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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8491932 | Compositions for the oral delivery of corticosteroids |
May, 2029
(4 years from now) | Active |
| US11896719 | Pharmaceutical compositions |
Jan, 2043
(18 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.
Latest Legal Activities on Tarpeyo's Patents
Given below is the list of recent legal activities going on the following patents of Tarpeyo.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 none 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 |
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 |
|---|---|---|---|
 | |||
| 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
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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 Generics:
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
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.
Market Authorisation 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 |