Juxtapid Patent Expiration

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

(4 months from now)

Active
US10016404 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Mar, 2025

(4 months from now)

Active
US9861622 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(4 months from now)

Active
US9433617 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(4 months from now)

Active
US8618135 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Mar, 2025

(4 months from now)

Active
US9364470 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(4 months from now)

Active
US9265758 Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side-effects
Mar, 2025

(4 months from now)

Active
US6492365 Microsomal triglyceride transfer protein
Dec, 2019

(4 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.

Given below is the list of recent legal activities going on the following patents of Juxtapid.

Activity Date Patent Number
Patent litigations
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 09 Mar, 2021 US10555938
Change in Power of Attorney (May Include Associate POA) 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.

Last updated on October 8, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Juxtapid has patent protection in a total of 18 countries. It's US patent count contributes only to 37.8% of its total global patent coverage. Click below to unlock the full patent family tree for Juxtapid.

Family Patents

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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 60MG BASE CAPSULE Discontinued ORAL
EQ 20MG BASE CAPSULE Prescription ORAL
EQ 5MG BASE CAPSULE Prescription ORAL
EQ 30MG BASE CAPSULE Prescription ORAL
EQ 40MG BASE CAPSULE Discontinued ORAL