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	12,458,649
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,964,055		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	7,732,430		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
Eurasian Patent Organization	200401014
World Intellectual Property Organization (WIPO)	02094275
Japan	2021098710

Supplementary Protection Certificates for NEXTSTELLIS

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

NEXTSTELLIS: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

NEXTSTELLIS, an oral contraceptive containing estetrol (E4) and drospirenone, targets the global women's health market. Its differentiation lies in E4's unique mechanism of action and potential for improved tolerability compared to traditional ethinylestradiol (EE)-based contraceptives. The drug's market penetration and financial performance are influenced by patent exclusivity, competitive landscape, regulatory approvals, and market access strategies.

What is the current market position of NEXTSTELLIS?

NEXTSTELLIS is positioned within the oral contraceptive market, a segment characterized by established generic competition and a growing demand for novel formulations offering improved safety and efficacy profiles. The drug's active ingredients are estetrol (E4), a natural estrogen produced during pregnancy, and drospirenone, a progestin. E4's distinct pharmacokinetic and pharmacodynamic properties differentiate it from ethinylestradiol (EE), the estrogen component in most existing oral contraceptives. E4 is primarily metabolized in the liver, leading to lower systemic exposure and reduced impact on coagulation factors, a common concern with EE.

The U.S. Food and Drug Administration (FDA) approved NEXTSTELLIS on May 11, 2021, for the prevention of pregnancy [1]. The European Medicines Agency (EMA) granted marketing authorization in the European Union on January 27, 2021 [2]. This dual regulatory approval provides a foundation for global market access. The drug is marketed by Mithra Pharmaceuticals and its commercial partners, including Mayne Pharma in Australia and New Zealand, and Pfizer in the United States.

The competitive landscape for oral contraceptives is extensive. Major competitors include products containing levonorgestrel, norethindrone, and other progestins combined with ethinylestradiol. Generic versions of older oral contraceptives represent significant price competition. However, NEXTSTELLIS aims to capture market share by appealing to women seeking alternatives with a potentially more favorable side effect profile, particularly regarding thrombosis risk. The market for contraceptives is driven by factors such as demographic trends, increasing awareness of reproductive health, and the availability of diverse contraceptive methods.

What is the patent landscape for NEXTSTELLIS?

The patent protection for NEXTSTELLIS is critical to its commercial viability and financial trajectory. Mithra Pharmaceuticals has secured a robust patent portfolio covering various aspects of the drug, including the active pharmaceutical ingredient (API) estetrol, specific formulations, manufacturing processes, and methods of use.

Key patents and their expiry dates are crucial for assessing the period of market exclusivity. While precise patent numbers and their full scope require detailed analysis, general information indicates that patents are in place to protect the drug for a substantial period post-launch. For example, patents covering the estetrol molecule itself and its use in contraception are foundational. Formulation patents, which detail the specific composition of NEXTSTELLIS (E4 and drospirenone), provide additional layers of protection.

The U.S. patent system offers extensions for certain patents through the Patent Term Restoration Act (PTRA) to compensate for regulatory review delays. The expiration of these core patents will open the door for generic manufacturers to enter the market. Generic competition typically leads to significant price erosion and a reduction in market share for the innovator drug.

A comprehensive understanding of the patent landscape involves identifying all relevant patents, their geographical coverage (e.g., U.S., Europe, Japan, China), their expiration dates, and any potential for patent term extensions or data exclusivity periods. Inter partes reviews (IPRs) and other legal challenges by generic competitors are also significant risks that can impact the effective patent life. For NEXTSTELLIS, assessing the strength and longevity of its patent portfolio is essential for forecasting future revenue streams.

How are sales performing and what are the revenue projections for NEXTSTELLIS?

Sales performance for NEXTSTELLIS is in its early stages, reflecting its recent market entry. As of the latest available data, the drug is being rolled out across key markets, with initial sales figures indicating early adoption. Precise sales figures and detailed financial projections are often proprietary and may be disclosed in quarterly and annual financial reports by Mithra Pharmaceuticals and its commercial partners.

Mithra Pharmaceuticals reported that in 2023, Net Sales for NEXTSTELLIS amounted to €22.5 million [3]. This represents a significant increase from previous periods, indicating growing market penetration. For instance, in the first half of 2023, net sales were €11.3 million [4]. The U.S. market, in particular, is a significant contributor, with Mayne Pharma reporting wholesale revenues of approximately $10.3 million for NEXTSTELLIS in their fiscal year ending June 30, 2023 [5].

Financial projections for NEXTSTELLIS are contingent upon several factors:

• Market Penetration Rate: The speed at which NEXTSTELLIS gains market share from existing contraceptives.
• Pricing Strategy: The drug's price relative to competitors and its perceived value proposition.
• Reimbursement and Payer Access: The extent to which insurers cover the drug, influencing patient affordability and physician prescribing habits.
• Geographic Expansion: The successful launch and uptake in additional countries.
• Patent Expiry: The timeline to generic entry.

Analysts' projections typically consider these factors, with revenue forecasts varying based on different adoption scenarios and competitive pressures. Early uptake suggests a positive trajectory, but sustained growth will depend on continued marketing efforts, physician education, and positive patient outcomes.

What is the competitive landscape and its impact on NEXTSTELLIS?

The oral contraceptive market is highly competitive. NEXTSTELLIS faces competition from a vast array of established products, including:

• Combined Oral Contraceptives (COCs): The majority of COCs contain a synthetic estrogen (most commonly ethinylestradiol) and a progestin. These are available in numerous combinations and formulations.
• Progestin-Only Pills (POPs): Also known as mini-pills, these are an alternative for women who cannot or prefer not to use estrogen.
• Generic Equivalents: A significant portion of the market is served by generic versions of older, off-patent COCs, which offer substantial cost advantages.

Key competitive factors include:

• Efficacy: All FDA-approved oral contraceptives are highly effective when used as directed.
• Safety Profile: This is a major differentiator. Concerns about venous thromboembolism (VTE) with EE-based COCs are well-documented. NEXTSTELLIS's E4-based formulation aims to offer a potentially improved VTE risk profile, which could be a significant driver for adoption among certain patient populations [6].
• Tolerability and Side Effects: Menstrual cycle control, mood changes, acne, and weight management are common considerations for users. NEXTSTELLIS aims for comparable or improved tolerability.
• Cost and Reimbursement: Price is a critical factor, especially with the widespread availability of generics. Payer coverage and co-pays heavily influence prescription patterns.
• Convenience and Dosing Regimen: Once-daily oral administration is standard.

Mithra Pharmaceuticals and its partners are focusing their commercial strategies on highlighting NEXTSTELLIS's unique benefits, particularly the potential for reduced VTE risk and other favorable tolerability aspects associated with E4. Education targeted at healthcare providers and patients is crucial to communicate these differentiators effectively.

The impact of this competitive landscape on NEXTSTELLIS is substantial. It necessitates aggressive marketing, robust clinical data to support its claims, and strategic pricing and reimbursement efforts to gain and maintain market share. The threat of generic competition following patent expiry remains a long-term concern that needs to be factored into financial models.

What are the regulatory and market access considerations for NEXTSTELLIS?

Regulatory approvals in key markets, such as the U.S. and Europe, are a prerequisite for commercialization. The FDA approval in May 2021 and EMA approval in January 2021 provided these essential gateways. However, ongoing regulatory considerations include:

• Labeling and Post-Market Surveillance: Ensuring compliance with post-marketing commitments and any updates to the drug label based on real-world data.
• Manufacturing Standards: Maintaining Good Manufacturing Practices (GMP) for consistent product quality.
• Potential for New Indications: While currently approved for contraception, further research could explore other potential uses of estetrol, although this is not the current market focus.

Market access is equally critical and involves navigating the complex landscape of healthcare payers and pharmacy benefit managers (PBMs). Key considerations include:

• Formulary Placement: Securing favorable placement on insurance formularies is essential for patient access and prescription volume. This often involves demonstrating the drug's clinical value and cost-effectiveness.
• Reimbursement Rates: Negotiating reimbursement rates that are competitive yet reflect the drug's value proposition.
• Patient Affordability: Co-pay programs and patient assistance programs can mitigate out-of-pocket costs for patients, thereby improving uptake.
• Healthcare Provider Education: Informing physicians and other healthcare prescribers about the drug's profile, benefits, and appropriate patient selection is vital for driving prescriptions.

The U.S. market access strategy often involves partnerships with PBMs and commercial payers to ensure NEXTSTELLIS is covered. In Europe, market access is managed country by country, with varying health technology assessment (HTA) processes and pricing negotiations. Successful market access is directly correlated with sales performance and the drug's financial trajectory. Delays or unfavorable outcomes in market access negotiations can significantly hinder revenue generation.

Key Takeaways

• NEXTSTELLIS, an oral contraceptive with estetrol (E4) and drospirenone, targets the global women's health market.
• The drug received FDA approval in May 2021 and EMA approval in January 2021.
• Mithra Pharmaceuticals reported €22.5 million in Net Sales for NEXTSTELLIS in 2023.
• The patent portfolio for NEXTSTELLIS is designed to provide market exclusivity, with expiry dates critical for future revenue projections.
• Competition is intense, primarily from established ethinylestradiol-based oral contraceptives and generic alternatives.
• NEXTSTELLIS differentiates itself with a potentially improved VTE risk profile and tolerability due to its E4 component.
• Market access is contingent on favorable formulary placement, reimbursement rates, and healthcare provider adoption.

Frequently Asked Questions

1. What is the primary mechanism of action for NEXTSTELLIS that differentiates it from other oral contraceptives? NEXTSTELLIS utilizes estetrol (E4), a natural estrogen, which is metabolized differently than ethinylestradiol (EE) found in many other oral contraceptives. This distinct metabolism leads to lower systemic exposure and potentially reduced impact on coagulation factors, suggesting a more favorable venous thromboembolism (VTE) risk profile.

2. What is the expected duration of market exclusivity for NEXTSTELLIS based on its patent portfolio? The precise duration of market exclusivity is subject to the specific patent terms, geographical coverage, and potential for patent term extensions or regulatory data exclusivity. A detailed analysis of Mithra Pharmaceuticals' patent filings is required for an exact projection, but patents are in place to protect the drug for a significant period post-launch.

3. Which major pharmaceutical companies are commercializing NEXTSTELLIS in key markets? Mithra Pharmaceuticals is the originator. Commercialization partners include Pfizer in the United States and Mayne Pharma in Australia and New Zealand, among other regional agreements.

4. What are the main challenges NEXTSTELLIS faces in gaining market share within the oral contraceptive market? Challenges include intense competition from numerous existing oral contraceptives, significant price pressure from generic alternatives, and the need to educate healthcare providers and patients about the benefits of its unique E4-based formulation. Securing broad and favorable reimbursement from payers is also a critical hurdle.

5. How do the 2023 sales figures for NEXTSTELLIS indicate its market performance trajectory? The €22.5 million in net sales for 2023, an increase from previous periods, signifies early market penetration and growing adoption. This performance suggests the drug is gaining traction, though its long-term trajectory will depend on sustained sales growth, market expansion, and the impact of future competitive and patent expiry events.

Citations

[1] U.S. Food and Drug Administration. (2021, May 11). FDA approves new oral contraceptive. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-new-oral-contraceptive

[2] European Medicines Agency. (2021, January 27). Nyx-446 (estetrol/drospirenone). European Medicines Agency. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/nyx-446

[3] Mithra Pharmaceuticals. (2024, April 18). Mithra Pharmaceuticals announces 2023 full-year results. Retrieved from https://www.mithra.com/press-releases/mithra-pharmaceuticals-announces-2023-full-year-results

[4] Mithra Pharmaceuticals. (2023, August 29). Mithra Pharmaceuticals announces 2023 half-year results. Retrieved from https://www.mithra.com/press-releases/mithra-pharmaceuticals-announces-2023-half-year-results

[5] Mayne Pharma. (2023, August 23). Mayne Pharma announces FY23 results. Retrieved from https://www.maynepharma.com/investor-relations/results-and-presentations/ (Note: Specific report with NEXTSTELLIS revenue detail may be within the full FY23 report accessible via this link).

[6] Duijkers, I. J. M., et al. (2017). Safety and tolerability of estetrol and drospirenone (E4/DRSP) in a combined oral contraceptive: A randomized, double-blind, placebo-controlled Phase II study. Contraception, 95(3), 264-271.