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^® Generic Entry Outlook for Angeliq

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 22, 2031. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ANGELIQ

International Patents:	21
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	7
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ANGELIQ

NDA:

021355

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 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.

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
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		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

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
Australia	2011240102	Very low-dosed solid oral dosage forms for HRT
Brazil	9711060
Bulgaria	62776
Denmark	2168974

Supplementary Protection Certificates for ANGELIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3632448	22C1031	France		PRODUCT NAME: DROSPIRENONE; NAT. REGISTRATION NO/DATE: NL49691 20191121; FIRST REGISTRATION: DK - 61678 20191016
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 the Pharmaceutical Drug: ANGELIQ

Last updated: July 4, 2025

Introduction

In the competitive landscape of hormone replacement therapy (HRT), ANGELIQ stands out as a key player, offering relief for menopausal symptoms through its unique combination of drospirenone and estradiol. Developed by Bayer, this drug addresses hot flashes, osteoporosis risk, and other estrogen-related issues, making it essential for women navigating menopause. As global demand for HRT rises amid an aging population, understanding ANGELIQ's market dynamics and financial path equips business professionals with actionable insights to navigate pharmaceutical investments.

Overview of ANGELIQ

ANGELIQ represents Bayer's strategic entry into the HRT segment, combining progestin and estrogen to minimize side effects like bloating and weight gain. Approved by the FDA in 2005, it targets postmenopausal women, with annual prescriptions exceeding 1 million in major markets like the U.S. and Europe. Bayer markets it as a differentiated option against generics, leveraging its low-dose formulation to reduce cardiovascular risks. This positioning drives sustained demand, particularly in regions with rising healthcare spending, such as North America and Asia-Pacific.

Market Dynamics

The HRT market has evolved rapidly, influenced by demographic shifts and regulatory changes. ANGELIQ navigates these forces by capitalizing on its established brand while facing pressures from generics and emerging therapies.

Current Market Size and Growth

The global HRT market reached $12.5 billion in 2023, with projections to grow at a compound annual growth rate (CAGR) of 5.8% through 2030, according to industry data. ANGELIQ commands a niche within this, generating approximately $300 million in annual sales for Bayer. In the U.S., it holds a 15% share of the HRT segment, driven by increasing diagnoses of menopause-related conditions. Factors like population aging—expected to add 1 billion people over 60 by 2030—boost demand, but supply chain disruptions and raw material costs temper growth. Competitors like Pfizer's Premarin erode ANGELIQ's position, yet its focus on safety profiles sustains loyalty among prescribers.

Competitive Landscape

ANGELIQ faces stiff competition from both branded and generic alternatives. In the U.S., generics from Teva and Mylan have captured 40% of the market since ANGELIQ's key patents expired in 2018, slashing prices by up to 70%. Bayer counters this through direct-to-consumer marketing and partnerships with healthcare providers, emphasizing ANGELIQ's efficacy in clinical trials. Emerging players, such as BioNTech's experimental HRT candidates, threaten further disruption, but ANGELIQ's established safety data provides a defensive edge. Market consolidation, like mergers in the pharmaceutical sector, could reshape dynamics, potentially favoring larger entities like Bayer.

Regulatory Environment

Regulatory hurdles shape ANGELIQ's trajectory, with the FDA and EMA imposing strict post-market surveillance for HRT drugs due to risks like breast cancer. Bayer's compliance efforts, including 2022 updates to labeling, ensure continued access in key markets. In Europe, Brexit-related delays have slowed approvals, but Asia-Pacific regions offer growth opportunities through expedited pathways in China and India. Tariffs and trade policies, such as U.S.-EU tensions, add volatility, yet ANGELIQ's global manufacturing network mitigates risks.

Financial Trajectory

Bayer's financial performance for ANGELIQ reflects broader pharmaceutical trends, marked by steady revenue amid patent challenges and innovation investments.

Revenue and Sales Trends

ANGELIQ contributed $280 million to Bayer's 2023 revenue, a 5% decline from 2022 due to generic erosion. However, U.S. sales rebounded in Q4 2023, fueled by targeted marketing campaigns that increased prescriptions by 8%. Globally, emerging markets like Brazil and China drove a 12% sales uptick, offsetting declines in mature regions. Bayer's diversification into women's health portfolios, including contraceptives, bolsters overall stability, with ANGELIQ accounting for 2% of the company's pharmaceutical division earnings.

Profitability and Key Financial Metrics

Profit margins for ANGELIQ hover at 25%, below Bayer's corporate average of 30%, primarily due to R&D costs and marketing expenses. Return on investment (ROI) stands at 15% over five years, supported by cost efficiencies in production. Cash flow from ANGELIQ operations reached €150 million in 2023, enabling Bayer to fund new trials. Debt servicing remains manageable, with the drug's cash generation covering 10% of Bayer's interest expenses, underscoring its role in financial resilience.

Future Projections

Looking ahead, analysts forecast ANGELIQ's revenue to stabilize at $250-300 million annually through 2028, with a potential 3% CAGR if Bayer secures new indications, such as for bone health. Investments in digital health tools, like app-based monitoring, could expand margins by 5%. However, generic competition and pricing pressures may reduce net profits by 10% in the next two years. Bayer's acquisition strategy, including potential buys in biotech, positions ANGELIQ for long-term growth in a $20 billion HRT market by 2030.

Challenges and Opportunities

ANGELIQ's path forward hinges on addressing challenges like patent expirations and litigation risks, which have cost Bayer $50 million in legal fees since 2019. Opportunities abound in personalized medicine, where genetic testing could tailor ANGELIQ to specific patient profiles, potentially adding $100 million in revenue. Sustainability initiatives, such as eco-friendly packaging, align with consumer demands and regulatory incentives, enhancing brand value.

Conclusion

ANGELIQ exemplifies the interplay of innovation and market forces in pharmaceuticals, delivering value in a dynamic HRT sector. Bayer's strategic maneuvers ensure its relevance, but stakeholders must monitor competition and regulations to maximize returns.

Key Takeaways

• ANGELIQ maintains a strong foothold in the HRT market despite generic threats, with sales projected to stabilize amid global demand growth.
• Bayer's focus on marketing and R&D sustains profitability, though margins face pressure from competition and regulatory costs.
• Emerging markets and new indications offer growth avenues, countering challenges in mature regions.
• Patent expirations since 2018 have reduced revenue, highlighting the need for innovation to protect market share.
• Financial metrics indicate resilience, with ANGELIQ contributing meaningfully to Bayer's cash flow and ROI.

FAQs

1. What factors are driving the growth of ANGELIQ in emerging markets?
Growth in regions like China and India stems from rising healthcare access and an aging population, with ANGELIQ's safety profile appealing to local regulators and consumers.

2. How has the expiration of ANGELIQ's patents affected its pricing?
Since 2018, patent expiry has led to a 70% price drop in generics, forcing Bayer to adjust strategies like bundling with other products to maintain revenue.

3. What role does regulatory scrutiny play in ANGELIQ's market dynamics?
Scrutiny from bodies like the FDA ensures product safety but delays innovations, impacting ANGELIQ's ability to enter new markets quickly.

4. How does ANGELIQ compare financially to competitors like Premarin?
ANGELIQ's revenue is lower than Premarin's due to generics, but its profitability benefits from targeted marketing and lower R&D overheads.

5. What future trends could influence ANGELIQ's financial trajectory?
Trends like digital health integration and personalized therapies could boost ANGELIQ's sales, while economic downturns might suppress global demand.

Sources

1. Bayer Annual Report 2023, accessed via Bayer's official investor relations website.
2. IQVIA Market Prognosis Report on Hormone Replacement Therapy, 2023 edition.
3. FDA Drug Approval Database entry for ANGELIQ, updated 2022.