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-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 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
Purdue Pharma LP	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

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

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

Last updated: June 22, 2026

LO LOESTRIN FE market dynamics and financial trajectory: pricing, volume drivers, exclusivity overhang, and competitive threats

LO LOESTRIN FE (ethinyl estradiol/norethindrone acetate with ferrous fumarate) sits in the U.S. oral contraceptive market where unit economics are driven by payer mix, generic penetration in legacy low-dose OCs, and formulary positioning versus brand and authorized generic alternatives. Financial trajectory in this class is typically constrained by (1) rapid price compression after generic entry, (2) high pharmacy benefit manager (PBM) influence on tiering, and (3) limited differentiation versus other combined oral contraceptives (COCs), including newer low-dose products and equivalent formulations.

What is LO LOESTRIN FE and what market does it compete in?

LO LOESTRIN FE is a combined oral contraceptive (COC) indicated for contraception and includes iron placebo tablets (ferrous fumarate). It competes in the U.S. oral contraceptive category dominated by multiple low-dose COCs across payers and retail channels.

How is the U.S. oral contraceptive market structured?

Oral contraception is characterized by:

• High baseline demand with steady prescription flows, but high substitution across equivalent COCs.
• PBM-driven formulary decisions that often relegate slow-moving brands to lower tiers or exclude them when therapeutically equivalent generics or authorized generics are available.
• Widespread patient switching between products when copays change or when prescribers are influenced by cost.

Who typically has leverage: prescribers, PBMs, or patient cost?

In oral contraceptives, PBMs and patient cost usually dominate:

• Formularies determine access and copay.
• Therapeutic equivalence enables switching without clinical barriers in most cases.
• Patient adherence is influenced by dosing schedule simplicity and brand preference, but not enough to prevent switching when economics deteriorate.

What drives LO LOESTRIN FE demand: contraception, cycle control, adherence, and payer mix?

Demand in COCs is shaped by three levers: medical need stability, adherence risk, and reimbursement.

Contraception demand is steady, but brands are exposed to substitutability

The core contraception indication produces consistent prescribing, but the market is exposed to substitution among COCs with equivalent hormone combinations and dosing schedules.

Breakthrough claims are limited by class norms

LO LOESTRIN FE differentiation is mostly dosing and the presence of iron placebo, with limited scope for durable premium pricing unless payer networks enforce brand-specific coverage.

Adherence and switching effects

Adherence tends to be stable for low-dose daily regimens, but persistence is sensitive to:

• Copay changes at renewal and reauthorization.
• Prior authorization triggers for brands.
• Pharmacy-level substitutions, including authorized generics.

How do LO LOESTRIN FE pricing and gross-to-net dynamics typically behave in this category?

Brand oral contraceptives usually experience:

• Initial pricing resilience around launch, then accelerated gross-to-net deterioration when generics or authorized generics expand.
• Higher rebates/discounting pressure as PBMs push brands into competitive tiers.
• Net price declines even when list price holds, driven by rebate intensity and contracting changes.

Net revenue pressure mechanisms

For a brand like LO LOESTRIN FE, net revenue typically declines through:

• Rebates tied to formulary placement.
• Increased demand loss when preferred generics displace brand usage.
• Contract renegotiations that harden after generic availability.

Why gross-to-net matters more than list price here

In oral contraceptives, list price can mask steep net-to-wholesale compression. Market participants focus on net sales, not sticker price, because PBM rebates and manufacturer incentives drive the outcome.

When do LO LOESTRIN FE patents and exclusivity end, and how does that translate into financial risk?

Brand COCs face financial cliff risk tied to generic launch timing and paragraph IV or authorized-generic strategy when applicable. The risk pattern is usually:

• A period of lower probability generic entry if patent protection and exclusivity block full substitution.
• Rapid market share erosion when generics launch, followed by further net sales compression as authorized generics and multiple ANDAs saturate.

What generic entry risks exist for LO LOESTRIN FE?

Financial risk is driven by:

• Whether the product has blocking patents or Orange Book-protected formulation/method-of-use claims.
• Whether an authorized generic is launched alongside the first ANDA, which accelerates net price compression.
• The number of approved ANDAs, which drives competition in wholesales and retail.

What is the typical post-entry financial trajectory?

In low-dose COCs:

• Brand unit share often declines quickly after first generic entry.
• Brand net sales compress more than units suggest because rebates and contracting worsen with competitive benchmarks.
• Remaining brand demand can be sustained in subsegments where payers keep a preferred brand tier, but these windows narrow quickly.

What is the Orange Book status of LO LOESTRIN FE?

No Orange Book dataset or listing set is provided in the prompt. Without the specific Orange Book entry (application numbers, listed patents, expiration dates, and exclusivity codes) it is not possible to produce a complete, accurate exclusivity and patent calendar for LO LOESTRIN FE in a way that supports litigation or launch-risk decisions.

Which companies compete with LO LOESTRIN FE, and how does competition affect revenue?

LO LOESTRIN FE competes primarily against:

• Therapeutically equivalent generics of the same or closely matched COC formulations.
• Other branded low-dose COCs with similar adherence profiles and payer contracting.
• Authorized generics that replicate brand economics but with lower pricing pressure on PBM tiers.

Competitive outcomes that move the financial needle

Two competitive dynamics matter most:

1. PBM tier changes that alter copay differentials.
2. Generic penetration that increases pharmacy substitution and reduces brand script capture.

How does competition translate into market share?

After generic entry, the brand’s share usually declines in layers:

• Early: formulary switching and scripts moved at renewal.
• Middle: substitution at pharmacy counter and new prescriptions routed to preferred generics.
• Late: fewer brand prescriptions except where coverage policies keep a brand option.

What does the LO LOESTRIN FE revenue trajectory likely look like?

For oral contraceptive brands, the common financial pattern is:

• Peak and stabilization post-launch while formulary access remains intact.
• Gradual net sales erosion as rebates rise and preferred generic options expand.
• Step-down around the first meaningful generic or authorized generic wave.
• Residual decline with remaining payer support and patient retention, often insufficient to restore premium economics.

Key financial sensitivities

The trajectory for LO LOESTRIN FE is particularly sensitive to:

• Timing of generic/authorized generic entry for therapeutically equivalent COCs.
• PBM contract renegotiations and rebate intensity.
• Dispensing channel mix between retail, mail, and 340B-influenced environments.

What role do FDA labeling, switching rules, and REMS play in financial outcomes?

Combined oral contraceptives typically do not face the kind of REMS constraints that block supply or limit access. Financial outcomes are instead driven by:

• Prescriber comfort with switching to equivalent products.
• Payer policies on “brand necessary” versus therapeutic interchange.
• Label nuances that influence payer tolerance for substitution.

How FDA labeling affects payer behavior

If labeling supports equivalent contraception and cycle control claims, payers tend to treat substitution as clinically acceptable. That increases the pace of market share erosion when generics enter.

How do manufacturing and supply considerations impact LO LOESTRIN FE financial performance?

In this category, supply chain disruptions can transiently shift demand to available products, but sustained financial lift is unlikely without formulary reversal or patent-based exclusion of competitors. For most COCs, manufacturing risk is usually secondary to pricing contracting.

What are the key market indicators to track for LO LOESTRIN FE?

High-value monitoring points:

• Prescription volume trends by brand vs generic.
• Net price and gross-to-net trend versus list price.
• Formulary status changes among top PBMs.
• Pharmacy claims distribution between retail and mail.
• NDA/ANDA approval and launch timing for equivalents.

What litigation or settlement agreements affect LO LOESTRIN FE?

No litigation or settlement dataset is provided in the prompt. Without identified dockets, patent numbers, or court filings tied to LO LOESTRIN FE, it is not possible to state whether Hatch-Waxman litigation exists, whether a settlement includes 180-day exclusivity waivers, or whether launch dates were delayed.

How does LO LOESTRIN FE compare with other low-dose COCs financially?

A proper comparison requires product-level financial disclosures (net sales by year), which are not included. In practice, comparisons in this class typically show:

• Brands with earlier generic exposure underperform versus later-introduced brands that retained coverage longer.
• Net sales divergence is driven more by contracting than by prescription counts, because PBM rebates and tiers compress margins quickly.

Key Takeaways

• LO LOESTRIN FE faces category-level economics typical of combined oral contraceptives: payer-driven contracting, rapid generic substitutability, and sharp net price compression when equivalents enter.
• Financial trajectory is governed less by clinical differentiation and more by formulary tiering, rebate intensity, and the timing of generic or authorized generic competition.
• Patent and Orange Book status, generic entry calendar, and litigation posture are the decisive variables for launch-risk and the timing of step-downs, but those details cannot be produced from the provided prompt.
• For high-stakes decisions, the actionable metrics are net sales trend, gross-to-net compression, formulary placement changes, and claims-based brand versus generic volume shifts.

FAQs

1. How fast do oral contraceptive brands like LO LOESTRIN FE lose market share after generic entry?
2. Which PBMs and payer channels most influence LO LOESTRIN FE net pricing?
3. Does authorized generic availability accelerate net revenue declines for LO LOESTRIN FE?
4. What formulation or dosing-schedule differences preserve brand coverage in low-dose COCs?
5. How should investors model LO LOESTRIN FE revenue around expected patent or exclusivity expirations?

References

No sources were provided in the prompt, and no Orange Book, FDA, litigation, or company financial disclosures were included; therefore, no compliant in-text citations or APA reference list can be generated.