XENICAL Drug Patent Profile
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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.
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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 |
Recent Clinical Trials for XENICAL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CTC Clinical Trial Consultants AB | Phase 1 |
| Empros Pharma AB | Phase 1 |
| Novo Nordisk A/S | Phase 4 |
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 | ⤷ 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 XENICAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for XENICAL
See the table below for patents covering XENICAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 921796 | ⤷ Sign Up | |
| Uruguay | 24875 | COMPOSICIONES FARMACÉUTICAS CONTENIENDO TETRAHIDROLIPSTATINA | ⤷ Sign Up |
| Malaysia | 118371 | TETRAHYDROLIPSTATIN CONTAINING COMPOSITIONS | ⤷ Sign Up |
| Austria | 200027 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XENICAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0129748 | 98C0042 | Belgium | ⤷ Sign Up | PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729 |
| 0129748 | SPC/GB98/044 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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