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Serving hundreds of leading biopharmaceutical companies globally:

Citi
US Department of Justice
McKinsey
Dow
Moodys
Argus Health
Chubb
Cipla
Daiichi Sankyo

Generated: August 16, 2018

DrugPatentWatch Database Preview

Drospirenone; ethinyl estradiol - Generic Drug Details

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What are the generic drug sources for drospirenone; ethinyl estradiol and what is the scope of drospirenone; ethinyl estradiol patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in fourteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Jubilant Cadista, Mylan Labs Ltd, PII, Watson Labs, Aurobindo Pharma Ltd, Labs Leon Farma, Novast Labs Ltd, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex Inc, Mayne Pharma, and Watson Labs Inc, and is included in twenty-eight NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; ethinyl estradiol has one hundred and sixty-five patent family members in forty-two countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol. Eighteen suppliers are listed for this compound.

Synonyms for drospirenone; ethinyl estradiol
(1R,2R,4R,10R,11S,14S,15S,16S,18S,19S)-10,14-DIMETHYLSPIRO[HEXACYCLO[9.8.0.0(2),?.0?,(1)?.0(1)?,(1)?.0(1)?,(1)?]NONADECANE-15,2'-OXOLAN]-5-ENE-5',7-DIONE; (1S,10R,11S,14R,15S)-14-ETHYNYL-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(
164017-31-6
19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-, mixt. with (2'S,6R,7R,8R,9S,10R,13S,14S,15S,16S)-3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro(17H-dicyclopropa(6,7:15,16)cyclopenta(a)ph
19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol,(17alpha)-,mixt.w/(2'S,6R,7R,8R,9S,10R,13S,14S,15S,16S)-3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro(17H-dicyclopropa(6,7:15,16)cyclopenta(a)phenanth
AC1L3VT1
BAY 86-5300
Drospirenone & Ethinyl Estradiol
drospirenone and ethinyl estradiol combination
Drospirenone mixture with Ethinyl estradiol
Drospirenone mixture with Ethinylestradiol
Drospirenone-ethinylestradiol mixt
Drospirenone(DRSP)
Drospirenone/Ethinyl Estradiol
EE20/DRSP
Ethinylestradiol mixture with drospirenone
Ethinylestradiol-drospirenone mixt
Gianvi
Loryna
LS-181813
Nikki
Ocella
Petibelle
PL047789
SCHEMBL8464101
Syeda
Vestura
Yasmin 28
YAZ
Yaz-28
Z 30.595
Zarah

US Patents and Regulatory Information for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd TYDEMY drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205948-001 Dec 12, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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 ➤ Sign Up
Aurobindo Pharma Ltd ZUMANDIMINE drospirenone; ethinyl estradiol TABLET;ORAL-28 209407-001 Mar 26, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for drospirenone; ethinyl estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,569,557 Compositions of estrogen-cyclodextrin complexes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 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
C019/2009 Ireland ➤ Sign Up SPC019/2009: 20091119, EXPIRES: 20220628
2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Deloitte
Express Scripts
Cantor Fitzgerald
Argus Health
Chubb
Harvard Business School
QuintilesIMS
Daiichi Sankyo

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.