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Celecoxib - Generic Drug Details
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What are the generic drug sources for celecoxib and what is the scope of freedom to operate?
Celecoxib
is the generic ingredient in three branded drugs marketed by Gd Searle, Acic Pharms, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Mylan, Nanjing, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica Labs Pvt Ltd, Watson Labs Inc, Yiling, and Dr Reddys, and is included in twenty-four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Celecoxib has twenty-three patent family members in twelve countries.
There are twenty-six drug master file entries for celecoxib. Fifty suppliers are listed for this compound.
Summary for celecoxib
| International Patents: | 23 |
| US Patents: | 6 |
| Tradenames: | 3 |
| Applicants: | 24 |
| NDAs: | 24 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 50 |
| Bulk Api Vendors: | 138 |
| Clinical Trials: | 491 |
| Patent Applications: | 7,210 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for celecoxib |
| Drug Sales Revenues: | Drug sales revenues for celecoxib |
| DailyMed Link: | celecoxib at DailyMed |
Recent Clinical Trials for celecoxib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Imperial College London | Phase 4 |
| BC Children's Hospital Research Institute | Phase 2 |
| International Obsessive-Compulsive Disorder Foundation | Phase 2 |
Pharmacology for celecoxib
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for celecoxib
US Patents and Regulatory Information for celecoxib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | CELECOXIB | celecoxib | CAPSULE;ORAL | 202240-004 | Jun 9, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Dr Reddys | ELYXYB | celecoxib | SOLUTION;ORAL | 212157-001 | May 5, 2020 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Watson Labs Inc | CELECOXIB | celecoxib | CAPSULE;ORAL | 200562-004 | Feb 11, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 celecoxib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-002 | Dec 31, 1998 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | Start Trial | Start Trial |
| Gd Searle | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for celecoxib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2987272 | Start Trial |
| South Korea | 20180012277 | Start Trial |
| South Korea | 101994129 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for celecoxib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0731795 | 10075033 | Germany | Start Trial | PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203 |
| >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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