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:	76
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
The Fourth Affiliated Hospital of Zhejiang University School of Medicine	PHASE4
XueMei Guo	NA
The People's Hospital of Liaoning Province	NA

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
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007		OTC	Yes	Yes
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999		RX	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
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007

EU/EMA Drug Approvals for orlistat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Alli (previously Orlistat GSK)	orlistat	EMEA/H/C/000854Alli 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
CHEPLAPHARM Arzneimittel GmbH	Xenical	orlistat	EMEA/H/C/000154Xenical 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

Market Dynamics and Financial Trajectory for Orlistat

Last updated: February 19, 2026

Orlistat is a gastrointestinal lipase inhibitor used for weight management and obesity treatment. Approved by the FDA in 1999, it has maintained a substantial presence in the obesity pharmacotherapy market. Market dynamics are shaped by regulatory, competitive, and consumer preference factors; financial trajectories are driven by sales volumes, pricing strategies, patent status, and the emergence of generics.

Market Size and Growth Trends

The global obesity drug market valuation was approximately USD 13 billion in 2021, with orlistat accounting for a significant portion. The market is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030, driven by rising obesity prevalence, especially in North America and parts of Asia.

Year	Market Size (USD Billion)
2021	13
2025	17.5
2030	22.8

In the U.S., orlistat's market share remains stable, with sales estimates around USD 400 million annually. Emerging markets exhibit higher growth potential due to increasing obesity rates and expanding healthcare access.

Regulatory Environment and Patent Status

Orlistat's original patent expired in 2010 in the U.S. and Europe; subsequent formulations and delivery methods have secured secondary patents extending exclusivity until 2025. The expiration triggered a surge in generic manufacturing, intensifying price competition.

Competitive Landscape

The market features several key players:

• Allergan (now part of AbbVie): Originally marketed Xenical; holds proprietary formulations.
• Generic Manufacturers: Offer cost-effective versions post-patent expiry.
• New Entrants & Alternatives: GLP-1 receptor agonists like liraglutide and semaglutide have gained traction for obesity treatment, challenging orlistat's market position.

The emergence of GLP-1 receptor agonists has caused a decline in orlistat's relative market share, especially due to superior efficacy and tolerability profiles.

Pricing and Revenue Trends

Orlistat's retail price varies:

Region	Approximate Price (USD) for a 30-day supply
U.S.	USD 90–USD 120 (brand and generic)
Europe	EUR 70–EUR 100
Asia	USD 30–USD 60

Post-generic entry, prices have fallen by approximately 40%. Revenue trajectories are sensitive to patent litigation, generic penetration, and competitive pressures from new drugs.

Market Challenges and Opportunities

• Challenges:

  • Limited efficacy compared to newer drugs.
  • Gastrointestinal side effects reduce adherence.
  • Patent expiries induce revenue decline.

• Opportunities:

  • Reformulation with improved delivery methods.
  • Combination therapies with other obesity drugs.
  • Growing global obesity prevalence expands market scope.

Financial Outlook

Projected revenues for orlistat are expected to decline by approximately 3–5% annually over the next five years, primarily due to generic competition and market shift towards newer therapies. Nonetheless, it remains a cost-effective option in low- and middle-income countries.

Summary

Aspect	Details
Market size (2021)	USD 13 billion globally
CAGR (2022–2030)	7%
Patent expiry	2010 (generic entry), secondary patents until 2025
Key competitors	Generic companies, GLP-1 receptor agonists
Pricing (US)	USD 90–USD 120/month
Revenue trend	Declining at 3–5% annually over next 5 years

Key Takeaways

• Orlistat remains a significant weight management drug but faces declining revenues due to generics and newer treatments.
• Expansion into emerging markets offers growth opportunities despite affordability constraints.
• Continued innovation and strategic positioning are critical for maintaining relevance amid evolving obesity treatment paradigms.

FAQs

1. How has patent expiration affected orlistat's sales?
It led to increased generic competition, reducing prices by approximately 40% and decreasing revenues by 3–5% annually.

2. What are the main competitors to orlistat?
GLP-1 receptor agonists such as liraglutide and semaglutide, which show higher efficacy and better tolerability.

3. Are there regulatory barriers to generic versions?
Secondary patents and formulation patents can delay generic entry until around 2025, depending on jurisdiction.

4. Can orlistat be combined with other weight loss drugs?
Currently ineffective due to regulatory and safety considerations; research on combination therapies is ongoing.

5. What market segments could restore orlistat's growth?
Low-cost formulations in emerging markets and development of improved delivery systems.

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References

1. Market Research Future. (2022). Obesity drug market research report.
2. U.S. Food and Drug Administration. (2019). FDA approval documents for orlistat.
3. GlobalData. (2022). Pharmaceutical market analysis.
4. IQVIA. (2022). Global prescription drug sales report.
5. European Medicines Agency. (2010). Summary of opinion on patent expiry and generic entry.