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, 13 drug patents are active and 30 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). | |||
|
US10864181 (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 |
|
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 |
|
US11253494 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(8 years from now) | Active |
|
US8772306 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(8 years from now) | Active |
| US9486426 | 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 |
| US11253494 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Mar, 2033
(8 years from now) | Active |
| US10213400 | 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 |
| US11986446 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Mar, 2033
(8 years from now) | Active |
|
US7668730 (Pediatric) | Sensitive drug distribution system and method |
Dec, 2024
(5 days ago) |
Expired
|
|
US7765106 (Pediatric) | Sensitive drug distribution system and method |
Dec, 2024
(5 days ago) |
Expired
|
|
US7765107 (Pediatric) | Sensitive drug distribution system and method |
Dec, 2024
(5 days ago) |
Expired
|
| US7668730 | Sensitive drug distribution system and method |
Jun, 2024
(6 months ago) |
Expired
|
| US7765106 | Sensitive drug distribution system and method |
Jun, 2024
(6 months ago) |
Expired
|
| US7765107 | Sensitive drug distribution system and method |
Jun, 2024
(6 months ago) |
Expired
|
|
US8457988 (Pediatric) | Sensitive drug distribution system and method |
Jun, 2023
(1 year, 6 months ago) |
Expired
|
|
US8589182 (Pediatric) | Sensitive drug distribution system and method |
Jun, 2023
(1 year, 6 months ago) |
Expired
|
|
US8731963 (Pediatric) | Sensitive drug distribution system and method |
Jun, 2023
(1 year, 6 months ago) |
Expired
|
|
US7895059 (Pediatric) | Sensitive drug distribution system and method |
Jun, 2023
(1 year, 6 months ago) |
Expired
|
| US8457988 | Sensitive drug distribution system and method |
Dec, 2022
(2 years ago) |
Expired
|
| US8589182 | Sensitive drug distribution system and method |
Dec, 2022
(2 years ago) |
Expired
|
| US8731963 | Sensitive drug distribution system and method |
Dec, 2022
(2 years ago) |
Expired
|
| US7895059 | Sensitive drug distribution system and method |
Dec, 2022
(2 years 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
|
| US7262219 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jul, 2020
(4 years ago) |
Expired
|
| US6780889 | 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
|
|
US8952062 (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
|
|
US8324275 (Pediatric) | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Jun, 2020
(4 years ago) |
Expired
|
| US8859619 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 years ago) |
Expired
|
| US9539330 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 years ago) |
Expired
|
| US7851506 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 years ago) |
Expired
|
| US8952062 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 years ago) |
Expired
|
| US8263650 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 years ago) |
Expired
|
| US8324275 | Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy |
Dec, 2019
(5 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.
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 |
|---|---|---|
 | ||
| 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 |
|---|---|---|---|---|
 | ||||
| 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 |
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 |
|---|---|---|---|
| | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
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 |
|
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 |