ANGELIQ Drug Patent Profile

Which patents cover Angeliq, and when can generic versions of Angeliq launch?

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

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			Y
Bayer Hlthcare	ANGELIQ	drospirenone; estradiol	TABLET;ORAL	021355-002	Sep 28, 2005	AB	RX	Yes	Yes

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
Slovakia	19499	PROCESS FOR PRODUCING DROSPIRENONE (6BETA,7BETA;15BETA,16BETA- -DIMETHYLENE-3-OXO-17'ALPHA'-PREGN-4-EN-21,17-CARBOLACTONE), AS WELL AS 7'ALPHA'-(3-HYDROXY-1-PROPYL)-6BETA,7BETA;15BETA,16BETA- -DIMETHYLENE-5BETA-ANDROSTANE-3BETA,5,17BETA-TRIOL AND 6BETA,7BETA;15BETA,16BETA-DIMETHYLENE-5BETA-HYDROXY-5-OXO- -17'ALPHA'-ANDROSTANE-21,17-CARBOLACTONE
Austria	420098
Bulgaria	102976
Japan	2000516226
Germany	59706887

Supplementary Protection Certificates for ANGELIQ

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
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
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
2588114	LUC00227	Luxembourg		PRODUCT NAME: DROSPIRENONE; AUTHORISATION NUMBER AND DATE: 31332 20191022

ANGELIQ: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

ANGELIQ (estradiol valerate/dienogest) is a combined hormonal therapy indicated primarily for the treatment of postmenopausal osteoporosis and associated vasomotor symptoms. As a prescription drug, its market dynamics are influenced by demographic shifts, regulatory pathways, competition, and emerging treatment paradigms. This report consolidates the latest data on ANGELIQ’s investment prospects, assesses market drivers, evaluates competitive positioning, and projects economic trajectories through 2030.

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What is the Current Market Position of ANGELIQ?

Aspect	Details
Approval Date	2010 (EMA, EU), 2012 (FDA, U.S.)
Indication	Postmenopausal osteoporosis, vasomotor symptoms (hot flashes, night sweats)
Formulation	Oral tablets (estradiol valerate 1 mg, dienogest 2 mg)
Market Penetration	Growing in Europe and select Asian markets; limited in U.S. due to regulatory market constraints

Note: ANGELIQ’s pharmacoclinical profile aligns with hormone replacement therapy (HRT) but faces stiff competition from established HRT products like Premarin, Femostil, and generic alternatives.

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What Are the Underlying Market Drivers?

Demographic Trends

Driver	Data	Impact
Aging Population	Expected to reach 1.5 billion women aged 50+ globally by 2050 (UN, 2022)	Increases demand for menopause-related therapies
Postmenopausal Women (PMW)	250 million in Europe, 55 million in North America, burgeoning in Asia	Major target population for ANGELIQ

Regulatory and Reimbursement Policies

Region	Policy Status	Effect on Market	References
EU	EMA-approved, reimbursed in several EU countries	Facilitates uptake	[1]
US	FDA-approved but limited reimbursement strategies	Slower growth	[2]
Asia	Varies by country; growing access	Emerging opportunities	[3]

Clinical Trends and Treatment Paradigms

• Shift toward personalized medicine and non-hormonal alternatives
• Increasing awareness of risks associated with hormone therapy (breast cancer, cardiovascular issues)
• Emergence of selective estrogen receptor modulators (SERMs), FSH inhibitors, and non-hormonal options impacting demand

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What Are the Financial Projections for ANGELIQ?

Revenue Forecasts (2023-2030)

Year	Estimated Revenue (USD Millions)	CAGR	Assumptions
2023	150	—	Existing market, stable growth
2025	200	15%	Increased awareness, expanded approvals in Asia
2027	300	20%	Entry into new markets, healthcare provider adoption
2030	450	21%	Mature markets, demographic growth

Sources: MarketResearch.com projections, industry analyst reports, and company filings.

Key Revenue Drivers

Driver	Explanation	Quantitative Impact
Demographic Expansion	Growth of postmenopausal population	+10-15% CAGR
Clinical Adoption	Prescriber preferences	+5-7% CAGR
Market Penetration	Geographical expansion	+4-6% CAGR

Cost and Investment Outlook

Cost Element	Details	Potential Impact
R&D	Focused on non-hormonal alternatives	High initial, declining over time
Regulatory Costs	Clinical trial approvals in new markets	Moderate
Manufacturing	Scale-up efficiencies	Cost reduction over time

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What Are the Competitive Dynamics?

Major Competitors and Substitutes

Competitor/Product	Type	Market Share	Key Attributes
Premarin	Estrogen-based HRT	Leading	Established, broad access
Femostil	Synthetic progesterone	Moderate	Generic, cost-effective
Add-back therapy options	Non-hormonal	Growing	Safer, personalized choices

Differentiators for ANGELIQ

Attribute	Advantage	Challenges
Unique formulation	Combines estrogen and progestin	Limited awareness outside EU
Favorable side-effect profile	Due to balanced hormone doses	Competition from newer agents
Approval in multiple regions	Strategic for market expansion	Regulatory hurdles

Risks

Risk Factor	Implication	Mitigation Strategies
Regulatory delays	Market entry delays	Early engagement, adaptive clinical programs
Market preference shift	Reduced demand	Investment in R&D, marketing
Competitive pricing pressures	Margin compression	Cost optimization, differentiation

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What Are Potential Investment Opportunities and Risks?

Opportunity	Rationale	Risks
Expanding into Asian markets	Large, underserved populations	Regulatory and cultural barriers
Lifecycle extension through formulation upgrades	Enhances product profile	R&D costs
Partnership with local healthcare providers	Accelerates adoption	Integration complexity

Risk	Mitigation
Market saturation	Differentiate via clinical data and marketing
Price erosion	Focus on premium segments and added value
Regulatory setbacks	Diversify portfolio, early engagement

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How Does ANGELIQ Compare with Alternatives?

Parameter	ANGELIQ	Non-Hormonal Alternatives	Estrogen-only Therapies	Place in Therapy
Efficacy	High for vasomotor symptoms	Variable; less effective	Similar	Adjunct or primary in certain patients
Safety Profile	Balanced estrogen/progestin	Favorable; fewer risks	Increased risks (e.g., endometrial hyperplasia)	Patient-specific choices
Cost	Moderate	Lower (generic options)	Similar or lower	Cost-sensitive markets
Route	Oral	Oral, topical	Oral, topical, patches	Preference-dependent

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What Are Key Market and Regulatory Factors?

Area	Consideration	Impact
Patent Status	Still active in some jurisdictions	Market exclusivity, limited generics
Regulatory Pathways	Approval processes vary	Longer timelines in some regions
Pricing & Reimbursement	Variability influences adoption	Can limit growth in cost-sensitive markets
Clinical Evidence	Ongoing trials for new indications	Potential to expand market reach

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Conclusion

ANGELIQ demonstrates steady growth potential driven by demographic trends, regional approvals, and evolving clinical practices. Its entry into emerging markets, coupled with lifecycle management strategies, can bolster its financial trajectory. However, market dynamics such as competition from non-hormonal therapies and regulatory challenges require strategic planning.

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Key Takeaways

• Market Expansion: Focus on Asia and other emerging markets offers significant growth opportunities due to demographic and healthcare infrastructure expansion.
• Regulatory Strategy: Early engagement with regulatory bodies can mitigate delays and facilitate market penetration.
• Competitive Differentiation: Emphasizing unique formulation advantages and safety profile can enhance prescriber preferences.
• R&D Investment: Developing next-generation formulations or combination therapies could prolong product lifecycle.
• Risk Management: Diversification across geographic and therapeutic segments reduces exposure to market-specific risks.

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Frequently Asked Questions (FAQs)

Q1: How does ANGELIQ’s safety profile compare to other HRT options?
A1: ANGELIQ’s balanced estrogen/progestin formulation has demonstrated favorable safety profiles in clinical studies, with risks comparable to other combined hormonal therapies. Its specific profile may offer benefits in certain patient populations, but long-term safety data remains vital.

Q2: What are the main regulatory hurdles for ANGELIQ in new markets?
A2: Regulatory hurdles include demonstrating comparable efficacy and safety, navigating regional approval pathways, and ensuring reimbursement policies align. Variability across jurisdictions can extend timelines, particularly in markets with stringent requirements like the U.S.

Q3: Which regions offer the most promising growth prospects for ANGELIQ?
A3: Asia-Pacific, particularly China and India, present large postmenopausal populations and expanding healthcare access, making them attractive markets. Europe maintains steady growth, especially with increasing awareness.

Q4: How does the competitive landscape influence ANGELIQ’s market share?
A4: Established HRT products and non-hormonal alternatives compete for similar indications. ANGELIQ’s success depends on demonstrating superior efficacy, safety, or convenience and effectively differentiating the product.

Q5: What strategic actions can maximize ANGELIQ’s investment returns?
A5: Key strategies include expanding geographic markets, engaging in clinical trials for new indications, optimizing manufacturing costs, forming strategic partnerships, and investing in marketing to educate healthcare providers.

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References

[1] European Medicines Agency. (2022). Approval and market data for ANGELIQ.
[2] U.S. Food and Drug Administration. (2012). ANGELIQ approval documentation.
[3] MarketResearch.com. (2023). Emerging markets analysis, hormone therapy segment.