Juxtapid is a drug owned by Chiesi Farmaceutici Spa. It is protected by 11 US drug patents filed from 2013 to 2020. Out of these, 8 drug patents are active and 3 have expired. Juxtapid's patents have been open to challenges since 21 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2027. Details of Juxtapid'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. | |||
| US5712279 | Inhibitors of microsomal triglyceride transfer protein and method |
Feb, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7932268 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects |
Aug, 2027
(2 years from now) | Active |
| US10555938 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects |
Mar, 2025
(2 months from now) | Active |
| US8618135 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects |
Mar, 2025
(2 months from now) | Active |
| US9433617 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects |
Mar, 2025
(2 months from now) | Active |
| US10016404 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects |
Mar, 2025
(2 months from now) | Active |
| US9364470 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects |
Mar, 2025
(2 months from now) | Active |
| US9861622 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects |
Mar, 2025
(2 months from now) | Active |
| US9265758 | Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects |
Mar, 2025
(2 months from now) | Active |
| US6492365 | Microsomal triglyceride transfer protein |
Dec, 2019
(5 years ago) |
Expired
|
| US5739135 | Inhibitors of microsomal triglyceride transfer protein and method |
Apr, 2015
(9 years ago) |
Expired
|
| US5712279 | Inhibitors of microsomal triglyceride transfer protein and method |
Feb, 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 Juxtapid's patents.
Latest Legal Activities on Juxtapid's Patents
Given below is the list of recent legal activities going on the following patents of Juxtapid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Feb, 2024 | US9433617 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Dec, 2023 | US9364470 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Aug, 2023 | US9265758 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Aug, 2023 | US10555938 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2022 | US7932268 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Jan, 2022 | US10016404 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Jun, 2021 | US9861622 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jun, 2021 | US8618135 |
| Email Notification Critical | 09 Mar, 2021 | US10555938 |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Mar, 2021 | US9265758 |
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 Juxtapid and ongoing litigations to help you estimate the early arrival of Juxtapid generic.
Juxtapid's Litigations
Juxtapid been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 28, 2015, against patent number US8618135. The petitioner COALITION FOR AFFORDABLE DRUGS VIII, LLC, challenged the validity of this patent, with The Trustees of the University of Pennsylvania as the respondent. Click below to track the latest information on how companies are challenging Juxtapid's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7932268 | August, 2015 |
FWD Entered
(06 Mar, 2017) | The Trustees of the University of Pennsylvania) | Coalition for Affordable Drugs VIII |
| US8618135 | August, 2015 |
Final Written Decision
(06 Mar, 2017) | The Trustees of the University of Pennsylvania | COALITION FOR AFFORDABLE DRUGS VIII, LLC |
FDA has granted some exclusivities to Juxtapid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Juxtapid, 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 Juxtapid.
Exclusivity Information
Juxtapid holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Juxtapid's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 21, 2017 |
| Orphan Drug Exclusivity(ODE) | Dec 21, 2019 |
| Orphan Drug Exclusivity(ODE-36) | Dec 21, 2019 |
Several oppositions have been filed on Juxtapid'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 Juxtapid's generic, the next section provides detailed information on ongoing and past EP oppositions related to Juxtapid patents.
Juxtapid's Oppositions Filed in EPO
Juxtapid has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 21, 2013, by Stein, Evan Md Phd. This opposition was filed on patent number EP05724887A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP05724887A | Aug, 2013 | Stein, Evan MD PhD | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Juxtapid 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 Juxtapid's family patents as well as insights into ongoing legal events on those patents.
Juxtapid's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Juxtapid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Juxtapid Generics:
There are no approved generic versions for Juxtapid as of now.
About Juxtapid
Juxtapid is a drug owned by Chiesi Farmaceutici Spa. It is used for treating hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia. Juxtapid uses Lomitapide Mesylate as an active ingredient. Juxtapid was launched by Chiesi in 2012.
Approval Date:
Juxtapid was approved by FDA for market use on 21 December, 2012.
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 Juxtapid is 21 December, 2012, its NCE-1 date is estimated to be 21 December, 2016.
Active Ingredient:
Juxtapid uses Lomitapide Mesylate as the active ingredient. Check out other Drugs and Companies using Lomitapide Mesylate ingredient
Treatment:
Juxtapid is used for treating hypercholesterolemia and hyperlipidemia in patients with homozygous familial hypercholesterolemia.
Dosage:
Juxtapid is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE | CAPSULE | Prescription | ORAL |
| EQ 40MG BASE | CAPSULE | Discontinued | ORAL |
| EQ 20MG BASE | CAPSULE | Prescription | ORAL |
| EQ 60MG BASE | CAPSULE | Discontinued | ORAL |
| EQ 5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 30MG BASE | CAPSULE | Prescription | ORAL |