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: | 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 | ⤷ 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 | 021453-004 | 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 | 021453-001 | 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 | 021453-003 | Dec 31, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol Myers Squibb | ZERIT XR | stavudine | CAPSULE, EXTENDED RELEASE;ORAL | 021453-003 | 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 |
|---|---|---|---|
| Peru | 20011179 | PEQUENAS ESFERAS O GLOBULOS QUE CONTIENEN ESTAVUDINA Y PERMITEN LA LIBERACION CONTROLADA DE LA MISMA | ⤷ Sign Up |
| Poland | 366089 | ⤷ Sign Up | |
| Hong Kong | 55896 | Pharmaceutical composition comprising 3'-deoxythymidin-2'-ene (3'-deoxy-2' 3'-didehydrothymidine) in treating patients infected with retrovirus | ⤷ Sign Up |
| Slovakia | 12822002 | Perličky s trvalým uvoľňovaním obsahujúce stavudín (Sustained release beadlets containing stavudine) | ⤷ Sign Up |
| Netherlands | 960024 | ⤷ Sign Up | |
| Australia | 593405 | ⤷ 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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