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-seven 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 has been one patent litigation case 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 Applications:	131
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

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

China

European Patent Office

Hong Kong

Israel

Mexico

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
China	104248639	Extended estrogen dosing contraceptive regimen
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES 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)
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
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
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	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124

LO MINASTRIN FE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lo Loestrin Fe

Introduction

Lo Loestrin Fe is a low-dose oral contraceptive that has been a significant player in the women's healthcare market, particularly in the contraception segment. Here, we will delve into the market dynamics and financial trajectory of this drug.

Product Overview

Lo Loestrin Fe is a combination oral contraceptive containing norethindrone acetate and ethinyl estradiol (EE), with a unique dosing regimen. It consists of 24 days of active tablets containing 10 mcg of EE and 1 mg of norethindrone acetate, followed by 2 days of tablets containing 10 mcg of EE, and finally 2 days of ferrous fumarate tablets[1].

Market Position

Lo Loestrin Fe is one of the several oral contraceptives available in the market, but it holds a distinct position due to its low-dose formulation and specific dosing regimen. The drug is primarily marketed by Warner Chilcott, which was later acquired by Allergan (now part of AbbVie)[2].

Clinical Efficacy and Safety

The clinical efficacy of Lo Loestrin Fe has been well-documented. The Pearl Index, a measure of contraceptive efficacy, was calculated to be 2.92 (95% CI 1.94, 4.21) based on a clinical trial involving 1,270 subjects over 12,482 completed cycles. The life-table pregnancy rate was 2.71 (95% CI 1.86, 3.95), indicating its effectiveness as a contraceptive[1].

Financial Performance

The financial performance of Lo Loestrin Fe has been robust. In the fourth quarter of 2019, Lo Loestrin Fe net revenues increased by 8.6% compared to the prior year quarter, reaching $156.2 million. This growth was part of Allergan's overall financial performance, which saw total net revenues of $4,351.0 million for the quarter[2].

Market Growth and Trends

The women's healthcare market, particularly the contraception segment, is expected to grow significantly. The global women's healthcare market was valued at $33.35 billion in 2023 and is projected to grow at a CAGR of 7.36% from 2024 to 2030. Contraception is one of the key segments driving this growth, with increased awareness and demand for effective contraceptive methods[4].

Competitive Landscape

The competitive landscape for Lo Loestrin Fe is characterized by limited generic competition. As of the latest reports, no companies currently market a generic version of Lo Loestrin Fe, although companies like Lupin and Actavis have plans to launch generic versions. The proposed acquisition between Actavis and Warner Chilcott raised anticompetitive concerns, leading to a consent agreement requiring Actavis to divest certain rights and assets related to generic versions of Lo Loestrin Fe to Amneal[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Lo Loestrin Fe. The FDA approval process and postmarketing surveillance are key factors. Lo Loestrin Fe received FDA approval based on its clinical efficacy and safety profile, with no postmarketing risk evaluation and mitigation strategies recommended. Standard post-marketing surveillance was advised to monitor any adverse events[1].

Sales and Prescriptions

The sales of Lo Loestrin Fe have been driven by an increase in filled prescriptions. For instance, in the quarter ended March 31, 2013, Lo Loestrin Fe net sales increased significantly due to a 78% increase in filled prescriptions[5].

Challenges and Opportunities

Despite its strong market position, Lo Loestrin Fe faces challenges such as potential generic competition and regulatory hurdles. However, the growing demand for women's healthcare products and the lack of timely generic competition present opportunities for continued market dominance.

Generic Competition

The entry of generic competitors is a significant factor in the market dynamics of Lo Loestrin Fe. However, the process of drug development and FDA approval, combined with regulatory exclusivity and patent litigation, delays the entry of generic competitors. This delay allows branded products like Lo Loestrin Fe to maintain their market share for a longer period[3].

Consumer Impact

The absence of generic competition and the potential for higher prices post-acquisition can significantly impact consumers. The proposed acquisition between Actavis and Warner Chilcott was expected to lead to higher prices for consumers due to reduced competition. However, the consent agreement requiring divestitures aims to mitigate these anticompetitive effects[3].

Key Takeaways

• Efficacy and Safety: Lo Loestrin Fe has a proven clinical efficacy and safety profile.
• Financial Performance: The drug has shown robust financial growth, contributing significantly to Allergan's revenues.
• Market Trends: The women's healthcare market, particularly the contraception segment, is expected to grow substantially.
• Competitive Landscape: Limited generic competition currently, but potential entries are anticipated.
• Regulatory Environment: FDA approval and post-marketing surveillance are crucial.
• Sales and Prescriptions: Increased filled prescriptions drive sales growth.

FAQs

Q: What is the primary indication for Lo Loestrin Fe? A: The primary indication for Lo Loestrin Fe is for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception[1].

Q: How does the dosing regimen of Lo Loestrin Fe differ from other oral contraceptives? A: Lo Loestrin Fe consists of 24 days of active tablets containing 10 mcg of EE and 1 mg of norethindrone acetate, followed by 2 days of tablets containing 10 mcg of EE, and finally 2 days of ferrous fumarate tablets[1].

Q: What are the financial highlights of Lo Loestrin Fe in recent years? A: In the fourth quarter of 2019, Lo Loestrin Fe net revenues increased by 8.6% to $156.2 million[2].

Q: Is there any generic competition for Lo Loestrin Fe? A: Currently, no generic versions of Lo Loestrin Fe are marketed, although companies like Lupin and Actavis plan to launch generic products[3].

Q: How does the regulatory environment impact Lo Loestrin Fe? A: The FDA approval process and post-marketing surveillance are critical. No postmarketing risk evaluation and mitigation strategies were recommended, but standard post-marketing surveillance was advised[1].

Sources

1. FDA Medical Review: Lo Loestrin Fe NDA 22-501.
2. Allergan Financial Results: Fourth Quarter and Full-Year 2019 Financial Results.
3. FTC Analysis: Analysis of Agreement Containing Consent Orders.
4. Maximize Market Research: Women Healthcare Market: Global Industry Analysis.
5. GlobeNewswire: Warner Chilcott Reports Operating Results for the Quarter Ended March 31, 2013.