Bidil is a drug owned by Azurity Pharmaceuticals 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 Sep 08, 2020. Details of Bidil'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). | |||
| US6465463 | Methods of treating and preventing congestive heart failure with hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate |
Sep, 2020
(4 years ago) |
Expired
|
| US6784177 | Methods using hydralazine compounds and isosorbide dinitrate or isosorbide mononitrate |
Sep, 2020
(4 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 Bidil's patents.
Latest Legal Activities on Bidil's Patents
Given below is the list of recent legal activities going on the following patents of Bidil.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 17 Oct, 2018 | US6784177 (Litigated) |
| Post Issue Communication - Certificate of Correction | 04 Aug, 2006 | US6784177 (Litigated) |
| Post Issue Communication - Certificate of Correction | 12 Jan, 2005 | US6784177 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 31 Aug, 2004 | US6784177 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 31 Aug, 2004 | US6784177 (Litigated) |
| Issue Notification Mailed Critical | 12 Aug, 2004 | US6784177 (Litigated) |
| Receipt into Pubs | 29 Jul, 2004 | US6784177 (Litigated) |
| Dispatch to FDC | 28 Jul, 2004 | US6784177 (Litigated) |
| Application Is Considered Ready for Issue Critical | 28 Jul, 2004 | US6784177 (Litigated) |
| Receipt into Pubs | 22 Jul, 2004 | US6784177 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Bidil 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 Bidil's family patents as well as insights into ongoing legal events on those patents.
Bidil's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bidil's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 08, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bidil Generic API suppliers:
Hydralazine Hydrochloride; Isosorbide Dinitrate is the generic name for the brand Bidil. 2 different companies have already filed for the generic of Bidil, with I3 Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bidil's generic
Alternative Brands for Bidil
Bidil which is used for treating heart failure., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Azurity |
| |||
About Bidil
Bidil is a drug owned by Azurity Pharmaceuticals Inc. It is used for treating heart failure. Bidil uses Hydralazine Hydrochloride; Isosorbide Dinitrate as an active ingredient. Bidil was launched by Azurity in 2005.
Approval Date:
Bidil was approved by FDA for market use on 23 June, 2005.
Active Ingredient:
Bidil uses Hydralazine Hydrochloride; Isosorbide Dinitrate as the active ingredient. Check out other Drugs and Companies using Hydralazine Hydrochloride; Isosorbide Dinitrate ingredient
Treatment:
Bidil is used for treating heart failure.
Dosage:
Bidil is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 37.5MG;20MG | TABLET | Prescription | ORAL |