LO MINASTRIN FE Drug Patent Profile

When do Lo Minastrin Fe patents expire, and what generic alternatives are available?

Lo Minastrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in LO MINASTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lo Minastrin Fe

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LO MINASTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO MINASTRIN FE

US Patents and Regulatory Information for LO MINASTRIN FE

LO MINASTRIN FE 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
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013		DISCN	Yes	No	7,704,984

International Patents for LO MINASTRIN FE

See the table below for patents covering LO MINASTRIN FE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2305266	Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
World Intellectual Property Organization (WIPO)	2006115871
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
China	101189015	Extended estrogen dosing contraceptive regimen

Supplementary Protection Certificates for LO MINASTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211

Last updated: February 10, 2026

What is LO MINASTRIN FE?

LO MINASTRIN FE is a combined oral contraceptive pill comprising ethinylestradiol (20 mcg) and norgestimate (250 mcg). It contains iron supplementation in the form of ferrous fumarate (Fe), designated by "FE." The drug targets contraception, primarily in women of reproductive age, and may also be used for menstrual regulation and management of hormonal imbalances.

Market Overview and Demand Drivers

Global Market for Combined Oral Contraceptives (COCs)

The global COC market reached approximately USD 9.7 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030. Growth stems from increasing acceptance of oral contraception, rising awareness of reproductive health, and expanding access in emerging markets.

Market Segmentation and Regional Dynamics

• North America accounts for roughly 35% of market revenue, driven by high contraceptive use rates and robust healthcare infrastructure.
• Europe contributes nearly 30%, with increasing acceptance of hormonal contraceptives.
• Asia-Pacific is the fastest-growing segment, with a CAGR of 5.8%, due to rising population, urbanization, and easing regulatory barriers.

Competitive Landscape

Major players include Bayer AG, Teva Pharmaceuticals, and Pfizer Inc. They dominate formulations similar to LO MINASTRIN FE, focusing on efficacy, safety, and patient compliance. Niche and generic formulations face stiff competition, but the increasing global demand supports opportunities for new entrants with differentiated features such as iron supplementation.

Patent and Regulatory Status

Patent Landscape

• Original patents on norgestimate and ethinylestradiol have expired in many jurisdictions, opening opportunities for generic development.
• Patent protections on specific dosage forms and combination formulations may still exist in certain markets, with expiration dates typically spanning 2024-2030.

Regulatory Pathways

• The drug is registered in numerous countries, often under its active ingredients with local brand names.
• Approval processes focus on safety, efficacy, and manufacturing quality, with fast-track pathways available in some regions for reproductive health products.

Investment Fundamentals

Patent Expiry and Market Entry

• Patent expirations for norgestimate and ethinylestradiol create near-term opportunities for generics.
• Companies can leverage existing formulations or develop innovative delivery systems (e.g., extended-release, lower-dose regimens).

R&D and Development Costs

• Generic entry requires substantial investment in bioequivalence studies, with clinical trials in some jurisdictions.
• Development costs for new formulations can range from USD 10 million to USD 50 million, depending on innovation scope and regulatory requirements.

Manufacturing and Supply Chain

• Established suppliers of active pharmaceutical ingredients (APIs) reduce costs and streamline entry.
• Quality compliance and adherence to Good Manufacturing Practices (GMP) are critical, particularly in markets with strict regulation.

Pricing and Reimbursement

• In high-income countries, reimbursement policies support premium pricing, but competitive pressures limit margins.
• In emerging markets, cost sensitivity drives demand for affordable generics, with pricing often constrained by government and insurance policies.

Risks and Challenges

Market Competition

• Widespread patent expiry leads to intense price competition among generic manufacturers.
• Brand loyalty to established contraceptive brands can limit market penetration.

Regulatory Hurdles

• Variability in approval standards necessitates tailored clinical data packages.
• Stringent regulatory environments increase time-to-market and costs.

Adoption and Acceptance

• Cultural attitudes toward contraception influence demand.
• Side effect concerns and safety perceptions impact user acceptance, especially for new formulations.

Financial Outlook and Strategic Implications

Revenue Projections

• For a successful market entrant with a differentiated or cost-advantaged product, potential global revenue could reach USD 200-350 million annually within five years.
• High-margin niches include formulations with added benefits (e.g., fewer pills, reduced side effects, combination with additional minerals).

Investment Timing

• Short-term investments should focus on patent landscapes, formulation development, and regulatory engagement.
• Long-term potential hinges on market penetration, geographic expansion, and possible product innovation (e.g., biodegradable packaging, digital adherence tools).

Strategic Opportunities

• Partnership with local distributors in emerging markets accelerates deployment.
• Differentiation through formulation enhancements or combination therapies can command premium pricing.
• Licensing of existing formulations can reduce R&D costs, but warrants careful evaluation of patent rights.

Key Takeaways

• LO MINASTRIN FE, as a combined contraceptive with iron supplementation, aligns with ongoing demand for multi-benefit hormonal therapies.
• Patent expirations and market growth forecast a favorable landscape for generic manufacturers, particularly in emerging markets.
• Competitive intensity and regulatory complexity require strategic planning, especially in formulation development and compliance.
• Licensing, partnership, and innovation present viable pathways for investment returns.

FAQs

1. What is the primary market for LO MINASTRIN FE?
The product primarily targets women in reproductive age globally, with significant markets in North America, Europe, and Asia-Pacific.

2. When are key patents related to LO MINASTRIN FE expected to expire?
Patents on norgestimate and ethinylestradiol typically expire between 2024 and 2030, facilitating generic entry.

3. What are the main competitive barriers?
Existing patent protections, brand loyalty, regulatory hurdles, and market saturation by established contraceptive brands.

4. How does regulation differ across markets?
Developed countries emphasize extensive clinical trials and safety data, while some emerging markets have streamlined approval processes but with variable standards.

5. What strategic considerations are important for new entrants?
Focusing on cost-effective manufacturing, regulatory compliance, regional partnerships, and potential product differentiation.

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Sources:

1. Grand View Research, “Oral Contraceptives Market Size & Trends,” 2022.
2. IQVIA, “Global Pharmaceuticals Market Report,” 2022.
3. U.S. Patent and Trademark Office, Patent expiry data, 2023.
4. WHO, “Family Planning/Contraceptive Use,” 2022.
5. Fitch Solutions, “Pharmaceutical Cost & Pricing Outlook,” 2022.