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Last Updated: September 24, 2020

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ZERIT XR Drug Profile

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Which patents cover Zerit Xr, and when can generic versions of Zerit Xr launch?

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

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

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

US ANDA Litigation and Generic Entry Outlook for Zerit Xr

A generic version of ZERIT XR was approved as stavudine by AUROBINDO PHARMA on December 29th, 2008.

  Start Trial

Summary for ZERIT XR
International Patents:28
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 106
Formulation / Manufacturing:see details
DailyMed Link:ZERIT XR at DailyMed
Drug patent expirations by year for ZERIT XR

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   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-003 Dec 31, 2002 DISCN No No   Start Trial   Start Trial Y   Start Trial
>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 ZERIT XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-004 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-003 Dec 31, 2002   Start Trial   Start Trial
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZERIT XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0273277 96C0039 Belgium   Start Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508
0273277 SPC/GB96/049 United Kingdom   Start Trial 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
0383472 96C0040 Belgium   Start Trial PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION:
0273277 C960024 Netherlands   Start Trial PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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