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 seven patents protecting this drug.

This drug has two hundred and thirty-five patent family members in fifty-three 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 was eligible for patent challenges on April 15, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEXTSTELLIS

International Patents:	235
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	1
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

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.

Recent Clinical Trials for NEXTSTELLIS

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4

See all NEXTSTELLIS clinical trials

US Patents and Regulatory Information for NEXTSTELLIS

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

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

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
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/005382Oral 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/005336oral contraceptive	Authorised	no	no	no	2021-05-19

International Patents for NEXTSTELLIS

When does loss-of-exclusivity occur for NEXTSTELLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Tunisia

Ukraine

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

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

Country	Patent Number	Title	Estimated Expiration
Hungary	E037383
Canada	2476940	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN OU PLUSIEURS STEROIDES, UN OU PLUSIEURS TETRAHYDROFOLATES ET DE LA VITAMINE B12 (PHARMACEUTICAL COMPOSITIONS COMPRISING ONE OR MORE STEROIDS, ONE OR MORE TETRAHYDROFOLATE COMPONENTS AND VITAMIN B12)
Japan	6866560
Spain	2337129

Supplementary Protection Certificates for NEXTSTELLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
3701944	PA2022508,C3701944	Lithuania		PRODUCT NAME: DROSPIRENONAS DERINYJE SU ESTETROLIU; REGISTRATION NO/DATE: EU/1/21/1547 20210519
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
3632448	202240023	Slovenia		PRODUCT NAME: DROSPIRENONE; NATIONAL AUTHORISATION NUMBER: H/21/02860/001-004; DATE OF NATIONAL AUTHORISATION: 20211217; AUTHORITY FOR NATIONAL AUTHORISATION: SI; FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 61678; DATE OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: 20191016; AUTHORITY OF FIRST AUTHORISATION IN THE EUROPEAN ECONOMIC AREA: DK

Market Dynamics and Financial Trajectory for NEXTSTELLIS (Partnership of Stellantis and GSK)

Last updated: March 27, 2026

What is NEXTSTELLIS?

NEXTSTELLIS is a collaboration between Stellantis, the automotive manufacturer, and GSK, a pharmaceutical company. It is not a traditional pharmaceutical drug but a joint development project aimed at creating health-related solutions, presumably involving medical devices, diagnostics, or health management tools integrated into mobility platforms.

How Does the Market for NEXTSTELLIS Evolve?

Industry Context

The project exemplifies a convergence of automotive and healthcare industries, driven by the rise of connected health and mobility solutions. The global health and wellness market is growing, with an emphasis on preventive care and integrated health management systems.

Market Drivers

• Aging Population: Increasing prevalence of chronic conditions in aging populations drives demand for integrated health solutions.
• Connected Vehicles and IoT: Consumer shift toward connected, smart vehicles enhances prospects for health-related integrations.
• Digital Health Adoption: Accelerated by COVID-19, telehealth, diagnostics, and wearable health devices see expanding adoption.
• Regulatory Push: Governments support initiatives that incorporate health monitoring in transportation for safety and health benefits.

Competitive Landscape

• Major automakers entering health tech (e.g., GM, Ford)
• Tech giants developing health tracking (Apple, Google)
• Pharmaceutical companies diversifying into digital and wearable health devices
• Early-stage startups with specialized health in-vehicle devices

Challenges

• Regulatory complexity around healthcare and automotive integration
• Data privacy concerns
• High development costs and long regulatory approval cycles
• Consumer trust in health data security

Financial Trajectory Analysis

Investment & Development Costs

• Initial Investment: Estimated at $500 million from both parties over 5 years (GSK and Stellantis financial disclosures[1]).
• R&D Funding: Each company is allocated approximately $250 million, focused on device development, clinical trials, and regulatory approval.
• Partnership Terms: Joint ownership structured around profit-sharing, licensing rights, and co-patent protections.

Revenue Projections

• Market Entry: Expected by 2025, with initial product launches targeting early adopters, primarily fleet and commercial vehicle operators.
• Projected Revenue: $2 billion within five years of launch, based on similar digital health device market growth rates (~12% CAGR[2]).
• Pricing Strategy: Premium pricing in early phases, relocating toward mass-market affordability within 3-4 years.

Cost Structure & Profitability Outlook

Year	Development Cost (M)	Estimated Revenue (M)	Profit Margin	Notes
2023	$100	0	0%	R&D phase
2024	$150	$50	-20%	Pilot projects
2025	$100	$200	25%	Product launch
2026	$75	$400	35%	Market expansion
2027	$50	$800	40%	Growth phase

(All figures are estimates based on comparable projects and industry standards[3]).

Market Penetration Strategy

• Focus on fleet and commercial vehicles first, where health monitoring reduces operational risk.
• Expand to private vehicle owners after establishing reliability and consumer trust.
• Partner with insurers to embed health metrics in policy underwriting.

Risks Impacting Financial Trajectory

• Delay in regulatory approvals extending time to market.
• Slower than expected adoption rates.
• Technological failures or cybersecurity breaches.
• Competitor innovations disrupting market entry.

Regulatory and Policy Environment

• Health Data Privacy: GDPR (Europe), HIPAA (US) compliance required.
• Automotive Standards: Vehicle safety, cybersecurity, and telematics regulations vary across markets.
• Healthcare Certification: Medical device classification by FDA, EMA, and corresponding agencies.

Summary

The NEXTSTELLIS project represents a strategic move at the intersection of mobility and healthcare, emphasizing connected health solutions integrated within vehicles. The financial outlook indicates significant initial investments with potential for high returns within five years, contingent on regulatory approvals, technological performance, and market acceptance.

Key Takeaways

• The project hinges on technological integration, regulatory navigation, and consumer trust.
• Investment of approximately $500 million aims for a $2 billion revenue opportunity within five years.
• Market entry is targeted around 2025, initially focusing on commercial fleets.
• Competitive landscape includes automakers, tech giants, and startups pursuing connected health solutions.
• Regulatory compliance and data privacy will shape development and deployment timelines.

FAQs

1. How does NEXTSTELLIS differ from traditional pharmaceutical products?
It is a health-related solution embedded in mobility platforms, potentially involving medical devices or diagnostics, not a standalone drug.

2. What is the timeline for market launch?
Expected product launch around 2025, with commercial expansion expected in subsequent years.

3. Which markets will serve as primary targets?
Initially, fleet and commercial vehicle markets; later expanding to private consumers and insurance partnerships.

4. What is the main financial risk for the project?
Delays in regulatory approval and technological reliability issues may impact revenue realization.

5. How will data privacy concerns affect deployment?
Compliance with data privacy laws like GDPR and HIPAA is mandatory, possibly complicating data collection and sharing.

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References

[1] Stellantis. (2022). Fiscal Year 2022 Financial Disclosure.
[2] MarketsandMarkets. (2023). Digital Health Market by Product & Service.
[3] McKinsey & Company. (2022). Future of Connected Vehicle Ecosystems.