Zejula is a drug owned by Glaxosmithkline Llc. It is protected by 8 US drug patents filed from 2017 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2039. Details of Zejula's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8071623 | Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors |
Mar, 2031
(5 years from now) | Active |
| US8436185 | Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide |
Apr, 2029
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11730725 | Niraparib formulations |
Jan, 2039
(13 years from now) | Active |
| US11673877 | Niraparib compositions |
Mar, 2038
(12 years from now) | Active |
| US11091459 | Niraparib compositions |
Mar, 2038
(12 years from now) | Active |
| US8859562 | Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer |
Aug, 2031
(5 years from now) | Active |
| US8071579 | DNA damage repair inhibitors for the treatment of cancer |
Aug, 2027
(1 year, 8 months from now) | Active |
| US8143241 | DNA damage repair inhibitors for treatment of cancer |
Aug, 2027
(1 year, 8 months 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 Zejula's patents.
Latest Legal Activities on Zejula's Patents
Given below is the list of recent legal activities going on the following patents of Zejula.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification
Critical | 13 Feb, 2024 | US11730725 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 12 Feb, 2024 | US11730725 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 12 Feb, 2024 | US11730725 |
| Pet Dec Routed to Certificate of Corrections Branch | 09 Feb, 2024 | US11730725 |
| Adjustment of PTA Calculation by PTO | 09 Feb, 2024 | US11730725 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 09 Feb, 2024 | US11730725 |
| Petition Entered | 13 Oct, 2023 | US11730725 |
| Recordation of Patent eGrant | 22 Aug, 2023 | US11730725 |
| Patent Issue Date Used in PTA Calculation
Critical | 22 Aug, 2023 | US11730725 |
| Recordation of Patent Grant Mailed
Critical | 22 Aug, 2023 | US11730725 |
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 Zejula and ongoing
litigations to
help you estimate the early arrival of Zejula generic.
Zejula's Litigations
Zejula been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 11, 2011, against patent number US8859562. The petitioner , challenged the validity of this patent, with Thomas Helleday as the respondent. Click below to track the latest information on how companies are challenging Zejula's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8859562 | October, 2011 |
Decision
(25 Mar, 2014) | Thomas Helleday | |
FDA has granted some exclusivities to Zejula. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Zejula,
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
Zejula.
Exclusivity Information
Zejula holds 9 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Zejula's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 27, 2022 |
| New Indication(I-813) | Oct 23, 2022 |
| New Indication(I-814) | Oct 23, 2022 |
| New Indication(I-833) | Apr 29, 2023 |
| Orphan Drug Exclusivity(ODE) | Mar 27, 2024 |
| Orphan Drug Exclusivity(ODE-133) | Mar 27, 2024 |
| Orphan Drug Exclusivity(ODE-277) | Oct 23, 2026 |
| Orphan Drug Exclusivity(ODE-278) | Oct 23, 2026 |
| Orphan Drug Exclusivity(ODE-295) | Apr 29, 2027 |
Several oppositions have been filed on Zejula'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 Zejula's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Zejula patents.
Zejula's Oppositions Filed in EPO
Zejula has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 13, 2012, by Adams, Harvey Vaughan John. This opposition was filed on patent number EP04743564A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04798705A | May, 2012 | STRAWMAN LIMITED | Opposition procedure closed |
| EP04798705A | May, 2012 | Adams, Harvey Vaughan John | Opposition procedure closed |
| EP04743564A | Apr, 2012 | STRAWMAN LIMITED | Patent maintained as amended |
| EP04743564A | Apr, 2012 | Adams, Harvey Vaughan John | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Zejula 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 Zejula's family patents as well as insights into
ongoing legal events
on those patents.
Zejula's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zejula's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zejula Generics:
There are no approved generic versions for Zejula as of now.
Alternative Brands for Zejula
Zejula which is used for treating ovarian, fallopian tube, or primary peritoneal cancer associated with HRD positive status and recurrent ovarian or fallopian tube cancer with BRCA mutations., has several other brand drugs using the same active ingredient (Niraparib Tosylate). 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 | |
|---|---|---|
| Janssen Biotech |
|
About Zejula
Zejula is a drug owned by Glaxosmithkline Llc. It is used for treating ovarian, fallopian tube, or primary peritoneal cancer associated with HRD positive status and recurrent ovarian or fallopian tube cancer with BRCA mutations. Zejula uses Niraparib Tosylate as an active ingredient. Zejula was launched by Glaxosmithkline in 2023.
Approval Date:
Zejula was approved by FDA for market use on 26 April, 2023.
Active Ingredient:
Zejula uses Niraparib Tosylate as the active ingredient. Check out other Drugs and Companies using Niraparib Tosylate ingredient
Treatment:
Zejula is used for treating ovarian, fallopian tube, or primary peritoneal cancer associated with HRD positive status and recurrent ovarian or fallopian tube cancer with BRCA mutations.
Dosage:
Zejula is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |
| EQ 200MG BASE | TABLET | Prescription | ORAL |
| EQ 300MG BASE | TABLET | Prescription | ORAL |