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Last Updated: March 18, 2024

ZERIT XR Drug Patent 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.

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.

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

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

International Patents for ZERIT XR

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

Country Patent Number Title Estimated Expiration
Poland 366089 ⤷  Try a Trial
Hong Kong 55896 Pharmaceutical composition comprising 3'-deoxythymidin-2'-ene (3'-deoxy-2' 3'-didehydrothymidine) in treating patients infected with retrovirus ⤷  Try a Trial
New Zealand 522250 Sustained release beadlets containing stavudine stabilised by magnesium stearate ⤷  Try a Trial
Japan H07116041 ⤷  Try a Trial
European Patent Office 0273277 PHARMACEUTICAL COMPOSITION COMPRISING 3'-DEOXYTHYMIDIN-2'-ENE (3'-DEOXY-2',3'-DIDEHYDROTHYMIDINE) IN TREATING PATIENTS INFECTED WITH RETROVIRUS ⤷  Try a Trial
Argentina 027748 PEQUENAS ESFERAS O GLOBULOS QUE CONTIENEN ESTAVUDINA Y PERMITEN LA LIBERACION CONTROLADA DE LA MISMA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZERIT XR

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

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