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/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
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

International Patents for ALLI

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

Country	Patent Number	Title	Estimated Expiration
Spain	8600650
Yugoslavia	49698
Indonesia	26509
Croatia	P980057	TETRAHYDROLIPSTATIN CONTAINING COMPOSITIONS
Spain	533557
Bulgaria	60766
Hungary	T34545

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

ALLI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Alli

Introduction

Alli, the over-the-counter (OTC) version of the anti-obesity drug orlistat, has been a significant player in the weight loss market since its launch in June 2007. Here, we delve into the market dynamics and financial trajectory of Alli, exploring its performance, challenges, and future prospects.

Market Launch and Initial Performance

Following its US launch, Alli recorded impressive sales figures. In the year ended December 31, 2007, Alli generated around $290 million in sales, although this included a large stock-up to get the product on shelves. Actual consumer sales for the same period were $121 million, and Q1 2008 sales stood at $17.5 million[1].

Mechanism of Action and Usage

Alli works by attaching to natural enzymes in the digestive system, preventing them from breaking down fat. This process requires users to follow a reduced-calorie, low-fat diet to maximize its effectiveness. The drug has been studied in over 100 clinical trials and is claimed to help users lose 50% more weight than dieting alone[1].

Market Position and Competition

Alli is a low-dose version of Xenical, which contains 120mg of orlistat compared to Alli's 60mg. Despite being in third place globally among weight loss drugs in 2007, Alli accounted for only 7% of all anti-obesity treatments worldwide[1].

The weight loss drug market has historically been underwhelming due to the limited efficacy and significant side effects of most products. However, new treatments in late-stage development are expected to change this landscape, offering better risk-benefit profiles and potentially capturing a significant market share[1].

Challenges and Side Effects

One of the major challenges for Alli is competition from dietary supplements, which attract some of its potential market share. GlaxoSmithKline's (GSK) petition to the FDA to classify all weight loss claims as drug claims could help mitigate this competition[1].

Users of Alli often report side effects such as diarrhea, particularly if they consume high-fat foods while taking the medication. This side effect can be a deterrent for some users but also serves as a behavioral modifier, discouraging the consumption of fatty foods[2].

User Reviews and Real-World Experience

User reviews highlight mixed experiences with Alli. Some users report significant weight loss when combined with a healthy diet and exercise, while others experience little to no weight loss and frustration with side effects. The importance of working with a physician to adjust diet and lifestyle is frequently emphasized[2].

Financial Projections and Market Growth

The global market for obesity drugs is expected to see significant growth. Morgan Stanley Research forecasts the market to reach $105 billion by 2030, up from an earlier forecast of $77 billion. This growth is driven by increasing demand and the development of new, more effective treatments[3].

The Orlistat market, specifically, was valued at $1.5 billion in 2023 and is projected to reach $3 billion by 2031, growing at a CAGR of 9.3%. This growth is supported by product diversification, including various formulations and combination therapies, which cater to different consumer preferences and needs[4].

Geographical Market Dynamics

The Orlistat market is segmented geographically, with North America and Europe being key regions due to high obesity prevalence and extensive healthcare infrastructure. The Asia-Pacific region, while presenting unique cultural and economic challenges, offers significant potential for market expansion as disposable incomes rise and dietary habits change[4].

Regulatory and Competitive Landscape

The Orlistat market faces competition from newer pharmaceutical agents with improved efficacy and safety profiles. Regulatory approvals and the rise of alternative weight-loss interventions, such as dietary supplements and surgical options, also pose challenges. However, the diversification of Orlistat products and combination therapies help maintain its market relevance[4].

Future Prospects and Consumerization

The obesity drug market is undergoing a significant transformation, driven by consumerization and the emergence of new treatments. While injectable drugs currently dominate the market, oral small molecule options are gaining traction due to their lower production costs and potential for combination therapies. This shift could impact the market share of drugs like Alli, but its established presence and ongoing product diversification position it for continued relevance[5].

Key Takeaways

• Initial Success: Alli recorded significant sales following its launch but faced challenges in maintaining market share.
• Mechanism and Usage: Alli works by inhibiting fat digestion and requires a low-fat diet for effectiveness.
• Market Position: Alli is in third place globally among weight loss drugs but faces competition from dietary supplements and newer pharmaceuticals.
• Challenges: Side effects like diarrhea and competition from alternatives are major hurdles.
• Financial Projections: The obesity drug market, including Orlistat, is expected to grow significantly, driven by new treatments and increasing demand.
• Geographical Dynamics: North America and Europe are key markets, with Asia-Pacific offering future growth potential.
• Regulatory and Competitive Landscape: The market is competitive, with regulatory approvals and product diversification crucial for maintaining market share.

FAQs

What is the active ingredient in Alli?

The active ingredient in Alli is orlistat, which works by attaching to natural enzymes in the digestive system and preventing them from breaking down fat[1].

How effective is Alli in weight loss?

Alli can help users lose 50% more weight than dieting alone, but its effectiveness varies widely among users and is highly dependent on dietary and lifestyle changes[1][2].

What are the common side effects of Alli?

Common side effects include diarrhea, particularly if users consume high-fat foods while taking the medication[1][2].

How does Alli compare to other weight loss drugs?

Alli is a low-dose version of Xenical and ranks third globally among weight loss drugs. It faces competition from newer pharmaceuticals with improved efficacy and safety profiles[1][5].

What are the future prospects for the Orlistat market?

The Orlistat market is projected to grow to $3 billion by 2031, driven by product diversification, combination therapies, and increasing demand for obesity treatments[4].

Sources

1. NutraIngredients Europe: "Alli and the weight loss drug market"
2. Drugs.com: "Alli for Weight Loss (Obesity/Overweight) User Reviews"
3. Morgan Stanley: "Scaling Up the Impact of Obesity Drugs"
4. Verified Market Research: "Orlistat Market Size, Share, Scope, Growth, Trends & Forecast"
5. Stifel: "Obesity Market Review - July 8, 2024"