Celecoxib - Generic Drug Details
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What are the generic sources for celecoxib and what is the scope of patent protection?
Celecoxib
is the generic ingredient in four branded drugs marketed by Upjohn, Acic Pharms, Alembic, Amneal Pharms, Apotex, Aurobindo Pharma, Cadila Pharms Ltd, Cipla, Cspc Ouyi, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Micro Labs, Nanjing, Norvium Bioscience, Qingdao Baheal Pharm, Sciegen Pharms Inc, Teva, Tianjin Tianyao, Torrent, Umedica, Unichem, Watson Labs Inc, Yabao Pharm, Yiling, Scilex Pharms, and Kowa Pharms, and is included in twenty-seven NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Celecoxib has twenty-five patent family members in twelve countries.
There are twenty-six drug master file entries for celecoxib. Sixty-five suppliers are listed for this compound.
Summary for celecoxib
International Patents: | 25 |
US Patents: | 13 |
Tradenames: | 4 |
Applicants: | 27 |
NDAs: | 27 |
Drug Master File Entries: | 26 |
Finished Product Suppliers / Packagers: | 65 |
Raw Ingredient (Bulk) Api Vendors: | 175 |
Clinical Trials: | 563 |
Patent Applications: | 7,333 |
Drug Prices: | Drug price trends 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 |
---|---|
Xintian Pharmaceutical | Phase 4 |
Translational Genomics Research Institute | Phase 1 |
HonorHealth Research Institute | Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Qingdao Baheal Pharm | CELECOXIB | celecoxib | CAPSULE;ORAL | 208856-004 | Aug 7, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Jubilant Generics | CELECOXIB | celecoxib | CAPSULE;ORAL | 207061-004 | Apr 4, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma | CELECOXIB | celecoxib | CAPSULE;ORAL | 206827-001 | Feb 1, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Apotex | CELECOXIB | celecoxib | CAPSULE;ORAL | 204197-003 | Jun 2, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Aurobindo Pharma | CELECOXIB | celecoxib | CAPSULE;ORAL | 206827-002 | Feb 1, 2016 | AB | RX | No | 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 celecoxib
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-001 | Dec 31, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-004 | Dec 15, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-002 | Dec 31, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Upjohn | CELEBREX | celecoxib | CAPSULE;ORAL | 020998-003 | Aug 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for celecoxib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2016191744 | ⤷ Sign Up | |
Russian Federation | 2708254 | Пероральная композиция целекоксиба для лечения боли (ORAL CELECOXIB COMPOSITION FOR TREATING PAIN) | ⤷ Sign Up |
Australia | 2017275844 | Oral composition of celecoxib for treatment of pain | ⤷ Sign Up |
European Patent Office | 3302429 | ⤷ Sign Up | |
Brazil | 112018074486 | composição oral de celecoxib para tratamento da dor | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for celecoxib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0731795 | 10075033 | Germany | ⤷ Sign Up | 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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