ALLI Drug Patent Profile

Which patents cover Alli, and what generic alternatives are available?

Alli is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in ALLI is orlistat. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the orlistat profile page.

Summary for ALLI

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	103
Drug Prices:	Drug price information for ALLI
What excipients (inactive ingredients) are in ALLI?	ALLI excipients list
DailyMed Link:	ALLI at DailyMed

See drug prices for ALLI

Pharmacology for ALLI

Drug Class	Intestinal Lipase Inhibitor
Mechanism of Action	Lipase Inhibitors

Paragraph IV (Patent) Challenges for ALLI

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

US Patents and Regulatory Information for ALLI

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

Expired US Patents for ALLI

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

EU/EMA Drug Approvals for ALLI

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

International Patents for ALLI

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1021313
Germany	3466538
Australia	6097298
Slovenia	0921796
European Patent Office	0921796	COMPOSITIONS CONTENANT DE LA TETRAHYDROLIPSTATINE (TETRAHYDROLIPSTATIN CONTAINING COMPOSITIONS)
Finland	842422
New Zealand	332659	pharmaceutical compositions containing particles of tetrahydrolipstatin with a stabilizer and an excipient

Supplementary Protection Certificates for ALLI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0129748	SPC/GB98/044	United Kingdom		PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
0129748	98C0042	Belgium		PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729

Market Dynamics and Financial Trajectory for Alli

Last updated: February 15, 2026

Overview

Alli (orlistat) is an over-the-counter (OTC) weight management drug developed by GlaxoSmithKline (GSK). Approved initially in 1999 as a prescription medication under the name Xenical, it was reclassified to OTC status in 2007, aiming to capture growth within the weight loss segment. Its primary mechanism is lipase inhibition, reducing fat absorption.

Market Size and Growth

The global weight management market estimated at over $300 billion ranks Alli as a modest but strategically positioned product. Alli's share within the broader weight management sector remains limited compared to prescription drugs like Wegovy (semaglutide). However, Alli benefits from OTC accessibility, lower price points, and broader availability.

Key market drivers include escalating obesity rates: the World Health Organization reports that obesity has nearly tripled since 1975, affecting over 650 million adults globally. This trend elevates demand for weight loss solutions, including OTC options.

Competitive Landscape

Alli competes with prescription drugs, dietary supplements, lifestyle modifications, and new pharmacotherapies. Notable competitors include:

• Prescription drugs: Wegovy (semaglutide), Saxenda (liraglutide)
• Dietary supplements: ostarine, green tea extracts, and other herbal products
• Behavioral interventions facilitated through digital health platforms

While prescription drugs exhibit higher efficacy, their higher cost and prescription requirement limit accessibility, favoring Alli's OTC model for initial market penetration.

Sales Performance

Since launch, Alli's global sales have plateaued, with GSK reporting revenues around GBP 50 million ($65 million) annually in recent years. Market share within OTC weight management is estimated at approximately 2-3%.

In the United States, Alli's primary market, annual sales hover near $40-50 million, with fluctuations due to competitive pressures and consumer preferences. In 2019, GSK announced plans to transition marketing to more targeted health platforms, reflecting strategic adjustments rather than revenue growth ambitions.

Pricing and Revenue Model

Alli is sold OTC at a retail price ranging from $40 to $60 for a 60-tablet pack, with a typical dose of 60 mg twice daily. Pricing strategies are influenced by retail margins, pharmacy distribution, and competitive OTC weight loss supplements.

Gross margins are estimated at 60-70% on each pack sold, considering manufacturing, distribution, and marketing costs. The relatively low market penetration constrains overall revenue growth.

Regulatory and Policy Environment

The OTC status of Alli reduces regulatory hurdles compared to prescription drugs. However, regulatory agencies like the FDA monitor safety claims and labeling, especially concerning adverse effects like gastrointestinal discomfort and increased risk of liver injury.

In 2019, the FDA issued warnings on possible liver injury, leading to more prominent labeling. No new regulatory restrictions have been implemented, but heightened safety communications influence consumer perceptions and sales.

Emerging Trends and Future Outlook

• Market Expansion: Alli remains the low-cost, accessible option for weight management, especially among demographics reluctant to seek prescription treatment.
• Product Improvements: GSK is exploring formulations with fewer side effects, but no substantial innovations have entered the market.
• Digital Health Integration: Partnerships with health apps and telemedicine platforms aim to boost adherence and consumer engagement.
• Competitive Pressure: The advent of pharmacotherapies with higher efficacy and better tolerability could erode Alli’s market share, particularly if regulatory environments favor prescription options.

Financial Trajectory

Alli's revenues are expected to remain flat or decline modestly, constrained by market saturation and competition. GSK's focus appears to shift toward higher-margin, prescription-based obesity therapies like semaglutide derivatives, which target a growing pipeline with high efficacy.

Potential growth hinges on:

• Increased consumer adoption due to rising obesity rates.
• Expanded distribution channels, including digital platforms.
• Strategic repositioning against new OTC weight management products.

Risks

• Safety concerns may prompt regulatory or consumer shifts.
• Competitive dynamics favor more effective prescription therapies.
• Market saturation limits revenue growth.

Key Takeaways

• Alli operates in a competitive, mature OTC weight management segment with stagnant sales.
• The molecular mechanism and OTC status provide advantages in accessibility but limit growth.
• Health warnings and safety concerns influence consumer and regulatory perceptions.
• GSK's strategic shift toward prescription obesity treatments suggests limited future investment in Alli.
• Market expansion may occur through digital health integrations, yet overall revenue remains constrained.

FAQs

1. What is the primary mechanism of action for Alli?
Alli inhibits gastrointestinal lipase enzymes, reducing fat absorption by approximately 30%. This mechanism lowers caloric intake from dietary fats.

2. How does Alli compare to prescription weight loss drugs in efficacy?
Prescription drugs like semaglutide exhibit higher weight loss efficacy, often resulting in 15-20% total body weight reduction, compared to Alli’s average of 5%. Alli's modest effect limits its utility to mild cases or as adjunct therapy.

3. What are the main safety concerns with Alli?
Adverse effects include gastrointestinal symptoms (oily stools, flatulence), and, rarely, liver injury. Safety warnings have led to cautious use and consumer risk assessments.

4. How has regulatory policy impacted Alli’s market?
Regulatory agencies like the FDA maintain OTC status but have issued safety warnings, influencing consumer perceptions and limiting marketing claims. No recent restrictions have curtailed sales significantly.

5. What strategic options does GSK have for Alli’s future?
GSK may focus on niche marketing, digital health partnerships, or incremental formulation improvements. However, the company appears to pivot investments toward higher-efficacy prescription treatments targeting obesity.

---

References

[1] World Health Organization. Obesity and Overweight. 2022.
[2] GSK Annual Report 2022.
[3] FDA. FDA Drug Safety Communication. 2019.
[4] Market Research Future. Global Weight Management Market Report. 2022.