SAFYRAL Drug Patent Profile
When do Safyral patents expire, and what generic alternatives are available?
Safyral is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in SAFYRAL is drospirenone; ethinyl estradiol; levomefolate calcium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
DrugPatentWatch® Generic Entry Outlook for Safyral
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for SAFYRAL?
- What are the global sales for SAFYRAL?
- What is Average Wholesale Price for SAFYRAL?
Summary for SAFYRAL
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 70 |
| Drug Prices: | Drug price information for SAFYRAL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAFYRAL |
| What excipients (inactive ingredients) are in SAFYRAL? | SAFYRAL excipients list |
| DailyMed Link: | SAFYRAL at DailyMed |
Paragraph IV (Patent) Challenges for SAFYRAL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SAFYRAL | Tablets | drospirenone; ethinyl estradiol; levomefolate calcium | 3 mg/0.03 mg/ 0.451 mg and 0.451 mg | 022574 | 1 | 2012-09-28 |
US Patents and Regulatory Information for SAFYRAL
SAFYRAL is protected by three US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | 11,617,751 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | 8,617,597 | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SAFYRAL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | 5,798,338 | ⤷ Start Trial |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | 7,163,931 | ⤷ Start Trial |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | 6,958,326 | ⤷ Start Trial |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | 6,441,168 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SAFYRAL
See the table below for patents covering SAFYRAL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 263578 | ⤷ Start Trial | |
| Canada | 2194979 | FORMES DE MEDICAMENTS SOLIDES CONTENANT DES CLATHRATES D'HORMONES SEXUELLES STEROIDIENNES (SOLID DRUG FORMS CONTAINING CLATHRATES OF STEROID SEX HORMONES) | ⤷ Start Trial |
| Germany | 122007000011 | ⤷ Start Trial | |
| Germany | 122007000013 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAFYRAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | SPC/GB04/032 | United Kingdom | ⤷ Start Trial | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
| 0398460 | 04C0022 | France | ⤷ Start Trial | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 0771217 | CA 2006 00038 | Denmark | ⤷ Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 0771217 | 07C0001 | France | ⤷ Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for SAFYRAL
Make Better Decisions: Try a trial or see plans & pricing
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch