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Durezol patents expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6114319 SANDOZ Compositions containing difluprednate
May, 2019

(4 years ago)

US6114319

(Pediatric)

SANDOZ Compositions containing difluprednate
Nov, 2019

(4 years ago)

Durezol is owned by Sandoz.

Durezol contains Difluprednate.

Durezol has a total of 2 drug patents out of which 2 drug patents have expired.

Expired drug patents of Durezol are:

  • US6114319
  • US6114319*PED

Durezol was authorised for market use on 23 June, 2008.

Durezol is available in emulsion;ophthalmic dosage forms.

Drug patent challenges can be filed against Durezol from 23 September, 2015.

The generics of Durezol are possible to be released after 18 November, 2019.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-26) Jun 13, 2019
Orphan Drug Exclusivity(ODE) Jun 13, 2019
M(M-127) Mar 22, 2016
New Chemical Entity Exclusivity(NCE) Jun 23, 2013
Pediatric Exclusivity(PED) Sep 22, 2016
New Indication(I-653) Jun 13, 2015

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Drugs and Companies using DIFLUPREDNATE ingredient

NCE-1 date: 23 September, 2015

Market Authorisation Date: 23 June, 2008

Treatment: NA

Dosage: EMULSION;OPHTHALMIC

How can I launch a generic of DUREZOL before it's drug patent expiration?
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DUREZOL family patents

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