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-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 Loestrin 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 LOESTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	206
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
ViiV Healthcare	PHASE1
Bristol-Myers Squibb	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	AB	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

See the table below for patents covering LO LOESTRIN 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)
European Patent Office	2305266	Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)

Supplementary Protection Certificates for LO LOESTRIN 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
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

LO LOESTRIN FE (norethindrone acetate 0.8 mg / ethinyl estradiol 0.025 mg plus ferrous fumarate) market dynamics and financial trajectory

Last updated: July 27, 2026

LO LOESTRIN FE is a branded combined oral contraceptive (COC) in the US with a mature market and ongoing generic competitive pressure. Key revenue drivers are continued contraception demand, payer coverage stability, and low switching resistance among plan formularies; key downside risks are generic substitution, wholesaler inventory swings, and any loss of coverage tied to competitive contracting.

What is LO LOESTRIN FE, and how is it positioned in the US COC market?

LO LOESTRIN FE is a low-dose COC regimen containing norethindrone acetate and ethinyl estradiol, plus ferrous fumarate during the placebo interval (common across many COCs). It targets women needing contraception and is sold as a prescription oral dosage form.

H2 subtopics: What therapeutic class and payer dynamics apply to LO LOESTRIN FE?

• Category economics: COCs typically price below blockbuster levels, but volume can be meaningful due to large eligible patient populations.
• Formulary structure: COCs are usually tiered; branded products face pressure when generics are available and when pharmacy benefit managers (PBMs) steer to preferred generics.
• Switching behavior: Patients often remain on a chosen COC if tolerated, but payer-driven substitution can reduce net revenue per unit over time.

H3: Why does “low dose” matter commercially?

• Clinical differentiation: “Low dose” can support prescriber preference where tolerability is a concern.
• Competitive reality: Low-dose positioning does not fully insulate against generic substitution because many COCs share similar estrogen/progestin components and dosing schedules.

How do market dynamics for low-dose COCs shape LO LOESTRIN FE revenue?

COC market dynamics are dominated by (1) generic penetration, (2) competitive contracting, (3) adherence and persistence, and (4) supply continuity.

H3: Generic penetration and substitution risk

• Generics with bioequivalent active ingredients reduce branded pricing power.
• PBMs frequently place multiple equivalent COCs on lower tiers; branded net price compresses even when the product remains on formularies.

H3: Contracting cycles and net price effects

• Net revenue typically tracks negotiated rebates and discounts, which PBMs adjust based on utilization and competing bids.
• When preferred positions move, branded volumes can fall even without product-level safety or efficacy issues.

H3: Persistence and adherence as a volume amplifier

• Oral contraceptives depend on sustained daily use.
• Switching at the pharmacy counter can be disruptive, but persistence is often driven by patient tolerance and prescriber training, which can support brand retention when formularies remain favorable.

What do financial trajectory patterns usually look like for mature COC brands like LO LOESTRIN FE?

For mature COC products, financial trajectories often follow a post-launch lifecycle:

1. Early growth phase driven by formulary adoption and prescriber education.
2. Mid-stage plateau as market share stabilizes amid generic launches.
3. Later-stage erosion as PBM preference shifts and pharmacy-level substitution intensifies.

In this lifecycle, the primary financial inflection is usually net price compression and share attrition, not a sudden demand collapse.

H3: Common KPIs to track for LO LOESTRIN FE

• Unit volume trends (prescription fills)
• Net sales per unit (net price erosion due to rebates)
• Channel inventory (wholesaler buying patterns)
• Plan coverage metrics (formulary status and tier placement)

When does LO LOESTRIN FE face exclusivity and patent expiration pressure?

This depends on specific US Orange Book listings (active ingredient(s), formulation, and method-of-use patents), and on whether any exclusivity extensions apply to this product. Without the product’s Orange Book patent-by-patent dataset, a complete exclusivity and expiration timeline cannot be stated with accuracy.

What patents protect LO LOESTRIN FE, and how strong is the patent estate?

Protection typically spans:

• Composition/formulation patents for specific dosage regimens and low-dose formulations
• Method-of-use patents tied to contraception and dosing schedules
• Manufacturing process patents if applicable

A credible, litigation-grade analysis requires the Orange Book patent list for LO LOESTRIN FE and any court docket filings referencing those patents. Without that listing and case record, the patent strength can’t be quantified.

What is the Orange Book status of LO LOESTRIN FE (patents, exclusivity, and listing types)?

An Orange Book status summary must be built from the exact Orange Book record for LO LOESTRIN FE, including:

• Listed patents (composition, method, formulation, or packaging)
• Patent expiration dates
• Regulatory exclusivities (if any) tied to application history

A complete Orange Book status statement cannot be produced without the Orange Book dataset for this specific product.

Are there current Paragraph IV challenges for LO LOESTRIN FE, and which companies are involved?

Paragraph IV filings are publicly trackable through FDA and litigation dockets, typically producing:

• ANDA filer names
• Listed patents challenged
• Litigation or settlement dates

A precise “which companies and what challenges” answer requires the case list tied to LO LOESTRIN FE’s Orange Book patents and associated FDA approvals. Without that, no actionable challenge landscape can be stated.

What generic entry risks exist for LO LOESTRIN FE if it loses coverage or faces patent challenges?

COC branded products face the same entry mechanics as other small-molecule prescription generics:

• ANDAs with bioequivalent generic combinations
• Switching at pharmacy once generics are on formulary and inventory stabilizes
• Net price pressure as PBMs demand higher discounts for continued brand inclusion

Risk severity depends on the exact remaining patent/exclusivity term and on payer contracting. Without a listing-based timeline, the entry-risk window cannot be quantified.

How does LO LOESTRIN FE compare with competing low-dose COCs financially and competitively?

For direct comparison, the correct method is to benchmark:

• Brand net sales (or proxy data from public filings if the holder discloses)
• Generic availability and number of equivalent products in-market
• PBM preferred positioning across major commercial plans

A valid cross-product financial comparison requires the specific competitors’ sales and utilization metrics, plus LO LOESTRIN FE’s own disclosed financials and its net price trajectory. Those data points are not available in the current prompt.

What FDA and regulatory status constraints affect LO LOESTRIN FE market access?

COCs are typically approved under standard drug pathways with labeling that includes contraception indications and the estrogen/progestin regimen. Market access constraints usually come from:

• Label changes that affect patient eligibility
• Drug supply interruptions
• Enforcement of current Good Manufacturing Practices

A product-specific regulatory timeline requires FDA submissions and labeling history for LO LOESTRIN FE, which are not provided here.

How do manufacturing, supply continuity, and wholesaler inventory dynamics affect LO LOESTRIN FE sales?

For oral contraceptives, supply disruptions can produce:

• temporary sales spikes due to channel fill
• follow-on volume declines when supply normalizes
• variability in net sales reporting due to wholesaler ordering patterns

A sales-causality analysis requires reported inventory levels, backorder data, or supply notifications, none of which are in the prompt.

Key revenue drivers to model for LO LOESTRIN FE (practical business levers)

Even without patent- and sales-data specifics, a usable modeling framework for COC brands is:

• Formulary position: tier and prior authorization requirements
• Net-to-gross dynamics: rebates and plan-specific discounts
• Generic count in class: number of equivalent AB-rated generic competitors
• Patient persistence: refill rates and discontinuation timing
• Seasonality: steady demand with possible minor variations

Key Takeaways

• LO LOESTRIN FE operates in a mature low-dose COC market where generic substitution and payer contracting drive most financial outcomes.
• Typical mature-brand trajectories show net price compression and share erosion rather than category demand collapse.
• A patent-exclusivity, Orange Book, and Paragraph IV/ANDA risk timeline requires the product’s Orange Book listing and litigation docket record; those data are not included in the input, so they cannot be stated accurately here.

FAQs

How can I estimate LO LOESTRIN FE net sales trend without disclosures?

Use prescription volume proxies from pharmacy audit datasets combined with industry-standard net price compression assumptions tied to generic entry and formulary tier shifts.

Which payer levers most affect LO LOESTRIN FE volume in commercial plans?

Formulary tier placement, preferred brand/generic rules, prior authorization triggers, and rebate structures during PBM contracting cycles.

What is the biggest financial risk for long-established COC brands?

Loss of preferred status that accelerates pharmacy-level substitution and lowers net price per fill.

How do supply interruptions typically affect oral contraceptive revenue?

They usually shift revenue between periods through channel stocking and normalization effects, not necessarily change long-run demand.

Do method-of-use patents matter for generic competition in COCs?

They can, but practical generic entry risk is driven by the specific Orange Book-listed patents tied to the approved regimen and the litigation outcomes over those patents.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA database).
2. FDA. ANDA Paragraph IV Certification and Drug Patent Information. (Accessed via FDA resources).
3. Bloomberg Law / CourtListener (for pharmaceutical patent litigation docket searches).