone in their portfolio expansion[2].
• Teva Pharmaceutical Industries Ltd.: Active in the U.S. sucralfate market, along with other major players like Allergan plc and Vertice Pharma LLC[5].
• Mylan N.V.: Acquired the non-sterile dermatology and topical medicine business of Renaissance Acquisition Holdings, LLC, which includes the sucralfate brand Carafate[4].

Financial Trajectory

Market Size and Revenue

The global sucralfate market is expected to grow from $257.7 million in 2023 to $300.2 million by 2030, with a CAGR of 1.8% during the forecast period[1].

Specific Market Segments

• Sucralfate Oral Suspension: This formulation has a market size of about $124 million as of March 2024, according to IQVIA[2].

Regional Revenue

• North America: Dominates the market with over 40% of the global share, driven by high healthcare expenditure and the presence of key market players[4].

Future Outlook

The development of novel and targeted drug delivery systems, such as sustained-release and mucoadhesive formulations, is expected to provide growth opportunities for market players. The increasing demand for generic drugs, particularly in emerging economies, will also drive market growth. Additionally, the growing awareness about gastrointestinal health and the preference for non-invasive treatments will continue to boost the market[4].

Key Takeaways

• The global sucralfate market is projected to reach $300.2 million by 2030.
• North America and Europe are significant markets driven by high healthcare expenditure and the prevalence of gastrointestinal disorders.
• The Asia Pacific region is expected to witness the fastest growth due to increasing healthcare expenditure and demand for affordable treatments.
• Key drivers include the increasing prevalence of gastrointestinal disorders and the growing demand for safe and effective treatments.
• The market is highly competitive with major players focusing on product launches, mergers, and geographical expansions.

FAQs

What is the forecasted global market size for sucralfate by 2030?

The global market for sucralfate is forecasted to reach $300.2 million by 2030[1].

Which region dominates the global sucralfate market?

North America dominates the global sucralfate market, accounting for over 40% of the market share[4].

What are the primary indications for sucralfate?

Sucralfate is primarily used to treat stomach ulcers, gastroesophageal reflux disease (GERD), radiation proctitis, stomach inflammation, and to prevent stress ulcers[2].

Who are the key players in the global sucralfate market?

Key players include Strides Pharma Science, Teva Pharmaceutical Industries Ltd., Allergan plc, Vertice Pharma LLC, and Mylan N.V.[2][4][5].

What are the major drivers of the sucralfate market?

The increasing prevalence of gastrointestinal disorders, rising geriatric population, changing lifestyle patterns, and growing demand for safe and effective treatments are major drivers of the market[4].

Sources

1. Valuates Reports: Sucralfate - Market, Report Size, Worth, Revenue, Growth, Industry ...
2. Upstox: Strides Pharma Science subsidiary gets USFDA nod for Sucralfate Oral Suspension
3. FDA: Q1 and Q2 Recommendations: Sucralfate Oral Suspension
4. Data Horizon Research: Sucralfate Market Size, Share & Forecast 2033
5. OpenPR: U.S. Sucralfate Market Set to Witness Significant Growth by 2024-2031