Doral is a drug owned by Galt Pharmaceuticals Llc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 03, 2028. Details of Doral'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). | |||
| US7608616 | Methods for reducing the risk of an adverse drug interaction in a patient suffering from insomnia |
Jun, 2028
(2 years from now) | Active |
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 Doral's patents.
Latest Legal Activities on Doral's Patents
Given below is the list of recent legal activities going on the following patents of Doral.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 29 Nov, 2021 | US7608616 |
| Maintenance Fee Reminder Mailed
Critical | 14 Jun, 2021 | US7608616 |
| Email Notification
Critical | 25 Nov, 2015 | US7608616 |
| Mail-Petition Decision - Granted | 17 Nov, 2015 | US7608616 |
| Petition Decision - Granted
Critical | 16 Nov, 2015 | US7608616 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 10 Nov, 2015 | US7608616 |
| Petition Entered | 13 Aug, 2015 | US7608616 |
| Patent Issue Date Used in PTA Calculation
Critical | 27 Oct, 2009 | US7608616 |
| Recordation of Patent Grant Mailed
Critical | 27 Oct, 2009 | US7608616 |
| Issue Notification Mailed
Critical | 07 Oct, 2009 | US7608616 |
US patents provide insights into the exclusivity only within the United States, but
Doral 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 Doral's family patents as well as insights into
ongoing legal events
on those patents.
Doral's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Doral's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 03, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Doral Generics:
There are no approved generic versions for Doral as of now.
About Doral
Doral is a drug owned by Galt Pharmaceuticals Llc. It is used for treating insomnia with reduced risk of adverse drug interactions. Doral uses Quazepam as an active ingredient. Doral was launched by Galt Pharms in 1987.
Approval Date:
Doral was approved by FDA for market use on 26 February, 1987.
Active Ingredient:
Doral uses Quazepam as the active ingredient. Check out other Drugs and Companies using Quazepam ingredient
Treatment:
Doral is used for treating insomnia with reduced risk of adverse drug interactions.
Dosage:
Doral is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG | TABLET | Prescription | ORAL |
| 7.5MG | TABLET | Discontinued | ORAL |