ELYXYB Drug Patent Profile

Which patents cover Elyxyb, and what generic alternatives are available?

Elyxyb is a drug marketed by Bdsi and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-five patent family members in twelve countries.

The generic ingredient in ELYXYB is celecoxib. There are twenty-six drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the celecoxib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elyxyb

A generic version of ELYXYB was approved as celecoxib by MYLAN on May 30^th, 2014.

Summary for ELYXYB

International Patents:	25
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	165
Patent Applications:	5,179
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ELYXYB
What excipients (inactive ingredients) are in ELYXYB?	ELYXYB excipients list
DailyMed Link:	ELYXYB at DailyMed

See drug prices for ELYXYB

Pharmacology for ELYXYB

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

Anatomical Therapeutic Chemical (ATC) Classes for ELYXYB

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

US Patents and Regulatory Information for ELYXYB

ELYXYB is protected by six US patents and one FDA Regulatory Exclusivity.

Patents protecting ELYXYB

FDA Regulatory Exclusivity protecting ELYXYB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bdsi	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No			Y
Bdsi	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No
Bdsi	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No			Y
Bdsi	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No			Y
Bdsi	ELYXYB	celecoxib	SOLUTION;ORAL	212157-001	May 5, 2020		DISCN	Yes	No			Y

EU/EMA Drug Approvals for ELYXYB

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 ELYXYB

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

Country	Patent Number	Title	Estimated Expiration
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)
World Intellectual Property Organization (WIPO)	2017208069
Canada	2987272	COMPOSITION ORALE DE CELECOXIB POUR LE TRAITEMENT DE LA DOULEUR (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN)
Japan	2018516266	疼痛治療のためのセレコキシブの経口用組成物
European Patent Office	3463340	COMPOSITION DE CÉLÉCOXIB À USAGE ORAL POUR LE TRAITEMENT DE LA DOULEUR (ORAL COMPOSITION OF CELECOXIB FOR TREATMENT OF PAIN)

Supplementary Protection Certificates for ELYXYB

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