When do the patents on HAILEY 24 FE expire, and when will HAILEY 24 FE go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	HAILEY 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	204847-001	Nov 17, 2017	AB	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 10, 2026

Hailey 24 Fe (ethinyl estradiol / norethindrone acetate / ferrous fumarate): investment scenario and fundamentals for manufacturers, investors, and IP stakeholders

Executive summary: Hailey 24 Fe is a branded combined oral contraceptive (COC) anchored to a long-running value chain of generic entry risk, ongoing formulary demand, and routine FDA product-cycle dynamics rather than high-IP breakthroughs. Investment fundamentals are dominated by (1) FDA-listed generic substitution and rebates, (2) patent estate strength in formulations and method-of-use, (3) regulatory lifecycle events (labeling changes, manufacturing changes, ANDA supply), and (4) litigation exposure that can shift timing for generic launches. For investors, upside is typically limited to incremental share gains, supply resilience, and any renewal of exclusivity-relevant IP; downside is largely driven by generic pricing and margin compression.

What is Hailey 24 Fe and how does it generate revenue today?

Hailey 24 Fe is a 24-day active COC regimen marketed in the United States. Like other COCs, revenue is driven by sustained contraceptive demand and payer coverage dynamics rather than breakthrough clinical differentiation.

Product and commercial mechanics

Therapeutic category: combined oral contraceptives (estrogen-progestin with iron placebo).
Core buyer behavior: generic substitution after patent or exclusivity barriers fall; pharmacy benefit manager (PBM) contracting and rebate structures determine net pricing.
Market structure: COC supply is broad, so sales are sensitive to:
- formulary tier placement,
- dispensing channel share (retail vs mail),
- wholesaler availability and backorders,
- net-to-gross economics under rebate pressure.

Fundamentals investors track for Hailey 24 Fe

Net price trend vs class comps (generic erosion tends to be fast once barriers fall).
Share stability in high-velocity plan formularies.
Gross margin resilience through supply stability and manufacturing cost control.
Switching costs for prescribers and patients (COC adherence and tolerability typically keep some branded share post-generic launch, but not enough to offset sustained rebate/generic pressure).

What patents protect Hailey 24 Fe and how strong is the patent estate?

For an investment scenario, the operative question is not “are there patents,” but “which patents can block an ANDA” and “when do they expire.” For COCs, patent estates often include a mix of:

formulation and composition patents (e.g., specific ratios, bead/tablet characteristics, coatings, dissolution profiles),
method-of-use or dosing regimen patents (sometimes less relevant because COC dosing can be considered conventional),
packaging or manufacturing method patents (often narrower enforcement).

How to assess “strength” for Hailey 24 Fe

A defensible patent estate typically needs at least one of the following:

a listed Orange Book “active” patent/section that is plausibly infringed by generic manufacturing,
a claims set that survives common obviousness/anticipation attacks,
enforcement history that leads to meaningful launch delay.

Investment implication: If the Orange Book listing is sparse or expiry is near, the branded lifecycle becomes an earnings-runoff story rather than an growth story.

What is the Orange Book status of Hailey 24 Fe?

Orange Book status is the gatekeeper metric for ANDA timing. The decisive dataset includes:

active patent list entries,
expiration dates by patent,
any exclusivity codes tied to reference product.

What investors need to know from Orange Book (mechanically)

Patent expiration dates (hard dates for generic viability).
Orphan exclusivity is unlikely for COCs, but other exclusivity types can apply.
Patent “scope relevance”: a patent listed but not realistically infringed by ANDA could be less protective than the listing implies.

When does Hailey 24 Fe lose exclusivity and what are the generic launch scenarios?

Base-case generic entry dynamics for COCs

In COCs, generic entry after barriers typically follows a predictable pattern:

ANDA filing window opens when patents/exclusivity permit.
FDA approval can be issued around the time of barrier expiry.
PBM contracting and pharmacy switch accelerate within 3 to 12 months.
Branded net revenue typically declines faster than unit sales because rebate pressure increases.

Generic launch scenarios investors model

Scenario A: Barrier holds longer (delayed ANDA approval).
Branded share is more stable; margin compression is slower; EBITDA runway extends.
Scenario B: Hard expiry with early Paragraph IV.
Generic launch can occur shortly after expiry; branded net price drops quickly.
Scenario C: Settlement-triggered launch timing.
A branded-to-generic settlement can add months to a year of delay depending on terms.

Investment implication: For portfolio decisions, model revenue with a non-linear drop in net price rather than a linear unit decline.

Do Paragraph IV challenges affect Hailey 24 Fe and how does that change timing?

For an ANDA filer, a Paragraph IV certification challenge is the key leverage point. For investors and brand holders, the key is whether challenges:

target patents with meaningful claim coverage,
create litigation injunction risk,
lead to settlement-based launch schedules.

What litigation outcomes matter for valuation

Dismissal or “no infringement” findings favor branded revenue retention.
Settlement can lock in a delayed generic launch date.
Loss in litigation can accelerate generic uptake.

Investment implication: A credible litigation pathway to delayed or prevented generic entry can materially extend cash flows for the brand.

What generic entry risks exist for Hailey 24 Fe?

Main risk vectors

Rapid class-level generic substitution once barriers fall.
Manufacturing readiness of ANDA suppliers (availability controls whether generic enters fully or partially).
Quality and compliance outcomes (FDA inspections can delay product launches and reshape competitive dynamics).
Labeling carve-outs that can affect interchangeability and patient switching.

Secondary risks

Market share loss from competitor COCs with favorable payer status.
Supply constraints in any single branded or generic supplier that can change near-term economics.

How does Hailey 24 Fe compare with other combined oral contraceptives on patent and competitive pressure?

Competitive reality for COCs

Most COCs face:

early generic availability in many SKUs,
ongoing competitive brand-to-generic churn,
dense pharmacy and PBM dynamics.

Practical comparative investment lens

Compare Hailey 24 Fe to class peers on:

time-to-next generic barrier event,
number of Orange Book listed patents,
whether the product has a durable niche (formulary placements, prescriber preferences, adherence advantages).

Investment implication: If peers have clearer or stronger barriers, Hailey 24 Fe’s relative valuation can compress due to earlier share erosion.

What formulations are protected by patents for Hailey 24 Fe (and do they block ANDAs)?

For COCs, formulation protection is often the most ANDA-relevant category when it involves:

specific tablet compositions,
stabilization technologies,
dissolution-rate targets,
manufacturing steps that create bioequivalence-sensitive attributes.

Typical enforcement logic

If a generic can demonstrate bioequivalence without copying the protected attribute, formulation patents can become harder to enforce.
If patents cover attributes that are directly copied or difficult to “design around,” they can have higher enforcement leverage.

Investment implication: The value of formulation IP is highest when it is both Orange Book-listed and claim-relevant to ANDA manufacturing.

What method-of-use or dosing regimen claims apply to Hailey 24 Fe?

COC method-of-use claims can be narrower than formulation claims. If claims are limited to:

dosing regimen timing,
specific therapeutic indications beyond contraception,
unique clinical protocols,

then enforcement becomes fact- and use-dependent. In practice, generic labels often align closely with approved COC contraception labeling, reducing infringement opportunities for method-of-use theories.

Investment implication: For valuation, formulation and manufacturing patents typically carry more impact than broad method-of-use claims for a COC product.

What FDA pathway and regulatory milestones drive Hailey 24 Fe’s product life?

Hailey 24 Fe is an FDA-approved drug product and is subject to the standard lifecycle of CMC updates, labeling supplements, and periodic manufacturing site maintenance.

Investor-relevant FDA milestones

Changes to manufacturing sites and FDA CMC supplement approvals.
Labeling updates tied to safety communication.
ANDA approvals by competitors (secondary data but directly impacts revenue).
Orange Book listing changes (additions/removals can shift investor assumptions about remaining barriers).

Which companies are likely competitors to Hailey 24 Fe, and where do they attack?

In COCs, competition comes from:

large generic manufacturers with broad ANDA portfolios,
other brand COCs with favorable payer status,
authorized generics or label-compatible competitors depending on the cycle.

Investment implication: Competitive pressure is rarely “one firm, one product.” It is usually class-wide, where multiple entrants hit the same payer contracts quickly after barriers fall.

What manufacturing/IP barriers can delay generic entry for Hailey 24 Fe?

Even when patents expire, practical barriers can delay generic uptake:

scale-up and validation of tablet attributes and dissolution profiles,
sourcing constraints for components,
regulatory compliance and inspection outcomes,
package configuration matching to reference product.

Investment implication: A “paper barrier” that is already expired can still create a lag due to CMC friction, but the lag is usually temporary.

What settlement agreements or licensing deals are common in COC generic entry, and how do they affect value?

Settlements in small-molecule generics frequently:

define a launch date,
include non-competition covenants for certain periods,
sometimes require royalty structures or “carve-outs” for specified product configurations.

Valuation mechanics

A settlement extends the branded cash flow runway by shifting the effective generic launch date.
It also reduces uncertainty and litigation costs, improving downside protection for investors.

Investment implication: The presence of a settlement generally increases the credibility of forecasted revenue survival until the agreed launch date.

What revenue exposure does Hailey 24 Fe have versus generic risk?

For investment analysis, exposure is a function of:

branded net sales concentration,
share of prescriptions that are likely to switch upon generic availability,
payer formulary elasticity,
any differentiating characteristics that reduce substitution speed.

How to structure the revenue model

Time-to-barrier-event (expiration + litigation/settlement delay).
Post-entry erosion curve (net price typically declines faster than units).
Competitive intensity (number of approved ANDAs and market penetration speed).

Investment implication: Branded COCs can retain some unit share, but net revenue typically compresses substantially after class substitution accelerates.

Key Takeaways

Hailey 24 Fe is a COC where generic entry timing and Orange Book barrier strength drive valuation more than incremental clinical value.
The investment case hinges on whether the patent estate meaningfully blocks ANDAs and on whether litigation/settlement history creates a credible effective launch delay.
Commercial fundamentals are dominated by PBM/formulary contracting and rebate dynamics, which can cause rapid net revenue erosion once barriers fall.
Generic risk is best modeled through scenarios tied to expiration, Paragraph IV outcomes, and settlement dates, not through linear assumptions.

FAQs

1) What happens to Hailey 24 Fe sales after generic approval even if patents still exist?

PBM placement and substitution can begin before full market penetration; competition may pressure net pricing even if full ANDA market rollout is later.

2) Do COC formulation changes from the brand holder affect generic design-around strategies?

CMC updates can change dissolution or tablet attributes, which can increase generic development friction, but only if they meaningfully affect bioequivalence-relevant characteristics and are reflected in regulatory filings.

3) How do Orange Book patent removals impact investment forecasts for Hailey 24 Fe?

Removals can signal narrowed enforceability or imminent expiry, often leading to faster reassessment of effective barrier dates and lower branded survival assumptions.

4) What is the typical timeline from patent expiry to meaningful branded margin compression for COCs?

Margin compression typically follows the first wave of substitution within months, with the steepest net price declines often occurring in the first 3 to 12 months after meaningful generic uptake.

5) Can COC litigation outcomes materially change market access for competitors?

Yes. Settlement terms and court decisions can shift effective launch dates, which can materially alter competitive intensity in specific formulary contracts.

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
U.S. Food and Drug Administration. Paragraph IV certifications and FDA ANDA review framework. https://www.fda.gov/ (FDA ANDA/Orange Book resources)

US Patents:	0
Applicants:	1
NDAs:	1

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Summary for HAILEY 24 FE