CARAFATE Drug Patent Profile

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

Carafate is a drug marketed by Abbvie and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carafate

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

Summary for CARAFATE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	10
Clinical Trials:	4
Drug Prices:	Drug price information for CARAFATE
Drug Sales Revenues:	Drug sales revenues for CARAFATE
What excipients (inactive ingredients) are in CARAFATE?	CARAFATE excipients list
DailyMed Link:	CARAFATE at DailyMed

See drug prices for CARAFATE

See drug sales revenues for CARAFATE

Recent Clinical Trials for CARAFATE

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

Sponsor	Phase
Thompson Cancer Survival Center	Phase 3
Ochsner Health System	N/A
LCMC Health	N/A

See all CARAFATE clinical trials

Pharmacology for CARAFATE

Drug Class

Aluminum Complex

US Patents and Regulatory Information for CARAFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CARAFATE	sucralfate	SUSPENSION;ORAL	019183-001	Dec 16, 1993	AB	RX	Yes	Yes
Abbvie	CARAFATE	sucralfate	TABLET;ORAL	018333-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for CARAFATE

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	3,432,489

International Patents for CARAFATE

See the table below for patents covering CARAFATE around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	895077
France	6064
France	1500571	Nouveaux composés aluminiques de polysulfates de disaccharides et leur procédé de préparation

Market Dynamics and Financial Trajectory for CARAFATE

Last updated: February 20, 2026

How does the market landscape surrounding CARAFATE (Sucralfate) influence its current and future financial performance?

CARAFATE (Sucralfate) has been a standard therapy for active duodenal ulcers and other gastrointestinal (GI) mucosal conditions since its approval in 1988. The overall market for gastrointestinal agents, the prevalence of GI disorders, and competition from newer therapies shape its market dynamics.

What are the key drivers impacting CARAFATE’s market share and revenue?

Market Size and Prevalence of Indications

The global gastrointestinal drugs market was valued at $45 billion in 2021 and is projected to reach $65 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 6% [1].

• Duodenal ulcers: 10-15% of patients with peptic ulcer disease.
• Gastroesophageal reflux disease (GERD): 20-30% prevalence in adults in developed countries.
• Erosive gastritis and other mucosal injuries: significant in hospitalized and elderly populations.

Competitive Landscape

CARAFATE’s primary competitors and alternatives include:

• Proton pump inhibitors (PPIs): Omeprazole, esomeprazole, pantoprazole.
• H2 receptor antagonists: Ranitidine, famotidine.
• Newer mucosal protectants and bioadhesive formulations.

PPIs dominate with higher efficacy and ease of use but carry risks of long-term safety concerns, influencing prescribing patterns.

Regulatory and Policy Environment

• Recommendations: US guidelines favor PPIs over sucralfate due to superior efficacy [2].
• Patent Status: Sucralfate’s original patent expired in the late 1990s; generic versions are widely available, exerting downward pricing pressure.
• Off-label and expanded uses: Limited approvals restrict revenue growth prospects.

How does the financial performance of CARAFATE look historically and forecast?

Historical Revenue and Sales Data

Major pharmaceutical companies like Shire (now part of Takeda) historically reported US sales peak around $200 million annually in the 2000s. Generic competition has likely reduced sales over the past decade to estimated levels around $50 million annually in the US, with limited international sales.

Revenue Forecasts and Market Trajectory

• Decline Predicted: Due to market saturation, generic pricing pressures, and dominance of PPIs.
• Potential Niche Markets: Usage in specific populations, such as pediatric or to avoid PPI side effects.
• New Formulations: Limited development efforts suggest minimal core innovation.

Profitability and Investment Outlook

Manufacturers have scaled back investments in sucralfate formulations. The drug’s low-margin profile and limited growth prospects make it less attractive for R&D investments. Mergers, generic manufacturing focus, and off-label use remain the primary revenue strategies.

What emerging trends could alter CARAFATE’s financial trajectory?

• Rise of Gastrointestinal Therapies: New drugs with fewer side effects and better efficacy could further displace sucralfate.
• Aging Populations: Increase in GI complications could sustain niche demand but unlikely to reverse decline.
• Expanded Indications: Research into mucosal healing in other GI conditions has not yet resulted in approved expanded uses for sucralfate.

Summary of Market and Financial Outlook

Aspect	Current Situation	Future Projection
Market Size	$45 billion global GI drugs market (2021)	Growth expected, but sucralfate’s segment remains flat or declining
Revenue	Estimated $50-100 million US sales (most recent years)	Likely to decrease due to generic competition and replacement by PPIs
Market Share	Limited; overshadowed by PPIs and H2 antagonists	Continues as niche therapy, with minimal share increase
Innovation	Minimal; no recent major formulation developments	No significant improvements anticipated

Key Takeaways

• The global GI market is growing, but CARAFATE’s market share diminishes due to competition and generic erosion.
• US sales are estimated to be around $50 million annually, with a declining trend.
• The drug’s patent expiry and the prevalence of alternative therapies restrict future growth.
• Limited pipeline or development activity weakens long-term prospects.
• CARAFATE remains a niche product primarily used in specific clinical situations unable to replace PPIs in general practice.

FAQs

1. Is CARAFATE likely to regain market share?
No. The combination of generic availability, widespread preference for PPIs, and limited new indications makes a market share rebound unlikely.

2. Are there any upcoming regulatory changes that could impact CARAFATE?
No significant regulatory changes are anticipated that would favor or hinder CARAFATE beyond existing guidelines.

3. What are alternative therapies to CARAFATE for similar indications?
PPIs and H2 receptor antagonists top the list, offering higher efficacy and broader acceptance.

4. Could off-label uses sustain CARAFATE’s revenues?
Limited off-label use exists, primarily in pediatric or specific mucosal injury cases, but it is insufficient to sustain or grow revenue substantially.

5. What strategic options do manufacturers have for CARAFATE?
Focusing on niche markets, exploring combination therapies, or developing new formulations for specific patient populations.

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References

[1] Grand View Research. (2022). Gastrointestinal Drugs Market Size, Share & Trends Analysis Report.
[2] American College of Gastroenterology. (2017). Practice Guidelines for Peptic Ulcer Disease.