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. Two 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:	19
Formulation / Manufacturing:	see details
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
Novo Nordisk A/S	Phase 4
The Cleveland Clinic	Phase 4
Khoo Teck Puat Hospital	Phase 4

See all XENICAL clinical trials

Pharmacology for XENICAL

Drug Class	Intestinal Lipase Inhibitor
Mechanism of Action	Lipase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for XENICAL

A08AB	Peripherally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

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
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999

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	533557
Australia	713192
Poland	330972
Japan	H0516426
South Africa	9800746
Finland	78694

Supplementary Protection Certificates for XENICAL

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