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Generated: October 21, 2018

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Drospirenone; ethinyl estradiol - Generic Drug Details

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What are the generic sources for drospirenone; ethinyl estradiol and what is the scope of drospirenone; ethinyl estradiol freedom to operate?

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, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex Inc, Mayne Pharma, and Watson Labs Inc, and is included in twenty-nine NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for drospirenone; ethinyl estradiol. Nineteen 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
Jubilant Cadista DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 209423-001 Dec 22, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 204296-001 Aug 17, 2015 AB RX No No ➤ 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
Glenmark Pharms Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848-001 Mar 25, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 BEYAZ drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022532-001 Sep 24, 2010 AB RX No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Watson Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078833-001 Nov 28, 2011 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 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
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ➤ Sign Up ➤ Sign Up
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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Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01 Switzerland ➤ Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
49/2008 Austria ➤ Sign Up PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
C/GB04/032 United Kingdom ➤ Sign Up PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
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:

Deloitte
Covington
Medtronic
Julphar
Fuji
McKesson
Moodys
Chubb
Teva

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