Increlex is a drug owned by Ipsen Biopharmaceuticals Inc. It is protected by 3 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 Sep 18, 2017. Details of Increlex'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). | |||
| US5681814 | Formulated IGF-I Composition |
Sep, 2017
(8 years ago) |
Expired
|
| US5824642 | Treatment of partial growth hormone insensitivity syndrome |
Jul, 2014
(11 years ago) |
Expired
|
| US6207640 | Treatment of partial growth hormone insensitivity syndrome |
Apr, 2014
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Increlex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Increlex, 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
Increlex.
Exclusivity Information
Increlex holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Increlex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Aug 30, 2012 |
US patents provide insights into the exclusivity only within the United States, but
Increlex 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 Increlex's family patents as well as insights into
ongoing legal events
on those patents.
Increlex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Increlex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 18, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Increlex Generics:
There are no approved generic versions for Increlex as of now.
About Increlex
Increlex is a drug owned by Ipsen Biopharmaceuticals Inc. It is used for treating primary IGF-1 deficiency. Increlex uses Mecasermin Recombinant as an active ingredient. Increlex was launched by Ipsen Inc in 2005.
Approval Date:
Increlex was approved by FDA for market use on 30 August, 2005.
Active Ingredient:
Increlex uses Mecasermin Recombinant as the active ingredient. Check out other Drugs and Companies using Mecasermin Recombinant ingredient
Treatment:
Increlex is used for treating primary IGF-1 deficiency.
Dosage:
Increlex is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/4ML (10MG/ML) | INJECTABLE | Prescription | SUBCUTANEOUS |