drospirenone Drug Patent Profile

Which patents cover Drospirenone, and what generic alternatives are available?

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

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

See drug prices for drospirenone

See drug sales revenues 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

FDA Regulatory Exclusivity protecting drospirenone

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
Lupin Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	201663-001	Dec 18, 2012	AB	RX	No	No
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
Mylan Labs Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202131-001	May 4, 2015	AB	RX	No	No
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No

International Patents for drospirenone

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4056186	COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA DROSPIRÉNONE ET ENSEMBLE CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)
Mexico	364971	COMPOSICION FARMACEUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO. (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT.)
Slovenia	3632448
Lithuania	3632448
Denmark	3632448

Supplementary Protection Certificates for drospirenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	C202230031	Spain		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): SE/H/1809/001/DC; DATE OF FIRST AUTHORISATION IN EEA: 20191016
2588114	2020C/518	Belgium		PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
2588114	301123	Netherlands		PRODUCT NAME: SLINDA; NATIONAL REGISTRATION NO/DATE: RGV 127386 20210317; FIRST REGISTRATION: DK 31332 20191016
2588114	19/2020	Austria		PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 139227 20191206; FIRST REGISTRATION: DK 31332 (MITTEILUNG) 20191022