Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Mallinckrodt
Colorcon
Medtronic
Johnson and Johnson

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022574

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 022574 describes SAFYRAL, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SAFYRAL profile page.

The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for 022574
Suppliers and Packaging for NDA: 022574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574 NDA Sandoz Inc 0781-4103 0781-4103-52 3 BLISTER PACK in 1 PACKAGE (0781-4103-52) > 1 KIT in 1 BLISTER PACK (0781-4103-15)
SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-403 50419-403-00 90 BLISTER PACK in 1 PACKAGE (50419-403-00) > 1 KIT in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022574
Tradename Dosage Ingredient NDA Submissiondate
SAFYRAL TABLET;ORAL drospirenone; ethinyl estradiol; levomefolate calcium 022574 2012-09-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date:Dec 16, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 17, 2020Product Flag?Substance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Dec 20, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 3, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREGNANCY

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Baxter
Johnson and Johnson
McKesson
McKinsey
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.