Tarpeyo Patent Expiration

Tarpeyo is a drug owned by Calliditas Therapeutics Ab. It is protected by 2 US drug patents filed from 2021 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 23, 2043. Details of Tarpeyo'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).
US11896719 Pharmaceutical compositions
Jan, 2043

(18 years from now)

Active
US8491932 Compositions for the oral delivery of corticosteroids
May, 2029

(4 years from now)

Active


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 Tarpeyo's patents.

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

Activity Date Patent Number
Patent litigations
Email Notification 27 Mar, 2024 US11896719
Email Notification 26 Mar, 2024 US11896719
Patent eCofC Notification 26 Mar, 2024 US11896719
Recordation of Patent eCertificate of Correction 26 Mar, 2024 US11896719
Mail Patent eCofC Notification 26 Mar, 2024 US11896719
Post Issue Communication - Certificate of Correction 05 Mar, 2024 US11896719
Patent Issue Date Used in PTA Calculation 13 Feb, 2024 US11896719
Mail Patent eGrant Notification 13 Feb, 2024 US11896719
Recordation of Patent eGrant 13 Feb, 2024 US11896719
Email Notification 13 Feb, 2024 US11896719


FDA has granted several exclusivities to Tarpeyo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tarpeyo, 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 Tarpeyo.

Exclusivity Information

Tarpeyo holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Tarpeyo's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 15, 2024
Orphan Drug Exclusivity(ODE-389) Dec 15, 2028
Orphan Drug Exclusivity(ODE-464) Dec 20, 2030

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Several oppositions have been filed on Tarpeyo'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 Tarpeyo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tarpeyo patents.

Tarpeyo's Oppositions Filed in EPO

Tarpeyo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Oct 01, 2014, by Dr. Falk Pharma Gmbh. This opposition was filed on patent number EP09746033A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP09746033A Oct, 2014 Dr. Falk Pharma GmbH Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Tarpeyo 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 Tarpeyo's family patents as well as insights into ongoing legal events on those patents.

Tarpeyo's Family Patents

Tarpeyo has patent protection in a total of 9 countries. It's US patent count contributes only to 10.0% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Tarpeyo.

Family Patents

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Generic Launch

Generic Release Date:

Tarpeyo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 23, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tarpeyo Generic API suppliers:

Budesonide is the generic name for the brand Tarpeyo. 21 different companies have already filed for the generic of Tarpeyo, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tarpeyo's generic

Alternative Brands for Tarpeyo

Tarpeyo which is used for reducing kidney function loss and proteinuria in adults with primary IgA nephropathy at risk of disease progression., has several other brand drugs using the same active ingredient (Budesonide). 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
Astrazeneca
Airsupra
Pulmicort Respules
Rhinocort
Symbicort
Symbicort Aerosphere
Astrazeneca Ab
Breztri Aerosphere
Cheplapharm
Pulmicort Flexhaler
Padagis Us
Entocort Ec
Salix
Uceris
Sun Pharm Inds Inc
Ortikos
Takeda Pharms Usa
Eohilia


Apart from brand drugs containing the same ingredient, some generics have also been filed for Budesonide, Tarpeyo's active ingredient. Check the complete list of approved generic manufacturers for Tarpeyo





About Tarpeyo

Tarpeyo is a drug owned by Calliditas Therapeutics Ab. It is used for reducing kidney function loss and proteinuria in adults with primary IgA nephropathy at risk of disease progression. Tarpeyo uses Budesonide as an active ingredient. Tarpeyo was launched by Calliditas in 2021.

Approval Date:

Tarpeyo was approved by FDA for market use on 15 December, 2021.

Active Ingredient:

Tarpeyo uses Budesonide as the active ingredient. Check out other Drugs and Companies using Budesonide ingredient

Treatment:

Tarpeyo is used for reducing kidney function loss and proteinuria in adults with primary IgA nephropathy at risk of disease progression.

Dosage:

Tarpeyo is available in capsule, delayed release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
4MG CAPSULE, DELAYED RELEASE Prescription ORAL