Colcrys Patent Expiration

Colcrys is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 17 US drug patents filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 17, 2029. Details of Colcrys'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).
US8093297 Methods for concomitant administration of colchicine and a second active agent
Oct, 2028

(4 years from now)

Active
US8415396 Colchine compositions and methods
Oct, 2028

(4 years from now)

Active
US7964648 Methods for concomitant administration of colchicine and a second active agent
Oct, 2028

(4 years from now)

Active
US7964647 Colchicine compositions and methods
Oct, 2028

(4 years from now)

Active
US8093296 Methods for concomitant administration of colchicine and macrolide antibiotics
Oct, 2028

(4 years from now)

Active
US8093298 Methods for concomitant administration of colchicine and macrolide antibiotics
Oct, 2028

(4 years from now)

Active
US8415395 Colchicine compositions and methods
Oct, 2028

(4 years from now)

Active
US8097655 Methods for concomitant administration of colchicine and macrolide antibiotics
Oct, 2028

(4 years from now)

Active
US7981938 Colchicine compositions and methods
Oct, 2028

(4 years from now)

Active
US7935731 Methods for concomitant administration of colchicine and macrolide antibiotics
Dec, 2028

(4 years from now)

Active
US7619004 Methods for concomitant administration of colchicine and macrolide antibiotics
Dec, 2028

(4 years from now)

Active
US7601758 Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares
Feb, 2029

(4 years from now)

Active
US7915269 Methods for concomitant administration of colchicine and a second active agent
Feb, 2029

(4 years from now)

Active
US7820681 Methods for concomitant administration of colchicine and a second active agent
Feb, 2029

(4 years from now)

Active
US8440721 Methods for concomitant administration of colchicine and a second active agent
Feb, 2029

(4 years from now)

Active
US7906519 Methods for concomitant administration of colchicine and a second active agent
Feb, 2029

(4 years from now)

Active
US8440722 Methods for concomitant administration of colchicine and a second active agent
Feb, 2029

(4 years from now)

Active


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

Exclusivity Information

Colcrys holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Colcrys's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-603) Jul 30, 2012
Orphan Drug Exclusivity(ODE) Jul 29, 2016

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

Colcrys's family patents

Colcrys has patent protection in a total of 1 countries. It has a significant patent presence in the US with 100.0% of its patents being US patents. Click below to unlock the full patent family tree for Colcrys.

Family Patents

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Generic Launch

Generic Release Date:

Colcrys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 17, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Colcrys Generics:

Colchicine is the generic name for the brand Colcrys. 12 different companies have already filed for the generic of Colcrys, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Colcrys's generic

How can I launch a generic of Colcrys before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Colcrys's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Colcrys's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Colcrys -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.3 mg 19 Jul, 2019 1 14 Nov, 2019 17 Feb, 2029 Eligible
0.6 mg 23 Dec, 2011 1 17 Feb, 2029 Extinguished




About Colcrys

Colcrys is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating gout flares and familial Mediterranean fever. Colcrys uses Colchicine as an active ingredient. Colcrys was launched by Takeda Pharms Usa in 2009.

Market Authorisation Date:

Colcrys was approved by FDA for market use on 29 July, 2009.

Active Ingredient:

Colcrys uses Colchicine as the active ingredient. Check out other Drugs and Companies using Colchicine ingredient

Treatment:

Colcrys is used for treating gout flares and familial Mediterranean fever.

Dosage:

Colcrys is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.6MG TABLET Prescription ORAL