Zortress is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 10 US drug patents filed in 2013 out of which all have expired. Zortress's patents have been open to challenges since 30 September, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 09, 2020. Details of Zortress'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). | |||
|
US5665772 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar, 2020
(6 years ago) |
Expired
|
| US5665772 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep, 2019
(7 years ago) |
Expired
|
|
US6239124 (Pediatric) | Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin |
Feb, 2018
(8 years ago) |
Expired
|
|
US6455518 (Pediatric) | Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin |
Jan, 2018
(8 years ago) |
Expired
|
| US6239124 | Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin |
Aug, 2017
(9 years ago) |
Expired
|
| US6455518 | Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin |
Jul, 2017
(9 years ago) |
Expired
|
|
US6004973 (Pediatric) | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jan, 2017
(9 years ago) |
Expired
|
| US6004973 | Pharmaceutical compositions comprising rafamycin coprecipitates |
Jul, 2016
(10 years ago) |
Expired
|
|
US6440990 (Pediatric) | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Mar, 2014
(12 years ago) |
Expired
|
| US6440990 | O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants |
Sep, 2013
(13 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 Zortress's patents.
Latest Legal Activities on Zortress's Patents
Given below is the list of recent legal activities going on the following patents of Zortress.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 10 Nov, 2018 | US6455518 (Litigated) |
| Post Issue Communication - Certificate of Correction | 10 Sep, 2018 | US6455518 (Litigated) |
| Post Issue Communication - Certificate of Correction | 21 Jun, 2018 | US6455518 (Litigated) |
| Post Issue Communication - Certificate of Correction | 14 May, 2018 | US6455518 (Litigated) |
| Mail Certificate of Correction Memo | 18 Apr, 2018 | US6455518 (Litigated) |
| Certificate of Correction Memo | 17 Apr, 2018 | US6455518 (Litigated) |
| Request for Trial Denied
Critical | 28 Apr, 2016 | US6455518 (Litigated) |
| Petition Requesting Trial | 26 Oct, 2015 | US6455518 (Litigated) |
| Patent Issue Date Used in PTA Calculation
Critical | 24 Sep, 2002 | US6455518 (Litigated) |
| Recordation of Patent Grant Mailed
Critical | 24 Sep, 2002 | US6455518 (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 Zortress and ongoing
litigations to
help you estimate the early arrival of Zortress generic.
Zortress's Litigations
Zortress been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 26, 2015, against patent number US6455518. The petitioner Par Pharmaceutical, Inc. et al., challenged the validity of this patent, with Novartis AG as the respondent. Click below to track the latest information on how companies are challenging Zortress's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5665772 | October, 2015 |
Final Written Decision
(11 Jan, 2018) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US5665772 | May, 2016 |
Final Written Decision
(27 Oct, 2016) | Novartis AG | BRECKENRIDGE PHARMACEUTICAL, INC. |
| US5665772 | May, 2016 |
Institution Denied
(27 Oct, 2016) | Novartis AG | Par Pharmaceutical, Inc. et al. |
| US5665772 | May, 2016 |
Final Written Decision
(27 Oct, 2016) | Novartis AG | Roxane Laboratories, Inc. et al. |
| US5665772 | May, 2016 |
Institution Denied
(27 Oct, 2016) | Novartis AG | Breckenridge Pharmaceutical, Inc. |
| US6455518 | October, 2015 |
Institution Denied
(28 Apr, 2016) | Novartis AG | Par Pharmaceutical, Inc. et al. |
FDA has granted some exclusivities to Zortress. Till the time these
exclusivities are
active, no other company can market a generic or bioequivalent version of Zortress,
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
Zortress.
Exclusivity Information
Zortress holds 4 exclusivities. All of its exclusivities have expired in 2016. Details of Zortress's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 20, 2013 |
| Pediatric Exclusivity(PED) | Sep 30, 2014 |
| New Chemical Entity Exclusivity(NCE) | Mar 30, 2014 |
| New Indication(I-668) | Feb 15, 2016 |
US patents provide insights into the exclusivity only within the United States, but
Zortress 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 Zortress's family patents as well as insights into
ongoing legal events
on those patents.
Zortress's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Zortress:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Zortress's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 09, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zortress Generic API suppliers:
Everolimus is the generic name for the brand Zortress. 13 different companies have already filed for the generic of Zortress, with Biocon Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zortress's generic
How can I launch a generic of Zortress before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zortress's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zortress'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 Zortress -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 30 Sep, 2013 | 09 Sep, 2019 | Extinguished Deferred | 12 Apr, 2018 | Moderate |
Alternative Brands for Zortress
Zortress which is used for preventing organ rejection in adult patients undergoing liver or renal transplant at low to moderate immunologic risk., has several other brand drugs using the same active ingredient (Everolimus). 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 | |
|---|---|---|
| Novartis |
| |
| Novartis Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Everolimus, Zortress's active ingredient. Check the complete list of approved generic manufacturers for Zortress
About Zortress
Zortress is a drug owned by Novartis Pharmaceuticals Corp. It is used for preventing organ rejection in adult patients undergoing liver or renal transplant at low to moderate immunologic risk. Zortress uses Everolimus as an active ingredient. Zortress was launched by Novartis in 2010.
Approval Date:
Zortress was approved by FDA for market use on 20 April, 2010.
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 Zortress is 20 April, 2010, its NCE-1 date is estimated to be 30 September, 2013.
Active Ingredient:
Zortress uses Everolimus as the active ingredient. Check out other Drugs and Companies using Everolimus ingredient
Treatment:
Zortress is used for preventing organ rejection in adult patients undergoing liver or renal transplant at low to moderate immunologic risk.
Dosage:
Zortress is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG | TABLET | Prescription | ORAL |
| 0.75MG | TABLET | Prescription | ORAL |
| 0.25MG | TABLET | Prescription | ORAL |