DROSPIRENONE; ESTETROL - Generic Drug Details

What are the generic drug sources for drospirenone; estetrol and what is the scope of patent protection?

Drospirenone; estetrol is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone; estetrol has two hundred and two patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for DROSPIRENONE; ESTETROL

International Patents:	202
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
DailyMed Link:	DROSPIRENONE; ESTETROL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DROSPIRENONE; ESTETROL

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DROSPIRENONE; ESTETROL

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Quotient Sciences	Phase 1
Estetra	Phase 2

See all DROSPIRENONE; ESTETROL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DROSPIRENONE; ESTETROL

G03AA	Progestogens and estrogens, fixed combinations
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

US Patents and Regulatory Information for DROSPIRENONE; ESTETROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for DROSPIRENONE; ESTETROL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Estetra SPRL	Lydisilka	estetrol, drospirenone	EMEA/H/C/005382 Oral contraception.The decision to prescribe Lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lydisilka compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).	Authorised	no	no	no	2021-05-19
Gedeon Richter Plc.	Drovelis	estetrol, drospirenone	EMEA/H/C/005336 oral contraceptive	Authorised	no	no	no	2021-05-19

International Patents for DROSPIRENONE; ESTETROL

Country	Patent Number	Title	Estimated Expiration
Portugal	1390042
Cuba	20170159	UNIDAD DE DOSIFICACIÓN ORODISPERSABLE QUE CONTIENE UN COMPONENTE ESTETROL
World Intellectual Property Organization (WIPO)	02094277

Supplementary Protection Certificates for DROSPIRENONE; ESTETROL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
0398460	04C0022	France		PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211