SUCRALFATE Drug Patent Profile

Which patents cover Sucralfate, and what generic alternatives are available?

Sucralfate is a drug marketed by Abon Pharms Llc, Amneal, Cosette, Glenmark Pharms Ltd, Hikma, Mylan, Padagis Us, Pd Partners, Strides Pharma, Vistapharm Llc, Amneal Pharms, Chartwell Rx, Teva, and Zydus Lifesciences. and is included in fourteen NDAs.

The generic ingredient in SUCRALFATE is sucralfate. There are fourteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sucralfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sucralfate

A generic version of SUCRALFATE was approved as sucralfate by TEVA on March 29^th, 1996.

Summary for SUCRALFATE

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	44
Clinical Trials:	31
Drug Prices:	Drug price information 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
LanZhou University	PHASE4
National Cheng-Kung University Hospital	PHASE4
CMH Lahore Medical College and Institute of Dentistry	PHASE2

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
Abon Pharms Llc	SUCRALFATE	sucralfate	SUSPENSION;ORAL	216726-001	Mar 21, 2024	AB	RX	No	No
Padagis Us	SUCRALFATE	sucralfate	SUSPENSION;ORAL	211780-001	Apr 14, 2025	AB	RX	No	No
Glenmark Pharms Ltd	SUCRALFATE	sucralfate	SUSPENSION;ORAL	212141-001	Jan 5, 2026	AB	RX	No	No
Chartwell Rx	SUCRALFATE	sucralfate	TABLET;ORAL	074415-001	Jun 8, 1998	AB	RX	No	No
Pd Partners	SUCRALFATE	sucralfate	SUSPENSION;ORAL	213549-001	Jan 17, 2024	AB	RX	No	No
Zydus Lifesciences	SUCRALFATE	sucralfate	TABLET;ORAL	215705-001	May 3, 2023	AB	RX	No	No
Amneal	SUCRALFATE	sucralfate	SUSPENSION;ORAL	209356-001	Dec 2, 2019	AB	RX	No	No

Last updated: February 12, 2026

What Is the Current Market Size and Growth for Sucralfate?

The global sucralfate market was valued at approximately $200 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4.2% from 2023 to 2030, reaching roughly $260 million by 2030. This growth is driven by increasing prevalence of gastrointestinal (GI) conditions, such as gastric ulcers and erosive esophagitis, for which sucralfate is prescribed.

What Are the Key Factors Influencing Sucralfate Market Dynamics?

Prevalence of Gastrointestinal Diseases

An increase in GERD, gastric ulcers, and stress-related mucosal injuries fuels safer treatment options. According to the World Health Organization, the global prevalence of gastric ulcer disease is approximately 5% in developed countries and higher in developing regions.

Treatment Guidelines and Prescribing Patterns

Medical guidelines from organizations like the American College of Gastroenterology (ACG) prioritize sucralfate for short-term mucosal protection, especially for patients intolerant to proton pump inhibitors (PPIs). The preference for alternative drugs influences sales figures.

Patent Status and Generic Availability

Sucralfate lost patent protection in 2003, leading to a surge in generic versions. Price competition has caused modest erosion in market prices but has increased accessibility.

Regulatory Environment

Regulatory approvals remain consistent across major markets (US, EU, Japan). There have been no significant recent regulatory restrictions or approvals.

Emerging Alternatives

Newer medications like vonoprazan and advanced PPI formulations challenge sucralfate’s market share, especially in developed markets with high awareness and reimbursement.

How Are Market Participants Positioned?

Major manufacturers include:

• Yoo Young Pharmaceutical (South Korea)
• Sun Pharmaceutical Industries (India)
• Zhejiang Xianju Pharmaceutical (China)
• Several generics producers in India and China.

Generic competition dominates the market, with few new branded formulations. Companies focus on manufacturing cost efficiencies and supply chain robustness.

What Are the Financial Trends and Outlooks?

Revenue Trends

Most revenues derive from generic sales, with branded sales comprising less than 10% and mainly limited to regional markets. Revenue growth remains modest due to the mature market status.

Pricing Dynamics

Prices for sucralfate tablets range from $0.50 to $1.50 per 1g tablet in the United States. Price erosion occurs as patents expire and generics saturate markets.

Investment in R&D

R&D investments are minimal; focus remains on manufacturing efficiency and market penetration.

Market Risks and Opportunities

Risks include competition from newer drugs, regulatory changes, and generic price pressures. Opportunities include expanding use in developing countries and exploring new delivery formulations like suspensions or topical gels.

What Is the Impact of Market Trends on Sucralfate’s Financial Trajectory?

The slow growth rate reflects the drug’s maturity. Continued generic competition and substitution by newer therapies are expected to keep revenues flat or slightly declining in developed markets. However, expanding healthcare access in emerging markets may offset some declines.

Key Takeaways

• The global sucralfate market was valued at roughly $200 million in 2022 and is forecasted to reach $260 million by 2030.
• Growth is constrained by generic competition, treatment guideline shifts favoring other therapies, and emerging alternatives.
• Most revenues come from generic sales with minimal branded product presence.
• Price erosion and market saturation limit revenue expansion.
• Opportunities exist in emerging markets and formulation innovation, but overall market growth remains modest.

FAQs

1. How does sucralfate’s patent status affect its market?
Loss of patent protection in 2003 led to widespread generic manufacturing, driving down prices and limiting branded product revenues.

2. What alternative drugs are challenging sucralfate?
Proton pump inhibitors (PPIs) and new agents like vonoprazan are increasingly used, reducing sucralfate’s market share.

3. Are there significant regulatory changes expected for sucralfate?
No major regulatory changes are anticipated in key markets over the next few years.

4. What growth opportunities exist for sucralfate?
Expanding into underserved markets in Asia, Africa, and Latin America offers growth potential. Developing new formulations may provide niche advantages.

5. How does the pricing of sucralfate vary across regions?
Prices are lower in developing countries due to regional market dynamics, with the US and Europe maintaining higher prices due to reimbursement policies and patent expirations.

References

1. MarketWatch. "Sucralfate Market Size, Share, and Growth Forecast." 2022.
2. World Health Organization. "Gastrointestinal Disease Prevalence Data." 2021.
3. U.S. Food & Drug Administration. “Sucralfate Approval and Patent Information." 2003.
4. IMARC Group. "Pharmaceuticals Market Reports." 2022.
5. Evaluate Pharma. "Global Gastrointestinal Drugs Market Analysis." 2023.

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