Kyprolis is a drug owned by Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc. It is protected by 18 US drug patents filed from 2013 to 2026. Out of these, 10 drug patents are active and 8 have expired. Kyprolis's patents have been open to challenges since 20 July, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 29, 2041. Details of Kyprolis'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. | |||
| US7417042 | Compounds for enzyme inhibition |
Jul, 2026
(2 months ago) |
Expired
|
| US7232818 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| US8207125 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| US8207297 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US12636340 (Pediatric) | Methods Of Treating Multiple Myeloma |
Oct, 2041
(15 years from now) | Active |
| US12636340 | Methods Of Treating Multiple Myeloma |
Apr, 2041
(14 years from now) | Active |
|
US9493582 (Pediatric) | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Aug, 2033
(6 years from now) | Active |
| US9493582 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Feb, 2033
(6 years from now) | Active |
|
USRE47954 (Pediatric) | Combination therapy with peptide epoxyketones |
Apr, 2030
(3 years from now) | Active |
| US9511109 | Combination therapy with peptide epoxyketones |
Oct, 2029
(3 years from now) | Active |
| USRE47954 | Combination therapy with peptide epoxyketones |
Oct, 2029
(3 years from now) | Active |
|
US7737112 (Pediatric) | Composition for enzyme inhibition |
Jun, 2028
(1 year, 8 months from now) | Active |
| US7737112 | Composition for enzyme inhibition |
Dec, 2027
(1 year, 2 months from now) | Active |
|
US7417042 (Pediatric) | Compounds for enzyme inhibition |
Jan, 2027
(3 months from now) | Active |
| US7491704 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| US8129346 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| US8207127 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months ago) |
Expired
|
| US8207126 | Compounds for enzyme inhibition |
Apr, 2025
(1 year, 5 months 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 Kyprolis's patents.
Latest Legal Activities on Kyprolis's Patents
Given below is the list of recent legal activities going on the following patents of Kyprolis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | USRE47954 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2024 | US9493582 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8207297 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8207125 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8207127 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8207126 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Aug, 2023 | US8129346 (Litigated) |
| Correspondence Address Change
Critical | 04 Dec, 2022 | US9493582 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Dec, 2021 | US7737112 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Aug, 2020 | US7491704 (Litigated) |
FDA has granted several exclusivities to Kyprolis. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Kyprolis, 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
Kyprolis.
Exclusivity Information
Kyprolis holds 10 exclusivities out of which 8 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Kyprolis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 20, 2017 |
| New Indication(I-712) | Jul 24, 2018 |
| New Indication(I-722) | Jan 21, 2019 |
| New Indication(I-723) | Jan 21, 2019 |
| Orphan Drug Exclusivity(ODE) | Jul 20, 2019 |
| Orphan Drug Exclusivity(ODE-27) | Jul 20, 2019 |
| New Dosing Schedule(D-172) | Sep 28, 2021 |
| New Indication(I-842) | Aug 20, 2023 |
| M(M-14) | May 22, 2028 |
| Pediatric Exclusivity(PED) | Nov 22, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Kyprolis 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 Kyprolis's family patents as well as insights into
ongoing legal events
on those patents.
Kyprolis's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Kyprolis:
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:
Kyprolis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 29, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kyprolis Generic API suppliers:
Carfilzomib is the generic name for the brand Kyprolis. 4 different companies have already filed for the generic of Kyprolis, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kyprolis's generic
How can I launch a generic of Kyprolis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kyprolis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kyprolis'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 Kyprolis -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Nov, 2018 | 27 Feb, 2033 | Deferred | 11 Jun, 2021 | Less | |
| 05 Oct, 2017 | 27 Feb, 2033 | Eligible | 20 Mar, 2020 | Less | |
| 20 Jul, 2016 | 07 Dec, 2027 | Eligible | 09 Sep, 2019 | High |
About Kyprolis
Kyprolis is a drug owned by Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc. It is used for treating relapsed or refractory multiple myeloma in patients who have received one to three lines of therapy. Kyprolis uses Carfilzomib as an active ingredient. Kyprolis was launched by Onyx Amgen in 2018.
Approval Date:
Kyprolis was approved by FDA for market use on 07 June, 2018.
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 Kyprolis is 07 June, 2018, its NCE-1 date is estimated to be 20 July, 2016.
Active Ingredient:
Kyprolis uses Carfilzomib as the active ingredient. Check out other Drugs and Companies using Carfilzomib ingredient
Treatment:
Kyprolis is used for treating relapsed or refractory multiple myeloma in patients who have received one to three lines of therapy.
Dosage:
Kyprolis is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 10MG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 30MG/VIAL | POWDER | Prescription | INTRAVENOUS |