Tauklarify Patent Expiration

Tauklarify is a drug owned by Cerveau Technologies Inc A Lantheus Co. It is protected by 2 US drug patents filed in 2026 out of which none have expired yet. Tauklarify's patents will be open to challenges from 13 August, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 09, 2035. Details of Tauklarify's patents and their expiration are given in the table below.

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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.
US9808542 Pyrrolo[2,3-C]Pyridines As Imaging Agents For Neurofibrillary
Jun, 2035

(8 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).
US10022461 Pyrrolo[2,3-C]Pyridines As Imaging Agents For Neurofibrilary Tangles
Jun, 2035

(8 years from now)

Active


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

Exclusivity Information

Tauklarify holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Tauklarify's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 13, 2031

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

Tauklarify's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Tauklarify's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 09, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tauklarify Generics:

There are no approved generic versions for Tauklarify as of now.





About Tauklarify

Tauklarify is a drug owned by Cerveau Technologies Inc A Lantheus Co. Tauklarify uses Florquinitau F-18 as an active ingredient. Tauklarify was launched by Cerveau Lantheus in 2026.

Approval Date:

Tauklarify was approved by FDA for market use on 13 August, 2026.

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 Tauklarify is 13 August, 2026, its NCE-1 date is estimated to be 13 August, 2030.

Active Ingredient:

Tauklarify uses Florquinitau F-18 as the active ingredient. Check out other Drugs and Companies using Florquinitau F-18 ingredient

Dosage:

Tauklarify is available in solution form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
1-40mCi/ML SOLUTION Prescription INTRAVENOUS