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DEXYCU KIT Drug Profile
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» See Plans and PricingWhich patents cover Dexycu Kit, and when can generic versions of Dexycu Kit launch?
Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are five patents protecting this drug.
This drug has thirty-four patent family members in eighteen countries.
The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
US ANDA Litigation and Generic Entry Outlook for Dexycu Kit
A generic version of DEXYCU KIT was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983.
Summary for DEXYCU KIT
| International Patents: | 34 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 3 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DEXYCU KIT at DailyMed |
Recent Clinical Trials for DEXYCU KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| MDbackline, LLC | Phase 2 |
| Ocular Therapeutix, Inc. | Phase 4 |
| Silverstein Eye Centers | Phase 4 |
US Patents and Regulatory Information for DEXYCU KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eyepoint Pharms | DEXYCU KIT | dexamethasone | SUSPENSION;INTRAOCULAR | 208912-001 | Feb 9, 2018 | 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 |
International Patents for DEXYCU KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20160040471 | Start Trial |
| China | 110339153 | Start Trial |
| Japan | 2014521372 | Start Trial |
| China | 105407896 | Start Trial |
| Australia | 2003273181 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for DEXYCU KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | SPC/GB12/058 | United Kingdom | Start Trial | PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003 |
| 1581193 | SPC/GB12/047 | United Kingdom | Start Trial | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| 1429780 | 13C0012 | France | Start Trial | PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
