~ Buy the NEXTSTELLIS (drospirenone; estetrol) Drug Profile, 2024 PDF Report in the Report Store ~

NEXTSTELLIS Drug Patent Profile

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

Nextstellis is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and fifty-seven patent family members in forty-four countries.

The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estetrol profile page.

DrugPatentWatch^® Generic Entry Outlook for Nextstellis

Nextstellis will be eligible for patent challenges on April 15, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEXTSTELLIS

International Patents:	157
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NEXTSTELLIS
What excipients (inactive ingredients) are in NEXTSTELLIS?	NEXTSTELLIS excipients list
DailyMed Link:	NEXTSTELLIS at DailyMed

See drug prices for NEXTSTELLIS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEXTSTELLIS

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

214154

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.

Anatomical Therapeutic Chemical (ATC) Classes for NEXTSTELLIS

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 NEXTSTELLIS

NEXTSTELLIS is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NEXTSTELLIS

FDA Regulatory Exclusivity protecting NEXTSTELLIS

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

EU/EMA Drug Approvals for NEXTSTELLIS

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 NEXTSTELLIS

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

Country	Patent Number	Title	Estimated Expiration
Serbia	73304
European Patent Office	1446128	UTILISATION DE COMPOSES OESTROGENES COMBINES A DES COMPOSES PROGESTOGENES EN THERAPIE DE SUBSTITUTION HORMONALE (USE OF ESTROGENIC COMPOUNDS IN COMBINATION WITH PROGESTOGENIC COMPOUNDS IN HORMONE-REPLACEMENT THERAPY)
European Patent Office	3701944	UNITÉ POSOLOGIQUE ORODISPERSIBLE CONTENANT UN COMPOSANT D'ESTÉTROL (ORODISPERSIBLE DOSAGE UNIT CONTAINING AN ESTETROL COMPONENT)
Israel	163579	KIT FOR USE IN HORMONAL CONTRACEPTIVE METHOD OR HORMONE REPLACEMENT THERAPY
Eurasian Patent Organization	007599	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ОДИН ИЛИ НЕСКОЛЬКО СТЕРОИДОВ, ОДИН ИЛИ НЕСКОЛЬКО ТЕТРАГИДРОФОЛАТНЫХ КОМПОНЕНТОВ И ВИТАМИН В (PHARMACEUTICAL COMPOSITIONS COMPRISING ONE OR MORE STEROIDS ONE OR MORE TETRAHYDROPOLATE COMPONENTS AND VITAMIN B)

Supplementary Protection Certificates for NEXTSTELLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	SPC/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
3701944	PA2022508	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
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 - 31332 20191016