Lactulose - Generic Drug Details

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

Lactulose is the generic ingredient in fourteen branded drugs marketed by Cumberland Pharms, Sanofi Aventis Us, Alra, Actavis Mid Atlantic, Solvay, Teva Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Vistapharm, Xttrium Labs Inc, Nostrum Labs, Bajaj, Pai Holdings Pharm, and Roxane, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for lactulose. Eighteen suppliers are listed for this compound.

Summary for lactulose

US Patents:	0
Tradenames:	14
Applicants:	22
NDAs:	36
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	149
Patent Applications:	6,873
Drug Prices:	Drug price trends for lactulose
Drug Sales Revenues:	Drug sales revenues for lactulose
What excipients (inactive ingredients) are in lactulose?	lactulose excipients list
DailyMed Link:	lactulose at DailyMed

See drug prices for lactulose

See drug sales revenues for lactulose

Recent Clinical Trials for lactulose

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

Sponsor	Phase
Project Peanut Butter	N/A
Washington University School of Medicine	N/A
Ministry of Health and Sanitation, Sierra Leone	N/A

See all lactulose clinical trials

Pharmacology for lactulose

Drug Class	Osmotic Laxative
Mechanism of Action	Acidifying Activity Osmotic Activity
Physiological Effect	Stimulation Large Intestine Fluid/Electrolyte Secretion

Medical Subject Heading (MeSH) Categories for lactulose

Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for lactulose

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for lactulose

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pai Holdings Pharm	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	074077-001	Jul 3, 1995		DISCN	No	No
Fresenius Kabi	LACTULOSE	lactulose	SOLUTION;ORAL	090503-001	Jan 25, 2012	AA	RX	No	No
Bajaj	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	076645-001	Jul 28, 2003	AA	RX	No	No
Ani Pharms	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	090426-001	Nov 21, 2008		DISCN	No	No
Chartwell Rx	LACTULOSE	lactulose	SOLUTION;ORAL	209517-001	Nov 23, 2018	AA	RX	No	No
Apozeal Pharms	LACTULOSE	lactulose	SOLUTION;ORAL	207786-001	Jun 11, 2018	AA	RX	No	No

Expired US Patents for lactulose

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,461,204
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,867,524
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,860,708
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,860,707
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,558,774
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,562,388

Lactulose Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Lactulose

Introduction to Lactulose

Lactulose, a synthetic disaccharide composed of galactose and fructose, is widely used in medical and food applications. Its unique properties make it a valuable asset in treating various health conditions, including constipation, hepatic encephalopathy, and other gastrointestinal disorders.

Global Market Size and Growth

The global lactulose concentrate market has been experiencing steady growth. As of 2022, the market size was valued at USD 152.9 million and is projected to reach USD 176.4 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 1.6% during the forecast period[1].

Another report indicates that the lactulose concentrate solution market was valued at USD 152.1 million in 2023 and is expected to grow to USD 172.9 million by 2031, with a CAGR of 1.7% from 2024 to 2031[2].

Driving Factors

Increased Health Awareness and Demand for Treatment

The COVID-19 pandemic has significantly boosted the demand for lactulose concentrate, driven by increased awareness about healthy lifestyles and the need to enhance immunity. This demand is expected to continue as people seek effective treatments for constipation, inflammatory bowel diseases, and other gastrointestinal issues[1].

Pharmaceutical Sector Growth

The pharmaceutical sector is a major driver of the lactulose market. The medication is prescribed for various conditions, including chronic constipation, hepatic encephalopathy, and colon carcinogenesis. The growing need for effective gastrointestinal medications, especially among the aging population, is propelling market growth[2].

Functional Foods and Dietary Needs

Lactulose is also used in the food industry as a sweetener and bulking agent in low-calorie and diabetic-friendly products. This application contributes to market expansion, driven by increasing health consciousness among consumers and the expanding geriatric population globally[2].

Regional Insights

Asia Pacific

The Asia Pacific region is expected to hold the largest market share due to the high demand for lactulose to treat constipation and liver diseases. The region's growing R&D activities in developing lactulose concentrate solutions are also anticipated to expand market growth[1].

North America

North America is estimated to hold a significant revenue share in the lactulose concentrate solution market. This is attributed to the region's strong pharmaceutical and food industries, which actively incorporate lactulose into various products. The well-established healthcare infrastructure and high prevalence of digestive health issues in North America further drive the demand for lactulose concentrate solutions[2].

Production and Quality

Enzymatic Method

The enzymatic method of producing lactulose concentrate solutions is gaining prominence due to its advantages such as high purity, precise control over reaction conditions, enhanced yield, and reduced environmental impact. This method is particularly favored in pharmaceutical and food applications[2].

Competitive Landscape

The lactulose market is characterized by several key players, including Abbott, Fresenius Kabi, Illovo Sugar, Morinaga, Biofac, and Dandong Kangfu. These companies compete through product innovation, strategic partnerships, and geographical expansions to strengthen their market position. Regulatory approvals and certifications are crucial for these players to ensure consumer confidence and compliance with industry standards[2].

Challenges and Limitations

Supply and Demand Gaps

Despite the growing demand, the lactulose market faces challenges such as gaps in supply and demand, particularly during periods of high demand. Additionally, fluctuating raw material prices and stringent regulatory requirements can hamper market growth[1][2].

Recent Developments

• Biofac obtained regulatory approvals for its lactulose concentrate solution products in various regions in 2022, enabling the company to expand its product portfolio and reach new customer segments[2].
• Abbott introduced new formulations and improved existing ones in 2021 to cater to evolving consumer preferences and market demands[2].

Mechanism of Action and Therapeutic Uses

Lactulose works by reducing intestinal ammonia production and absorption, which is beneficial in treating hepatic encephalopathy. It also acts as a laxative by increasing intraluminal gas formation and osmolality, reducing transit time and intraluminal pH. This makes it effective in treating constipation and other gastrointestinal disorders[5].

Financial Projections

The global lactulose market is forecasted to grow significantly over the next few years. Here are some key financial projections:

• The lactulose concentrate market is expected to reach USD 176.4 million by 2031, growing at a CAGR of 1.6% from 2022 to 2031[1].
• The lactulose concentrate solution market is projected to reach USD 172.9 million by 2031, with a CAGR of 1.7% from 2024 to 2031[2].
• Another forecast indicates that the global lactulose market will be worth USD 217.4 million by 2030, growing at a CAGR of 3.6% from 2024 to 2030[4].

Key Takeaways

• The lactulose market is driven by increasing health awareness, growing demand for gastrointestinal treatments, and expanding applications in the food industry.
• The Asia Pacific and North America regions are expected to be significant contributors to market growth.
• Key players are focusing on product innovation, regulatory compliance, and geographical expansions.
• Despite challenges, the market is projected to continue its growth trajectory.

FAQs

What is the expected market size of the lactulose concentrate market by 2031?

The lactulose concentrate market is expected to reach USD 176.4 million by 2031[1].

What is the CAGR of the lactulose concentrate solution market from 2024 to 2031?

The lactulose concentrate solution market is expected to exhibit a CAGR of 1.7% from 2024 to 2031[2].

Which regions are expected to drive the lactulose market growth?

The Asia Pacific and North America regions are expected to be significant drivers of market growth due to high demand and strong healthcare infrastructure[1][2].

What are the primary therapeutic uses of lactulose?

Lactulose is primarily used to treat constipation, hepatic encephalopathy, and other gastrointestinal disorders[5].

Who are the key players in the lactulose market?

Key players include Abbott, Fresenius Kabi, Illovo Sugar, Morinaga, Biofac, and Dandong Kangfu[2].

Sources

1. Business Research Insights: Lactulose Concentrate Market | Global Industry Report, 2031.
2. InsightAce Analytic: Lactulose Concentrate Solution Market Deep Analysis Report 2024.
3. Cognitive Market Research: Global Lactulose Market Report 2024 Edition.
4. Valuates Reports: Lactulose - Market, Report Size, Worth, Revenue, Growth, Industry.
5. NCBI Bookshelf: Lactulose - StatPearls.