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
Austria	200027
Latvia	5747	Heksadekanskabes un heksadekadienskabes atvasinajumi
Australia	572851

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

ALLI Market Analysis and Financial Projection

Last updated: April 26, 2026

ALLI: Market Dynamics and Financial Trajectory

What is ALLI in commercial terms?

“ALLI” is the brand name most commonly associated with Orlistat 60 mg (marketed as an over-the-counter weight-loss product in the U.S. under the name Alli). Orlistat is a gastrointestinal lipase inhibitor used to reduce dietary fat absorption. This matters for market dynamics because the product is category-driven (weight-loss OTC), competes on price, distribution depth, rebate programs, and consumer retention, and is exposed to regulatory labeling constraints and substitution to other OTC anti-obesity options.

How does the demand engine work for Alli (orlistat 60 mg)?

The commercial demand for an OTC weight-loss drug is driven by four forces:

1. Consumer trial and repeat purchase

   • Alli users typically buy initial trial packs and then decide whether to continue based on side effects, perceived fat reduction outcomes, and ongoing promotional pricing.

2. Retail execution

   • Market penetration depends on chain pharmacy placement, planogram visibility, and whether retailers run promotions aligned with seasonal demand (spring weight-loss pushes and summer travel periods).

3. Competitive substitution

   • The main substitution pressure comes from other OTC weight-management and diet-support products, including:
     • Other orlistat formulations (where available)
     • Oral appetite/weight-support products
     • Prescription weight-loss alternatives sold through clinics but often referenced in consumer consideration

4. Health claims and compliance

   • Orlistat’s efficacy framing is limited by labeling and evidence thresholds. This constrains marketing to approved claims, increasing dependence on retailer promotions and consumer education rather than broad performance narratives.

What are the market dynamics shaping Alli’s sales trajectory?

Key dynamics for Alli-orlistat OTC products include:

• Price sensitivity and promotion cadence

  • OTC weight-loss buyers respond strongly to discounting. When generic comparators or alternative brands intensify promos, Alli’s sales often compress unless it matches promotional depth.

• Supply chain stability and shelf availability

  • Out-of-stocks can erase momentum because OTC weight-loss purchase is often short-cycle. Brand recovery after stock gaps is usually slower than the initial promotional lift.

• Regulatory and label-driven marketing boundaries

  • Competitive campaigns can shift consumer perception even when they do not improve clinical outcomes. Alli’s market share movement is therefore frequently a function of marketing spend and retail deals, not only formulation performance.

• Consumer tolerability

  • Orlistat is associated with gastrointestinal side effects in some users. That affects continuation rates and repeat purchasing, which drives lifetime value more than first purchase volumes.

How does Alli compete financially in the OTC weight-loss landscape?

Financial performance for OTC brands like Alli is determined by:

• Gross margin vs. trade spend

  • Retail deals often take the form of slotting-like terms, promotional allowances, and retailer-funded discounts. These can reduce net revenue growth even when gross sales hold.

• Marketing efficiency

  • Brands must sustain consumer awareness without violating labeling. Where marketing efficiency declines, net sales growth slows and promotional reliance increases.

• Category headwinds from prescription GLP-1 era

  • Even though Alli is OTC, the broader market context can reduce the addressable consumer base for non-prescription weight loss, particularly among higher-income consumers who shift to prescription options.

What is Alli’s financial trajectory over time (directional)?

Available public disclosures tied to an “Alli” brand without specifying the exact corporate entity and reporting period cannot be used here to produce a complete, accurate time-series financial trajectory. This analysis therefore focuses on the market-structure dynamics that determine financial outcomes for an OTC orlistat 60 mg product, including the typical pattern seen in OTC weight-loss brands:

• Sales rise around promotional peaks (seasonality-driven)
• Volatility increases with competitive promo intensity
• Net sales growth tends to lag gross sales when trade spend rises
• Long-run performance often plateaus when category saturation and substitutability rise

Because you asked for financial trajectory, the key actionable view for decision-makers is how these dynamics translate into revenue stability, margin pressure, and cash conversion for Alli-like OTC products.

What variables determine upside or downside for Alli’s next 12 to 24 months?

For a company allocating R&D or marketing budgets to an OTC weight-loss brand equivalent to Alli, the highest-impact variables typically are:

• Retail promotional depth and share-of-shelf
• Distribution breadth across major chains and mass
• Repeat purchase and continuation rate
• Consumer acquisition efficiency (cost per incremental buyer)
• Competitive intensity from alternative OTC weight-management products

Under stronger retailer promo and better retention, Alli-style products can sustain revenue even if the category is mature. Under intensified competition and weaker tolerability-related continuation, net sales growth typically falls into a promotional treadmill: more discounts required to keep volume, raising net revenue pressure.

Financial drivers that matter specifically to Alli (orlistat OTC)

Unlike prescription oncology or biologics, the financial model for an OTC orlistat product is largely driven by:

• Unit economics
  • Net price less retailer allowances and chargebacks
• Trade and marketing
  • Funding to retailers and consumer marketing intensity
• Return rates and compliance-driven inventory management
  • Expiration management matters for branded OTC products with seasonal cycles
• Working capital
  • Seasonal ramp increases inventory needs; markdowns can damage profitability if demand is weaker than forecast

Competitive and regulatory overlay

Two practical overlays shape Alli’s trajectory:

1. Therapeutic substitution risk

   • As prescription weight-loss options become more accessible, consumers often shift away from OTC attempts.

2. Category claim pressure

   • Competitors that can message outcomes in clearer, perception-driven ways can take share even if evidence parity is not comparable.

Investment and business implications (actionable)

For stakeholders evaluating a position tied to Alli-orlistat OTC performance, the decision-relevant signals are:

• Retail sales velocity during promotional windows

  • If velocity rises with promo but does not persist, the product is trading volume for margin.

• Net revenue stability vs. gross sales

  • Widening discount-to-net implies escalating trade spend.

• Repeat rate indicators

  • If consumer continuation weakens, the brand must increase acquisition spend to hold sales, compressing margins.

• Share capture or share loss within major chains

  • OTC brands often live or die by chain-level placement. Movement in share at top retailers is more predictive than broader category narratives.

Key Takeaways

• Alli’s market dynamics are dominated by seasonality, retail execution, promotional intensity, tolerability-driven repeat purchase, and substitution pressure from other weight-loss options.
• Financial trajectory for an OTC orlistat product typically shows promotion-led volatility, with net revenue margin pressure when trade spend increases.
• The most decision-relevant forward indicators are net price realization, promotional depth, repeat purchase/continuation, and chain-level distribution and shelf share.

FAQs

1) Is Alli primarily a prescription product or OTC?

Alli is marketed as an OTC weight-loss product centered on orlistat 60 mg, making it sensitive to retailer promotions and consumer repeat purchase.

2) What drives Alli volume most strongly?

Volume is most driven by seasonal demand cycles, retail shelf placement, and promotion timing, with continuation affected by gastrointestinal tolerability.

3) Why can net sales decline even when gross sales look stable?

Because OTC brands often face rising trade spend, including promotional allowances and retailer-funded discounts that reduce net revenue.

4) What competitive pressure most affects Alli’s growth?

Substitution from other OTC weight-management options and the broader shift of some consumers toward prescription weight-loss therapies changes the addressable market.

5) What operational factor most impacts OTC profitability for Alli-style products?

Inventory planning around expiration and seasonal ramp influences markdowns and working capital, directly affecting cash generation.

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References

[1] U.S. Food and Drug Administration. “Labeling for OTC Orlistat Products (Alli).” FDA.
[2] DrugBank Online. “Orlistat.” DrugBank.
[3] National Center for Biotechnology Information (NCBI). “Orlistat Mechanism of Action.” PubMed Central.

DrugChatter Q&A for ALLI

Can i take alli while on lipitor medication?