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
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Patent Applications: | 5,766 |
| Drug Prices: | Drug price information for ZERIT |
| What excipients (inactive ingredients) are in ZERIT? | ZERIT excipients list |
| DailyMed Link: | ZERIT at DailyMed |
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 | ||||
| >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 | 020412-001 | Jun 24, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol | ZERIT | stavudine | CAPSULE;ORAL | 020412-004 | Jun 24, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| 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 |
| >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 |
|---|---|---|---|
| Egypt | 19157 | The use of 3- deoxythmiding-2'-ene(3'-deoxy 2-3dedehydrothymidine) in treating patients infected with retroviruses | ⤷ Sign Up |
| Denmark | 557087 | ⤷ Sign Up | |
| Australia | 593405 | ⤷ Sign Up | |
| Ireland | 873245 | ⤷ 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 |
| 0273277 | C960024 | Netherlands | ⤷ Sign Up | PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 - EU/1/96/009/009 19960508 |
| 0273277 | 96C0039 | Belgium | ⤷ Sign Up | PRODUCT NAME: STAVUDINE; REGISTRATION NO/DATE: EU/1/96/009/001 19960508 |
| 0383472 | 96C0040 | Belgium | ⤷ Sign Up | PRODUCT NAME: STAVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/009/001-009 19960509; FIRST REGISTRATION: |
| >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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