Thyrogen 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 Nov 24, 2015. Details of Thyrogen'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). | |||
| US6365127 | Isolation of a gene encoding human thyrotropin beta subunit |
Nov, 2015
(9 years ago) |
Expired
|
| US5840566 | Isolation of a gene encoding human thyrotropin beta subunit |
Nov, 2015
(9 years ago) |
Expired
|
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Thyrogen and ongoing litigations to help you estimate the early arrival of Thyrogen generic.
Thyrogen's Litigations
Thyrogen been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 03, 1996, against patent number US5840566. The petitioner , challenged the validity of this patent, with KOURIDES et al as the respondent. Click below to track the latest information on how companies are challenging Thyrogen's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5840566 | January, 1996 |
Decision
(04 Jul, 1776) | KOURIDES et al | |
FDA has granted some exclusivities to Thyrogen. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Thyrogen, 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 Thyrogen.
Exclusivity Information
Thyrogen holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Thyrogen's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Dec 14, 2014 |
US patents provide insights into the exclusivity only within the United States, but Thyrogen 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 Thyrogen's family patents as well as insights into ongoing legal events on those patents.
Thyrogen's Family Patents
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Generic Launch
Generic Release Date:
Thyrogen's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 24, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Thyrogen Generics:
There are no approved generic versions for Thyrogen as of now.
About Thyrogen
Thyrogen is a drug owned by Genzyme Corp. It is used for diagnostic purposes in serum thyroglobulin (TG) testing. Thyrogen uses Thyrotropin Alfa as an active ingredient. Thyrogen was launched by Genzyme in 1998.
Approval Date:
Thyrogen was approved by FDA for market use on 30 November, 1998.
Active Ingredient:
Thyrogen uses Thyrotropin Alfa as the active ingredient. Check out other Drugs and Companies using Thyrotropin Alfa ingredient
Treatment:
Thyrogen is used for diagnostic purposes in serum thyroglobulin (TG) testing.
Dosage:
Thyrogen is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.1MG/VIAL | INJECTABLE | Prescription | INJECTION |