`
`FDA Home3 Drug Databases4 Orange Book5
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Patent and Exclusivity Search Results from query on Appl No 021196 Product 001 in the OB_Rx list.
`
`Patent Data
`
`Appl No
`
`Prod No
`
`Patent No
`
`Patent
`Expiration
`
`Drug Substance
`Claim
`
`Drug Product
`Claim
`
`Patent Use
`Code
`
`Delist
`Requested
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`6780889
`
`7262219
`
`7668730
`
`7765106
`
`7765107
`
`7851506
`
`7851506
`
`7895059
`
`8263650
`
`8263650
`
`Jul 4, 2020
`
`Jul 4, 2020
`
`Jun 16, 2024
`
`Jun 16, 2024
`
`Jun 16, 2024
`
`Dec 22, 2019
`
`Dec 22, 2019
`
`Dec 17, 2022
`
`Dec 22, 2019
`
`Dec 22, 2019
`
`Dec 22, 2019
`
`Y
`
`Y
`
`Y
`
`Y
`
`U - 1110
`
`U - 1069
`
`U - 1070
`
`U - 1101
`
`U - 1102
`
`U - 1110
`
`U - 1101
`
`U - 1102
`
`U - 1101
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`N021196
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`001
`
`8324275
`
`8324275
`
`8457988
`
`8589182
`
`8731963
`
`8772306
`
`8859619
`
`8952062
`
`8952062
`
`9050302
`
`Dec 22, 2019
`
`Dec 17, 2022
`
`Dec 17, 2022
`
`Dec 17, 2022
`
`Mar 15, 2033
`
`Dec 22, 2019
`
`Dec 22, 2019
`
`Dec 22, 2019
`
`Mar 15, 2033
`
`Exclusivity Data
`There is no unexpired exclusivity for this product.
`
`Additional information:
`
`U - 1102
`
`U - 1110
`
`U - 1110
`
`U - 1110
`
`U - 1532
`
`U - 1101
`
`U - 1102
`
`U - 1532
`
`Y
`
`1. 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).
`
`2. 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.
`
`View a list of all patent use codes
`View a list of all exclusivity codes
`
`Return to Electronic Orange Book Home Page6
`
`FDA/Center for Drug Evaluation and Research
`Office of Generic Drugs
`Division of Labeling and Program Support
`Update Frequency:
`
`Orange Book Data - Monthly
`Generic Drug Product Information & Patent Information - Daily
`Orange Book Data Updated Through September 2015
`Patent and Generic Drug Product Data Last Updated November 03, 2015
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5. ../default.cfm
`
`6. ../default.cfm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`
`1/2
`
`Page 1 of 2
`
`JAZZ EXHIBIT 2013
`Amneal Pharms. et al. (Petitioners) v. Jazz Pharms., Inc. (Patent Owner)
`Case IPR2015-01903
`
`
`
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
`
`
`
`
`
`
`
`
`
`
`
`
`
`For Government For Press
`
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`
`Links on this page:
`
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`
`2. http://www.addthis.com/bookmark.php
`
`3. http://www.fda.gov/default.htm
`
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`
`5. ../default.cfm
`
`6. ../default.cfm
`
`http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021196&Product_No=001&table1=OB_Rx
`
`2/2
`
`Page 2 of 2
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
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.
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.
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
