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LO LOESTRIN FE Drug Patent Profile

Which patents cover Lo Loestrin Fe, and what generic alternatives are available?

Lo Loestrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

The generic ingredient in LO LOESTRIN 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 Loestrin Fe

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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 LOESTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	7
Patent Applications:	130
Drug Prices:	Drug price information for LO LOESTRIN FE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO LOESTRIN FE
What excipients (inactive ingredients) are in LO LOESTRIN FE?	LO LOESTRIN FE excipients list
DailyMed Link:	LO LOESTRIN FE at DailyMed

See drug prices for LO LOESTRIN FE

See drug sales revenues for LO LOESTRIN FE

Recent Clinical Trials for LO LOESTRIN FE

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
Purdue Pharma LP	Phase 1
Eisai Inc.	Phase 1

See all LO LOESTRIN FE clinical trials

Paragraph IV (Patent) Challenges for LO LOESTRIN FE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LO LOESTRIN FE	Tablets	ethinyl estradiol; norethindrone acetate	1 mg/0.01 mg, 0.01 mg and 75 mg	022501	1	2011-04-29

US Patents and Regulatory Information for LO LOESTRIN FE

LO LOESTRIN 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 LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010		RX	Yes	Yes	7,704,984

Expired US Patents for LO LOESTRIN FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	5,552,394

International Patents for LO LOESTRIN FE

When does loss-of-exclusivity occur for LO LOESTRIN 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 LOESTRIN 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)

Supplementary Protection Certificates for LO LOESTRIN 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

LO LOESTRIN FE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LO LOESTRIN FE

Introduction to LO LOESTRIN FE

LO LOESTRIN FE is a low-dose oral contraceptive developed by Allergan (now part of AbbVie), designed for the prevention of pregnancy in women. It combines norethindrone acetate and ethinyl estradiol, with a unique regimen that includes ferrous fumarate tablets to help women remember to take their pills[3].

Target Market and Marketing Strategies

The primary target market for LO LOESTRIN FE is young millennial women aged 18 to 24 who are either starting birth control for the first time or switching from other birth control methods. Allergan's marketing strategy, particularly through the "Women Who Know" campaign, aims to connect with this demographic using humor, real-world scenarios, and bold messaging. This campaign is featured across various media channels, including TV, print, and digital platforms, and is promoted through outlets like Refinery29, Instagram, Bravo!, HGTV, and Cosmopolitan[1].

Competitive Advantage

LO LOESTRIN FE differentiates itself from competitors by highlighting its lowest dose of estrogen among oral contraceptives. This unique selling point is crucial in attracting health-conscious women who are increasingly aware of the ingredients in their medications and their potential side effects[1].

Financial Performance

Quarterly and Annual Revenue

In the fourth quarter of 2019, LO LOESTRIN FE generated net revenues of $156.2 million, representing an 8.6% increase compared to the same quarter in the previous year. For the full year 2019, the product continued to be a significant revenue driver for Allergan's women's health business[2].

In the first quarter of 2018, LO LOESTRIN FE brought in $114 million, a 14% increase over the first quarter of 2017. This growth was notable despite a 33% decline in Allergan's overall women's health business during the same period[1].

Market Impact and Sales Trends

The shift in promotional focus from LOESTRIN 24 FE to LO LOESTRIN FE, starting in early 2011, significantly impacted sales. While LOESTRIN 24 FE saw a decline in net sales and filled prescriptions, LO LOESTRIN FE generated $33 million in net sales in the quarter ended September 30, 2012, and continued to be the primary focus of Allergan's women's healthcare sales efforts[5].

Pricing and Affordability

The list price (wholesale acquisition cost) of LO LOESTRIN FE is $171 per month. However, with insurance coverage and the use of savings cards, eligible patients can pay as little as $25 for a three-month prescription fill. For those without commercial insurance coverage, the out-of-pocket cost can be as low as $30 per month or $70 for a three-month prescription fill[4].

Clinical and Safety Profile

LO LOESTRIN FE has demonstrated a safe and effective profile in clinical trials. The Pearl Index, a measure of contraceptive efficacy, was calculated to be 2.92, indicating a low pregnancy rate. The safety profile, including the risk of arterial and venous thrombosis, is comparable to other low-dose oral contraceptives and did not raise any new or unexpected safety concerns[3].

Regulatory and Postmarket Surveillance

LO LOESTRIN FE received FDA approval based on a comprehensive clinical review, and no postmarketing risk evaluation and mitigation strategies were recommended. Standard post-marketing surveillance was suggested to monitor any potential safety issues, but extensive postmarketing experience has not revealed any worrisome safety signals[3].

Impact of Marketing Campaigns

The "Women Who Know" campaign, which includes educational phases and partnerships with influencers like Vanessa Bayer and Shay Mitchell, has been instrumental in raising awareness and driving engagement among the target audience. This campaign's focus on relatability and self-awareness is expected to increase new-to-brand patients and reinforce LO LOESTRIN FE's market position[1].

Future Outlook

Given its strong financial performance, unique selling points, and effective marketing strategies, LO LOESTRIN FE is poised to continue as a significant player in the oral contraceptive market. The ongoing efforts to make the product more affordable and accessible through savings programs will likely sustain its growth trajectory.

"Encouraging women to be aware of the pill they are prescribed – the same way we’ve grown hyper aware of the foods that we eat, we also need to be aware of what’s in the pill, and how it can affect us," - Cindy Schwartz, Associate VP of Marketing at Allergan Women’s Healthcare[1].

Key Takeaways

• Target Market: LO LOESTRIN FE is primarily marketed to young millennial women aged 18 to 24.
• Competitive Advantage: It has the lowest dose of estrogen among oral contraceptives.
• Financial Performance: Significant revenue growth, with $156.2 million in Q4 2019 and $114 million in Q1 2018.
• Pricing and Affordability: Affordable options available through insurance and savings cards.
• Clinical and Safety Profile: Demonstrated safety and efficacy in clinical trials.
• Regulatory and Postmarket Surveillance: Approved by FDA with standard post-marketing surveillance.
• Marketing Impact: Effective campaigns have increased brand awareness and engagement.

FAQs

Q: What is the primary target market for LO LOESTRIN FE?

A: The primary target market is young millennial women aged 18 to 24 who are either starting birth control for the first time or switching from other methods.

Q: What differentiates LO LOESTRIN FE from other oral contraceptives?

A: LO LOESTRIN FE has the lowest dose of estrogen among oral contraceptives, which is a key selling point.

Q: How has LO LOESTRIN FE performed financially?

A: It has shown significant revenue growth, with $156.2 million in Q4 2019 and $114 million in Q1 2018.

Q: How affordable is LO LOESTRIN FE?

A: With insurance coverage and savings cards, eligible patients can pay as little as $25 for a three-month prescription fill.

Q: What is the safety profile of LO LOESTRIN FE?

A: It has a safe and effective profile, with no new or unexpected safety concerns raised in clinical trials.

Sources

1. Allergan gets candid about birth control in Lo Loestrin Fe campaign - MMM-Online
2. Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results - AbbVie News
3. FDA Approval Document for Lo Loestrin Fe - FDA
4. Pricing Information - Lo Loestrin® Fe - LoLoestrin.com
5. Warner Chilcott Reports Operating Results for the Quarter - GlobeNewswire