Benicar is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 4 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 May 19, 2022. Details of Benicar'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). | |||
|
US6878703 (Pediatric) | Pharmaceutical composition |
May, 2022
(2 years ago) |
Expired
|
| US6878703 | Pharmaceutical composition |
Nov, 2021
(2 years ago) |
Expired
|
|
US5616599 (Pediatric) | Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use |
Oct, 2016
(8 years ago) |
Expired
|
| US5616599 | Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use |
Apr, 2016
(8 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 Benicar's patents.
Latest Legal Activities on Benicar's Patents
Given below is the list of recent legal activities going on the following patents of Benicar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 11 May, 2009 | US6878703 (Litigated) |
| Correspondence Address Change Critical | 25 Apr, 2005 | US6878703 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Apr, 2005 | US6878703 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 12 Apr, 2005 | US6878703 (Litigated) |
| Issue Notification Mailed Critical | 23 Mar, 2005 | US6878703 (Litigated) |
| Receipt into Pubs | 14 Mar, 2005 | US6878703 (Litigated) |
| Dispatch to FDC | 11 Mar, 2005 | US6878703 (Litigated) |
| Application Is Considered Ready for Issue Critical | 11 Mar, 2005 | US6878703 (Litigated) |
| Issue Fee Payment Received Critical | 01 Mar, 2005 | US6878703 (Litigated) |
| Issue Fee Payment Verified Critical | 01 Mar, 2005 | US6878703 (Litigated) |
FDA has granted several exclusivities to Benicar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Benicar, 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 Benicar.
Exclusivity Information
Benicar holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Benicar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Feb 04, 2013 |
| Pediatric Exclusivity(PED) | Aug 04, 2013 |
US patents provide insights into the exclusivity only within the United States, but Benicar 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 Benicar's family patents as well as insights into ongoing legal events on those patents.
Benicar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Benicar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Benicar Generic API suppliers:
Olmesartan Medoxomil is the generic name for the brand Benicar. 24 different companies have already filed for the generic of Benicar, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Benicar's generic
How can I launch a generic of Benicar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Benicar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Benicar'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 Benicar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 20 mg and 40 mg | 25 Apr, 2006 | 1 | 26 Oct, 2016 | 19 Nov, 2021 | Eligible |
Alternative Brands for Benicar
Benicar which is used for lowering high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Olmesartan Medoxomil). 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott |
| |||||||||||||||
| Abbvie |
| |||||||||||||||
| Adhera |
| |||||||||||||||
| Allergan |
| |||||||||||||||
| Ani Pharms |
| |||||||||||||||
| Azurity |
| |||||||||||||||
| Boehringer Ingelheim |
| |||||||||||||||
| Cosette |
| |||||||||||||||
| Noden Pharma |
| |||||||||||||||
| Novartis |
| |||||||||||||||
| Upjohn |
| |||||||||||||||
| Waylis Therap |
| |||||||||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Olmesartan Medoxomil, Benicar's active ingredient. Check the complete list of approved generic manufacturers for Benicar
About Benicar
Benicar is a drug owned by Cosette Pharmaceuticals Inc. It is used for lowering high blood pressure. Benicar uses Olmesartan Medoxomil as an active ingredient. Benicar was launched by Cosette in 2002.
Approval Date:
Benicar was approved by FDA for market use on 25 April, 2002.
Active Ingredient:
Benicar uses Olmesartan Medoxomil as the active ingredient. Check out other Drugs and Companies using Olmesartan Medoxomil ingredient
Treatment:
Benicar is used for lowering high blood pressure.
Dosage:
Benicar is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |