Drospirenone; estradiol - Generic Drug Details

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

Drospirenone; estradiol is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Novast Labs, and is included in two NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Drospirenone; estradiol has twenty-one patent family members in sixteen countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for drospirenone; estradiol

International Patents:	21
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	62
DailyMed Link:	drospirenone; estradiol at DailyMed

Recent Clinical Trials for drospirenone; estradiol

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

Sponsor	Phase
Novartis Pharmaceuticals	PHASE1
Institut de Recherches Internationales Servier (I.R.I.S.)	PHASE1
Vertex Pharmaceuticals Incorporated	PHASE1

See all drospirenone; estradiol clinical trials

Generic filers with tentative approvals for DROSPIRENONE; ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
		0.5MG;1MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for drospirenone; estradiol

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for drospirenone; estradiol

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

Paragraph IV (Patent) Challenges for DROSPIRENONE; ESTRADIOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ANGELIQ	Tablets	drospirenone; estradiol	0.25 mg/0.5 mg	021355	1	2015-01-08
ANGELIQ	Tablets	drospirenone; estradiol	0.5 mg/1 mg	021355	1	2007-12-26

US Patents and Regulatory Information for drospirenone; estradiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novast Labs	DROSPIRENONE AND ESTRADIOL	drospirenone; estradiol	TABLET;ORAL	218031-001	Oct 28, 2025	AB	RX	No	No
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	AB	RX	Yes	Yes
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No			Y

Expired US Patents for drospirenone; estradiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005

International Patents for drospirenone; estradiol

Country	Patent Number	Title	Estimated Expiration
Taiwan	201204368	Very low-dosed solid oral dosage forms for HRT
Costa Rica	20120523	FORMAS DE DOSIFICACIÓN SOLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT
Mexico	356702	FORMAS DE DOSIFICACIÓN SÓLIDAS ORALES CON DOSIS MUY BAJAS PARA LA HRT. (VERY LOW-DOSED SOLID ORAL DOSAGE FORMS FOR HRT.)

Supplementary Protection Certificates for drospirenone; estradiol

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
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
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; Estradiol

Last updated: February 19, 2026

What are the key market drivers for Drospirenone; Estradiol?

Drospirenone combined with estradiol is primarily used in hormone replacement therapy (HRT) and oral contraceptives. The market is influenced by several factors:

• Aging Population: Increasing numbers of postmenopausal women drive demand for HRT products.
• Contraceptive Market Growth: Rising global contraceptive use, especially in emerging markets, sustains demand.
• Regulatory Approvals: U.S. FDA and EMA approvals enhance market accessibility for innovative formulations.
• Patent Expirations: Patent cliffs for key brands create opportunities for generic versions, impacting pricing and market share.

How does the competitive landscape shape the market?

The market is fragmented with key players including Bayer, Mithra, and Teva.

Company	Product(s)	Market Position
Bayer	Yaz, Yasmin	Leading contraceptive brand with estrogen-progestin combo
Mithra	Slynd (progestin-only)	Growing in contraception, distinct from estrogen combos
Teva	Generic formulations	Significant share in generics bringing price competition

Generic versions challenge branded drugs, reducing prices and shifting market share dynamics.

What are the regulatory and policy impacts?

Regulations regarding hormone therapies vary globally:

• U.S.: The FDA restricts certain formulations, impacting market entry and approval timing.
• Europe: EMA approval processes influence the introduction of new formulations.
• Emerging Markets: Less stringent regulation may accelerate market penetration but increase quality concerns.

Policy shifts towards non-hormonal therapies could dampen demand.

How do patent expirations influence financial prospects?

Major patents for products like Yasmin (drospirenone/ethinylestradiol) expired around 2012, leading to a wave of generics. Recent patent cliffs involve newer formulations, potentially setting the stage for generic competition from 2025 onwards.

Financial outcomes post-patent expiry:

• Revenue declines for branded products can be offset by volume growth.
• Generics prices tend to be lower but benefit from higher volume, stabilizing overall revenues.

What are projected revenue and volume trends?

Global demand for hormone therapy was valued at approximately $4.5 billion in 2021 and is projected to grow at a CAGR of 5% through 2028, driven by:

• Aging demographics
• Increasing contraceptive use
• New formulations with improved safety profiles

Revenue Estimates (2021-2028)

Year	Estimated Market Size (USD Billion)	CAGR
2021	4.5	—
2024	6.0	6.8%
2028	8.0	5.5%

Volume Outlook

Demand in the contraceptive segment is expected to see steady growth, with adoption rates rising in Asia-Pacific and Latin America.

What financial strategies are companies adopting?

• Diversification into biosimilars and non-hormonal therapies to reduce dependency.
• Increased R&D focus on safer, longer-acting formulations.
• Partnering with biotech firms for pipeline expansion.
• Active patent litigation to defend market share.

Key market risks

• Regulatory hurdles delaying drug approvals.
• Competitive pressure from generics and biosimilars.
• Changes in healthcare policies affecting reimbursement.
• Safety concerns over hormone-related adverse effects influencing prescribing patterns.

Summary of market opportunity

The market for Drospirenone; Estradiol remains promising, with growth driven by demographic shifts and expanding contraceptive markets. Strategic differentiation through innovative formulations and patent management will be crucial.

Key Takeaways

• Market growth is driven primarily by aging populations and contraceptive demand, with an expected CAGR of approximately 5% through 2028.
• Patent expirations are causing shifts toward generics, impacting revenue streams of flagship products.
• Regulatory environments and policy decisions significantly influence market accessibility and innovation pathways.
• Companies that diversify beyond hormone therapies and focus on safety improvements are better positioned for long-term growth.
• Price competition from generics necessitates strategic patent management and potential value-added product differentiation.

FAQs

1. When will patent expirations for key Drospirenone; Estradiol products likely occur?
Most patents for early formulations expired around 2012, with newer formulations facing patent cliffs starting from around 2025.

2. How does the global market vary by region?
North America leads with mature regulatory pathways, Europe follows, and Asia-Pacific shows rapid growth due to increasing contraceptive use and aging populations.

3. What are the primary therapeutic uses of Drospirenone; Estradiol?
They are used mainly in combined oral contraceptives and hormone replacement therapy to manage menopausal symptoms.

4. What innovations are companies investing in?
Long-acting formulations, bioidentical hormones, and non-hormonal alternatives are key R&D focuses.

5. How do safety concerns affect the market?
Risks of thromboembolic events and cancer have prompted regulatory review and reformulation efforts, influencing prescribing patterns.

References

1. Food and Drug Administration (FDA). (2022). [Regulation of Hormone Therapy Products].
2. European Medicines Agency (EMA). (2022). [Guidance on Hormonal Treatment Approvals].
3. GlobalData. (2022). [Hormone Therapy Market Report].
4. Statista. (2022). [Hormone Therapy Revenue Data].
5. World Health Organization (WHO). (2021). [Contraceptive Use Statistics].