XENICAL Drug Patent Profile

When do Xenical patents expire, and what generic alternatives are available?

Xenical is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in XENICAL 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 XENICAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	20
Drug Prices:	Drug price information for XENICAL
What excipients (inactive ingredients) are in XENICAL?	XENICAL excipients list
DailyMed Link:	XENICAL at DailyMed

See drug prices for XENICAL

Recent Clinical Trials for XENICAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Empros Pharma AB	Phase 1
CTC Clinical Trial Consultants AB	Phase 1
Novo Nordisk A/S	Phase 4

See all XENICAL clinical trials

Pharmacology for XENICAL

Drug Class	Intestinal Lipase Inhibitor
Mechanism of Action	Lipase Inhibitors

US Patents and Regulatory Information for XENICAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999		RX	Yes	Yes

Expired US Patents for XENICAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	4,598,089*PED
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	6,004,996*PED

EU/EMA Drug Approvals for XENICAL

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 XENICAL

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

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

Supplementary Protection Certificates for XENICAL

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

XENICAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XENICAL (Orlistat)

Introduction to XENICAL (Orlistat)

XENICAL, also known as Orlistat, is a prescription drug approved for the management of obesity. It belongs to a class of anti-obesity drugs that work by inhibiting the absorption of fats from the diet.

Mechanism of Action and Dosage

Orlistat functions by inhibiting pancreatic lipase, an enzyme that breaks down fats in the intestine. This mechanism reduces the absorption of dietary fats, thereby aiding in weight loss. The drug is administered orally in the form of hard gelatin capsules, typically taken with meals[4].

Market Overview

The global anti-obesity drugs market, which includes XENICAL, is projected to grow significantly over the coming years. Here are some key market dynamics:

Global Market Size and Growth

The global anti-obesity drugs market was estimated at $2.7 billion in 2023 and is expected to reach $4.8 billion by 2030, growing at a CAGR of 8.7% from 2023 to 2030[3].

Regional Market Performance

• North America: This region holds a significant share of the global Orlistat market, with a market size of $1.26 billion in 2024 and a projected CAGR of 4.3% from 2024 to 2031. The high prevalence of obesity and robust distribution channels drive this growth[5].
• Europe: The European market for Orlistat is substantial, with a market size of $945.66 million in 2024 and a projected CAGR of 4.6% from 2024 to 2031[5].
• Asia Pacific: This region shows dynamic growth, with a market size of $725.01 million in 2024 and a projected CAGR of 8.1% from 2024 to 2031, driven by rising obesity rates and lifestyle changes[5].

Competitive Landscape

XENICAL operates in a competitive market dominated by other anti-obesity drugs such as Saxenda. Here are some key points about the competitive landscape:

Market Leaders

• Saxenda currently dominates the anti-obesity market, but newer drugs like semaglutide are emerging as strong competitors[3].
• Novo Nordisk is a major player in the U.S. market, which is the largest for anti-obesity drugs[3].

Challenges and Opportunities

Despite the presence of various medications, the anti-obesity market faces significant unmet needs. Reluctance among patients, physicians, and payers poses challenges to market growth. However, ongoing efforts in new drug development and the exploration of opportunities by diabetes drug companies in the anti-obesity space offer positive signs for future growth[3].

Regulatory Milestones and Development Activities

XENICAL has undergone extensive research and development activities, including regulatory milestones:

Regulatory Approvals

• Orlistat was the first in a new class of anti-obesity drugs approved by the FDA, marking a significant regulatory milestone[4].

Development Activities

• The drug has been under continuous evaluation for its efficacy and safety, with detailed analyses of its performance in various clinical trials across the United States, Europe, and Japan[1].

Financial Trajectory

Here are some key financial insights into the market performance of XENICAL:

Market Forecast

• The XENICAL market is forecasted to continue growing, with detailed market size projections provided for various regions, including the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan, from 2019 to 2032[1].

Sales Performance

• The global Orlistat market size was estimated at $3.15 billion in 2024 and is expected to grow at a CAGR of 6.1% from 2024 to 2031[5].
• In the 7MM (United States, EU5, and Japan), the market size and growth projections are detailed, highlighting the drug's performance in each region[1].

SWOT Analysis and Analyst Views

• A comprehensive SWOT analysis and analyst views are provided to give a holistic understanding of XENICAL's market position and future prospects. This includes insights into the drug's strengths, weaknesses, opportunities, and threats, as well as the views of industry analysts[1].

Impact of Emerging Therapies

The launch of late-stage emerging therapies in the anti-obesity market is expected to significantly impact XENICAL's market share:

Competition from New Drugs

• Newer drugs like semaglutide and other emerging therapies are expected to provide tough competition to XENICAL, potentially altering the market dynamics[1][3].

Patent and Expiry Timeline

The patent status and expiry timeline of XENICAL are crucial for understanding its future market position:

Patent Information

• Detailed information on the patents and their expiry timelines is provided, which can impact the drug's market exclusivity and generic competition[1].

Key Takeaways

• Growing Market: The global anti-obesity drugs market, including XENICAL, is projected to grow significantly, driven by increasing obesity rates and new drug developments.
• Regional Performance: North America, Europe, and the Asia Pacific are key regions driving the growth of the Orlistat market.
• Competitive Landscape: XENICAL faces competition from dominant players like Saxenda and emerging therapies.
• Regulatory and Development Activities: Continuous regulatory approvals and development activities are crucial for XENICAL's market position.
• Financial Trajectory: The drug's market size and growth projections indicate a positive financial outlook, despite potential competition from emerging therapies.

FAQs

Q: What is the mechanism of action of XENICAL (Orlistat)? A: XENICAL works by inhibiting pancreatic lipase, an enzyme that breaks down fats in the intestine, thereby reducing the absorption of dietary fats.

Q: What is the projected global market size for anti-obesity drugs by 2030? A: The global anti-obesity drugs market is projected to reach $4.8 billion by 2030, growing at a CAGR of 8.7% from 2023 to 2030[3].

Q: Which regions are driving the growth of the Orlistat market? A: North America, Europe, and the Asia Pacific are the key regions driving the growth of the Orlistat market, with North America holding the largest share[5].

Q: What are the challenges faced by the anti-obesity drugs market, including XENICAL? A: The market faces challenges such as reluctance among patients, physicians, and payers, despite ongoing efforts in new drug development[3].

Q: How does the launch of emerging therapies impact XENICAL's market position? A: The launch of late-stage emerging therapies is expected to provide tough competition to XENICAL, potentially altering its market share and dynamics[1][3].

Sources:

1. ResearchAndMarkets.com - XENICAL (Orlistat), Drug Insight and Market Forecast - 2032
2. S&P Global - Roche Q1 Performance Beats Forecasts, Sales Up 6%
3. GlobeNewswire - Anti-Obesity Drugs Global Strategic Business Report 2024
4. GlobalData - Net Present Value Model: Xenical
5. Cognitive Market Research - Orlistat Market Report