Celecoxib - Generic Drug Details

What are the generic drug sources for celecoxib and what is the scope of freedom to operate?

Celecoxib is the generic ingredient in four branded drugs marketed by Upjohn, Acic Pharms, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma, 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, Yiling, Bdsi, and Kowa Pharms, and is included in twenty-six 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. Fifty-four suppliers are listed for this compound.

Summary for celecoxib

International Patents:	25
US Patents:	13
Tradenames:	4
Applicants:	26
NDAs:	26
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	54
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	553
Patent Applications:	7,202
Formulation / Manufacturing:	see details
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

See drug prices for celecoxib

See drug sales revenues for celecoxib

Recent Clinical Trials for celecoxib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sun Yat-sen University	Phase 2
Arthritis Innovation Corporation	Phase 3
Allucent	Phase 3

See all celecoxib clinical trials

Pharmacology for celecoxib

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for celecoxib

Cyclooxygenase 2 Inhibitors

Paragraph IV (Patent) Challenges for CELECOXIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CELEBREX	Capsules	celecoxib	50 mg	020998	1	2008-03-21

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
Cipla	CELECOXIB	celecoxib	CAPSULE;ORAL	207446-001	Sep 23, 2015	AB	RX	No	No
Jubilant Generics	CELECOXIB	celecoxib	CAPSULE;ORAL	207061-003	Apr 4, 2017		DISCN	No	No
Sciegen Pharms Inc	CELECOXIB	celecoxib	CAPSULE;ORAL	205129-001	Dec 3, 2020	AB	RX	No	No
Acic Pharms	CELECOXIB	celecoxib	CAPSULE;ORAL	212925-002	Dec 9, 2020		DISCN	No	No
Watson Labs Inc	CELECOXIB	celecoxib	CAPSULE;ORAL	200562-001	Feb 11, 2015	AB	RX	No	No
Yiling	CELECOXIB	celecoxib	CAPSULE;ORAL	211412-001	Mar 6, 2020	AB	RX	No	No

Expired US Patents for celecoxib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-004	Dec 15, 2006
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998

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

International Patents for celecoxib

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2018146386	ПЕРОРАЛЬНАЯ КОМПОЗИЦИЯ ЦЕЛЕКОКСИБА ДЛЯ ЛЕЧЕНИЯ БОЛИ
China	107847437
Australia	2019203815
Russian Federation	2017144574
Brazil	112017025445
China	114469858	用于治疗疼痛的塞来昔布口服组合物 (Oral composition of celecoxib for treating pain)

Supplementary Protection Certificates for celecoxib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	10075033	Germany		PRODUCT NAME: CELECOXIB; NAT. REGISTRATION NO/DATE: 48802.00.00 20000518; FIRST REGISTRATION: SE 14838 19991203