CELECOXIB Drug Patent Profile
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When do Celecoxib patents expire, and when can generic versions of Celecoxib launch?
Celecoxib is a drug marketed by 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, Unichem, Watson Labs Inc, and Yiling. and is included in twenty-three NDAs.
The generic ingredient in CELECOXIB is celecoxib. There are twenty-six drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the celecoxib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Celecoxib
A generic version of CELECOXIB was approved as celecoxib by MYLAN on May 30th, 2014.
Summary for CELECOXIB
| US Patents: | 0 |
| Applicants: | 23 |
| NDAs: | 23 |
| Finished Product Suppliers / Packagers: | 50 |
| Raw Ingredient (Bulk) Api Vendors: | 154 |
| Clinical Trials: | 542 |
| Patent Applications: | 5,104 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CELECOXIB |
| Drug Sales Revenues: | Drug sales revenues for CELECOXIB |
| What excipients (inactive ingredients) are in CELECOXIB? | CELECOXIB excipients list |
| DailyMed Link: | CELECOXIB at DailyMed |
Recent Clinical Trials for CELECOXIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Third Affiliated Hospital, Sun Yat-Sen University | Phase 2 |
| Tanta University | Phase 3 |
| Lai Wei | Phase 2 |
Pharmacology for CELECOXIB
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for CELECOXIB
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Umedica Labs Pvt Ltd | CELECOXIB | celecoxib | CAPSULE;ORAL | 210628-003 | Nov 27, 2019 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Micro Labs | CELECOXIB | celecoxib | CAPSULE;ORAL | 204776-001 | Apr 30, 2018 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Jubilant Generics | CELECOXIB | celecoxib | CAPSULE;ORAL | 207061-004 | Apr 4, 2017 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Nanjing | CELECOXIB | celecoxib | CAPSULE;ORAL | 213598-001 | May 13, 2020 | AB | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for CELECOXIB
| 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 |
