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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Questions you can ask:
- What is the 5 year forecast for XENICAL?
- What are the global sales for XENICAL?
- What is Average Wholesale Price for XENICAL?
Summary for XENICAL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 20 |
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 |
![XENICAL drug patent expirations Drug patent expirations by year for XENICAL](/p/graph/s/t/XENICAL-patent-expirations.png)
![Drug Prices for XENICAL](/p/graph/drug-price/XENICAL.png)
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 |
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 |
---|---|---|---|
Czech Republic | 9803528 | ⤷ Sign Up | |
Morocco | 24466 | ⤷ Sign Up | |
New Zealand | 332659 | pharmaceutical compositions containing particles of tetrahydrolipstatin with a stabilizer and an excipient | ⤷ 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 |