Xyrem is a drug owned by Jazz Pharmaceuticals Inc. It is protected by 43 US drug patents filed from 2013 to 2024. Out of these, 16 drug patents are active and 27 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2033. Details of Xyrem's patents and their expiration are given in the table below.

A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Xyrem's patents.

Latest Legal Activities on Xyrem's Patents

Given below is the list of recent legal activities going on the following patents of Xyrem.

Activity	Date	Patent Number
Legal Activities for all Patents
Payment of Maintenance Fee, 4th Year, Large Entity	29 May, 2024	US10864181
Maintenance Fee Reminder Mailed Critical	29 Apr, 2024	US8263650 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity	24 Apr, 2024	US9486426
Expire Patent Critical	27 Mar, 2023	US7895059 (Litigated)
Expire Patent Critical	20 Mar, 2023	US8952062 (Litigated)
Expire Patent Critical	16 Jan, 2023	US7851506 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity	23 Nov, 2022	US9050302 (Litigated)
Expire Patent Critical	21 Nov, 2022	US8859619 (Litigated)
Maintenance Fee Reminder Mailed Critical	10 Oct, 2022	US7895059 (Litigated)
Maintenance Fee Reminder Mailed Critical	03 Oct, 2022	US8952062 (Litigated)

While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Xyrem and ongoing litigations to help you estimate the early arrival of Xyrem generic.

Xyrem's Litigations

Xyrem been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 20, 2008, against patent number US7668730. The petitioner , challenged the validity of this patent, with Dayton T. Reardan et al as the respondent. Click below to track the latest information on how companies are challenging Xyrem's patents.

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
Live updates
US8731963	September, 2015	Final Written Decision (22 Mar, 2017)	Jazz Pharmaceuticals, Inc.	Par Pharmaceutical, Inc. et al.
US7765106	August, 2015	Final Written Decision (03 Jan, 2017)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG et al.
US8772306	February, 2016	Terminated-Denied (28 Jul, 2016)	Jazz Pharmaceutical, Inc.	Amneal Pharmaceuticals LLC
US7668730	January, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC. et al.
US7668730	August, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG et al.
US7765106	January, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals LLC et al.
US7765107	January, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals LLC et al.
US7765107	August, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG et al.
US7895059	January, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC.
US7895059	August, 2015	FWD Entered (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals LLC
US7895059	August, 2015	FWD Entered (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG
US8457988	January, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC.
US8457988	August, 2015	FWD Entered (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals LLC
US8457988	August, 2015	FWD Entered (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG
US8589182	January, 2015	FWD Entered (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals LLC
US8589182	August, 2015	Final Written Decision (27 Jul, 2016)	Jazz Pharmaceuticals, Inc.	Wockhardt Bio AG et al.
US8772306	October, 2015	Terminated-Settled (23 May, 2016)	Jazz Pharmaceutical, Inc.	Ranbaxy, Inc.
US9050302	March, 2016	Terminated-Denied (23 May, 2016)	Jazz Pharmaceuticals Ireland Limited	RANBAXY INC
US8772306	October, 2015	Terminated-Denied (12 Apr, 2016)	Jazz Pharmaceutical, Inc.	Par Pharmaceutical, Inc.
US7895059	April, 2015	Terminated-Denied (15 Oct, 2015)	Jazz Pharmaceuticals, Inc.	Coalition for Affordable Drugs III LLC
US7765106	August, 2014	Terminated-Denied (09 Feb, 2015)	Jazz Pharmaceuticals, Inc.	Roxane Laboratories, Inc.
US7765107	August, 2014	Terminated-Denied (09 Feb, 2015)	Jazz Pharmaceuticals Inc.	Roxane Laboratories, Inc.
US7668730	July, 2014	Terminated-Denied (13 Jan, 2015)	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC.
US7895059	June, 2014	Terminated-Denied (13 Jan, 2015)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals, LLC
US8457988	July, 2014	Terminated-Denied (13 Jan, 2015)	Jazz Pharmaceuticals, Inc.	Amneal Pharmaceuticals, LLC
US8589182	July, 2014	Terminated-Denied (13 Jan, 2015)	Jazz Pharmaceuticals, Inc.	PAR PHARMACEUTICAL, INC.
US7668730	May, 2008	Decision (31 Aug, 2009)	Dayton T. Reardan et al

FDA has granted some exclusivities to Xyrem. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xyrem, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xyrem.

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Several oppositions have been filed on Xyrem's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xyrem's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xyrem patents.

Xyrem's Oppositions Filed in EPO

Xyrem has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 23, 2018, by Hoffmann Eitle. This opposition was filed on patent number EP14709858A. Click below to reveal the latest opposition data.

Application	Filing Date	Opposition Party	Legal Status
Live updates
EP17200764A	Sep, 2020	Ter Meer Steinmeister & Partner Patentanwälte mbB	Granted and Under Opposition
EP17200764A	Sep, 2020	Hexal AG	Granted and Under Opposition
EP17200764A	Sep, 2020	Zentiva, k.s.	Granted and Under Opposition
EP17200764A	Mar, 2020	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Granted and Under Opposition
EP14709858A	Aug, 2018	Hexal AG	Revoked
EP14709858A	Aug, 2018	Ter Meer Steinmeister & Partner Patentanwälte mbB	Revoked
EP14709858A	Jul, 2018	Hoffmann Eitle	Revoked

US patents provide insights into the exclusivity only within the United States, but Xyrem is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Xyrem's family patents as well as insights into ongoing legal events on those patents.

Xyrem's Family Patents

Xyrem has patent protection in a total of 21 countries. It's US patent count contributes only to 50.0% of its total global patent coverage. Click below to unlock the full patent family tree for Xyrem.

Full family tree

Generic Launch

About Xyrem

Xyrem is a drug owned by Jazz Pharmaceuticals Inc. It is used for treating patients with narcolepsy and reducing excessive daytime sleepiness and cataplexy when administered with specific medications. Xyrem uses Sodium Oxybate as an active ingredient. Xyrem was launched by Jazz Pharms in 2002.