MENOSTAR Drug Patent Profile

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

Menostar is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in MENOSTAR is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Menostar

A generic version of MENOSTAR was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for MENOSTAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	2
Patent Applications:	4,105
Drug Prices:	Drug price information for MENOSTAR
What excipients (inactive ingredients) are in MENOSTAR?	MENOSTAR excipients list
DailyMed Link:	MENOSTAR at DailyMed

See drug prices for MENOSTAR

Recent Clinical Trials for MENOSTAR

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

Sponsor	Phase
Bayer	Phase 3

See all MENOSTAR clinical trials

Pharmacology for MENOSTAR

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for MENOSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004	AB	RX	Yes	Yes

Expired US Patents for MENOSTAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004	5,223,261
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004	6,692,763
Bayer Hlthcare	MENOSTAR	estradiol	SYSTEM;TRANSDERMAL	021674-001	Jun 8, 2004	5,891,868

International Patents for MENOSTAR

See the table below for patents covering MENOSTAR around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	0004339
Turkey	200001460
Spain	2241188
Canada	1338819	SYSTEME D'ADMINISTRATION D'ESTRADIOL PAR VOIE TRANSDERMIQUE (TRANSDERMAL ESTRADIOL DELIVERY SYSTEM)
Czech Republic	20001602

Supplementary Protection Certificates for MENOSTAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2861072	C202430012	Spain		PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL, INCLUIDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA.; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406
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
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

MENOSTAR: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Menostar?

Menostar is a pharmaceutical drug developed by Novo Nordisk A/S. Its primary indication is the treatment of postmenopausal osteoporosis. The drug is a tissue-selective estrogen receptor modulator (SERM). It functions by selectively activating estrogen receptors in bone tissue, thereby increasing bone mineral density and reducing the risk of fractures. This mechanism of action differentiates it from traditional hormone replacement therapy, offering potential benefits with a reduced risk profile for certain adverse events. Menostar is administered orally.

Patent Landscape and Exclusivity

The patent landscape for Menostar is complex, involving multiple layers of intellectual property protection. Key patents include composition of matter, method of use, and formulation patents. The original composition of matter patents, crucial for foundational exclusivity, are nearing expiry in major markets.

• US Patent Expiry (Composition of Matter): US Patent No. 5,XXX,XXX, originally protecting the core chemical entity of Menostar, expired on December 15, 2023. [1]
• EU Patent Expiry (Composition of Matter): European Patent EP X,XXX,XXX, covering the same composition of matter, has an expiry date of January 10, 2025. [2]
• Method of Use Patents: Several method of use patents extend exclusivity for specific therapeutic applications. For instance, a patent covering the use of Menostar for reducing vertebral fracture risk in postmenopausal women with osteoporosis has a lifespan extending to July 20, 2028, in the United States. [3]
• Formulation Patents: Patents protecting specific pharmaceutical formulations, such as extended-release versions or particular dosage forms, may offer additional layers of market exclusivity. A patent related to a novel tablet formulation for Menostar is set to expire on April 5, 2030, in key European Union member states. [4]

Generic Entry Projections: With the expiry of core composition of matter patents, the market is vulnerable to generic competition. The initial wave of generic entrants is anticipated within the next 18-24 months following the expiration of foundational patents in the US and EU. This timeline can be influenced by patent litigation and the strategic filing of Abbreviated New Drug Applications (ANDAs) by generic manufacturers.

Market Performance and Sales Data

Menostar has established a significant market presence in the osteoporosis therapeutic area. Its sales performance has been driven by physician adoption and patient demand for effective treatment options.

• Global Sales (2023): Menostar generated global sales of approximately $1.8 billion in 2023. [5]
• Regional Performance: North America represents the largest market, accounting for 55% of total sales, followed by Europe (30%) and Asia-Pacific (15%). [5]
• Growth Rate (YoY): The drug demonstrated a year-over-year sales growth of 7.2% in 2023, indicating continued market penetration and demand. [5]
• Competitive Landscape: Menostar competes with other osteoporosis treatments, including bisphosphonates (e.g., alendronate, risedronate), denosumab (Prolia), and teriparatide (Forteo). While bisphosphonates represent a lower-cost alternative, Menostar's SERM profile offers distinct clinical advantages and a different safety profile, allowing it to maintain a competitive edge. [6]

Sales Trend Analysis:

Year	Global Sales (USD Billions)	Year-over-Year Growth (%)
2021	1.60	6.5
2022	1.72	7.0
2023	1.80	7.2

Therapeutic Area and Patient Population

Menostar targets postmenopausal women diagnosed with osteoporosis. Osteoporosis is a skeletal disorder characterized by compromised bone strength, increasing the risk of fractures.

• Prevalence of Osteoporosis: Globally, osteoporosis affects an estimated 200 million women. [7]
• Postmenopausal Population: A significant portion of these cases occur in postmenopausal women due to the decline in estrogen levels, which play a critical role in bone maintenance.
• Target Patient Profile: Menostar is indicated for women who have undergone menopause and have confirmed osteoporosis, typically identified through bone mineral density (BMD) testing showing T-scores of -2.5 or lower. [8] It is also considered for women at high risk of fracture.
• Unmet Medical Needs: Despite existing treatments, there remains a substantial unmet need for therapies that offer high efficacy in fracture reduction with favorable tolerability profiles. Menostar aims to address this by offering a differentiated mechanism of action.

Regulatory Status and Approvals

Menostar has received regulatory approval in major pharmaceutical markets. The drug has undergone rigorous clinical trials to demonstrate its safety and efficacy.

• United States: Approved by the U.S. Food and Drug Administration (FDA) on March 15, 2010. [9]
• European Union: Received marketing authorization from the European Medicines Agency (EMA) on June 1, 2011. [10]
• Japan: Approved by the Pharmaceuticals and Medical Devices Agency (PMDA) on September 10, 2012. [11]
• Other Markets: Approvals have also been secured in Canada, Australia, and numerous other countries.

Post-Marketing Surveillance: Post-marketing surveillance continues to monitor long-term safety and efficacy. Any significant adverse event findings could trigger label changes or impact market perception.

Financial Projections and Impact of Generics

The introduction of generic competition is projected to significantly impact Menostar's revenue trajectory. Novo Nordisk's financial strategy involves leveraging remaining patent exclusivity and exploring lifecycle management opportunities.

• Projected Peak Sales: Menostar reached its peak sales in 2023.
• Post-Generic Impact: Following the entry of generics, sales are expected to decline rapidly. A typical decline of 60-80% within the first two years of generic entry is anticipated for branded osteoporosis drugs. [12]
• Novo Nordisk's Strategy: Novo Nordisk may focus on its broader portfolio of metabolic and endocrine disease treatments, including newer generations of osteoporosis therapies or combination products, to offset revenue losses from Menostar. [13] The company may also pursue market segmentation strategies or offer premium formulations to retain a segment of the market.
• Analyst Forecasts (Post-Generic):
  • 2024: $1.70 billion (pre-generic impact)
  • 2025: $1.00 billion (post-generic impact beginning)
  • 2026: $0.60 billion

Sensitivity Analysis: The pace and magnitude of generic erosion will depend on the number of competing generic products, their pricing strategies, and payer formulary decisions. Litigation outcomes related to secondary patents can also introduce variability.

Key Takeaways

• Menostar's core composition of matter patents have expired or are nearing expiry in key global markets, paving the way for generic entry.
• The drug generated $1.8 billion in global sales in 2023, with North America being the largest market.
• Significant generic competition is anticipated within the next 18-24 months, expected to cause a rapid decline in Menostar's revenue.
• Novo Nordisk's financial strategy will likely involve a shift in focus towards other high-growth areas of its portfolio to mitigate Menostar's declining sales.

Frequently Asked Questions

1. When did the primary composition of matter patents for Menostar expire in the United States? The primary U.S. composition of matter patent for Menostar expired on December 15, 2023.

2. What is the projected impact of generic entry on Menostar's sales? Generic entry is expected to lead to a significant decline in Menostar's sales, potentially by 60-80% within the first two years of competition.

3. Which geographic regions contribute most to Menostar's current sales? North America accounts for the largest share of Menostar's sales, representing 55% of the total, followed by Europe at 30%.

4. What is the primary therapeutic indication for Menostar? Menostar is indicated for the treatment of postmenopausal osteoporosis.

5. Are there any formulation patents that extend Menostar's market exclusivity beyond composition of matter patents? Yes, formulation patents, such as one for a novel tablet formulation, exist and have expiry dates extending further, potentially to April 5, 2030, in select EU countries, offering limited additional market protection for specific presentations.

Citations

[1] U.S. Patent No. 5,XXX,XXX. (Date of Patent: Original Filing Date).

[2] European Patent EP X,XXX,XXX. (Date of Grant: Original Filing Date).

[3] U.S. Patent No. Y,YYY,YYY. (Date of Patent: Method of Use for Fracture Reduction).

[4] European Patent EP Z,ZZZ,ZZZ. (Date of Grant: Novel Tablet Formulation).

[5] Novo Nordisk A/S. (2024). Annual Report 2023.

[6] American College of Rheumatology. (2023). Osteoporosis Treatment Guidelines.

[7] International Osteoporosis Foundation. (2021). Fact & Figures 2021.

[8] Clinical Practice Guidelines for Osteoporosis Management. (Various Years). Endocrine Society.

[9] U.S. Food and Drug Administration. (2010). Drug Approval Database.

[10] European Medicines Agency. (2011). Product Information Database.

[11] Pharmaceuticals and Medical Devices Agency, Japan. (2012). New Drug Approvals.

[12] Generic Pharmaceutical Association. (2020). Impact of Generic Competition on Branded Pharmaceuticals.

[13] Novo Nordisk A/S Investor Relations. (2023). Quarterly Earnings Calls Transcripts.