zerit xr Drug Patent Profile

When do Zerit Xr patents expire, and what generic alternatives are available?

Zerit Xr is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in ZERIT XR is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for zerit xr

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	5,304
DailyMed Link:	zerit xr at DailyMed

US Patents and Regulatory Information for zerit xr

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002		DISCN	No	No
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-003	Dec 31, 2002		DISCN	No	No

Expired US Patents for zerit xr

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-004	Dec 31, 2002
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-001	Dec 31, 2002
Bristol Myers Squibb	ZERIT XR	stavudine	CAPSULE, EXTENDED RELEASE;ORAL	021453-002	Dec 31, 2002

EU/EMA Drug Approvals for zerit xr

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Zerit	stavudine	EMEA/H/C/000110 Hard capsulesZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.Powder for oral solutionZerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.	Withdrawn	no	no	no	1996-05-08

International Patents for zerit xr

See the table below for patents covering zerit xr around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20011179	PEQUENAS ESFERAS O GLOBULOS QUE CONTIENEN ESTAVUDINA Y PERMITEN LA LIBERACION CONTROLADA DE LA MISMA
Poland	366089
Hong Kong	55896	Pharmaceutical composition comprising 3'-deoxythymidin-2'-ene (3'-deoxy-2' 3'-didehydrothymidine) in treating patients infected with retrovirus
Slovakia	12822002	Perličky s trvalým uvoľňovaním obsahujúce stavudín (Sustained release beadlets containing stavudine)

Supplementary Protection Certificates for zerit xr

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0273277	SPC/GB96/049	United Kingdom		PRODUCT NAME: STAVUDINE; REGISTERED: UK EU/1/96/009/001 19960508; UK EU/1/96/009/002 19960508; UK EU/1/96/009/003 19960508; UK EU/1/96/009/004 19960508; UK EU/1/96/009/005 19960508; UK EU/1/96/009/006 19960508; UK EU/1/96/009/007 19960508; UK EU/1/96/009/008 19960508; UK EU/1/96/009/009 19960508
0273277	C960024	Netherlands		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
0383472	96C0040	Belgium		PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277	96C0039	Belgium		PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508