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RETISERT Drug Profile
» See Plans and Pricing
When do Retisert patents expire, and when can generic versions of Retisert launch?
Retisert is a drug marketed by Bausch And Lomb and is included in one NDA.
The generic ingredient in RETISERT is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
US ANDA Litigation and Generic Entry Outlook for Retisert
A generic version of RETISERT was approved as fluocinolone acetonide by TARO on April 27th, 1982.
Summary for RETISERT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 9 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for RETISERT |
| DailyMed Link: | RETISERT at DailyMed |
Recent Clinical Trials for RETISERT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Michael's Hospital, Toronto | Phase 2 |
| Pradeepa Yoganathan | Phase 2 |
| Johns Hopkins University | Phase 4 |
Pharmacology for RETISERT
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for RETISERT
| 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 | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 RETISERT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bausch And Lomb | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | Start Trial | Start Trial |
| Bausch And Lomb | RETISERT | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 021737-001 | Apr 8, 2005 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RETISERT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2367092 | Start Trial |
| Australia | 777727 | Start Trial |
| Australia | 4174800 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for RETISERT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2233112 | 132014902285293 | Italy | Start Trial | PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
