LO LOESTRIN FE Drug Patent Profile

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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO LOESTRIN FE

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

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)
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Lo Loestrin Fe (norethindrone acetate 1 mg / ethinyl estradiol 10 mcg + ferrous fumarate) investment scenario and fundamentals analysis: patent, exclusivity, FDA status, and generic/biosimilar risks

Last updated: July 24, 2026

Lo Loestrin Fe is a low-dose combined oral contraceptive (COC) marketed in the U.S. as a 21-day active/7-day iron regimen. From a commercialization and IP standpoint, the investment case is driven by (1) how much time remains on Orange Book-protected brand exclusivity for the listed active/drug product, (2) whether generics can enter via bioequivalent products without crossing Hatch-Waxman barriers, and (3) how competitive the portfolio economics are given the depth of generic COC availability.

Bottom line: The brand’s forward revenue durability depends less on a long-running “biologics-style” protection model and more on the remaining term and breadth of drug product/formulation and/or method-of-use patents listed in the Orange Book, plus the likelihood and timing of ANDA approvals and market entry.

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What is Lo Loestrin Fe and what are the core commercial fundamentals?

What is the drug composition and dosing regimen?

Lo Loestrin Fe is a combined oral contraceptive tablet regimen containing:

• Norethindrone acetate (progestin): 1 mg
• Ethinyl estradiol (estrogen): 10 mcg
• Placebo/iron component: ferrous fumarate (commonly used to improve adherence; iron is not an active contraceptive)

Typical pack structure:

• 24 days of active hormone tablets (varies by labeled regimen formatting) and iron-containing inert tablets (label-dependent; marketed as an iron-containing COC)

Where does it sit in the contraceptive competitive set?

In the U.S., Lo Loestrin Fe competes in the crowded low-dose COC category where therapeutic differentiation is limited and brand pricing power depends on:

• patient and prescriber preference
• formulary positioning (PBM access)
• switching friction and adherence outcomes
• managed-care rebates and contracting

COCs are historically fast to face price pressure once generics are established.

Investment-relevant KPIs for a COC brand

For an investment view, the key drivers are:

• prescription volume and TRx growth/decline trajectory
• net revenue after rebates and chargebacks
• formulary share across major PBMs
• persistence and discontinuation rate (affects churn and refills)
• medical benefit offset is typically minimal for COC-only use, so ROI is mostly pharmacy economics

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What is the Orange Book status of Lo Loestrin Fe (active ingredient and drug product protection)?

What does Orange Book coverage typically look like for COCs?

For oral contraceptives, Orange Book protection often includes:

• active ingredient listing (base patent(s) on composition of matter)
• formulation patents (tablet composition, coating, stability, or manufacturing)
• method-of-use patents (less common for COCs, but not rare for specific regimens)
• certain drug product patents (processes, polymorph control, or bioavailability-related attributes)

How to read the Orange Book for investment timing

Investment decisions rely on:

• earliest expiration among listed patents for the specific dosage form and strengths
• whether patents are drug substance vs drug product
• whether patents are “blocking” Orange Book listings for ANDA approval (directly affecting Para IV/ANDA litigation incentives)

Exclusivity framing: Even if patents expire, exclusivity extensions (like marketing exclusivity) can delay generic approvals, though COC products often face generic entry primarily through patent and ANDA mechanisms rather than long standalone exclusivity.

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When does Lo Loestrin Fe lose exclusivity, and what is the expected ANDA entry window?

Core timing mechanics

Generic entry timing is a function of:

1. patent expiration dates on Orange Book
2. any 30-month stay triggered by a Paragraph IV ANDA challenge
3. whether final court outcomes delay effective date of generic launch
4. FDA ANDA approval timelines after settlement or resolution

Practical investment interpretation

• If multiple Orange Book patents remain near-term, the market should expect delayed ANDA launch or lower probability that early filers win.
• If only a narrow subset remains, generic entry can occur in waves, starting with the first successful ANDA.

For COCs, the investment risk is binary: once the brand loses meaningful patent protection, pricing compresses quickly due to high generic substitutability.

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What patents protect Lo Loestrin Fe, and how strong is the patent estate?

How to evaluate patent strength for a COC brand

A strong estate in this category typically means:

• multiple, overlapping Orange Book listings across drug product and formulation
• earlier-filed patents with long remaining life
• limited “easy workarounds” (such as simple reformulation or switching manufacturing approaches)

A weak estate typically means:

• patents are either near expiry or narrow in scope
• generic versions can design around without meaningful cost or risk
• only method-of-use claims remain and are hard to enforce against an ANDA product label

What makes Lo Loestrin Fe hard to differentiate legally

COCs share the same core actives (norethindrone acetate + ethinyl estradiol). That reduces scope for novel composition-of-matter claims unless a specific formulation or method-of-manufacture is protected.

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Which companies are challenging Lo Loestrin Fe via Paragraph IV, and what is the litigation landscape?

Why Paragraph IV matters for returns

A Paragraph IV filing signals:

• a generic’s belief that listed patents are invalid, unenforceable, or not infringed
• potential triggers for a 30-month stay
• the start of predictable generic launch waves after resolution

What to track in disputes

Investment-grade monitoring focuses on:

• first Paragraph IV filer identities
• whether settlements narrow the future entry window
• whether generic launch is delayed by court injunctions
• whether license agreements permit earlier launch for a subset of strengths

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What settlement agreements and licensing deals exist for Lo Loestrin Fe?

Deal types that change the investment thesis

For oral contraceptives, common deal forms include:

• “no license” settlements that allow a generic launch only after a negotiated date
• partial license terms by strength, dosage form, or pack configuration
• stipulations that limit launch timing or marketing claims

How deals impact valuation

• A settlement with a clear launch date shifts the risk from “litigation probability” to “schedule certainty.”
• A license that grants early commercial rights reduces litigation uncertainty but can cap brand revenue upside.

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What is the FDA regulatory status of Lo Loestrin Fe (approval pathway and current label posture)?

Approval pathway implications

Lo Loestrin Fe is an approved NDA product. For investor analysis, the practical concern is whether:

• ongoing label updates create additional method-of-use scope (which can affect infringement if patents cover labeled indications or dosing instructions)
• risk evaluation and mitigation strategies (REMS) apply (COCs usually have standard contraceptive risk communications)

Manufacturing and quality as an investment risk

For a mature brand, regulatory risks typically come from:

• post-approval manufacturing changes
• facility compliance
• stability or dissolution characteristics for tablets

These risks can affect supply and net revenue but are less likely than patent expiry to dominate the horizon.

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What generic entry risks exist for Lo Loestrin Fe?

Why COCs face fast commoditization

Once a generic is approved and the brand loses enforceable patent barriers, price competition can be swift because:

• prescribers can substitute based on equivalence and formulary rules
• payers prefer low net-cost options
• switching is relatively low friction compared with specialized injectables

Key entry scenarios to model

• Early ANDA success: generic launch well before later patent expirations if the remaining estate is narrow.
• Multiple staggered launches: different ANDAs win at different times for different pack configurations or label updates.
• Denial or design-around: generics may pivot manufacturing/process to avoid certain formulation claims.

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How does Lo Loestrin Fe compare with other low-dose oral contraceptives on patent and competitive risk?

Competitive comparison framework

Investors should compare:

• remaining patent life on the closest competitors in the low-dose COC segment
• the number of Orange Book listings per product (more listings can slow generic entry but do not always confer strong enforceability)
• the current rate of generic substitution in the PBM formulary mix

What usually differentiates brands in this class

• brand-specific adherence framing or discontinuation reduction messaging
• insurance coverage and contracting
• pharmacy stocking and switching patterns

These factors affect near-term revenue but do not generally extend beyond the period of enforceable IP.

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Is Lo Loestrin Fe biologic-like or subject to biosimilar risk?

Answer

No. Lo Loestrin Fe is a small-molecule oral contraceptive. Biosimilar frameworks do not apply, and the relevant competitive pathway is ANDA-based generic competition under Hatch-Waxman.

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Dosage form and manufacturing IP: what delivery/format matters for generic design-around?

Why tablet formulation patents can matter

Generic developers can face barriers if:

• the brand has patents on specific excipient systems
• coating and dissolution profiles are claimed
• manufacturing processes are protected in ways that are difficult to replicate

What matters for investors

• If remaining patents are mostly “drug product” and “formulation,” generic timing can be delayed more reliably than if only broad use claims remain.
• If the estate is narrow or late-filed with limited remaining life, design-around and quicker launches dominate.

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Revenue exposure model for a COC brand facing generic entry

Investment-relevant revenue mechanics

When generics enter:

• gross-to-net pricing compresses quickly
• market share shifts to the lowest net-price products
• brand volume typically drops sharply and only partially recovers through patient-specific use cases

How to structure the horizon

Model three phases:

1. Pre-expiry: brand stability with incremental volume changes tied to contracting cycles.
2. Patent sunset: accelerated demand run-rate if physicians stock or if payers re-optimize.
3. Post-launch: steep TRx decline and margin compression after generic substitution.

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Key Takeaways

• Lo Loestrin Fe’s investment case is primarily an IP-and-timing story under Hatch-Waxman, not a biosimilar or biologic-style contest.
• The decisive variable is the remaining Orange Book-protected patent and exclusivity clock for the specific drug product and strengths.
• Generic entry risk is high in the COC class once enforceable barriers lift, due to deep market substitutability and aggressive PBM-driven switching.
• Patent estate strength is evaluated by the number, type, and remaining term of Orange Book listings, plus the existence and outcome of any Paragraph IV disputes and settlements.

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FAQs

1. How do Paragraph IV settlements typically affect Lo Loestrin Fe generic launch dates?
2. What Orange Book patent categories (drug substance vs drug product vs method of use) are most likely to block ANDA approval for COCs?
3. What factors drive net price compression for oral contraceptives after generic entry?
4. Do label updates or new dosing language materially change Lo Loestrin Fe infringement risk?
5. What manufacturing or formulation changes most commonly enable design-around for tablet COCs?

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References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”). U.S. Food and Drug Administration.
2. FDA. Hatch-Waxman Drug Development and Patent Term Restoration Act: Paragraph IV ANDA overview. U.S. Food and Drug Administration.
3. U.S. Code. 21 U.S.C. § 355(j) (ANDA; Paragraph IV). Legal Information Institute, Cornell Law School.