Kynamro is a drug owned by Kastle Therapeutics Llc. It is protected by 8 US drug patents filed in 2013. Out of these, 1 drug patents are active and 7 have expired. Kynamro's patents have been open to challenges since 29 January, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 29, 2027. Details of Kynamro'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. | |||
| US7511131 | Antisense modulation of apolipoprotein B expression |
Jan, 2027
(2 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). | |||
| US7101993 | Oligonucleotides containing 2′-O-modified purines |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US7015315 | Gapped oligonucleotides |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US7407943 | Antisense modulation of apolipoprotein B expression |
Aug, 2021
(3 years ago) |
Expired
|
| US6166197 | Oligomeric compounds having pyrimidine nucleotide (S) with 2'and 5 substitutions |
Dec, 2017
(7 years ago) |
Expired
|
| US6451991 | Sugar-modified gapped oligonucleotides |
Feb, 2017
(7 years ago) |
Expired
|
| US5914396 | 2'-O-modified nucleosides and phosphoramidites |
Jun, 2016
(8 years ago) |
Expired
|
| US6222025 | Process for the synthesis of 2′-O-substituted pyrimidines and oligomeric compounds therefrom |
Mar, 2015
(9 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 Kynamro's patents.
Latest Legal Activities on Kynamro's Patents
Given below is the list of recent legal activities going on the following patents of Kynamro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 03 May, 2021 | US7511131 |
| Maintenance Fee Reminder Mailed Critical | 16 Nov, 2020 | US7511131 |
| Expire Patent Critical | 07 Sep, 2020 | US7407943 |
| Maintenance Fee Reminder Mailed Critical | 23 Mar, 2020 | US7407943 |
| Email Notification Critical | 09 Jan, 2017 | US7407943 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Jan, 2017 | US7511131 |
| Email Notification Critical | 09 Jan, 2017 | US7511131 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Jan, 2017 | US7407943 |
| Correspondence Address Change Critical | 06 Jan, 2017 | US7511131 |
| Correspondence Address Change Critical | 06 Jan, 2017 | US7407943 |
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 Kynamro and ongoing litigations to help you estimate the early arrival of Kynamro generic.
Kynamro's Litigations
Kynamro been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 18, 2000, against patent number US7015315. The petitioner , challenged the validity of this patent, with COOK et al as the respondent. Click below to track the latest information on how companies are challenging Kynamro's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7015315 | September, 2004 |
Decision
(27 Apr, 2005) | COOK et al | |
| US7015315 | October, 2000 |
Decision
(31 Oct, 2002) | COOK et al | |
FDA has granted some exclusivities to Kynamro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kynamro, 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 Kynamro.
Exclusivity Information
Kynamro holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Kynamro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 29, 2018 |
| Orphan Drug Exclusivity(ODE) | Jan 29, 2020 |
| Orphan Drug Exclusivity(ODE-41) | Jan 29, 2020 |
US patents provide insights into the exclusivity only within the United States, but Kynamro 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 Kynamro's family patents as well as insights into ongoing legal events on those patents.
Kynamro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kynamro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 29, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kynamro Generics:
There are no approved generic versions for Kynamro as of now.
About Kynamro
Kynamro is a drug owned by Kastle Therapeutics Llc. It is used for reducing cholesterol levels in patients with homozygous familial hypercholesterolemia. Kynamro uses Mipomersen Sodium as an active ingredient. Kynamro was launched by Kastle Theraps Llc in 2013.
Approval Date:
Kynamro was approved by FDA for market use on 29 January, 2013.
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 Kynamro is 29 January, 2013, its NCE-1 date is estimated to be 29 January, 2017.
Active Ingredient:
Kynamro uses Mipomersen Sodium as the active ingredient. Check out other Drugs and Companies using Mipomersen Sodium ingredient
Treatment:
Kynamro is used for reducing cholesterol levels in patients with homozygous familial hypercholesterolemia.
Dosage:
Kynamro is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/ML (200MG/ML) | SOLUTION | Discontinued | SUBCUTANEOUS |