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Last Updated: October 6, 2022

DROSPIRENONE Drug Patent Profile


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When do Drospirenone patents expire, and when can generic versions of Drospirenone launch?

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

This drug has sixty patent family members in twenty-seven 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

Annual sales in 2019 were $59mm indicating the motivation for generic entry.

Indicators of Generic Entry

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Drug patent expirations by year for DROSPIRENONE
Drug Prices for DROSPIRENONE

See drug prices for DROSPIRENONE

Drug Sales Revenue Trends for DROSPIRENONE

See drug sales revenues for DROSPIRENONE

Recent Clinical Trials for DROSPIRENONE

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

SponsorPhase
Chemo ResearchPhase 3
Insud PharmaPhase 3
Insud PharmaPhase 4

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 nine US patents.

Patents protecting DROSPIRENONE

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthetic progestogens and pharmaceutical compositions comprising the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising active drugs, contraceptive kits comprising active drugs, and methods of administering the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Exeltis Usa Inc DROSPIRENONE drospirenone TABLET, CHEWABLE;ORAL 216285-001 Jun 29, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Barr DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 077527-001 May 9, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 202131-001 May 4, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
New Zealand 605176 Pharmaceutical composition comprising drospirenone and contraceptive kit See Plans and Pricing
Hungary E047689 See Plans and Pricing
Denmark 3632448 See Plans and Pricing
Denmark 2588114 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3632448 122022000040 Germany See Plans and Pricing PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DAENEMARK 61678 20191016
3632448 2022C/529 Belgium See Plans and Pricing PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
2588114 C202030026 Spain See Plans and Pricing PRODUCT NAME: DROSPIRENONA; NATIONAL AUTHORISATION NUMBER: 84603-SE/H/1869/001/DC; DATE OF AUTHORISATION: 20191025; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 61678; DATE OF FIRST AUTHORISATION IN EEA: 20191016
3632448 PA2022513 Lithuania See Plans and Pricing PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Boehringer Ingelheim
Colorcon
Moodys
McKesson

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.