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

Annual sales in 2021 were $29mm indicating the motivation for generic entry (peak sales were $59mm in 2019).

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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Summary for DROSPIRENONE

International Patents:	65
US Patents:	13
Applicants:	13
NDAs:	20
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	98
Patent Applications:	2,065
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DROSPIRENONE
Drug Sales Revenues:	Drug sales revenues for DROSPIRENONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DROSPIRENONE
DailyMed Link:	DROSPIRENONE at DailyMed

Drug patent expirations by year for DROSPIRENONE

Recent Clinical Trials for DROSPIRENONE

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
Bristol Myers Squibb Company (BMS)	Phase 1
Janssen Pharmaceutica N.V., Belgium	Phase 1

See all DROSPIRENONE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE

G03AC	Progestogens
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting DROSPIRENONE

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Mexico	339952	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.)	⤷ Try a Trial
New Zealand	605176	Pharmaceutical composition comprising drospirenone and contraceptive kit	⤷ Try a Trial
Japan	2013529665		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DROSPIRENONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	29/2022	Austria	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022
3632448	PA2022513	Lithuania	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
0398460	04C0022	France	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description