OPTIMARK Drug Patent Profile
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Which patents cover Optimark, and what generic alternatives are available?
Optimark is a drug marketed by Liebel-flarsheim and is included in three NDAs.
The generic ingredient in OPTIMARK is gadoversetamide. There is one drug master file entry for this compound. Additional details are available on the gadoversetamide profile page.
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Summary for OPTIMARK
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 3 |
| Patent Applications: | 1,010 |
| Drug Prices: | Drug price information for OPTIMARK |
| DailyMed Link: | OPTIMARK at DailyMed |
Recent Clinical Trials for OPTIMARK
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 2 |
| University of Miami | Phase 1 |
| Mallinckrodt | Phase 1 |
US Patents and Regulatory Information for OPTIMARK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020975-001 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-003 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-003 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-004 | Dec 8, 1999 | 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 OPTIMARK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020975-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-002 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-003 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OPTIMARK
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Deutschland GmbH | Optimark | gadoversetamide | EMEA/H/C/000745 This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology. |
Withdrawn | no | no | no | 2007-07-23 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OPTIMARK
See the table below for patents covering OPTIMARK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0425571 | AGENTS D'IMAGERIE A RESONANCE MAGNETIQUE (NOVEL MAGNETIC RESONANCE IMAGING AGENTS) | ⤷ Sign Up |
| Japan | H082855 | ⤷ Sign Up | |
| Japan | H0920785 | NONIONIC PARAMAGNETIC ION COMPLEX AND COMPLEXING AGENT FOR FORMING THE SAME | ⤷ Sign Up |
| Brazil | 1101072 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OPTIMARK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0425571 | 2007C/064 | Belgium | ⤷ Sign Up | PRODUCT NAME: GADOVERSETAMIDE; REGISTRATION NO/DATE: EU/1/07/398/001 20070724 |
| 0425571 | 300299 | Netherlands | ⤷ Sign Up | 300299, 20090719, EXPIRES: 20140718 |
| 0425571 | SPC/GB07/052 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GADOVERSETAMIDE (A CHELATE CONTAINING GADOLINIUM AND VERSETAMIDE); REGISTERED: UK EU/1/07/398/001 20070723; UK EU/1/07/398/002 20070723; UK EU/1/07/398/003 20070723; UK EU/1/07/398/004 20070723 |
| 0425571 | 07C0052 | France | ⤷ Sign Up | PRODUCT NAME: GADOVERSETAMIDE (CHELATE CONTENANT DU GADOLILIUM ET DE LA VERSETAMIDE); REGISTRATION NO/DATE IN FRANCE: EU/1/07/398/001 DU 20070723; REGISTRATION NO/DATE AT EEC: EU/1/07/398/001 DU 20070723 |
| >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.
ISSN: 2162-2639
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