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, Lupin Ltd, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc. and is included in twenty-one NDAs. There are fifteen patents protecting this drug.

This drug has sixty-six 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:	66
US Patents:	15
Applicants:	13
NDAs:	21
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	101
Patent Applications:	2,065
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
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Eli Lilly and Company	Phase 1
Bristol-Myers Squibb	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 fifteen 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
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Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Synthetic progestogens and pharmaceutical compositions comprising the same
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Patent Expiration: ⤷ Sign Up

Synthetic progestogens and pharmaceutical compositions comprising the same
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Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

Synthetic progestogens and pharmaceutical compositions comprising the same
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Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Patented Use: PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE

FDA Regulatory Exclusivity protecting DROSPIRENONE

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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
Naari Pte Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	207245-001	Nov 22, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	204848-001	Mar 25, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	202131-001	May 4, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL-28	213034-001	Jan 24, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Exeltis Usa Inc	DROSPIRENONE	drospirenone	TABLET, CHEWABLE;ORAL	216285-001	Jun 29, 2022		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	078515-001	Mar 30, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Canada	3003062	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA DROSPIRENONE ET KIT CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)	⤷ Sign Up
Japan	5810159		⤷ Sign Up
Guatemala	201200336B	COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE DROSPIRENONA Y KIT ANTICONCEPTIVO (SOLICITUD DIVISIONAL NO. 2)	⤷ Sign Up
Portugal	2588114		⤷ Sign Up
South Korea	102164693		⤷ Sign Up
European Patent Office	3632448	COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA DROSPIRÉNONE ET ENSEMBLE CONTRACEPTIF (PHARMACEUTICAL COMPOSITION COMPRISING DROSPIRENONE AND CONTRACEPTIVE KIT)	⤷ Sign Up
>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
2588114	LUC00227	Luxembourg	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3632448	2022C/529	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENON; AUTHORISATION NUMBER AND DATE: BE548284 20191107
3632448	122022000040	Germany	⤷ Sign Up	PRODUCT NAME: DROSPIRENON; NAT. REGISTRATION NO/DATE: 7002248.00.00 20210426; FIRST REGISTRATION: DAENEMARK 61678 20191016
1380301	2009C/007	Belgium	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
3632448	LUC00266	Luxembourg	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	PA2022513	Lithuania	⤷ Sign Up	PRODUCT NAME: DROSPIRENONAS; REGISTRATION NO/DATE: LT/1/21/4721/001-004 20210419
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description