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-three 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:	13
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
LCMC Health	N/A
Ochsner Health System	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

International Patents for CARAFATE

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

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

CARAFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Carafate (Sucralfate)

Introduction to Carafate (Sucralfate)

Carafate, known generically as sucralfate, is a cytoprotective agent used primarily to treat and prevent ulcers in the upper gastrointestinal tract. It works by forming a protective barrier over the ulcer site, shielding it from stomach acid and promoting healing.

Market Size and Growth

The global sucralfate market, which includes Carafate, was valued at USD 500 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2021 to 2033[3].

Regional Market Analysis

• North America: This region dominated the global sucralfate market in 2021, accounting for over 40% of the market share. The high prevalence of gastrointestinal disorders, well-established healthcare infrastructure, and the adoption of novel drug delivery systems are key drivers in this region[3].
• Europe: Europe is another significant market, driven by the high prevalence of gastrointestinal disorders, a rising geriatric population, and the demand for non-invasive treatments[3].
• Asia Pacific: This region is expected to witness the fastest growth due to the increasing prevalence of gastrointestinal disorders, rising healthcare expenditure, and the demand for affordable treatments[3].

Market Drivers

Increasing Prevalence of Gastrointestinal Disorders

The rising incidence of peptic ulcers, gastritis, and other gastrointestinal disorders is a significant driver for the sucralfate market. For instance, in the U.S., duodenal ulcers have a prevalence of 6% to 12%, and Helicobacter pylori infections are associated with a substantial portion of these ulcers[5].

Aging Population

The aging population is more susceptible to gastrointestinal problems, which increases the demand for medications like sucralfate. This demographic shift is particularly influential in regions like North America and Europe[3].

Personalized Medicine and Alternative Formulations

There is a growing trend toward personalized medicine, where treatment plans are tailored to individual patient needs. Additionally, the development of alternative formulations such as chewable tablets and liquid suspensions is catering to patient preferences and ease of administration[1].

Financial Trajectory

Revenue and Market Share

• The U.S. sucralfate market, which includes Carafate, was valued at US$ 296.2 million in 2017 and is expected to grow at a CAGR of 3.1% from 2018 to 2026[5].
• The tablet segment dominates the market, accounting for over 70% of the global revenue share due to its ease of administration and widespread availability[3].

Key Players and Market Strategies

The global sucralfate market is highly competitive, with key players focusing on strategies such as mergers and acquisitions, product launches, and geographical expansions. For example, Mylan N.V. acquired the non-sterile dermatology and topical medicine business of Renaissance Acquisition Holdings, LLC, which includes the sucralfate brand Carafate, to expand its dermatology portfolio[3].

Financial Performance of Related Companies

While Cara Therapeutics is not directly associated with Carafate, it provides insight into the financial dynamics of pharmaceutical companies in the gastrointestinal treatment space. Cara Therapeutics reported a net loss of $118.5 million for the full year 2023, with total revenue of $20.968 million. The company's financial performance is influenced by its focus on late-stage clinical programs and collaborations with other companies[4].

Distribution Channels and Market Share

Hospital Pharmacies

Hospital pharmacies account for the largest market share due to the increasing number of hospital admissions for gastrointestinal complications and the rising demand for inpatient ulcer treatment[3].

Retail Pharmacies and Online Platforms

Retail pharmacies and online platforms also play a significant role, especially with the increasing preference for home care and self-administration of medications.

Competitive Landscape

The market is characterized by the presence of both large multinational companies and small and medium-sized enterprises (SMEs), particularly in regions like Asia Pacific and Latin America. Companies are focusing on innovative drug delivery systems, such as sustained-release and mucoadhesive formulations, to strengthen their market position[3].

Future Outlook

Growth Opportunities

• The development of novel drug delivery systems and the increasing demand for generic drugs, especially in emerging economies, are expected to drive market growth[3].
• The rising geriatric population and the increasing prevalence of gastrointestinal disorders will continue to fuel the demand for sucralfate.

Challenges

• Side effects associated with long-term use of sucralfate and the availability of alternative ulcer treatments may hamper market growth.
• Stringent regulations and quality standards for pharmaceuticals, as well as increasing competition from regional and local players, could affect market dynamics[3].

Key Takeaways

• The global sucralfate market is driven by the increasing prevalence of gastrointestinal disorders and an aging population.
• North America and Europe are significant markets due to well-established healthcare infrastructure and high healthcare expenditure.
• The market is expected to grow at a CAGR of 4.5% from 2021 to 2033.
• Key players are focusing on mergers and acquisitions, product launches, and geographical expansions.
• Novel drug delivery systems and the demand for generic drugs are expected to drive future growth.

FAQs

What is the primary use of Carafate (Sucralfate)?

Carafate (Sucralfate) is primarily used to treat and prevent ulcers in the upper gastrointestinal tract by forming a protective barrier over the ulcer site.

Which regions dominate the global sucralfate market?

North America and Europe dominate the global sucralfate market, with North America accounting for over 40% of the market share.

What are the key drivers of the sucralfate market?

The key drivers include the increasing prevalence of gastrointestinal disorders, an aging population, and the trend toward personalized medicine and alternative formulations.

What is the expected growth rate of the global sucralfate market?

The global sucralfate market is expected to grow at a CAGR of 4.5% from 2021 to 2033.

What challenges might affect the sucralfate market growth?

Challenges include side effects associated with long-term use, the availability of alternative treatments, stringent regulations, and increasing competition from regional players.

Sources

1. IMARC Group: Sucralfate (Carafate) Manufacturing Plant Report: Setup Cost.
2. GlobeNewswire: Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results.
3. DataHorizon Research: Sucralfate Market Size, Share & Forecast 2033.
4. Cara Therapeutics: Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results.
5. Coherent Market Insights: U.S. Sucralfate Market Size, Trends and Forecast to 2026.