Clorotekal Patent Expiration

Clorotekal is a drug owned by B Braun Medical Inc. It is protected by 2 US drug patents filed in 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2033. Details of Clorotekal'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).
US8969412 Use for a composition comprising chloroprocaine HCL, a new composition comprising chloroprocaine HCL and a method for its manufacture
Sep, 2026

(2 years from now)

Active
US9504666 Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration
Dec, 2033

(9 years from now)

Active


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

Exclusivity Information

Clorotekal holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Clorotekal's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Sep 26, 2020

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

Clorotekal's family patents

Clorotekal has patent protection in a total of 28 countries. It's US patent count contributes only to 6.5% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Clorotekal.

Family Patents

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Generic Launch

Generic Release Date:

Clorotekal's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Clorotekal Generics:

Chloroprocaine Hydrochloride is the generic name for the brand Clorotekal. 2 different companies have already filed for the generic of Clorotekal, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clorotekal's generic





About Clorotekal

Clorotekal is a drug owned by B Braun Medical Inc. It is used for regional anesthesia through intrathecal administration. Clorotekal uses Chloroprocaine Hydrochloride as an active ingredient. Clorotekal was launched by B Braun Medical Inc in 2017.

Market Authorisation Date:

Clorotekal was approved by FDA for market use on 26 September, 2017.

Active Ingredient:

Clorotekal uses Chloroprocaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Chloroprocaine Hydrochloride ingredient

Treatment:

Clorotekal is used for regional anesthesia through intrathecal administration.

Dosage:

Clorotekal is available in solution form for intrathecal use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG/5ML (10MG/ML) SOLUTION Discontinued INTRATHECAL