CELEBREX Drug Patent Profile

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-four 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 TEVA on May 30^th, 2014.

Summary for CELEBREX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	240
Patent Applications:	4,555
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

See drug prices for CELEBREX

See drug sales revenues for CELEBREX

Recent Clinical Trials for CELEBREX

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

Sponsor	Phase
University of Miami	Phase 3
University of Arizona	Phase 1
Translational Genomics Research Institute	Phase 1

See all CELEBREX clinical trials

Pharmacology for CELEBREX

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

Paragraph IV (Patent) Challenges for CELEBREX

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

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
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-003	Aug 29, 2002	AB	RX	Yes	Yes
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-001	Dec 31, 1998	AB	RX	Yes	No

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
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998
Upjohn	CELEBREX	celecoxib	CAPSULE;ORAL	020998-002	Dec 31, 1998

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

International Patents for CELEBREX

See the table below for patents covering CELEBREX around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2276945	PYRAZOLYLE BENZENESULFONAMIDE TRICYCLIQUE-SUBSTITUE ET LEURSCOMPOSITIONS PHARMACEUTIQUES (TRICYCLIC-SUBSTITUTED PYRAZOLYL BENZENESULFONAMIDES AND PHARMACEUTICAL COMPOSITIONS THEREOF)
Netherlands	300380
European Patent Office	0731795	BENZENESULFONAMIDES DE PYRAZOLYLE SUBSTITUES DESTINES AU TRAITEMENT DES INFLAMMATIONS (SUBSTITUTED PYRAZOLYL BENZENESULFONAMIDES FOR THE TREATMENT OF INFLAMMATION)

Supplementary Protection Certificates for CELEBREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0731795	0090013-4	Sweden
0731795	2009C/009	Belgium		PRODUCT NAME: MAVACOXIB; REGISTRATION NO/DATE: EU/0/08/084/001 20080911
0731795	4/2009	Austria		PRODUCT NAME: MAVACOXIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/2/08/084/001-005 20080909