Orlistat - Generic Drug Details

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What are the generic sources for orlistat and what is the scope of freedom to operate?

Orlistat is the generic ingredient in two branded drugs marketed by Haleon Us Holdings and Cheplapharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for orlistat. Three suppliers are listed for this compound.

Summary for orlistat

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	64
Patent Applications:	6,603
Drug Prices:	Drug price trends for orlistat
What excipients (inactive ingredients) are in orlistat?	orlistat excipients list
DailyMed Link:	orlistat at DailyMed

See drug prices for orlistat

Recent Clinical Trials for orlistat

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

Sponsor	Phase
Empros Pharma AB	Phase 1
CTC Clinical Trial Consultants AB	Phase 1
Affiliated Hospital of Nantong University	Phase 1

See all orlistat clinical trials

Pharmacology for orlistat

Drug Class	Intestinal Lipase Inhibitor
Mechanism of Action	Lipase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for orlistat

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

Paragraph IV (Patent) Challenges for ORLISTAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ALLI	Capsules	orlistat	60 mg	021887	1	2010-09-08

US Patents and Regulatory Information for orlistat

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for orlistat

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	⤷ Sign Up	⤷ Sign Up
Cheplapharm	XENICAL	orlistat	CAPSULE;ORAL	020766-001	Apr 23, 1999	⤷ Sign Up	⤷ Sign Up
Haleon Us Holdings	ALLI	orlistat	CAPSULE;ORAL	021887-001	Feb 7, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for orlistat

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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