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Last Updated: March 29, 2024

DROSPIRENONE Drug Patent Profile


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Which patents cover Drospirenone, and when can generic versions of Drospirenone launch?

Drospirenone is a drug marketed by Exeltis Usa Inc, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, Apotex, Dr Reddys Labs Sa, Lupin Ltd, Naari Pte Ltd, and Watson Labs Inc. and is included in twenty NDAs. There are thirteen patents protecting this drug.

This drug has sixty-five patent family members in twenty-nine countries.

The generic ingredient in DROSPIRENONE is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

DrugPatentWatch® Generic Entry Outlook for Drospirenone

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DROSPIRENONE
Drug Prices for DROSPIRENONE

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Drug Sales Revenue Trends for DROSPIRENONE

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Recent Clinical Trials for DROSPIRENONE

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

SponsorPhase
University of Colorado, DenverPhase 2
Bristol Myers Squibb Company (BMS)Phase 1
Janssen Pharmaceutica N.V., BelgiumPhase 1

See all DROSPIRENONE clinical trials

Paragraph IV (Patent) Challenges for DROSPIRENONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SLYND Tablets drospirenone 4 mg 211367 1 2022-01-07

US Patents and Regulatory Information for DROSPIRENONE

DROSPIRENONE is protected by thirteen US patents and one FDA Regulatory Exclusivity.

Patents protecting DROSPIRENONE

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic progestogens and pharmaceutical compositions comprising the same
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Patent Expiration: ⤷  Try a Trial

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
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Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

FDA Regulatory Exclusivity protecting DROSPIRENONE

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

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 203593-001 Oct 11, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 201663-001 Dec 18, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131-001 May 4, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Exeltis Usa Inc DROSPIRENONE drospirenone TABLET, CHEWABLE;ORAL 216285-001 Jun 29, 2022 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DROSPIRENONE

See the table below for patents covering DROSPIRENONE around the world.

Country Patent Number Title Estimated Expiration
France 20C1020 ⤷  Try a Trial
Denmark 2588114 ⤷  Try a Trial
Canada 3003062 COMPOSITION PHARMACEUTIQUE CONTENANT DE LA DROSPIRENONE ET KIT CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT) ⤷  Try a Trial
South Korea 20130048227 PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT ⤷  Try a Trial
Croatia P20220332 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3632448 301186 Netherlands ⤷  Try a Trial PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RVG 127386 20210317; FIRST REGISTRATION: DK 61678 20191022
3632448 29/2022 Austria ⤷  Try a Trial PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
2588114 LUC00227 Luxembourg ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
2588114 301123 Netherlands ⤷  Try a Trial PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016
0398460 SPC/GB04/032 United Kingdom ⤷  Try a 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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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 verification 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.