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Drospirenone; ethinyl estradiol - Generic Drug Details

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Drospirenone; ethinyl estradiol is the generic ingredient in ten branded drugs marketed by Sandoz, Barr, Novast Labs Ltd, Jai Pharma Ltd, Watson Labs, Glenmark Pharms Ltd, Lupin Ltd, and Bayer Hlthcare, and is included in eighteen NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and four patent family members in forty-two countries.

There are ten drug master file entries for drospirenone; ethinyl estradiol. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: drospirenone; ethinyl estradiol

Tradenames:10
Patents:8
Applicants:8
NDAs:18
Drug Master File Entries: see list10
Suppliers / Packaging: see list10
Formulation / Manufacturing:see details

Tentative approvals for DROSPIRENONE; ETHINYL ESTRADIOL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL3MG,N/A; 0.02MG,N/A; 0.451MG,0.451MG

Clinical Trials for: drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
LORYNA
drospirenone; ethinyl estradiol
TABLET;ORAL079221-001Mar 28, 2011RXNo<disabled><disabled>
Jai Pharma Ltd
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL-28202131-001May 4, 2015RXNo<disabled><disabled>
Barr
DROSPIRENONE AND ETHINYL ESTRADIOL
drospirenone; ethinyl estradiol
TABLET;ORAL078515-001Mar 30, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: drospirenone; ethinyl estradiol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE37564<disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 2006RE43916<disabled>
Bayer Hlthcare
YAZ
drospirenone; ethinyl estradiol
TABLET;ORAL021676-001Mar 16, 20065,569,652<disabled>
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Non-Orange Book Patents for Generic Ingredient: 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
7,569,557Compositions of estrogen-cyclodextrin complexes<disabled in preview>
6,121,465 Process for production drospirenone and intermediate products of the process<disabled in preview>
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International Patent Family for Ingredient: drospirenone; ethinyl estradiol

Country Document Number Estimated Expiration
Australia5981098<disabled in preview>
Germany122007000013<disabled in preview>
Eurasian Patent Organization001947<disabled in preview>
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Supplementary Protection Certificates for Tradename: DROSPIRENONE; ETHINYL ESTRADIOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C019/2009Ireland<disabled>SPC019/2009: 20091119, EXPIRES: 20220628
2006 00038Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
C0022France<disabled>PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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