Lusedra is a drug owned by Eisai Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Lusedra's patents have been open to challenges since 12 December, 2012. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2022. Details of Lusedra'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). | |||
| US6204257 | Water soluble prodrugs of hindered alcohols |
Jul, 2022
(2 years ago) |
Expired
|
| US6872838 | Water soluble prodrugs of hindered alcohols |
Aug, 2018
(6 years ago) |
Expired
|
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 Lusedra's patents.
Latest Legal Activities on Lusedra's Patents
Given below is the list of recent legal activities going on the following patents of Lusedra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 21 Apr, 2017 | US6872838 |
| Patent Term Extension (156) Dismissed Critical | 13 Sep, 2011 | US6872838 |
| Election in Response to Notice of Final Determination | 18 Aug, 2011 | US6872838 |
| Notice of Final Determination -Election Required | 01 Aug, 2011 | US6872838 |
| FDA Final Eligibility Letter Critical | 18 Feb, 2011 | US6872838 |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Oct, 2010 | US6872838 |
| Correspondence Address Change Critical | 01 Oct, 2010 | US6872838 |
| transaction for FDA Determination of Regulatory Review Period | 05 Apr, 2010 | US6872838 |
| transaction for FDA Determination of Regulatory Review Period | 24 Mar, 2010 | US6872838 |
| Second letter to regulating agency to determine regulatory review period | 25 Nov, 2009 | US6872838 |
FDA has granted several exclusivities to Lusedra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lusedra, 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 Lusedra.
Exclusivity Information
Lusedra holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Lusedra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2013 |
US patents provide insights into the exclusivity only within the United States, but Lusedra 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 Lusedra's family patents as well as insights into ongoing legal events on those patents.
Lusedra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lusedra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lusedra Generics:
There are no approved generic versions for Lusedra as of now.
About Lusedra
Lusedra is a drug owned by Eisai Inc. It is used for sedation during monitored anesthesia care. Lusedra uses Fospropofol Disodium as an active ingredient. Lusedra was launched by Eisai Inc in 2008.
Approval Date:
Lusedra was approved by FDA for market use on 12 December, 2008.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Lusedra is 12 December, 2008, its NCE-1 date is estimated to be 12 December, 2012.
Active Ingredient:
Lusedra uses Fospropofol Disodium as the active ingredient. Check out other Drugs and Companies using Fospropofol Disodium ingredient
Treatment:
Lusedra is used for sedation during monitored anesthesia care.
Dosage:
Lusedra is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1050MG/30ML (35MG/ML) | SOLUTION | Discontinued | INTRAVENOUS |