Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Boehringer Ingelheim
Merck
Medtronic
Express Scripts

Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Drospirenone; ethinyl estradiol; levomefolate calcium - Generic Drug Details

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

Drospirenone; ethinyl estradiol; levomefolate calcium is the generic ingredient in four branded drugs marketed by Bayer Hlthcare, Lupin Ltd, and Watson Labs Inc, and is included in six NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; ethinyl estradiol; levomefolate calcium has one hundred and twenty patent family members in forty countries.

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

Recent Clinical Trials for drospirenone; ethinyl estradiol; levomefolate calcium

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

SponsorPhase
BayerPhase 3

See all drospirenone; ethinyl estradiol; levomefolate calcium clinical trials

Recent Litigation for drospirenone; ethinyl estradiol; levomefolate calcium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Merck & Cie v. Lupin Ltd.2015-10-08
Merck & Cie v. Watson Laboratories Inc.2015-09-24
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05

See all drospirenone; ethinyl estradiol; levomefolate calcium litigation

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
BEYAZ TABLET;ORAL drospirenone; ethinyl estradiol; levomefolate calcium 022532 2012-11-13
SAFYRAL TABLET;ORAL drospirenone; ethinyl estradiol; levomefolate calcium 022574 2012-09-28

US Patents and Regulatory Information for drospirenone; ethinyl estradiol; levomefolate calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203594-001 Oct 11, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205947-001 Jun 13, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd TYDEMY drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 205948-001 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 203593-001 Oct 11, 2016 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; levomefolate calcium

Supplementary Protection Certificates for drospirenone; ethinyl estradiol; levomefolate calcium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Dow
Merck
Medtronic
Mallinckrodt

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