Xyrem Patent Expiration

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.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8772306

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US9486426

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US9050302

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US10213400

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US10864181

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US11253494

(Pediatric)

Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Sep, 2033

(8 years from now)

Active
US10213400 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US9050302 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US8772306 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US11986446 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US10864181 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US11253494 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US9486426 Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
Mar, 2033

(8 years from now)

Active
US7765106

(Pediatric)

Sensitive drug distribution system and method
Dec, 2024

(2 months from now)

Active
US7765107

(Pediatric)

Sensitive drug distribution system and method
Dec, 2024

(2 months from now)

Active
US7668730

(Pediatric)

Sensitive drug distribution system and method
Dec, 2024

(2 months from now)

Active
US7765107 Sensitive drug distribution system and method
Jun, 2024

(3 months ago)

Expired
US7765106 Sensitive drug distribution system and method
Jun, 2024

(3 months ago)

Expired
US7668730 Sensitive drug distribution system and method
Jun, 2024

(3 months ago)

Expired
US8731963

(Pediatric)

Sensitive drug distribution system and method
Jun, 2023

(1 year, 3 months ago)

Expired
US8589182

(Pediatric)

Sensitive drug distribution system and method
Jun, 2023

(1 year, 3 months ago)

Expired
US8457988

(Pediatric)

Sensitive drug distribution system and method
Jun, 2023

(1 year, 3 months ago)

Expired
US7895059

(Pediatric)

Sensitive drug distribution system and method
Jun, 2023

(1 year, 3 months ago)

Expired
US7895059 Sensitive drug distribution system and method
Dec, 2022

(1 year, 9 months ago)

Expired
US8731963 Sensitive drug distribution system and method
Dec, 2022

(1 year, 9 months ago)

Expired
US8457988 Sensitive drug distribution system and method
Dec, 2022

(1 year, 9 months ago)

Expired
US8589182 Sensitive drug distribution system and method
Dec, 2022

(1 year, 9 months ago)

Expired
US7262219

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jan, 2021

(3 years ago)

Expired
US6780889

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jan, 2021

(3 years ago)

Expired
US6780889 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jul, 2020

(4 years ago)

Expired
US7262219 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jul, 2020

(4 years ago)

Expired
US8263650

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US7851506

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US9539330

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US8324275

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US8859619

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US8952062

(Pediatric)

Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Jun, 2020

(4 years ago)

Expired
US7851506 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired
US8324275 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired
US9539330 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired
US8859619 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired
US8263650 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired
US8952062 Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
Dec, 2019

(4 years ago)

Expired


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.

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

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

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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.

Exclusivity Information

Xyrem holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Xyrem's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Nov 18, 2012
New Patient Population(NPP) Oct 26, 2021
Orphan Drug Exclusivity(ODE-231) Oct 26, 2025
Pediatric Exclusivity(PED) Apr 26, 2026

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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
Patent litigations
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.

Family Patents

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Generic Launch

Generic Release Date:

Xyrem's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 15, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Xyrem Generics:

Sodium Oxybate is the generic name for the brand Xyrem. 1 company has already filed for the generic of Xyrem. Check out the entire list of companies who have already received approval for Xyrem's generic

How can I launch a generic of Xyrem before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Xyrem's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xyrem's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Xyrem -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
500 mg/mL 08 Jul, 2010 1 17 Jan, 2017 16 Jun, 2024 Eligible

Alternative Brands for Xyrem

Xyrem which is used for treating patients with narcolepsy and reducing excessive daytime sleepiness and cataplexy when administered with specific medications., has several other brand drugs in the same treatment category and using the same active ingredient (Sodium Oxybate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Harmony
Wakix Used for treating cataplexy in patients with narcolepsy.
Jazz
Xywav

(uses Sodium Oxybate)

used for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Sodium Oxybate. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Avadel Cns
Lumryz


Apart from brand drugs containing the same ingredient, some generics have also been filed for Sodium Oxybate, Xyrem's active ingredient. Check the complete list of approved generic manufacturers for Xyrem





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.

Approval Date:

Xyrem was approved by FDA for market use on 17 July, 2002.

Active Ingredient:

Xyrem uses Sodium Oxybate as the active ingredient. Check out other Drugs and Companies using Sodium Oxybate ingredient

Treatment:

Xyrem is used for treating patients with narcolepsy and reducing excessive daytime sleepiness and cataplexy when administered with specific medications.

Dosage:

Xyrem is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.5GM/ML SOLUTION Prescription ORAL


Xyrem News

Accusations of Delaying Release of Generic Sleep Disorder Drug Hurled at Jazz and Hikma to Keep Prices High

28 Aug, 2024

Legal action required for Jazz and Hikma to address allegations of 'reverse payment' related to narcolepsy medication - XM

27 Aug, 2024

Jazz Pharmaceuticals and Hikma Pharmaceuticals to address allegations of 'reverse payment' concerning narcolepsy medication - Westlaw Today

27 Aug, 2024

Jazz Pharmaceuticals decision paves the way for a competitor's narcolepsy drug in the U.S., as reported by Yahoo Lifestyle Canada.

05 Mar, 2024

See More