throbber
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`back to D.ru.g..Database.s.
`
`Orange Book: Approved Drug Products with
`Therapeutic Equivalence Evaluations
`
`[] SHARE
`
`[] LINKEDIN [] PIN IT [] [] EMAIL [] PRINT
`
`..H.o.m.e I ..B.ac.k...to.p..r.o.d.u.c.t...D..e!a!]s.
`
`Additional Information about Patents
`
`Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt
`date as described in 21 CFR 314.53(d)(5).
`
`Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and
`submitted by the sponsor. These patents may not be flagged with respect to other claims which may
`apply.
`
`Patent and Exclusivity for: N203567
`
`Product 001
`EFINACONAZOLE (JUBLIA) SOLUTION 10%
`
`Patent Data
`
`http://www.accessdata.fda.g~v/scripts/cder/~b/patent~inf~.cfm?Pr~duct~N~=~~~&App~~N~=2~3567&App~~type=N[~~/26/2~~6 12:59:42 PM]
`
`ARGENTUM EX1004
`
`Page 1
`
`

`

`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`001
`
`001
`
`001
`
`001
`
`7214506 Oct 5,
`2021
`
`8039494 Jul8,2030
`
`8486978 Oct 24,
`2030
`
`9302009 Oct 24,
`2030
`
`Exclusivity Data
`
`U-281
`
`U-281
`
`DP
`
`DP
`
`001
`
`NCE
`
`Jun 6, 2019
`
`..v.!.e...w...a..JN..o. !..a.!!. p..a..t.e..n..t..u...s..e...c.Q~.e...s.
`..V. !ew. a. Ji.s..t.o.f..a] !. excJu.s..ivj.ty., codes
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`http://www.accessdata.fda.g~v/scripts/cder/~b/patent~inf~.cfm?Pr~duct~N~=~~~&App~~N~=2~3567&App~~type=N[~~/26/2~~6 12:59:42 PM]
`
`Page 2
`
`

`

`Orange Book: Approved Drug Products wifll Therapeutic Equivalence Evaluations
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`1-888-1NFO-FDA (1-888-463-6332)
`
`[] FDA Archive
`
`[] Combination Products
`
`[] Advisory Committees
`
`[] Regulatory Information
`
`¯ Safety
`
`[J Emergency Preparedness
`
`[] International Programs
`
`[] News & Events
`
`[] Training & Continuing Education
`
`[] Inspections & Compliance
`
`[] Federal, State & Local Officials
`
`[] Consumers
`
`u Health Professionals
`
`[] Science & Research
`
`[] Industry
`
`http://www.accessdata.fda.g~v/scripts/cder/~b/patent~inf~.cfm?Pr~duct~N~=~~~&App~~N~=2~3567&App~~type=N[~~/26/2~~6 12:59:42 PM]
`
`Page 3
`
`

`

`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`http://www.accessdata.fda.g~v/scripts/cder/~b/patent~inf~.cfm?Pr~duct~N~=~~~&App~~N~=2~3567&App~~type=N[~~/26/2~~6 12:59:42 PM]
`
`Page 4
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket