Clolar is a drug owned by Genzyme Corp. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 14, 2018. Details of Clolar'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). | |||
|
US5661136 (Pediatric) | 2-halo-2'-fluoro ARA adenosines as antinoplastic agents |
Jul, 2018
(8 years ago) |
Expired
|
| US5661136 | 2-halo-2'-fluoro ARA adenosines as antinoplastic agents |
Jan, 2018
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Clolar. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Clolar, 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
Clolar.
Exclusivity Information
Clolar holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Clolar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Dec 28, 2011 |
| Pediatric Exclusivity(PED) | Jun 28, 2012 |
US patents provide insights into the exclusivity only within the United States, but
Clolar 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 Clolar's family patents as well as insights into
ongoing legal events
on those patents.
Clolar's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Clolar:
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:
Clolar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 14, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clolar Generic API suppliers:
Clofarabine is the generic name for the brand Clolar. 12 different companies have already filed for the generic of Clolar, with Abon Pharms Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clolar's generic
How can I launch a generic of Clolar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clolar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clolar'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 Clolar -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 23 Feb, 2012 | 14 Jan, 2018 | Eligible | 09 May, 2017 | Less |
About Clolar
Clolar is a drug owned by Genzyme Corp. It is used for treating pediatric patients aged 1 to 21 years with relapsed or refractory acute lymphoblastic leukemia. Clolar uses Clofarabine as an active ingredient. Clolar was launched by Genzyme in 2004.
Approval Date:
Clolar was approved by FDA for market use on 28 December, 2004.
Active Ingredient:
Clolar uses Clofarabine as the active ingredient. Check out other Drugs and Companies using Clofarabine ingredient
Treatment:
Clolar is used for treating pediatric patients aged 1 to 21 years with relapsed or refractory acute lymphoblastic leukemia.
Dosage:
Clolar is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG/20ML (1MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |