CELEBREX Drug Patent Profile
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Which patents cover Celebrex, and when can generic versions of Celebrex launch?
Celebrex is a drug marketed by Upjohn and is included in one NDA.
The generic ingredient in CELEBREX is celecoxib. There are twenty-six drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Celebrex
A generic version of CELEBREX was approved as celecoxib by MYLAN on May 30th, 2014.
Summary for CELEBREX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 162 |
| Clinical Trials: | 235 |
| Patent Applications: | 5,145 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CELEBREX |
| Drug Sales Revenues: | Drug sales revenues for CELEBREX |
| What excipients (inactive ingredients) are in CELEBREX? | CELEBREX excipients list |
| DailyMed Link: | CELEBREX at DailyMed |
Recent Clinical Trials for CELEBREX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Atriva Therapeutics GmbH | Phase 1 |
| United States Army Research Institute of Environmental Medicine | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for CELEBREX
US Patents and Regulatory Information for CELEBREX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | AB | RX | Yes | No | ⤷ 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 CELEBREX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-002 | Dec 31, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for CELEBREX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Limited | Onsenal | celecoxib | EMEA/H/C/000466 Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4).The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4.4 and 5.1) |
Withdrawn | no | no | no | 2003-10-17 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for CELEBREX
See the table below for patents covering CELEBREX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 100379727 | ⤷ Sign Up | |
| Germany | 69429836 | ⤷ Sign Up | |
| China | 1268614 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for CELEBREX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0731795 | SZ 4/2009 | Austria | ⤷ Sign Up | PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES |
| 0731795 | C300380 | Netherlands | ⤷ Sign Up | PRODUCT NAME: MAVACOXIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/2/08/084/001-005 20080909 |
| 0731795 | 2009C/009 | Belgium | ⤷ Sign Up | PRODUCT NAME: MAVACOXIB; REGISTRATION NO/DATE: EU/0/08/084/001 20080911 |
| >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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