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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11617751 | Pharmaceutical composition containing a tetrahydrofolic acid |
Jul, 2030
(4 years from now) | Active |
| US8617597 | Pharmaceutical composition containing a tetrahydrofolic acid |
Feb, 2030
(3 years from now) | Active |
| US7163931 | Compositions of estrogen-cyclodextrin complexes |
Mar, 2022
(4 years ago) |
Expired
|
| US6958326 | Cyclodextrin-drospirenone inclusion complexes |
Dec, 2021
(4 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
(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 Safyral's patents.
Latest Legal Activities on Safyral's Patents
Given below is the list of recent legal activities going on the following patents of Safyral.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jun, 2025 | US8617597 |
| Patent Issue Date Used in PTA Calculation | 04 Apr, 2023 | US11617751 |
| Recordation of Patent Grant Mailed | 04 Apr, 2023 | US11617751 |
| Email Notification | 16 Mar, 2023 | US11617751 |
| Issue Notification Mailed | 15 Mar, 2023 | US11617751 |
| Dispatch to FDC | 15 Feb, 2023 | US11617751 |
| Issue Fee Payment Verified | 13 Feb, 2023 | US11617751 |
| Issue Fee Payment Received | 13 Feb, 2023 | US11617751 |
| Mail Notice of Allowance | 05 Dec, 2022 | US11617751 |
| Electronic Review | 05 Dec, 2022 | US11617751 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Sep, 2012 | 03 Mar, 2022 | Extinguished | 11 Oct, 2016 | Less |
Alternative Brands for Safyral
Safyral which is used for preventing pregnancy and raising folate levels to reduce the risk of neural tube defects in pregnancy., 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, Safyral's active ingredient. Check the complete list of approved generic manufacturers for Safyral
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 in 2010.
Approval 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 |