Orlistat - Generic Drug Details

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

Orlistat is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Cheplapharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for orlistat. Three suppliers are listed for this compound.

Summary for orlistat

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	64
Patent Applications:	6,603
Drug Prices:	Drug price trends for orlistat
What excipients (inactive ingredients) are in orlistat?	orlistat excipients list
DailyMed Link:	orlistat at DailyMed

See drug prices for orlistat

Recent Clinical Trials for orlistat

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

Sponsor	Phase
Empros Pharma AB	Phase 1
CTC Clinical Trial Consultants AB	Phase 1
Affiliated Hospital of Nantong University	Phase 1

See all orlistat clinical trials

Pharmacology for orlistat

Drug Class	Intestinal Lipase Inhibitor
Mechanism of Action	Lipase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for orlistat

A08AB	Peripherally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for ORLISTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALLI	Capsules	orlistat	60 mg	021887	1	2010-09-08

US Patents and Regulatory Information for orlistat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999		RX	Yes	Yes
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007		OTC	Yes	Yes

Expired US Patents for orlistat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999

EU/EMA Drug Approvals for orlistat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
CHEPLAPHARM Arzneimittel GmbH	Xenical	orlistat	EMEA/H/C/000154 Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors.Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.	Authorised	no	no	no	1998-07-29
GlaxoSmithKline (Ireland) Limited	Alli (previously Orlistat GSK)	orlistat	EMEA/H/C/000854 Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.	Authorised	no	no	no	2007-07-22

Market Dynamics and Financial Trajectory for the Drug: Orlistat

Introduction to Orlistat

Orlistat, a lipase inhibitor, is a widely used medication for the treatment of obesity. It works by reducing the absorption of fat from the diet, thereby aiding in weight loss. The global orlistat market has been experiencing significant growth, driven by various factors.

Market Size and Growth

The orlistat market has shown robust growth in recent years. As of 2023, the market size was valued at $2.85 billion, and it is expected to reach $3.03 billion in 2024, growing at a compound annual growth rate (CAGR) of 6.4%[1][3][4].

Forecasted Growth

The market is projected to continue its strong growth trajectory, reaching $3.91 billion by 2028 at a CAGR of 6.5%[1][3]. This forecasted growth is attributed to several key factors, including increasing healthcare spending on obesity treatments, sedentary lifestyles combined with unhealthy eating habits, government initiatives promoting weight loss and healthy living, an aging population, and the shift from prescription to over-the-counter options.

Key Drivers of the Orlistat Market

Growing Awareness of Obesity-Related Health Risks

The increasing awareness of the health risks associated with obesity has driven demand for effective weight loss medications like orlistat. As more people become aware of the dangers of obesity, the demand for orlistat is expected to rise[1].

Regulatory Approvals and Availability

Regulatory approvals for orlistat as both a prescription medication and in lower doses over-the-counter have significantly expanded its market reach. This dual availability has made orlistat more accessible to a broader range of consumers[1].

Physician Recommendations

Physician recommendations play a crucial role in the adoption of orlistat. Healthcare professionals often prescribe orlistat as part of a comprehensive weight loss plan, which has contributed to its market growth[1].

Increasing Costs of Obesity-Related Healthcare

The rising costs associated with obesity-related healthcare have prompted individuals and healthcare systems to seek effective and cost-efficient weight loss solutions, further driving the demand for orlistat[1].

Regional Market Analysis

North America

North America holds a significant share of the global orlistat market, with a market size of $1,260.88 million in 2024. This region is expected to grow at a CAGR of 4.3% from 2024 to 2031. The high prevalence of obesity and related health concerns, along with a diverse consumer base seeking both over-the-counter and prescription weight loss aids, drive this growth[4].

Europe

Europe accounts for over 30% of the global orlistat market revenue, with a market size of $945.66 million in 2024. The region is expected to grow at a CAGR of 4.6% from 2024 to 2031. The significant prevalence of obesity across Europe and supportive regulatory frameworks contribute to this growth[4].

Asia Pacific

The Asia Pacific region holds around 23% of the global orlistat market revenue, with a market size of $725.01 million in 2024. This region is expected to grow at a CAGR of 8.1% from 2024 to 2031, driven by rising obesity rates, particularly in countries undergoing rapid urbanization and lifestyle changes[4].

Middle East and Africa

In the Middle East and Africa, the orlistat market is smaller but growing, with a market size of $63.04 million in 2024 and a CAGR of 5.8% from 2024 to 2031. This growth is driven by urbanization, sedentary lifestyles, and changing dietary habits[4].

Competitive Landscape

The orlistat market is dominated by several key players, including Roche, GSK Group, Teva, Sandoz (Novartis), STADA-VN J.V.Co. Ltd, Hexal AG, National Company for Pharmaceutical Industry, and Lunan Pharmaceutical Group Corporation. These companies play a significant role in shaping the market through their strategic developments, product offerings, and distribution channels[2][5].

Emerging Trends

AI-Powered Diet Plans

The integration of AI in diet planning is becoming increasingly popular, offering personalized weight loss strategies that complement orlistat treatment. This trend is expected to enhance the effectiveness of orlistat by providing a holistic approach to weight management[3].

Telehealth Services

Telehealth services have expanded access to healthcare, including consultations for weight loss medications like orlistat. This trend is particularly beneficial in regions with limited healthcare infrastructure[3].

Automated Devices for Medication Adherence

Automated devices that remind patients to take their medications and track adherence are becoming more common. These devices can improve the efficacy of orlistat treatment by ensuring consistent use[3].

Virtual Reality Workouts

Virtual reality workouts are emerging as a new trend in fitness, offering engaging and immersive exercise experiences. These workouts can be part of a comprehensive weight loss plan that includes orlistat[3].

Digital Therapeutics

Digital therapeutics, which include mobile apps and other digital tools for health management, are gaining traction. These tools can support orlistat treatment by providing behavioral interventions and monitoring progress[3].

SWOT and PESTLE Analysis

SWOT Analysis

• Strengths: Strong brand recognition, wide availability, and regulatory approvals.
• Weaknesses: Side effects, competition from alternative weight loss solutions.
• Opportunities: Growing demand for weight loss medications, expanding into new markets.
• Threats: Regulatory hurdles, competition from new entrants[2].

PESTLE Analysis

• Political: Government initiatives promoting weight loss and healthy living.
• Economic: Increasing healthcare spending on obesity treatments.
• Social: Rising awareness of obesity-related health risks.
• Technological: Integration of AI, telehealth services, and digital therapeutics.
• Legal: Regulatory approvals and compliance.
• Environmental: Lifestyle changes and urbanization[2].

Financial Trajectory

The financial trajectory of the orlistat market is promising, with a projected growth from $2.85 billion in 2023 to $3.91 billion by 2028. The CAGR of 6.5% indicates a steady and robust growth path. Here are some key financial highlights:

• Global Market Size 2024: $3.03 billion[1][3][4].
• Global Market Size 2028: $3.91 billion[1][3].
• CAGR 2024-2028: 6.5%[1][3].
• Regional Market Sizes:
  • North America: $1,260.88 million in 2024, growing at a CAGR of 4.3%[4].
  • Europe: $945.66 million in 2024, growing at a CAGR of 4.6%[4].
  • Asia Pacific: $725.01 million in 2024, growing at a CAGR of 8.1%[4].
  • Middle East and Africa: $63.04 million in 2024, growing at a CAGR of 5.8%[4].

Key Takeaways

• The orlistat market is experiencing robust growth driven by increasing awareness of obesity-related health risks, regulatory approvals, and physician recommendations.
• The market is projected to reach $3.91 billion by 2028 at a CAGR of 6.5%.
• Regional markets, particularly North America, Europe, and Asia Pacific, are significant contributors to the global market size.
• Emerging trends such as AI-powered diet plans, telehealth services, and digital therapeutics are expected to enhance the market.
• Key players in the market include Roche, GSK Group, Teva, and others.

FAQs

What is the current market size of the global orlistat market?

The current market size of the global orlistat market is $3.03 billion as of 2024[1][3][4].

What is the projected growth rate of the orlistat market from 2024 to 2028?

The orlistat market is projected to grow at a CAGR of 6.5% from 2024 to 2028[1][3].

Which regions are the major contributors to the global orlistat market?

North America, Europe, and Asia Pacific are the major contributors to the global orlistat market[4].

What are some of the key drivers of the orlistat market?

Key drivers include growing awareness of obesity-related health risks, regulatory approvals, physician recommendations, and increasing costs of obesity-related healthcare[1].

What emerging trends are expected to impact the orlistat market?

Emerging trends include AI-powered diet plans, telehealth services, automated devices for medication adherence, virtual reality workouts, and digital therapeutics[3].

Sources

1. The Business Research Company, "Orlistat Market Size, Share, Revenue, Trends, and Drivers For 2024-2033"[1].
2. Market Research Guru, "Orlistat Market 2024: Growth Analysis by Strategic Developments, Market Size, and Future Projections by 2032"[2].
3. Research and Markets, "Orlistat Market Size, Competitors, Trends & Forecast to 2028"[3].
4. Cognitive Market Research, "Orlistat Market will grow at a CAGR of 6.10% from 2024 to 2031"[4].
5. EIN Presswire, "Orlistat Market Detailed In New Research Report 2022 | Roche Holding AG, GlaxoSmithKline, Teva Pharmaceutical Industries"[5].