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Last Updated: July 16, 2024

ZERIT Drug Patent Profile


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

Zerit is a drug marketed by Bristol and Bristol Myers Squibb and is included in three NDAs.

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

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Summary for ZERIT
Drug patent expirations by year for ZERIT
Drug Prices for ZERIT

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US Patents and Regulatory Information for ZERIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol ZERIT stavudine CAPSULE;ORAL 020412-001 Jun 24, 1994 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-001 Dec 31, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ZERIT XR stavudine CAPSULE, EXTENDED RELEASE;ORAL 021453-002 Dec 31, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-002 Jun 24, 1994 DISCN Yes 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 ZERIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol ZERIT stavudine CAPSULE;ORAL 020412-005 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine FOR SOLUTION;ORAL 020413-001 Sep 6, 1996 ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-001 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-003 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
Bristol ZERIT stavudine CAPSULE;ORAL 020412-004 Jun 24, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ZERIT

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZERIT

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

Country Patent Number Title Estimated Expiration
Australia 593405 ⤷  Sign Up
South Africa 8707171 ⤷  Sign Up
European Patent Office 0273277 PHARMACEUTICAL COMPOSITION COMPRISING 3'-DEOXYTHYMIDIN-2'-ENE (3'-DEOXY-2',3'-DIDEHYDROTHYMIDINE) IN TREATING PATIENTS INFECTED WITH RETROVIRUS ⤷  Sign Up
Ireland 60866 The use of 3'-deoxythymidin-2'-ene (3'-deoxy-2',3'-didehydrothymidine) in treating patients infected with retroviruses ⤷  Sign Up
Denmark 174627 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZERIT

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