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 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-four 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:	64
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	563
Patent Applications:	7,330
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
Xintian Pharmaceutical	Phase 4
Translational Genomics Research Institute	Phase 1
HonorHealth Research Institute	Phase 1

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

Anatomical Therapeutic Chemical (ATC) Classes for CELECOXIB

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

M01AH	Coxibs
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CELECOXIB	celecoxib	CAPSULE;ORAL	204519-004	Aug 21, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Umedica	CELECOXIB	celecoxib	CAPSULE;ORAL	210628-003	Nov 27, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	CELECOXIB	celecoxib	CAPSULE;ORAL	204590-003	Mar 16, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yiling	CELECOXIB	celecoxib	CAPSULE;ORAL	211412-002	Mar 6, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	CELECOXIB	celecoxib	CAPSULE;ORAL	204590-002	Mar 16, 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

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

EU/EMA Drug Approvals for CELECOXIB

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	6605047		⤷ Sign Up
Japan	2018516266	疼痛治療のためのセレコキシブの経口用組成物	⤷ Sign Up
China	107847437		⤷ Sign Up
European Patent Office	3302429		⤷ Sign Up
Australia	2019203815		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CELECOXIB

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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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