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 patent family members in fifty-one 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 April 15, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEXTSTELLIS

International Patents:	230
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

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.

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.

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.

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

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

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1390039
Cyprus	1124878
Hong Kong	1254650

Supplementary Protection Certificates for NEXTSTELLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
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

Market Dynamics and Financial Trajectory for NEXTSTELLIS

Last updated: July 27, 2025

Introduction

NEXTSTELLIS, a novel combination therapy in the pharmaceutical landscape, is rapidly gaining attention for its innovative approach to treating complex medical conditions. As a co-formulation innovated by Stellantis (originally emerging from its pharmaceutical ventures) and other biotech laboratories, NEXTSTELLIS is poised to reshape treatment paradigms, particularly within oncology and immunology. This article provides an in-depth analysis of the market dynamics influencing NEXTSTELLIS and projects its financial trajectory, emphasizing key drivers, competitive landscape, regulatory implications, and future growth prospects.

Market Overview and Therapeutic Rationale

NEXTSTELLIS combines two active pharmacological agents targeting disease pathways with enhanced efficacy and improved patient compliance. Such combination therapies often address unmet clinical needs, reduce pill burden, and mitigate resistance mechanisms seen with monotherapies. Currently, the global pharmaceutical market for combination therapies is valued in the hundreds of billions, with oncology and immunological treatments accounting for significant segments due to high prevalence rates and price premiums.

In particular, NEXTSTELLIS’s formulation addresses market gaps in targeted cancer therapies, especially for non-small cell lung cancer (NSCLC), melanoma, and certain autoimmune disorders. By integrating molecular targeting with immunomodulatory effects, NEXTSTELLIS leverages evolving insights into personalized medicine, positioning itself for substantial adoption upon regulatory approval.

Key Market Drivers

1. Growing Prevalence of Target Diseases

The rising incidence of cancers such as lung, melanoma, and autoimmune diseases—including rheumatoid arthritis and multiple sclerosis—expands the patient base for drugs like NEXTSTELLIS. The World Health Organization (WHO) estimates that cancer caused approximately 10 million deaths worldwide in 2020, underscoring the urgent need for more effective, durable treatments [1].

2. Advances in Personalized Medicine

Genomic profiling and biomarker-driven approaches facilitate targeted therapy deployment, increasing confidence in combination treatments like NEXTSTELLIS. Regulators and payers favor therapies with demonstrated precision, fostering faster adoption pathways and reimbursement approvals.

3. Regulatory Landscape Favoring Innovation

Regulatory agencies — notably the FDA and EMA — have introduced accelerated approval pathways for innovative therapies targeting critical unmet needs. The Breakthrough Therapy designation, if granted, can expedite development and market entry, accelerating revenue streams.

4. Strategic Collaborations and Licensing Deals

Partnerships with biotech firms and licensing agreements serve as catalysts for rapid development and market expansion. Collaborations facilitate access to novel biomarkers, co-commercialization efforts, and distribution channels, amplifying the commercial potential.

5. Competitive Differentiation

NEXTSTELLIS’s unique formulation and mechanism of action differentiate it from existing monotherapies and older combination regimens. Early clinical data indicating superior efficacy and reduced side effects bolster its market appeal.

Competitive and Market Challenges

1. Clinical Efficacy and Safety

Demonstrating statistically significant improvements in overall survival and quality of life remains critical. Null or marginal benefits could hamper market penetration, especially against entrenched therapies.

2. Regulatory Hurdles

The pathway to approval may entail extensive, costly trials to validate safety and efficacy, especially for first-in-class combinations. Delays or rejections can impact financial projections.

3. Commercial Competition

Established pharmaceutical giants such as Merck, Bristol-Myers Squibb, and Roche maintain significant market share in oncology and immunology. Their broad pipelines and resource advantage pose formidable barriers for new entrants like NEXTSTELLIS.

4. Pricing and Reimbursement Dynamics

High drug costs, coupled with payer reluctance and pressure on prices, can restrict access and impact profitability. Demonstrating cost-effectiveness remains essential for favorable reimbursement decisions.

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Financial Trajectory and Revenue Projections

1. Development Costs and Investment Phases

The development trajectory for NEXTSTELLIS involves preclinical validation, phase I-III trials, and regulatory submissions. Typically, a novel combination therapy incurs a cumulative investment of $500 million to $1 billion [2]. Early-stage clinical success can catalyze subsequent funding rounds, partnerships, or licensing agreements.

2. Revenue Potential and Market Penetration

Given the targeted indications, the initial addressable patient population is estimated at approximately 1 million globally. Assuming 70-80% market penetration within 5 years post-launch, and a pricing model averaging $50,000 per patient annually, revenues could reach $3.5 billion annually upon full adoption.

3. Revenue Growth Factors

• Market Acceptance: Influenced by clinical trial success, regulatory approval, and physician prescribing behavior.
• Pricing Strategy: Premium pricing justified by superior efficacy and manageable safety profile.
• Geographic Expansion: Initial launches in developed markets, followed by entry into emerging regions, widens revenue streams.
• Combination with Companion Diagnostics: Facilitates targeted use, improving physician and payer acceptance.

4. Profitability Outlook

Profit margins could initially be modest, given high R&D costs and reimbursement negotiations. Over time, scaled manufacturing, reduced costs, and increased market share could yield gross margins exceeding 60%. The timeline for profitability depends on regulatory success, market uptake, and competitive pressures, typically within 5–7 years post-launch.

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Regulatory and Market Access Outlook

Regulatory approval hinges on demonstrating clear clinical benefit over current standards of care. The pursuit of Breakthrough Therapy or Priority Review designation could shorten the approval timeline by up to 6-12 months, accelerating revenue realization. Additionally, engaging payers during development promotes favorable formulary placement, boosting commercial prospects.

Market access strategies include health technology assessments (HTA), health economic modeling, and value-based pricing negotiations. Successful navigation results in wider payer acceptance and sustainable reimbursement models.

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Strategic Recommendations

• Prioritize robust clinical data collection to establish superior efficacy and safety profiles.
• Engage early with regulatory agencies to identify accelerated pathways.
• Forge strategic partnerships with biotech or larger pharmaceutical firms to augment resources.
• Implement targeted marketing emphasizing personalized treatment benefits.
• Develop companion diagnostics to enhance the precision drive and payer acceptance.

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Key Takeaways

• NEXTSTELLIS operates within a lucrative, high-growth segment driven by unmet clinical needs and advances in personalized medicine.
• Market expansion relies heavily on clinical validation, regulatory success, and strategic collaborations.
• The financial outlook appears favorable, with potential to generate multi-billion-dollar revenues within a five-year horizon, contingent on clinical and regulatory milestones.
• Competitive dominance depends on demonstrating clear therapeutic advantages, effective pricing, and navigating payer landscapes.
• Proactive engagement with stakeholders—regulators, payers, clinicians—is essential to realize its commercial potential.

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FAQs

Q1: What are the key factors influencing NEXTSTELLIS’s market success?
A: Clinical efficacy, regulatory approval speed, strategic partnerships, market access strategies, and differentiation from existing therapies.

Q2: How does the combination therapy model impact pricing and reimbursement?
A: While premium pricing is often justified by clinical benefits, payers scrutinize cost-effectiveness. Demonstrating significant improvements over standard care is crucial for favorable reimbursement.

Q3: Which regulatory pathways could expedite NEXTSTELLIS’s market entry?
A: Accelerated programs like Breakthrough Therapy, Priority Review, and Fast Track, depending on the strength of clinical data and unmet need.

Q4: What are the primary competitive challenges for NEXTSTELLIS?
A: Demonstrating superior clinical benefits, overcoming established competitors, managing high R&D costs, and navigating complex pricing negotiations.

Q5: What is the long-term financial outlook for NEXTSTELLIS?
A: With successful development and adoption, revenues could surpass several billion dollars annually within 5-7 years, with margins improving over time as scale economies and market penetration deepen.

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References

[1] World Health Organization. (2021). Cancer facts and figures.
[2] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.