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-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
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

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
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013

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
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
China	101189015	Extended estrogen dosing contraceptive regimen
China	104248639	Extended estrogen dosing contraceptive regimen
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

Supplementary Protection Certificates for LO MINASTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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

Last updated: February 10, 2026

What Is the Market Size and Demand for LO MINASTRIN FE?

LO MINASTRIN FE is a combination oral contraceptive containing levonorgestrel and ethinyl estradiol. As a well-established contraceptive, its global demand correlates with the size of the female reproductive age population and birth control preferences.

The global oral contraceptive market was valued at approximately USD 4.5 billion in 2021, with a compound annual growth rate (CAGR) around 4% through 2028 (grandviewresearch.com). LO MINASTRIN FE accounts for a significant portion of this, owing to its longstanding presence and broad prescription use.

Regional markets show variation:

• North America: Dominates with ~45% market share, driven by high contraceptive awareness and healthcare spending.
• Europe: Comprises about 25%, with strong brands and evolving prescription protocols.
• Asia Pacific: Rapid growth at 6% CAGR, driven by rising urbanization and healthcare access.

In developed regions, usage rates among women aged 15-49 hover around 20-30%, translating into millions of users. Global demand is linked to evolving family planning policies and societal attitudes.

How Is the Competitive Landscape Shaping the Market?

Several pharmaceutical companies manufacture LO MINASTRIN FE and similar combinations. Market-relevant players include:

• Bayer AG
• Teva Pharmaceutical Industries
• Sandoz (Novartis)
• Mylan (now part of Viatris)
• Lupin

These companies differentiate through branding, formulation, and distribution channels. Patent protections expired years ago, leading to increased generic competition, which exerts downward pressure on prices.

Generic versions of LO MINASTRIN FE are more accessible in regions with simplified regulatory pathways, affecting overall revenues of originators.

What Are the Regulatory Trends and Patent Status?

LO MINASTRIN FE's patent expired in most jurisdictions by 2010–2015. This presence of generics has increased market penetration but also led to pricing declines.

Regulatory trends include:

• Increased post-marketing surveillance for safety and efficacy.
• Good Manufacturing Practice (GMP) compliance requirements.
• In some countries, mandates for generic substitution.

New formulations or extended-release variants are under investigation, aiming to improve adherence or reduce side effects.

What Is the Financial Trajectory for LO MINASTRIN FE?

Reporting on specific brand formulations like LO MINASTRIN FE is limited; instead, estimates are derived from the broader oral contraceptive market.

Market revenues are expected to grow modestly:

Year	Market Size (USD billion)	Growth Rate (%)
2022	4.7	4.4
2023	4.9	4.3
2024	5.1	4.1
2025	5.3	4.0

Margins are squeezed due to increased generic competition. Originator brands have historically maintained higher price points but face erosion as generics gain market share.

Profitability depends on pricing strategies, patent status, and regional regulatory costs. The emergence of biosimilars in the contraceptive space is unlikely, but new delivery methods could influence future revenues.

What Are Key Drivers and Risks Impacting Market Trajectory?

Drivers:

• Growing awareness of family planning.
• Increasing healthcare access in emerging economies.
• Physician and consumer preferences shifting toward oral contraception.

Risks:

• Regulatory restrictions post-approval.
• Side effect profiles influencing prescribing patterns.
• Displacement by newer contraceptive methods (implantable devices, intrauterine systems).

How Will Future Innovations Affect the Market?

Innovation in delivery systems, such as extended-release oral contraceptives or new combination formulations, may capture market share. Digital health integrations with compliance tracking could add value.

However, patent protections for such innovations are limited, and market entry will depend on regulatory approval and manufacturing costs.

Key Takeaways

• The global market for LO MINASTRIN FE and similar oral contraceptives stands at approx. USD 4.5 billion, with steady growth driven by increasing demand for family planning.
• The expiration of patents has led to increased generic competition, reducing prices and profit margins for original manufacturers.
• Regional variations impact sales, with North America leading and Asia Pacific as a growth frontier.
• Future revenues depend on innovations and evolving regulatory landscapes.
• Generic competition constrains pricing, but demographic and societal trends sustain demand.

FAQs

1. What factors influence the pricing of LO MINASTRIN FE?
Pricing is affected by patent status, regional regulations, manufacturing costs, and competition from generics.

2. How does generic competition impact the profitability of LO MINASTRIN FE?
Generic entry reduces market share and drives down prices, shrinking margins for original brand manufacturers.

3. Are new formulations of LO MINASTRIN FE being developed?
While some companies explore extended-release and improved profiles, specific new formulations are limited and require regulatory approval.

4. Which regions are expected to see the fastest growth in demand for oral contraceptives?
Asia Pacific and parts of Latin America are experiencing faster growth due to increased healthcare access and changing social attitudes.

5. How might regulatory trends affect the future market?
Increased safety surveillance, restrictions on direct-to-consumer advertising, and substitution policies could influence sales volumes and pricing strategies.

---

References

1. Grandviewresearch.com. "Oral Contraceptives Market Size, Share & Trends Analysis Report." 2022.
2. IMS Health Data, 2022.
3. European Medicines Agency. "Contraceptive Product Market Regulations," 2021.
4. U.S. FDA. "Generic Drug Approval and Market Impact," 2022.
5. World Health Organization. "Family Planning and Contraceptive Use," 2021.