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SAFYRAL Drug Patent Profile

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Which patents cover Safyral, and when can generic versions of Safyral launch?

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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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

Drug patent expirations by year for SAFYRAL

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

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Patented Use: PREVENTION OF PREGNANCY

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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
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Glossary

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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

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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
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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2013047280	STABLE CRYSTALLINE 5-METHYLTETRAHYDROFOLATE SALT	⤷ Sign Up
Eurasian Patent Organization	007411	КОМПОЗИЦИИ КОМПЛЕКСОВ ЭСТРОГЕН-ЦИКЛОДЕКСТРИН (COMPOSITIONS OF ESTROGEN-CYCLODEXTRIN COMPLEXES)	⤷ Sign Up
Czech Republic	20031985		⤷ Sign Up
Switzerland	693905	Stabile kristalline Salze von 5-Methyltetrahydrofolsäure.	⤷ Sign Up
Japan	2009102424	COMPOSITIONS OF ESTROGEN-CYCLODEXTRINS COMPLEXES	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SAFYRAL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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 - 61678 20191016
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