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?
- 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: | 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 |
---|---|---|---|
Japan | 2009102424 | COMPOSITIONS OF ESTROGEN-CYCLODEXTRINS COMPLEXES | ⤷ Sign Up |
Ukraine | 77626 | COMPOSITIONS COMPRISING COMPLEXES OF ESTROGEN AND CYCLODEXTRIN | ⤷ Sign Up |
Slovakia | 9142003 | Compositions of estrogen-cyclodextrin complexes | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAFYRAL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3632448 | LUC00266 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401 |
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 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |