SAFYRAL Drug Patent Profile
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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 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.
DrugPatentWatch® Generic Entry Outlook for Safyral
There have been two 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
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Questions you can ask:
- What is the 5 year forecast for SAFYRAL?
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Summary for SAFYRAL
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Patent Applications: | 8 |
| 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.
Patents protecting SAFYRAL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: RAISE FOLATE LEVELS IN WOMEN WHO CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION FOR THE PURPOSE OF REDUCING THE RISK OF A NEURAL TUBE DEFECT IN A PREGNANCY
Pharmaceutical composition containing a tetrahydrofolic acid
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Bayer Hlthcare | SAFYRAL | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 022574-001 | Dec 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Israel | 156437 | ⤷ Sign Up | |
| Bulgaria | 108002 | ⤷ Sign Up | |
| Peru | 20020709 | COMPOSICIONES DE COMPLEJOS DE ESTROGENO-CICLODEXTRINA | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAFYRAL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0398460 | 04C0022 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| 3632448 | LUC00266 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
| 3632448 | 22C1031 | France | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 31332 20191016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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. 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.
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