VITRASERT Drug Patent Profile
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Which patents cover Vitrasert, and what generic alternatives are available?
Vitrasert is a drug marketed by Bausch And Lomb and is included in one NDA.
The generic ingredient in VITRASERT is ganciclovir. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.
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Summary for VITRASERT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 150 |
Clinical Trials: | 1 |
DailyMed Link: | VITRASERT at DailyMed |
Recent Clinical Trials for VITRASERT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins Bloomberg School of Public Health | Phase 2/Phase 3 |
US Patents and Regulatory Information for VITRASERT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch And Lomb | VITRASERT | ganciclovir | IMPLANT;IMPLANTATION | 020569-001 | Mar 4, 1996 | 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 VITRASERT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bausch And Lomb | VITRASERT | ganciclovir | IMPLANT;IMPLANTATION | 020569-001 | Mar 4, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VITRASERT
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH.. | Vitrasert Implant | ganciclovir | EMEA/H/C/000120 The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use). |
Withdrawn | no | no | no | 1997-03-18 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VITRASERT
See the table below for patents covering VITRASERT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0577646 | SYSTEMES D'ADMINISTRATION DE MEDICAMENTS A LIBERATION PROLONGEE (SUSTAINED RELEASE DRUG DELIVERY DEVICES) | ⤷ Sign Up |
Spain | 2366573 | ⤷ Sign Up | |
Japan | 2003002825 | DELIVERY APPARATUS FOR SUSTAINED-RELEASE DRUG | ⤷ Sign Up |
Australia | 660012 | ⤷ Sign Up | |
Spain | 2125259 | ⤷ Sign Up | |
Denmark | 0577646 | ⤷ Sign Up | |
Austria | 511832 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VITRASERT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0694547 | 2002/028 | Ireland | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013 |
0694547 | C300071 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920 |
0694547 | 03C0003 | France | ⤷ Sign Up | PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920 |
0694547 | SPC/GB02/027 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |