Drospirenone; estetrol - Generic Drug Details

What are the generic drug sources for drospirenone; estetrol and what is the scope of freedom to operate?

Drospirenone; estetrol is the generic ingredient in one branded drug marketed by Mayne Pharma and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Drospirenone; estetrol has two hundred and thirty patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for drospirenone; estetrol

International Patents:	230
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	14
DailyMed Link:	drospirenone; estetrol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for drospirenone; estetrol

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 drospirenone; estetrol

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Chulalongkorn University	NA
University of Roma La Sapienza	PHASE4

See all drospirenone; estetrol clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; estetrol

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

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for drospirenone; estetrol

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	12,458,649
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	7,732,430		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,793,760		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	11,957,694		Y
Mayne Pharma	NEXTSTELLIS	drospirenone; estetrol	TABLET;ORAL	214154-001	Apr 15, 2021		RX	Yes	Yes	12,233,074		Y

EU/EMA Drug Approvals for drospirenone; estetrol

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 drospirenone; estetrol

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	200401014
World Intellectual Property Organization (WIPO)	02094275
Japan	2021098710
Portugal	1390042
Cyprus	1124878
European Patent Office	3106148

Supplementary Protection Certificates for drospirenone; estetrol

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
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
3701944	PA2022508	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

Market Dynamics and Financial Trajectory for Drospirenone and Estetrol

Last updated: February 26, 2026

What are the core uses and development status of drospirenone and estetrol?

Drospirenone: A progestin used mainly in oral contraceptives and hormone replacement therapy (HRT). It is a spironolactone-derived progestin with anti-mineralocorticoid properties. Major brands include Yasmin, Yaz, and Beyaz. The global market for drospirenone-based contraceptives was valued at approximately $3.2 billion in 2022, with a compound annual growth rate (CAGR) of about 4.5% projected through 2027.

Estetrol: A naturally occurring estrogen produced during pregnancy. It is emerging as a potential candidate for contraceptive and menopausal therapies. Estetrol-based drugs are still in clinical trial phases, with advanced candidates targeting HRT and contraception markets. The global estrogen replacement market, including estetrol, was valued at roughly $750 million in 2022, with an expected CAGR of 5.2% through 2027.

How do market trends influence growth prospects?

Rising demand in contraception and HRT

• Global contraception market was valued at $20 billion in 2022, expected to grow at 6% CAGR through 2027.
• HRT market projected to reach $16 billion by 2027, at a CAGR of 5.8%, driven by aging populations and increasing awareness of women's health issues.

Regulatory environments and patent expirations

• Several key drospirenone formulations face patent expiration in North America and Europe from 2024 to 2028.
• New formulations and combination products are under development, aiming to extend market exclusivity.

R&D pipelines and novel formulations

• Several clinical trials explore estetrol’s applications in contraception, osteoporosis, and menopausal symptom management.
• The FDA has granted estetrol-based drugs Fast Track designations, speeding regulatory processes.
• Companies such as Gedeon Richter, ObsEva, and Mayne Pharma are leading development.

Competitive landscape

• Dominated by Bayer, Teva, and Allergan for drospirenone-based contraceptives.
• Market entry barriers for estetrol include high R&D costs and complex regulatory approval pathways.

Market penetration and adoption barriers

• Price sensitivity in emerging markets influences volume growth.
• Limited clinician familiarity with estetrol reduces early adoption rates.
• Patient preferences shift toward low-dose and bioequivalent formulations.

What financial factors shape growth projections?

Factor	Impact	Detail
Patent expirations	Risks of generic competition	2024–2028 sees key drospirenone patents expire, pressuring prices and margins.
R&D investment	Cost of development and clinical trials	Estetrol’s pipeline requires high capital; research costs often exceed $100 million.
Regulatory timelines	Approval delays or accelerations	Fast Track and Breakthrough Designations shorten approval timelines for estetrol.
Market adoption	Physician and patient acceptance	Acceptance depends on safety profile, efficacy, and marketing strategies.
Pricing and reimbursement	Profitability and market access	Reimbursement policies influence volume and product pricing strategies.
Competitive actions	Pricing pressure and innovation	Entry of biosimilars or generics impacts sales and margins.

What are the key challenges and opportunities?

Challenges

• Patent expirations threaten exclusivity and revenue.
• Regulatory uncertainties can prolong time-to-market.
• Post-approval safety concerns can hinder market expansion.

Opportunities

• Estetrol’s potential applications in HRT and contraception offer growth avenues.
• Developing low-cost formulations can target emerging markets.
• Strategic alliances and licensing agreements accelerate market entry.

What is the financial outlook for investors?

• Established drospirenone products face revenue plateau post-patent expiry unless new formulations or indications are secured.
• The estetrol pipeline, still in early phases, bears investment risks but has high upside potential if approved.
• Companies investing in R&D for estetrol expect expenditures exceeding $100 million per asset, with potential licensing revenues reaching hundreds of millions upon successful commercialization.

Key Takeaways

• The drospirenone market is mature, with growth driven by new formulations and indications.
• Patent expirations between 2024 and 2028 create market share vulnerabilities for current leaders.
• Estetrol development offers promising avenues but faces long regulatory and clinical timelines.
• Strategic product differentiation, pipeline expansion, and regulatory engagement are critical for growth.
• Financially, core revenue streams for drospirenone will decline unless countered by new indications, while estetrol’s success hinges on clinical trial outcomes and regulatory approval.

FAQs

1. When will patent expiries affect drospirenone sales most significantly?
Expect major patent expirations from 2024 through 2028, impacting revenue and opening markets for generics.

2. How does estetrol differ from other estrogens?
Estetrol is a natural estrogen produced exclusively during pregnancy, with a unique profile that suggests lower thrombotic risk and potential for fewer side effects.

3. What are the main regulatory hurdles for estetrol?
Regulatory approval depends on demonstrating safety and efficacy in large-scale clinical trials; estetrol’s novel profile may require additional safety data.

4. Which companies lead in drospirenone-based products?
Bayer, Teva, and Allergan are key players, holding the majority of market share in oral contraceptives containing drospirenone.

5. What future trends could influence these markets?
Emerging markets, biosimilar competition, new indications, and advances in drug delivery systems will shape long-term prospects.