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Last Updated: June 29, 2022

NEXTSTELLIS Drug Patent Profile


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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 is one patent protecting this drug.

This drug has ninety-two patent family members in twenty-nine 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

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Summary for NEXTSTELLIS
International Patents:92
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
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
Drug patent expirations by year for NEXTSTELLIS
Drug Prices for NEXTSTELLIS

See drug prices for NEXTSTELLIS

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NEXTSTELLIS
Generic Entry Date for NEXTSTELLIS*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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.

US Patents and Regulatory Information for NEXTSTELLIS

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEXTSTELLIS is See Plans and Pricing.

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

Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE BY FEMALES OF REPRODUCTIVE POTENTIAL TO PREVENT PREGNANCY

FDA Regulatory Exclusivity protecting NEXTSTELLIS

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for NEXTSTELLIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 04C0022 France See Plans and Pricing PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2588114 LUC00227 Luxembourg See Plans and Pricing PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
0398460 SPC/GB04/032 United Kingdom See Plans and Pricing PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Express Scripts
McKinsey
Colorcon
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.