Safyral is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2023. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 17, 2030. Details of Safyral'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5798338 | Solid dosage forms that contain clathrates of 17α-ethinyl estradiol |
Jul, 2015
(9 years ago) |
Expired
|
| US6441168 | Stable crystalline salts of 5-methyltetrahydrofolic acid |
Apr, 2020
(4 years ago) |
Expired
|
| US6958326 | Cyclodextrin-drospirenone inclusion complexes |
Dec, 2021
(2 years ago) |
Expired
|
| US7163931 | Compositions of estrogen-cyclodextrin complexes |
Mar, 2022
(2 years ago) |
Expired
|
| US8617597 | Pharmaceutical composition containing a tetrahydrofolic acid |
Feb, 2030
(5 years from now) | Active |
| US11617751 | Pharmaceutical composition containing a tetrahydrofolic acid |
Jul, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Safyral. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Safyral, 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 Safyral.
Exclusivity Information
Safyral holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Safyral's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 16, 2013 |
US patents provide insights into the exclusivity only within the United States, but Safyral 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 Safyral's family patents as well as insights into ongoing legal events on those patents.
Safyral's family patents
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Generic Launch
Generic Release Date:
Safyral'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)
Safyral Generics:
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium is the generic name for the brand Safyral. 2 different companies have already filed for the generic of Safyral, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Safyral's generic
How can I launch a generic of Safyral before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Safyral's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Safyral'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 Safyral -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg/0.03 mg/ 0.451 mg and 0.451 mg | 28 Sep, 2012 | 1 | 11 Oct, 2016 | 03 Mar, 2022 | Extinguished |
About Safyral
Safyral is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for preventing pregnancy and raising folate levels to reduce the risk of neural tube defects in pregnancy. Safyral uses Drospirenone; Ethinyl Estradiol; Levomefolate Calcium as an active ingredient. Safyral was launched by Bayer Hlthcare in 2010.
Market Authorisation Date:
Safyral was approved by FDA for market use on 16 December, 2010.
Active Ingredient:
Safyral uses Drospirenone; Ethinyl Estradiol; Levomefolate Calcium as the active ingredient. Check out other Drugs and Companies using Drospirenone; Ethinyl Estradiol; Levomefolate Calcium ingredient
Treatment:
Safyral is used for preventing pregnancy and raising folate levels to reduce the risk of neural tube defects in pregnancy.
Dosage:
Safyral is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | TABLET | Prescription | ORAL |