Zytiga is a drug owned by Janssen Biotech Inc. It is protected by 2 US drug patents filed from 2013 to 2017. Out of these, 1 drug patents are active and 1 has expired. Zytiga's patents have been open to challenges since 29 April, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2027. Details of Zytiga'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). | |||
| US8822438 | Methods and compositions for treating cancer |
Aug, 2027
(2 years from now) | Active |
| US5604213 | 17-substituted steroids useful in cancer treatment |
Feb, 2014
(10 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 Zytiga's patents.
Latest Legal Activities on Zytiga's Patents
Given below is the list of recent legal activities going on the following patents of Zytiga.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Feb, 2022 | US8822438 |
| Review Certificate Mailed | 21 Oct, 2019 | US8822438 |
| Review Certificate | 11 Sep, 2019 | US8822438 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2018 | US8822438 |
| Post Issue Communication - Certificate of Correction | 02 Feb, 2018 | US8822438 |
| Termination or Final Written Decision | 17 Jan, 2018 | US8822438 |
| Post Issue Communication - Certificate of Correction | 12 Dec, 2017 | US8822438 |
| Post Issue Communication - Certificate of Correction | 06 Oct, 2017 | US8822438 |
| Workflow - Request for CPA - Begin | 08 Aug, 2017 | US8822438 |
| Request for Trial Granted Critical | 12 Apr, 2017 | US8822438 |
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 Zytiga and ongoing litigations to help you estimate the early arrival of Zytiga generic.
Zytiga's Litigations
Zytiga been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 08, 2017, against patent number US8822438. The petitioner ACTAVIS LABORATORIES FL, INC., challenged the validity of this patent, with Janssen Oncology, Inc. as the respondent. Click below to track the latest information on how companies are challenging Zytiga's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8822438 | December, 2015 |
FWD Entered
(17 Jan, 2018) | Janssen Oncology, Inc. | Amerigen Pharmaceuticals, Ltd. |
| US8822438 | June, 2016 |
FWD Entered
(17 Jan, 2018) | Janssen Oncology, Inc. | Argentum Pharmaceuticals LLC |
| US8822438 | June, 2016 |
FWD Entered
(17 Jan, 2018) | Janssen Oncology, Inc. | Mylan Pharmaceuticals Inc. |
| US8822438 | August, 2016 |
FWD Entered
(17 Jan, 2018) | Janssen Oncology, Inc. | Wockhardt Bio AG |
| US8822438 | February, 2017 |
FWD Entered
(17 Jan, 2018) | Janssen Oncology, Inc. | ACTAVIS LABORATORIES FL, INC. |
FDA has granted some exclusivities to Zytiga. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zytiga, 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 Zytiga.
Exclusivity Information
Zytiga holds 3 exclusivities. All of its exclusivities have expired in 2021. Details of Zytiga's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-663) | Dec 10, 2015 |
| New Chemical Entity Exclusivity(NCE) | Apr 28, 2016 |
| New Indication(I-765) | Feb 07, 2021 |
US patents provide insights into the exclusivity only within the United States, but Zytiga 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 Zytiga's family patents as well as insights into ongoing legal events on those patents.
Zytiga's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zytiga's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zytiga Generic API suppliers:
Abiraterone Acetate is the generic name for the brand Zytiga. 13 different companies have already filed for the generic of Zytiga, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zytiga's generic
How can I launch a generic of Zytiga before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zytiga's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zytiga'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 Zytiga -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg | 28 Apr, 2015 | 13 | 31 Oct, 2018 | 24 Aug, 2027 | Eligible |
| 500 mg | 23 Aug, 2017 | 1 | 24 Aug, 2027 | Extinguished |
Alternative Brands for Zytiga
Zytiga which is used for the treatment of advanced prostate cancer in combination with prednisone, including metastatic castration-resistant and high-risk castration-sensitive types., has several other brand drugs using the same active ingredient (Abiraterone Acetate). 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 brand drugs containing the same ingredient, some generics have also been filed for Abiraterone Acetate, Zytiga's active ingredient. Check the complete list of approved generic manufacturers for Zytiga
About Zytiga
Zytiga is a drug owned by Janssen Biotech Inc. It is used for the treatment of advanced prostate cancer in combination with prednisone, including metastatic castration-resistant and high-risk castration-sensitive types. Zytiga uses Abiraterone Acetate as an active ingredient. Zytiga was launched by Janssen Biotech in 2011.
Approval Date:
Zytiga was approved by FDA for market use on 28 April, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zytiga is 28 April, 2011, its NCE-1 date is estimated to be 29 April, 2015.
Active Ingredient:
Zytiga uses Abiraterone Acetate as the active ingredient. Check out other Drugs and Companies using Abiraterone Acetate ingredient
Treatment:
Zytiga is used for the treatment of advanced prostate cancer in combination with prednisone, including metastatic castration-resistant and high-risk castration-sensitive types.
Dosage:
Zytiga is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG | TABLET | Prescription | ORAL |
| 500MG | TABLET | Prescription | ORAL |