Diclegis is a drug owned by Duchesnay Inc. 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 Jun 21, 2021. Details of Diclegis'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). | |||
| US6340695 | Rapid onset formulation |
Jun, 2021
(3 years ago) |
Expired
|
| US7560122 | Pharmaceutical dosage form bearing pregnancy-friendly indicia |
Jan, 2019
(5 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 Diclegis's patents.
Latest Legal Activities on Diclegis's Patents
Given below is the list of recent legal activities going on the following patents of Diclegis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 16 Aug, 2021 | US7560122 |
| Maintenance Fee Reminder Mailed Critical | 01 Mar, 2021 | US7560122 |
| Correspondence Address Change Critical | 21 Jul, 2010 | US6340695 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 14 Jul, 2009 | US7560122 |
| Recordation of Patent Grant Mailed Critical | 14 Jul, 2009 | US7560122 |
| Issue Notification Mailed Critical | 24 Jun, 2009 | US7560122 |
| Application Is Considered Ready for Issue Critical | 15 Jun, 2009 | US7560122 |
| Dispatch to FDC | 15 Jun, 2009 | US7560122 |
| Issue Fee Payment Received Critical | 12 Jun, 2009 | US7560122 |
| Issue Fee Payment Verified Critical | 12 Jun, 2009 | US7560122 |
FDA has granted several exclusivities to Diclegis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Diclegis, 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 Diclegis.
Exclusivity Information
Diclegis holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Diclegis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 08, 2016 |
US patents provide insights into the exclusivity only within the United States, but Diclegis 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 Diclegis's family patents as well as insights into ongoing legal events on those patents.
Diclegis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Diclegis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Diclegis Generic API suppliers:
Doxylamine Succinate; Pyridoxine Hydrochloride is the generic name for the brand Diclegis. 4 different companies have already filed for the generic of Diclegis, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diclegis's generic
How can I launch a generic of Diclegis before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Diclegis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Diclegis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Diclegis -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/10 mg | 01 Aug, 2013 | 1 | 19 Aug, 2016 | 21 Jun, 2021 | Extinguished |
Alternative Brands for Diclegis
Diclegis which is used for treating nausea and vomiting of pregnancy in women who do not respond to conservative management., has several other brand drugs in the same treatment category and using the same active ingredient (Doxylamine Succinate; Pyridoxine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Duchesnay |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Doxylamine Succinate; Pyridoxine Hydrochloride, Diclegis's active ingredient. Check the complete list of approved generic manufacturers for Diclegis
About Diclegis
Diclegis is a drug owned by Duchesnay Inc. It is used for treating nausea and vomiting of pregnancy in women who do not respond to conservative management. Diclegis uses Doxylamine Succinate; Pyridoxine Hydrochloride as an active ingredient. Diclegis was launched by Duchesnay in 2013.
Approval Date:
Diclegis was approved by FDA for market use on 08 April, 2013.
Active Ingredient:
Diclegis uses Doxylamine Succinate; Pyridoxine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Doxylamine Succinate; Pyridoxine Hydrochloride ingredient
Treatment:
Diclegis is used for treating nausea and vomiting of pregnancy in women who do not respond to conservative management.
Dosage:
Diclegis is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;10MG | TABLET, DELAYED RELEASE | Prescription | ORAL |