Beyaz is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2013 to 2023. Out of these, 2 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 17, 2030. Details of Beyaz'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). | |||
| US11617751 | Pharmaceutical composition containing a tetrahydrofolic acid |
Jul, 2030
(5 years from now) | Active |
| US8617597 | Pharmaceutical composition containing a tetrahydrofolic acid |
Feb, 2030
(4 years from now) | Active |
| US7163931 | Compositions of estrogen-cyclodextrin complexes |
Mar, 2022
(3 years ago) |
Expired
|
| US6958326 | Cyclodextrin-drospirenone inclusion complexes |
Dec, 2021
(3 years ago) |
Expired
|
| US6441168 | Stable crystalline salts of 5-methyltetrahydrofolic acid |
Apr, 2020
(5 years ago) |
Expired
|
| US5798338 | Solid dosage forms that contain clathrates of 17α-ethinyl estradiol |
Jul, 2015
(9 years ago) |
Expired
|
| USRE37838 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| USRE43916 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| USRE38253 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| USRE37564 | Composition for contraception |
Jun, 2014
(10 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 Beyaz's patents.
Latest Legal Activities on Beyaz's Patents
Given below is the list of recent legal activities going on the following patents of Beyaz.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 04 Apr, 2023 | US11617751 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Apr, 2023 | US11617751 |
| Email Notification Critical | 16 Mar, 2023 | US11617751 |
| Issue Notification Mailed Critical | 15 Mar, 2023 | US11617751 |
| Dispatch to FDC | 15 Feb, 2023 | US11617751 |
| Issue Fee Payment Verified Critical | 13 Feb, 2023 | US11617751 |
| Issue Fee Payment Received Critical | 13 Feb, 2023 | US11617751 |
| Mail Notice of Allowance Critical | 05 Dec, 2022 | US11617751 |
| Electronic Review Critical | 05 Dec, 2022 | US11617751 |
| Email Notification Critical | 05 Dec, 2022 | US11617751 |
FDA has granted several exclusivities to Beyaz. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Beyaz, 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 Beyaz.
Exclusivity Information
Beyaz holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Beyaz's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Sep 24, 2013 |
| New Product(NP) | Sep 24, 2013 |
US patents provide insights into the exclusivity only within the United States, but Beyaz 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 Beyaz's family patents as well as insights into ongoing legal events on those patents.
Beyaz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Beyaz's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 17, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Beyaz Generic API suppliers:
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium is the generic name for the brand Beyaz. 2 different companies have already filed for the generic of Beyaz, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Beyaz's generic
How can I launch a generic of Beyaz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Beyaz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Beyaz'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 Beyaz -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg/0.02 mg/ 0.451 mg and 0.451 mg | 13 Nov, 2012 | 1 | 11 Oct, 2016 | 03 Mar, 2022 | Eligible |
Alternative Brands for Beyaz
Beyaz which is used for contraception, prevention of pregnancy, and treating mood changes and anxiety in women with PMDD who choose oral contraceptives., has several other brand drugs in the same treatment category and using the same active ingredient (Drospirenone; Ethinyl Estradiol; Levomefolate Calcium). 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil |
| |||||||||||
| Bayer Hlthcare |
| |||||||||||
| Evofem Inc |
| |||||||||||
| Organon |
| |||||||||||
| Teva Branded Pharm |
| |||||||||||
| Wyeth Pharms Inc |
| |||||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Drospirenone; Ethinyl Estradiol; Levomefolate Calcium, Beyaz's active ingredient. Check the complete list of approved generic manufacturers for Beyaz
About Beyaz
Beyaz is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for contraception, prevention of pregnancy, and treating mood changes and anxiety in women with PMDD who choose oral contraceptives. Beyaz uses Drospirenone; Ethinyl Estradiol; Levomefolate Calcium as an active ingredient. Beyaz was launched by Bayer Hlthcare in 2010.
Approval Date:
Beyaz was approved by FDA for market use on 24 September, 2010.
Active Ingredient:
Beyaz uses Drospirenone; Ethinyl Estradiol; Levomefolate Calcium as the active ingredient. Check out other Drugs and Companies using Drospirenone; Ethinyl Estradiol; Levomefolate Calcium ingredient
Treatment:
Beyaz is used for contraception, prevention of pregnancy, and treating mood changes and anxiety in women with PMDD who choose oral contraceptives.
Dosage:
Beyaz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | TABLET | Prescription | ORAL |