LO MINASTRIN FE Drug Patent Profile

When do Lo Minastrin Fe patents expire, and when can generic versions of Lo Minastrin Fe launch?

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-six 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
Raw Ingredient (Bulk) Api Vendors:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO MINASTRIN FE
DailyMed Link:	LO MINASTRIN FE at DailyMed

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

Expired US Patents for LO MINASTRIN FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	5,552,394
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	6,667,050

International Patents for LO MINASTRIN FE

When does loss-of-exclusivity occur for LO MINASTRIN FE?

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

Canada

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 LO MINASTRIN FE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
World Intellectual Property Organization (WIPO)	2006115871
China	104248639	Extended estrogen dosing contraceptive regimen
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

Supplementary Protection Certificates for LO MINASTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LO MINASTRIN FE

Last updated: July 29, 2025

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Introduction

LO MINASTRIN FE, a combined oral contraceptive pill containing levonorgestrel and ethinylestradiol, represents a prominent product within the reproductive health market. As a trusted contraceptive option, its market dynamics are influenced by demographic shifts, regulatory landscapes, competitive forces, and evolving consumer preferences. This analysis explores the factors shaping LO MINASTRIN FE's market position and projects its financial trajectory amidst current industry trends.

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Market Overview

The global oral contraceptives market is projected to reach approximately USD 8.5 billion by 2027, expanding at a compound annual growth rate (CAGR) of 4.5%, driven by rising awareness of reproductive rights and increased healthcare access [1]. Central to this sector are combination pills like LO MINASTRIN FE, favored for their efficacy, safety profile, and ease of use.

The contraceptive market is segmented based on product type—combined oral contraceptives (COCs), progestin-only pills, intrauterine devices (IUDs), implants, patches, and rings. Among these, COCs dominate due to longstanding usage and strong clinical validation, with LO MINASTRIN FE contributing a significant share.

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Market Drivers

1. Growing Consumer Demand for Reliable Contraception
   Increasing awareness about family planning, particularly among women aged 15–49 years, fuels demand for effective contraceptive methods. The World Health Organization reports a rising preference for reversible methods like COCs, driven by educational initiatives and shifting societal attitudes [2].

2. Advancements in Formulation and Delivery
   Enhanced formulations aimed at reducing side effects and improving compliance bolster consumer confidence. LO MINASTRIN FE's extended cycle and low-dose ethinylestradiol formulation appeal to users seeking improved tolerability.

3. Expanding Access and Healthcare Infrastructure
   Countries investing in healthcare infrastructure and subsidies facilitate broader access to contraceptives, directly impacting sales. Emerging markets such as India, China, and Southeast Asia demonstrate strong growth trajectories due to population expansion and increasing health expenditure.

4. Regulatory Approvals and Reimbursement Policies
   Approval of LO MINASTRIN FE for non-contraceptive uses, such as managing menstrual disorders, widens its therapeutic scope and market potential. Reimbursement policies further incentivize prescription and utilization.

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Market Challenges

1. Regulatory and Patent Dynamics
   Patent expirations for key formulations open the market to generic competitors, exerting downward pressure on prices. Regulatory hurdles also pose challenges in launching new formulations or indications.

2. Competition from Generic and Alternative Contraceptives
   Growing availability of generics reduces the premium pricing historically associated with branded products. Alternative contraceptive methods like long-acting reversible contraceptives (LARCs) are gaining market share due to convenience and reduced dosing frequency.

3. Consumer Preferences and Cultural Factors
   In certain regions, cultural resistance and misconceptions hinder adoption. Misinformation about side effects persists, impacting market penetration.

4. Stringent Regulatory Environment
   Varied approval requirements across jurisdictions increase compliance costs and delay market entry.

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Financial Trajectory and Revenue Forecasts

Revenue Trends
LO MINASTRIN FE's financial performance hinges on multiple factors: volume growth, pricing strategies, regulatory landscape, and competitive pressures. Historically, established brands in this space have experienced stable sales with incremental growth aligned to demographic trends.

Short-term Outlook (Next 1–3 years):
In mature markets, revenues are likely to plateau due to saturation. Nonetheless, targeted marketing, healthcare provider partnerships, and expanded indications (e.g., hyperandrogenism, menstrual regulation) can sustain growth. Launching generic versions post-patent expiry will induce price competition but can expand access, potentially offsetting declines with increased volume.

Medium to Long-term Outlook (3–10 years):
Emerging markets present substantial growth opportunities. As demographic dividends unfold, increased contraceptive penetration can double revenues in these regions. Furthermore, innovations—such as extended-cycle formulations, lower-dose options, and combination therapies—are poised to command premium pricing, enhancing profit margins.

Investment in Research and Development (R&D):
Focused R&D around non-contraceptive benefits will be critical. Developing formulations responsive to patient preferences (e.g., lower hormone doses, fewer side effects) can provide competitive differentiation and allow premium pricing.

Impact of Regulatory Events:
Patent expiries or regulatory approvals for new indications can alter the financial trajectory. Strategic alliances and licensing agreements with generic manufacturers will be instrumental in navigating these shifts.

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Market Strategies and Future Outlook

• Diversification of Product Portfolio: Incorporating additional formulations and indications can mitigate revenue volatility.

• Emerging Market Focus: Tailoring marketing strategies to regional preferences and healthcare reimbursement schemes will accelerate adoption rates.

• Partnerships and Licensing: Strategic collaborations with local manufacturers can optimize distribution channels and regulatory compliance.

• Innovation and Technology: Investing in research to develop novel delivery systems (e.g., implantable, transdermal) can position LO MINASTRIN FE as a comprehensive reproductive health solution.

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Key Market Trends Impacting Future Profits

• Shift Towards Long-acting Reversible Contraceptives (LARCs): Despite the dominance of oral contraceptives, LARCs are gaining popularity; however, combined pills like LO MINASTRIN FE remain essential due to ease of use and patient preference.

• Digital Healthcare Integration: Telemedicine and digital adherence tools can enhance patient engagement, leading to sustained sales.

• Regulatory Favorability in Emerging Markets: Governments promoting reproductive health initiatives create expansion avenues for branded contraceptives.

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Regulatory and Patent Landscape

Patent protections for LO MINASTRIN FE’s formulation typically last around 20 years from filing, but expiry dates vary depending on jurisdictional patent laws. Post-expiry, generic manufacturers rapidly capture market share, prompting companies to invest in formulation and process innovations to sustain exclusivity.

Regulatory agencies such as the FDA, EMA, and national authorities assess safety, efficacy, and manufacturing standards. Recent regulatory trends favor approval for additional indications, which can bolster economic value.

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Conclusion

LO MINASTRIN FE benefits from a stable foundation rooted in proven efficacy, consumer acceptance, and expanding markets, especially in emerging economies. Its financial trajectory will hinge on patent strategies, competitive positioning, regulatory adherence, and ongoing innovation. While mature markets present near-term revenue stabilization, long-term growth depends on tapping into underserved regions, diversifying indications, and maintaining compliance in an evolving regulatory environment.

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Key Takeaways

• Market growth is driven by increasing reproductive health awareness and demographic shifts, particularly in emerging markets.
• Competitive pressures from generics and evolving contraceptive preferences necessitate continuous innovation and strategic positioning.
• Patent expiries require proactive formulation and licensing strategies to protect profitability.
• Emerging markets represent the primary growth engine for LO MINASTRIN FE over the next decade.
• Innovation in formulations and indications will be key to sustaining margins and market share amid competitive and regulatory challenges.

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FAQs

1. How does patent expiry affect LO MINASTRIN FE’s market share?
Patent expiry typically leads to increased generic competition, reducing prices and eroding profit margins. Companies can counteract this through formulation innovation, new indications, and strategic licensing to maintain revenue streams.

2. What are the main competitors to LO MINASTRIN FE?
Generic versions of levonorgestrel/ethinylestradiol oral contraceptives, as well as alternative contraceptive methods like IUDs and implants, compete directly with LO MINASTRIN FE in terms of price and convenience.

3. Which markets offer the most growth potential for LO MINASTRIN FE?
Emerging markets in Asia, Africa, and Latin America present significant growth opportunities due to expanding populations, increasing healthcare infrastructure, and rising awareness of contraceptive options.

4. How important is product innovation for the future of LO MINASTRIN FE?
Crucial. Innovations that improve tolerability, reduce side effects, and explore new indications will enhance market relevance, allow premium pricing, and prolong product lifecycle.

5. What regulatory challenges does LO MINASTRIN FE face?
Variations in approval standards internationally, delays in registration, and evolving safety requirements can hinder market entry or expansion, especially in regions with stringent regulatory processes.

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References

1. Grand View Research, "Oral Contraceptives Market Size, Share & Trends Analysis," 2022.
2. WHO, "Family Planning/Contraceptive Use," 2021.