Yaz is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 11 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 Dec 20, 2021. Details of Yaz'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). | |||
| US7163931 | Compositions of estrogen-cyclodextrin complexes |
Dec, 2021
(2 years ago) |
Expired
|
| US6958326 | Cyclodextrin-drospirenone inclusion complexes |
Dec, 2021
(2 years ago) |
Expired
|
| US6787531 | Pharmaceutical composition for use as a contraceptive |
Aug, 2020
(4 years ago) |
Expired
|
| US6987101 | Therapeutic gestagens for the treatment of premenstrual dysphoric disorder |
Dec, 2017
(6 years ago) |
Expired
|
| US6933395 | PROCESSING FOR PRODUCING OF DROSPIRENONE (6β, 7β, 15β, 16β-DIMETHYLENE-3-OXO-17α-PREGN-4-EN-21, 17-CARBOLACTONE, DRSP) AS WELL AS 7α-(3-HYDOXY-1-PROPLY)-6β, 7β; 15β, 16β-DIMETHYLENE-5β-ANDROSTANE-3β, 5,17β-TRIOL(ZK 92836) AND 6β, 7β; 15β, 16β-DIMETHYLENE-5β-HYDROXY |
Aug, 2017
(7 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
|
| USRE38253 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| USRE37564 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| USRE43916 | Composition for contraception |
Jun, 2014
(10 years ago) |
Expired
|
| US5569652 | Dihydrospirorenone as an antiandrogen |
Oct, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Yaz 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 Yaz's family patents as well as insights into ongoing legal events on those patents.
Yaz's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Yaz's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 20, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Yaz Generic API suppliers:
Drospirenone; Ethinyl Estradiol is the generic name for the brand Yaz. 14 different companies have already filed for the generic of Yaz, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Yaz's generic
How can I launch a generic of Yaz before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Yaz's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Yaz'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 Yaz -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg/0.02 mg | 29 Sep, 2006 | 1 | 30 Mar, 2009 | 20 Dec, 2021 | Extinguished Deferred |
Alternative Brands for Yaz
Yaz which is used for contraception, prevention of pregnancy, and treating premenstrual dysphoric disorder in premenopausal females., has several other brand drugs in the same treatment category and using the same active ingredient (Drospirenone; Ethinyl Estradiol). 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 |
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| Teva Branded Pharm |
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| Wyeth Pharms Inc |
| |||||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Drospirenone; Ethinyl Estradiol, Yaz's active ingredient. Check the complete list of approved generic manufacturers for Yaz
About Yaz
Yaz is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for contraception, prevention of pregnancy, and treating premenstrual dysphoric disorder in premenopausal females. Yaz uses Drospirenone; Ethinyl Estradiol as an active ingredient. Yaz was launched by Bayer Hlthcare in 2006.
Approval Date:
Yaz was approved by FDA for market use on 16 March, 2006.
Active Ingredient:
Yaz uses Drospirenone; Ethinyl Estradiol as the active ingredient. Check out other Drugs and Companies using Drospirenone; Ethinyl Estradiol ingredient
Treatment:
Yaz is used for contraception, prevention of pregnancy, and treating premenstrual dysphoric disorder in premenopausal females.
Dosage:
Yaz is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG;0.02MG | TABLET | Prescription | ORAL |