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, Pai Holdings, 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, Pharmobedient, Taro, Vistapharm Llc, Nostrum Labs, Bajaj, Pai Holdings Pharm, Roxane, and Sciegen Pharms Inc, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for lactulose. Twenty-one suppliers are listed for this compound.

Summary for LACTULOSE

US Patents:	0
Tradenames:	14
Applicants:	25
NDAs:	38
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	165
Patent Applications:	7,497
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
Laval University	NA
General Hospital of Shenyang Military Region	NA
Post Graduate Institute of Medical Education and Research, Chandigarh	PHASE4

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
Pharm Assoc	LACTULOSE	lactulose	SOLUTION;ORAL	074623-001	Jul 30, 1996	AA	RX	No	Yes
Paco	LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	072029-001	Aug 25, 1992		DISCN	No	No
Morton Grove	GENERLAC	lactulose	SOLUTION;ORAL, RECTAL	071842-001	Sep 27, 1988		DISCN	No	No
Lannett Co Inc	LACTULOSE	lactulose	SOLUTION;ORAL	075993-001	Jul 26, 2001	AA	RX	No	No
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cumberland Pharms	LACTULOSE	lactulose	FOR SOLUTION;ORAL	074712-001	Dec 10, 1997	AA	RX	No	Yes
Actavis Mid Atlantic	ENULOSE	lactulose	SOLUTION;ORAL, RECTAL	071548-001	Aug 15, 1988		DISCN	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	3,860,707
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	3,562,388
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,558,774

Market Dynamics and Financial Trajectory for Lactulose

Last updated: October 15, 2025

Introduction

Lactulose, a synthetic disaccharide used primarily as a laxative and in managing hepatic encephalopathy, has sustained a significant presence within the pharmaceutical landscape. Its unique mechanism, coupled with expanding indications, positions lactulose as a critical asset in gastrointestinal and neuropsychiatric therapy. This analysis explores the current market landscape, growth drivers, competitive dynamics, regulatory factors, and financial outlook shaping lactulose's future trajectory.

Market Overview and Growth Drivers

Global Market Size and Trends

The global lactulose market was valued at approximately USD 350 million in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4-6% over the next five years [1]. The expansion is driven by rising prevalence of liver diseases, increasing geriatric populations, and growing awareness of bowel health management.

Key Indications and Expanding Usage

Lactulose's primary indications include:

• Chronic Constipation: A long-standing use, enhanced by increasing consumer health consciousness.
• Hepatic Encephalopathy: The dominant therapeutic usage, where lactulose reduces ammonia absorption, thereby improving neurocognitive functions in patients with cirrhosis.

Emerging uses in bowel cleansing procedures and diverticulitis management further diversify its application base.

Prevalence of Target Conditions

The global burden of liver cirrhosis and chronic constipation substantially influences demand. The World Health Organization estimates over 1.5 billion individuals globally suffer from chronic constipation, and liver cirrhosis accounts for approximately 1 million deaths annually [2], fostering a continual need for effective treatments like lactulose.

Demographic and Lifestyle Factors

An aging global population and lifestyle factors such as high-fat diets and sedentarism fuel gastrointestinal disorders, reinforcing demand projections. Additionally, increasing healthcare awareness facilitates earlier intervention, boosting market size.

Competitive Landscape and Market Players

Key Manufacturers

Leading companies include:

• Ursapharm (Germany)
• Fresenius Kabi (Germany)
• Mylan (USA)
• LGM Pharma (India)
• Hovid (Malaysia)

These entities hold dominant shares, leveraging manufacturing expertise, established distribution channels, and regulatory approvals.

Generic vs. Branded Formulations

The market is predominantly composed of generics, making competitive pricing a decisive factor. Patent expirations of formulations have led to a proliferation of low-cost alternatives, intensifying price competition.

Research and Development

While current formulations are well-established, ongoing R&D focuses on novel delivery mechanisms to enhance patient compliance, such as sachets, liquid formulations with improved taste, and combination therapies.

Regulatory and Patent Considerations

Regulatory Pathways

Lactulose is generally recognized as safe (GRAS) and has widespread regulatory approval, facilitating rapid market access. However, formulation-specific patents can affect market exclusivity periods.

Patent Expirations and Market Entry Barriers

The expiration of patents on key formulations has opened avenues for competitors but also increased market penetration challenges for biosimilar entrants. Regulatory hurdles, especially for new delivery systems, remain a barrier to innovation-driven market share growth.

Pricing Trends and Reimbursement Landscape

Price margins remain compressed, especially in mature markets like the U.S. and EU, due to price regulation and competitive generic offerings. Reimbursement policies generally favor cost-effective therapies, emphasizing the importance of pricing strategies for market sustainability.

Future Financial Trajectory and Market Drivers

Projected Growth Factors

• Increasing prevalence of liver diseases: Growing burden of hepatitis, alcohol-related cirrhosis, and non-alcoholic fatty liver disease (NAFLD) predicts sustained demand.
• Healthcare infrastructure expansion: Emerging markets in Asia-Pacific, Africa, and Latin America are investing in healthcare, increasing access and utilization.
• Ethnic and demographic shifts: Aging populations in Europe and North America position lactulose as a staple in chronic disease management.

Market Challenges

• Pricing pressures: Economies of scale and competition may exert downward price forces.
• Competition from alternative therapies: Newer neurotherapy agents and laxatives could challenge lactulose's market share.
• Formulation challenges: Improving palatability and patient adherence remains an ongoing concern.

Financial Outlook

Based on historical growth and current demand dynamics, annual revenues are expected to reach USD 500-600 million by 2028, with select markets offering higher margins due to localized pricing and reimbursement policies.

Strategic Opportunities

• Product innovation: Developing more palatable formulations and combination therapies can expand usage.
• Market penetration: Targeting underserved emerging markets presents significant growth prospects.
• Regulatory engagement: Streamlining approval processes for new indications will accelerate revenue streams.

Conclusion

Lactulose's market remains robust, driven by high-prevalence indications and aging populations. The financial trajectory indicates steady growth, contingent on effective competitive strategies, regulatory navigation, and innovation adoption. Companies that can optimize supply chains, tailoring formulations to diverse markets while managing pricing pressures, stand to capitalize on the evolving landscape.

Key Takeaways

• The global lactulose market is projected to grow at a CAGR of 4-6%, driven mainly by gastrointestinal and hepatic indications.
• Patent expirations and the rise of generics have intensified price competition, demanding strategic positioning from manufacturers.
• Emerging markets and aging demographic trends present significant revenue growth avenues.
• Innovation in formulation and targeted marketing are critical to differentiate and expand share.
• Regulatory stability and reimbursement policies profoundly influence market stability and profit margins.

FAQs

1. What are the main therapeutic indications for lactulose?
Lactulose is primarily used for chronic constipation and hepatic encephalopathy. Emerging applications include bowel cleansing and diverticulitis management.

2. How does patent expiration impact lactulose market dynamics?
Patent expiries facilitate generic entry, lowering prices and increasing accessibility. However, they also challenge brand loyalty and profit margins for originators.

3. What challenges do companies face in expanding lactulose markets?
Pricing competition, formulation preferences, regulatory hurdles, and competition from newer therapies pose significant challenges.

4. Which regions are expected to drive future lactulose demand?
Emerging markets in Asia-Pacific, Africa, and Latin America, along with aging populations in North America and Europe, will significantly influence future demand.

5. How can manufacturers sustain profitability amid price pressures?
Investing in formulation innovation, entering new indications, expanding regional presence, and optimizing supply chain efficiency are vital strategies.

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References

[1] MarketDataForecast, "Lactulose Market Forecast," 2022.
[2] WHO, "Global Burden of Liver Diseases," 2021.