Optison is a drug owned by Ge Healthcare. 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 Apr 20, 2021. Details of Optison'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). | |||
| US6723303 | Ultrasound contrast agents including protein stabilized microspheres of perfluoropropane, perfluorobutane or perfluoropentane |
Apr, 2021
(3 years ago) |
Expired
|
| US5529766 | Contrast agents |
Jun, 2013
(11 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 Optison and ongoing litigations to help you estimate the early arrival of Optison generic.
Optison's Litigations
Optison been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 28, 2000, against patent number US6723303. The petitioner , challenged the validity of this patent, with QUAY as the respondent. Click below to track the latest information on how companies are challenging Optison's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6723303 | March, 2000 |
Decision
(30 Oct, 2003) | QUAY | |
FDA has granted some exclusivities to Optison. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Optison, 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 Optison.
Exclusivity Information
Optison holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Optison's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-120) | Aug 17, 2015 |
US patents provide insights into the exclusivity only within the United States, but Optison 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 Optison's family patents as well as insights into ongoing legal events on those patents.
Optison's Family Patents
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Generic Launch
Generic Release Date:
Optison's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 20, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Optison Generics:
There are no approved generic versions for Optison as of now.
About Optison
Optison is a drug owned by Ge Healthcare. It is used for enhancing ultrasound imaging during medical procedures. Optison uses Albumin Human as an active ingredient. Optison was launched by Ge Healthcare in 1997.
Approval Date:
Optison was approved by FDA for market use on 31 December, 1997.
Active Ingredient:
Optison uses Albumin Human as the active ingredient. Check out other Drugs and Companies using Albumin Human ingredient
Treatment:
Optison is used for enhancing ultrasound imaging during medical procedures.
Dosage:
Optison is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/ML | INJECTABLE | Prescription | INJECTION |