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	4,598,089
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	6,004,996

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
China	1193752
Germany	19875045
Ireland	841566

Supplementary Protection Certificates for ALLI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0129748	98C0042	Belgium		PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALLI

Last updated: July 27, 2025

Introduction

Alli (orlistat 60 mg), a non-prescription weight management medication, has positioned itself as a significant player in the global obesity management market. Originally approved by the FDA in 1999 as a prescription drug (Xenical), its over-the-counter (OTC) version, Alli, launched in 2007, has redefined access and consumer behavior within this sector. This report outlines the market dynamics and financial trajectory of Alli, considering evolving competitive landscapes, regulatory changes, consumer adoption patterns, and broader healthcare trends.

Market Overview

Global Obesity and Weight Management Market

The global obesity management market worth approximately USD 1.0 billion in 2022 is projected to grow at a CAGR of around 4.8% through 2030 [1]. The rising prevalence of obesity, driven by sedentary lifestyles, unhealthy diets, and genetic factors, sustains demand for pharmacological interventions. Alli, as a non-prescription option, addresses consumer need for accessible, over-the-counter weight control solutions, leveraging the increasing demand for convenient, low-cost weight management options.

Positioning and Market Share of Alli

Aligned with other pharmaceutical products for obesity, Alli’s core competitive advantage lies in its OTC availability, differentiating it from prescription options like Xenical. As of 2022, Alli holds approximately 15-20% of the global OTC weight management market share, mainly in North America and Europe [2]. Its appeal benefits from affordability and familiarity, directly competing with herbal supplements and other OTC weight loss products.

Market Drivers

• Rising Obesity Rates: Global obesity prevalence has nearly tripled since 1975, with over 650 million adults classified as obese [3]. This fuels demand for pharmacological interventions.

• Consumer Preference for OTC Options: Increased consumer preference for at-home treatment options, driven by cost, convenience, and stigma around weight management, bolsters Alli’s market position.

• Regulatory Environment: Relaxation in OTC drug regulations and FDA approvals facilitates wider distribution and marketing.

• Healthcare Cost Pressures: Healthcare systems’ push towards preventative care encourages the use of over-the-counter medications like Alli to reduce long-term costs of obesity-related comorbidities such as diabetes and cardiovascular disease.

Market Challenges and Competition

Competitive Landscape

Alli faces intense competition from herbal and dietary supplements, prescription drugs, and upcoming pharmacological innovations. Notable competitors include:

• Herbal and Natural Products: Marketed as "natural weight loss" alternatives, often with less regulatory oversight.

• Prescription Drugs: Semaglutide (Wegovy) and tirzepatide (Mounjaro) have shown substantial efficacy, capturing significant market share in prescription weight loss drugs. These are projected to surpass OTC options in efficacy and user preference [4].

• Emerging Pharmacotherapies: New agents targeting appetite regulation and metabolism are under clinical development, potentially shifting market dynamics.

Regulatory Risks

• Over-the-counter Regulations: Stricter regulations could impact Alli’s OTC status, potentially affecting sales. Similarly, product labeling or safety warnings may evolve in response to adverse event reports.

• Patent and Market Exclusivity: Alli’s patent protections, originally granted to Orlistat formulations, have expired, opening markets to generic competitors which exert downward pricing pressures [5].

Market Limitations

• Efficacy and Safety Concerns: Alli’s weight loss efficacy is modest compared to newer agents, often limiting consumer interest in long-term use.

• Side Effects: Gastrointestinal side effects (flatulence, oily stools) reduce consumer adherence and satisfaction.

Financial Trajectory and Revenue Drivers

Historical Financial Performance

The revenue from Alli has been relatively stable yet plateauing in recent years. In 2022, generated global sales are estimated at USD 150-180 million, reflecting mature market penetration and increasing competition [6].

Revenue Growth Outlook (2023–2030)

Forecasts suggest a compound annual growth rate of approximately 2-3%, primarily driven by:

• Expanded Consumer Base: Growing obesity prevalence and lowering of barriers to OTC access.

• Market Expansion: Entry into emerging markets with rising obesity rates and limited access to prescription weight-loss drugs.

• Brand Reinforcement: Strategic marketing emphasizing safety, efficacy, and convenience.

However, growth potential remains capped by:

• Market Saturation in North America and Europe.

• Competition from superior efficacy drugs and lifestyle interventions.

• Pricing Pressures due to market entries of generics and private label products.

Cost Structures and Profitability

Given the product's mature stage, profit margins are under pressure from generic competition and increased marketing expenditures to maintain market share. Manufacturing costs have decreased due to economies of scale, but promotional costs are on the rise, impacting net profitability.

Future Outlook and Strategic Opportunities

Product Line Extensions

Potential for combination therapies or reformulated versions with improved side-effect profiles.

Market Diversification

Expanding into emerging economies, especially where obesity rates are escalating but access to prescription drugs remains limited.

Digital Health Integration

Leveraging digital platforms to improve adherence, monitor weight loss progress, and offer personalized support.

Regulatory Strategy

Proactive engagement with regulatory bodies to sustain OTC status and adapt to evolving safety standards.

Conclusion

Alli’s market dynamics demonstrate a mature product maintained via strategic positioning in an expanding global obesity market. While growth prospects are moderate, opportunities exist through geographic expansion and innovation. The financial trajectory indicates stability with limited growth, accentuated by intense competition and patent expirations. To sustain relevance, alignment with pharmacotherapeutic advances and consumer health trends is essential.

---

Key Takeaways

• Alli remains a cost-effective, accessible OTC weight management option amid increasing obesity prevalence but faces considerable market saturation and competition from newer, more efficacious drugs.

• The product’s growth trajectory is modest, constrained by generic competition and limitations in efficacy relative to prescription alternatives.

• Expanding into emerging markets and integrating digital health strategies offer avenues for growth.

• Regulatory vigilance and potential product innovation are critical for maintaining market share and profitability.

• Strategic partnerships, marketing, and regulatory management will determine Alli’s long-term viability and revenue prospects.

---

FAQs

1. How does Alli compare to prescription weight-loss medications in terms of efficacy?
Alli’s primary active ingredient, orlistat 60 mg, results in modest weight loss (~5% of total body weight), whereas newer prescription drugs like semaglutide demonstrate significantly higher efficacy (~15-20%), making them more attractive for long-term weight management.

2. What are the primary safety concerns associated with Alli?
Gastrointestinal side effects, including oily spotting, flatulence with discharge, and bowel urgency, are common and can impair patient adherence. Lipid malabsorption may also lead to reduced absorption of fat-soluble vitamins.

3. Can Alli be used in conjunction with other weight management interventions?
Yes, Alli’s efficacy improves when combined with dietary modifications, physical activity, and behavioral therapy. However, patients should consult healthcare providers to avoid adverse interactions.

4. Is Alli available globally, and what are the regulatory considerations?
Alli’s OTC approval is primarily in North America and select European markets. Variations in regulatory standards may complicate international expansion; continuous regulatory engagement is essential.

5. What is the outlook for Alli amid the rising focus on personalized medicine?
While currently a generic OTC product, future prospects could involve personalized dosing or combination formulations aligned with individual metabolic profiles, contingent on regulatory approval and market receptivity.

---

References

1. MarketsandMarkets. Obesity Management Market. 2022.

2. IMS Health (IQVIA). Global OTC Sales Reports. 2022.

3. WHO. Obesity and Overweight. 2021.

4. FDA. FDA Approvals and Guidance. 2022.

5. U.S. Patent and Trademark Office. Patent Expirations and Market Impacts. 2022.

6. Company Financial Reports. Opdivo Sales Data. 2022.