Xywav is a drug owned by Jazz Pharmaceuticals Ireland Ltd. It is protected by 22 US drug patents filed from 2020 to 2024. Out of these, 20 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 19, 2037. Details of Xywav'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8731963 | Sensitive drug distribution system and method |
Dec, 2022
(1 year, 7 months ago) |
Expired
|
|
US8731963 (Pediatric) | Sensitive drug distribution system and method |
Jun, 2023
(1 year, 1 month ago) |
Expired
|
| US9132107 | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
Jan, 2033
(8 years from now) | Active |
| US10675258 | Method of using gamma-hydroxybutyrate compositions for the treatment of disorders |
Jan, 2033
(8 years from now) | Active |
| US8901173 | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
Jan, 2033
(8 years from now) | Active |
| US10195168 | Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders |
Jan, 2033
(8 years from now) | Active |
| US8591922 | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
Jan, 2033
(8 years from now) | Active |
| US11554102 | Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders |
Jan, 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 |
| US11253494 | 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 |
| US10213400 | 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 |
| US8772306 | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Mar, 2033
(8 years from now) | Active |
|
US9486426 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
|
US8772306 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
|
US11253494 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
|
US10864181 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
|
US9050302 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
|
US10213400 (Pediatric) | Method of administration of gamma hydroxybutyrate with monocarboxylate transporters |
Sep, 2033
(9 years from now) | Active |
| US11426373 | Gamma-hydroxybutyrate compositions and their use for the treatment of disorders |
Sep, 2037
(13 years from now) | Active |
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 Xywav's patents.
Latest Legal Activities on Xywav's Patents
Given below is the list of recent legal activities going on the following patents of Xywav.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 May, 2024 | US10864181 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 24 Apr, 2024 | US9486426 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Nov, 2023 | US10675258 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Mar, 2023 | US9132107 |
| Patent Issue Date Used in PTA Calculation | 17 Jan, 2023 | US11554102 |
| Recordation of Patent Grant Mailed | 17 Jan, 2023 | US11554102 |
| Email Notification | 29 Dec, 2022 | US11554102 |
| Issue Notification Mailed | 28 Dec, 2022 | US11554102 |
| Application Is Considered Ready for Issue | 13 Dec, 2022 | US11554102 |
| Dispatch to FDC | 13 Dec, 2022 | US11554102 |
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 Xywav and ongoing litigations to help you estimate the early arrival of Xywav generic.
Xywav's Litigations
Xywav has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 14, 2015, against patent number US8731963. The petitioner Par Pharmaceutical, Inc. et al., challenged the validity or infringement of this patent, with Jazz Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Xywav's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9050302 | March, 2016 | Terminated-Denied | Jazz Pharmaceuticals Ireland Limited | RANBAXY INC |
| US8772306 | February, 2016 | Terminated-Denied | Jazz Pharmaceutical, Inc. | Amneal Pharmaceuticals LLC |
| US8772306 | October, 2015 | Terminated-Settled | Jazz Pharmaceutical, Inc. | Ranbaxy, Inc. |
| US8772306 | October, 2015 | Terminated-Denied | Jazz Pharmaceutical, Inc. | Par Pharmaceutical, Inc. |
| US8731963 | September, 2015 | Final Written Decision | Jazz Pharmaceuticals, Inc. | Par Pharmaceutical, Inc. et al. |
FDA has granted some exclusivities to Xywav. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xywav, 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 Xywav.
Exclusivity Information
Xywav holds 5 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Xywav's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 21, 2023 |
| New Indication(I-870) | Aug 12, 2024 |
| Orphan Drug Exclusivity(ODE-361) | Jul 21, 2027 |
| Orphan Drug Exclusivity(ODE-231) | Jul 21, 2027 |
| Orphan Drug Exclusivity(ODE-369) | Aug 12, 2028 |
Several oppositions have been filed on Xywav'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 Xywav's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xywav patents.
Xywav's oppositions filed in EPO
Xywav 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 Xywav 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 Xywav's family patents as well as insights into ongoing legal events on those patents.
Xywav's family patents
Coming Soon
Patent Strength Analyzer
YesNo
Thank you for your response 🥳
Generic Launch
Generic Release Date:
Xywav's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 19, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xywav Generics:
There are no approved generic versions for Xywav as of now.
How can I launch a generic of Xywav before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xywav's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xywav'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 Xywav -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.234 g/0.096 g/ 013 g/0.04 g per mL | 12 Apr, 2021 | 1 | 15 Mar, 2033 |
About Xywav
Xywav is a drug owned by Jazz Pharmaceuticals Ireland Ltd. It is used for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy. Xywav uses Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate as an active ingredient. Xywav was launched by Jazz in 2020.
Market Authorisation Date:
Xywav was approved by FDA for market use on 21 July, 2020.
Active Ingredient:
Xywav uses Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate as the active ingredient. Check out other Drugs and Companies using Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate ingredient
Treatment:
Xywav is used for treating excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Dosage:
Xywav is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | SOLUTION | Prescription | ORAL |