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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7915269 | Methods for concomitant administration of colchicine and a second active agent |
Feb, 2029
(2 years from now) | Active |
| US7906519 | Methods for concomitant administration of colchicine and a second active agent |
Feb, 2029
(2 years from now) | Active |
| US8440721 | Methods for concomitant administration of colchicine and a second active agent |
Feb, 2029
(2 years from now) | Active |
| US8440722 | Methods for concomitant administration of colchicine and a second active agent |
Feb, 2029
(2 years from now) | Active |
| US7820681 | Methods for concomitant administration of colchicine and a second active agent |
Feb, 2029
(2 years from now) | Active |
| US7601758 | Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares |
Feb, 2029
(2 years from now) | Active |
| US7619004 | Methods for concomitant administration of colchicine and macrolide antibiotics |
Dec, 2028
(2 years from now) | Active |
| US7935731 | Methods for concomitant administration of colchicine and macrolide antibiotics |
Dec, 2028
(2 years from now) | Active |
| US7964648 | Methods for concomitant administration of colchicine and a second active agent |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8093296 | Methods for concomitant administration of colchicine and macrolide antibiotics |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8415396 | Colchine compositions and methods |
Oct, 2028
(1 year, 11 months from now) | Active |
| US7964647 | Colchicine compositions and methods |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8093297 | Methods for concomitant administration of colchicine and a second active agent |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8097655 | Methods for concomitant administration of colchicine and macrolide antibiotics |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8093298 | Methods for concomitant administration of colchicine and macrolide antibiotics |
Oct, 2028
(1 year, 11 months from now) | Active |
| US8415395 | Colchicine compositions and methods |
Oct, 2028
(1 year, 11 months from now) | Active |
| US7981938 | Colchicine compositions and methods |
Oct, 2028
(1 year, 11 months 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 Colcrys's patents.
Latest Legal Activities on Colcrys's Patents
Given below is the list of recent legal activities going on the following patents of Colcrys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 12 May, 2025 | US8440722 (Litigated) |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 12 May, 2025 | US8440721 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 May, 2025 | US8440722 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 May, 2025 | US8440721 (Litigated) |
| Maintenance Fee Reminder Mailed | 30 Dec, 2024 | US8440722 (Litigated) |
| Maintenance Fee Reminder Mailed | 30 Dec, 2024 | US8440721 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Sep, 2024 | US8415396 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Sep, 2024 | US8415395 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 08 Jan, 2024 | US8093298 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Jan, 2024 | US8093298 (Litigated) |
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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Colcrys:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Generic API suppliers:
Colchicine is the generic name for the brand Colcrys. 14 different companies have already filed for the generic of Colcrys, with Ph Health 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 19 Jul, 2019 | 17 Feb, 2029 | Eligible | 14 Nov, 2019 | Less | |
| 23 Dec, 2011 | 17 Feb, 2029 | Extinguished | Less |
Alternative Brands for Colcrys
Colcrys which is used for treating gout flares and familial Mediterranean fever., has several other brand drugs in the same treatment category and using the same active ingredient (Colchicine). 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 | Treatment Area | ||
|---|---|---|---|---|
| Hikma Intl Pharms |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Colchicine. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Colchicine, Colcrys's active ingredient. Check the complete list of approved generic manufacturers for Colcrys
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 in 2009.
Approval 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |