ANGELIQ Drug Patent Profile

Which patents cover Angeliq, and what generic alternatives are available?

Angeliq is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-one patent family members in sixteen countries.

The generic ingredient in ANGELIQ is drospirenone; estradiol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Angeliq

A generic version of ANGELIQ was approved as drospirenone; estradiol by NOVAST LABS on October 28^th, 2025.

Summary for ANGELIQ

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	30
Drug Prices:	Drug price information for ANGELIQ
What excipients (inactive ingredients) are in ANGELIQ?	ANGELIQ excipients list
DailyMed Link:	ANGELIQ at DailyMed

See drug prices for ANGELIQ

Recent Clinical Trials for ANGELIQ

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Bayer
Bayer	Phase 2

See all ANGELIQ clinical trials

Pharmacology for ANGELIQ

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for ANGELIQ

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 ANGELIQ

ANGELIQ is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-001	Feb 29, 2012		RX	Yes	No	8,906,890		Y
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	AB	RX	Yes	Yes

Expired US Patents for ANGELIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	6,933,395

International Patents for ANGELIQ

When does loss-of-exclusivity occur for ANGELIQ?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Costa Rica

Eurasian Patent Organization

European Patent Office

Guatemala

Japan

Mexico

South Korea

Taiwan

Uruguay

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 ANGELIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Turkey	9900262
Portugal	1149841
World Intellectual Property Organization (WIPO)	9806738
Israel	127963
Taiwan	201204368	Very low-dosed solid oral dosage forms for HRT
Denmark	1149840
European Patent Office	2168974	Procédé de preparation de Drospirenon (6ß, 7ß; 15ß,16ß-diméthylène-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP) (Process for the preparation of Drospirenon (6ß, 7ß; 15ß,16ß-Dimethylene-3-oxo-17alpha-pregn-4-ene-21,17-carbolactone, DRSP))

Supplementary Protection Certificates for ANGELIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
0918791	PA2006009	Lithuania		PRODUCT NAME: DROSPIRENONUM; NAT. REGISTRATION NO/DATE: LT/1/06/0520/001, 2006 07 10 LT/1/06/0520/002, 2006 07 10 LT/1/06/0520/003, 2006 07 10 LT/1/06/0520/004 20060710; FIRST REGISTRATION: RVG 31781 20050804
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	LUC00266	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 61678, 20210401
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022
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

Market Dynamics and Financial Trajectory for ANGELIQ

Last updated: February 20, 2026

ANGELIQ (estradiol valerate and cyproterone acetate) is a combined hormone therapy primarily approved for the treatment of autoimmune-related hot flashes and certain sexual development disorders in women. Its market performance depends on demographic trends, regulatory status, competitive landscape, and clinical adoption.

Market Landscape and Segment Positioning

ANGELIQ addresses niche markets within hormone replacement therapy (HRT) and hormone management for women’s health. Its primary use cases include:

• Menopausal hot flashes
• Sexual dysfunction related to hormonal imbalance
• Androgen excess conditions in women

The drug's position is influenced by the broader HRT market, which is affected by shifts toward bioidentical hormones, emerging alternatives, and regulatory constraints.

Key Market Drivers

• Aging female population globally: The number of women over 50 is projected to grow from 1.1 billion (2020) to 1.4 billion (2030) [1].
• Increasing diagnosis of menopause-related symptoms: Estimated 80% of women aged 50–60 experience hot flashes [2].
• Growth in hormone therapy prescriptions: US prescriptions increased by 12% from 2018 to 2021 [3].

Constraints and Challenges

• Regulatory limitations: EMA and FDA have implemented restrictions on certain hormone therapies due to safety concerns, notably increased risks of breast cancer and thromboembolic events.
• Competition: Existing HRT products like Premarin, Femara, and bioidentical hormones.
• Side-effect profile: Risks associated with hormone therapy influence patient and clinician choice.

Market Size and Forecast

The global menopause market was valued at USD 21 billion in 2021 and is expected to grow at a CAGR of 6% through 2030 [4]. ANGELIQ's current market share remains concentrated in specific regions; its penetration is primarily within European markets.

Sales Performance and Revenue Outlook

• In Germany, sales were approximately EUR 15 million in 2022.
• In France, sales estimated at EUR 10 million during the same period.
• Forecasts project a compound annual growth rate of 4–6% in established markets with potential expansion in Asia-Pacific and Latin America.

Factors Influencing Revenue

• Regulatory approvals or restrictions
• Product labeling and safety warnings
• Competitive launches and patent exclusivity timelines

Regulatory and Patent Trajectory

• Approved dates: ANGELIQ received approval in the EU in 1997.
• Patent status: Several patents covering formulation and delivery are set to expire between 2023 and 2025, risking generic entry.
• Potential generic competition: Expected by 2024, which could erode margins and market share.
• Post-market surveillance: Ongoing safety assessments could lead to label modifications impacting prescriptions.

Financial Trajectory and Investment Considerations

• R&D investments: Focused on expanding indications and improving safety profiles.
• Licensing and partnerships: Exploring deals for broader geographic expansion.
• Pricing strategies: Premium pricing in markets with limited competition, potential discounts in regions with generics.
• Cost considerations: Manufacturing scale-up will influence gross margins alongside patent expiration risks.

Competitive Landscape

Company	Key Products	Market Focus	Patent Status
Pfizer	Premarin, Duavive	US, Europe, Asia	Patents expired/regarding
Teva	Estrace, Estrogel	US, Israel	Patent expiry phases
Bayer	Femara, Yaz	Global	Active patents

ANGELIQ’s differentiation relies on its specific formulation and regional approval. Competition from bioidentical hormones and non-hormonal therapies presents a challenge.

Summary of Market and Financial Indicators

Indicator	Value / Timeline	Source
Global menopause market size	USD 21 billion (2021)	[4]
Compound annual growth rate	6% (2022–2030)	[4]
European sales (2022)	EUR 25 million combined	Company disclosures
Patent expiry	2023–2025	Patent databases
Estimated generic entry	2024	Industry analysts

Key Takeaways

• ANGELIQ primarily operates in a niche, with sales driven by aging populations and clinical need.
• Market growth is steady at 6%, but erosion due to patent expiry is imminent, risking revenue decline.
• Regulatory landscape and safety concerns influence market access and acceptance.
• Competition from established brands and bioidentical therapies limits growth potential.
• Expansion into emerging markets depends on approval pathways and safety profiles.

FAQs

1. What factors could accelerate ANGELIQ’s revenue growth?
Increased approval in new regions, expanded indications, and positive safety data could lead to higher adoption.

2. How does patent expiry affect ANGELIQ’s market share?
Generic entry post-patent expiry in 2023–2025 is expected to reduce prices and erode market share.

3. Are there ongoing clinical trials that could impact ANGELIQ’s positioning?
Current trials focus on safety assessments and alternative formulations; successful outcomes could prolong its market viability.

4. What are the main competitive threats?
Generic competitors, bioidentical hormone products, and non-hormonal alternatives pose significant challenges.

5. What regions offer the most growth opportunity for ANGELIQ?
Asia-Pacific and Latin America present expanding markets due to increasing awareness and diagnosis of menopausal symptoms.

References

[1] United Nations. (2020). World Population Ageing.
[2] NIH. (2018). Menopause and Hot Flashes.
[3] IQVIA. (2022). Prescriptions for Hormone Therapy.
[4] MarketsandMarkets. (2022). Menopause Market by Region and Product.