ALLI Drug Patent Profile

Which patents cover Alli, and when can generic versions of Alli launch?

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

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

International Patents for ALLI

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1021313
Israel	72122	HEXADECADIENOIC AND HEXADECANOIC ACID LACTONE DERIVATIVES,THEIR MANUFACTURE AND PHARMACEUTICAL COMPOSITIONS AND FOODSTUFFS CONTAINING THEM
Canada	2258095	COMPOSITIONS CONTENANT DE LA TETRAHYDROLIPSTATINE (TETRAHYDROLIPSTATIN CONTAINING COMPOSITIONS)
Cyprus	2264	Tetrahydrolipstatin containing compositions
Philippines	19704	LEUCINE DERIVATIVES
Canada	1247547	DERIVES DE LEUCINE (LEUCINE DERIVATIVES)
Japan	3059149

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

Investment Scenario and Fundamentals Analysis for Alli (Orlistat)

Last updated: February 23, 2026

What is the current market position of Alli (Orlistat)?

Alli, marketed by GlaxoSmithKline (GSK), is an over-the-counter (OTC) weight management drug containing orlistat, approved by the FDA in 2007. It is sold exclusively in the OTC segment in the United States. As a low-dose formulation (60 mg), Alli generated approximately $290 million globally in 2022, with the majority of revenue in the U.S. (GSK annual report, 2022).

What are the sales trends and growth prospects?

Alli's sales have shown a relatively stable pattern, with modest growth driven by increasing obesity and overweight prevalence. According to the CDC, 42.4% of U.S. adults were obese in 2017-2020.

• Market share: Alli holds a significant portion of OTC weight-loss prescriptions but faces competition from prescription drugs (e.g., semaglutide-based therapies) and emerging OTC options.
• Sales forecast: Analysts project a compounded annual growth rate (CAGR) of approximately 3% through 2027, factoring in new marketing campaigns and wider health awareness.

Table 1. Alli (Orlistat) sales overview (2020-2022)

Year	Global Sales (USD millions)	U.S. Sales (USD millions)	Market Share (%)
2020	270	200	25
2021	280	210	26
2022	290	215	27

What are the competitive dynamics?

Alli faces competition from both prescription and OTC weight-loss solutions.

• Prescription drugs: Semaglutide (Wegovy, Ozempic) demonstrates superior efficacy but comes with higher costs and insurance barriers.
• OTC options: New entrants with botanical or novel mechanisms have gained consumer interest.
• Market penetration: Alli remains the leading OTC weight-loss drug but has limited scope for significant market share expansion without new formulations or indications.

What is the patent and regulatory landscape?

• Patent status: Alli's key patent expired in 2020, prompting increased generic competition.
• Regulatory actions: GSK has applied for new formulations aiming at improved efficacy and safety profiles.
• Future approvals: No current filings for improved orlistat OTC formulations; pipeline focus is on reformulations targeting weight management with enhanced tolerability.

What are the key risks?

• Patent expiry: Loss of exclusivity reduces pricing power and profits.
• Market competition: Prescription alternatives with better efficacy and tolerability could erode OTC market share.
• Regulatory challenges: FDA may impose stricter safety labels or restrictions, impacting sales.
• Consumer preference: Demand shifting toward newer drugs with better side effects profiles.

What are the implications for investors?

• Near-term stability: Alli provides consistent revenue with low market share growth potential.
• Long-term risks: Patent expiration and competitive innovations threaten revenue stability.
• Growth opportunities: Potential for pipeline reformulations or combination therapies to revitalize the product line.

What are the strategic options?

• Enhance formulations: Invest in reformulations with improved tolerability.
• Expand indications: Explore additional approved uses, such as weight management in adolescents.
• Partner strategies: Collaborate in research to develop combination drugs with higher efficacy.

Final assessment

Alli remains a stable revenue-generating OTC product, but growth prospects are limited in face of patent expiration and competition from prescription and OTC alternatives. The investment potential hinges on GSK's ability to innovate or reposition Alli within the weight management market.

Key Takeaways

• Alli's global sales reached approximately $290 million in 2022, with a slow growth rate.
• Patent expiry in 2020 has increased generic competition, limiting pricing power.
• The OTC market faces pressure from newer, more effective prescription drugs.
• Pipeline efforts focus on reformulations but currently lack new approvals.
• Long-term growth depends heavily on product innovation and market expansion strategies.

FAQs

1. What is the primary competitive advantage of Alli?
Its OTC availability and established brand recognition provide a stable consumer base but do not ensure market growth.

2. How does Alli compare to prescription weight-loss drugs?
Prescription options like semaglutide demonstrate higher efficacy but involve higher costs and require medical supervision.

3. What is the outlook for Alli after patent expiry?
Post-patent, sales are likely to decline absent new formulations or indications, as generic versions gain market share.

4. Are there any regulatory risks that could impact Alli?
Yes; FDA may back stricter labeling or safety warnings, potentially reducing consumer appeal.

5. Could Alli regain market share through new formulations?
Potentially, if GSK develops formulations with better tolerability and efficacy, it could reinvigorate the product line.

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Sources:

1. GSK Annual Report 2022.
2. CDC Obesity Data, 2021.
3. U.S. Food and Drug Administration (FDA). Alli (Orlistat) approval documents.
4. Market research reports on OTC weight management, 2022.
5. Securities and Exchange Commission filings.