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.
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Summary for ZERIT XR
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Patent Applications: | 4,597 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ZERIT XR at DailyMed |
![ZERIT XR drug patent expirations Drug patent expirations by year for ZERIT XR](/p/graph/s/t/ZERIT_XR-patent-expirations.png)
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-004 | Dec 31, 2002 | DISCN | No | 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 Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-003 | Dec 31, 2002 | DISCN | No | 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 XR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-003 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-001 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-004 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-002 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-004 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
Argentina | 027748 | PEQUENAS ESFERAS O GLOBULOS QUE CONTIENEN ESTAVUDINA Y PERMITEN LA LIBERACION CONTROLADA DE LA MISMA | ⤷ Sign Up |
Japan | H07116041 | ⤷ Sign Up | |
European Patent Office | 1267879 | ⤷ Sign Up | |
South Africa | 200207760 | Sustained release beadlets containing stavudine. | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZERIT XR
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 |
0273277 | C960024 | Netherlands | ⤷ Sign Up | PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |