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Last Updated: December 14, 2019

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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 patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Anda Repository, Barr, Glenmark Pharms Ltd, Hetero Labs Ltd, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Sun Pharm, Aurobindo Pharma Ltd, Xiromed, Novast Labs, Lupin Ltd, Bayer Hlthcare, Accord Hlthcare, Apotex Inc, Mayne Pharma, and Watson Labs Inc, and is included in thirty-two 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 seventy-three patent family members in forty-two countries.

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

Recent Clinical Trials for drospirenone; ethinyl estradiol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San FranciscoPhase 4
Navy General Hospital, BeijingN/A
Pherin Pharmaceuticals, Inc.Phase 3

See all drospirenone; ethinyl estradiol clinical trials

Recent Litigation for drospirenone; ethinyl estradiol

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Bayer Schering Pharma AG v. Mylan Pharmaceuticals Inc.2011-04-19
BRAINTREE LABORATORIES, INC. v. LUPIN ATLANTIS HOLDINGS SA2011-03-09

See all drospirenone; ethinyl estradiol litigation

Synonyms for drospirenone; ethinyl estradiol
164017-31-6
AC1L3VT1
BAY 86-5300
DR1021
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
SCHEMBL8464101
Syeda
Vestura
Yasmin 28
YAZ
Yaz-28
Z 30.595
Zarah
Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
YAZ TABLET;ORAL drospirenone; ethinyl estradiol 021676 2006-09-29
YASMIN TABLET;ORAL-28 drospirenone; ethinyl estradiol 021098 2005-01-07

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 NIKKI drospirenone; ethinyl estradiol TABLET;ORAL 201661-001 May 27, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 205876-001 Sep 21, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Barr DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 077527-001 May 9, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
>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 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   Start Trial   Start Trial
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006   Start Trial   Start Trial
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for drospirenone; ethinyl estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Johnson and Johnson
McKesson
Boehringer Ingelheim
Colorcon

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