HAILEY 24 FE Drug Patent Profile

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Which patents cover Hailey 24 Fe, and when can generic versions of Hailey 24 Fe launch?

Hailey 24 Fe is a drug marketed by Glenmark Pharms Ltd and is included in one NDA.

The generic ingredient in HAILEY 24 FE is ethinyl estradiol; norethindrone acetate. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for HAILEY 24 FE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	HAILEY 24 FE at DailyMed

Recent Clinical Trials for HAILEY 24 FE

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

Sponsor	Phase
Yale University	PHASE2
Janssen Scientific Affairs, LLC	PHASE2
University Hospital, Toulouse	Phase 1

See all HAILEY 24 FE clinical trials

US Patents and Regulatory Information for HAILEY 24 FE

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

HAILEY 24 FE Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 23, 2026

Hailey 24 Fe is a low-dose combined oral contraceptive containing norethindrone acetate 1 mg, ethinyl estradiol 20 mcg, and ferrous fumarate placebo tablets. It is a generic version of the 24-active-tablet contraceptive formulation associated with Minastrin 24 Fe and competes with Taytulla, Mibelas 24 Fe, Blisovi 24 Fe, and other norethindrone acetate/ethinyl estradiol products.

The product’s commercial outlook is driven by generic pricing, payer formulary placement, pharmacy substitution, supply reliability, and the number of competing ANDA suppliers. Public filings do not disclose Hailey 24 Fe-specific revenue, prescription volume, gross margin, or market share. Its financial trajectory is therefore best assessed through product type, competitive density, manufacturer strategy, and the broader U.S. generic contraceptive market.

What is Hailey 24 Fe and how does it work?

Hailey 24 Fe is an oral hormonal contraceptive with 24 active tablets followed by four non-hormonal ferrous fumarate tablets. The active ingredients are norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. The product prevents ovulation and changes cervical mucus and the endometrium, consistent with the pharmacology of combined oral contraceptives. [1]

Attribute	Hailey 24 Fe
Active ingredients	Norethindrone acetate and ethinyl estradiol
Strength	1 mg / 20 mcg
Dosage form	Oral tablet
Regimen	24 active tablets plus four ferrous fumarate tablets
Therapeutic class	Combined hormonal contraceptive
Regulatory pathway	Abbreviated New Drug Application, or ANDA
Reference product family	Minastrin 24 Fe / related branded 24-day regimen
Primary market	United States
Biosimilar exposure	None
Main commercial competitors	Taytulla, Mibelas 24 Fe, Blisovi 24 Fe, other generic equivalents

The ferrous fumarate tablets are non-hormonal reminder tablets. They distinguish the product from 21-day contraceptive regimens and contribute to adherence positioning, but they do not create a biologic or manufacturing barrier comparable to those found in injectable or complex drug products.

What is the FDA regulatory status of Hailey 24 Fe?

Hailey 24 Fe is an FDA-approved generic oral contraceptive marketed under the ANDA pathway. ANDA approval requires the applicant to demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug rather than repeat the full clinical development program required for an innovator product. [2]

The regulatory characteristics are commercially important:

• FDA approval permits pharmacy substitution where state law and payer policy allow it.
• The product does not carry the clinical-development burden of a new contraceptive.
• The ANDA pathway allows multiple manufacturers to enter after applicable exclusivity and patent restrictions expire.
• Commercial differentiation depends primarily on price, supply continuity, contracting, packaging, and channel access.

Hailey 24 Fe is not a biologic. Biosimilar competition is therefore irrelevant. The relevant competitive threat is additional small-molecule generic entry.

What is the Orange Book status of Hailey 24 Fe?

Hailey 24 Fe itself is not expected to have a conventional Orange Book patent estate because ANDA products generally do not receive separate patent listings in the Orange Book. The Orange Book primarily lists patents and exclusivity associated with the reference listed drug and approved new drug applications. [3]

The relevant regulatory distinction is:

Issue	Hailey 24 Fe position
Standalone NDA patent listings	Not expected
ANDA product patent estate	Generally absent from the Orange Book
Patent strategy	Dependent on reference-product patents and applicant certifications
Pediatric exclusivity	No product-specific public indication identified
New chemical entity exclusivity	Not applicable
Generic approval pathway	ANDA
Paragraph IV exposure	Relevant during approval if reference-product patents remained listed

For a generic contraceptive, the practical patent question is whether reference-product patents remain enforceable and whether the ANDA applicant challenged them under Paragraph IV. A Paragraph IV certification states that a listed patent is invalid, unenforceable, or not infringed. The certification can trigger patent litigation and a potential 30-month stay of approval under the Hatch-Waxman framework. [4]

No product-specific public litigation record establishes that Hailey 24 Fe has an active, material Paragraph IV dispute affecting current commercialization. The commercial risk is therefore more likely to arise from routine generic competition than from a current patent injunction.

When did Hailey 24 Fe lose exclusivity?

Hailey 24 Fe did not possess new-drug exclusivity as a generic product. Any relevant exclusivity period would have attached to the reference product or to another applicant’s ANDA approval, not to Hailey 24 Fe as an independent branded innovation.

The product is commercially exposed to competition because:

1. The active ingredients are established small molecules.
2. The dosage form is a conventional oral tablet.
3. The product does not require a complex delivery device.
4. FDA approval can be obtained by multiple ANDA applicants.
5. Pharmacy and payer substitution can rapidly redirect volume to lower-priced suppliers.

The end of reference-product exclusivity does not create a single “patent cliff” for Hailey 24 Fe. Generic contraceptive markets usually experience progressive price erosion as manufacturers enter and contracts are rebid.

What patents protect Hailey 24 Fe?

No material standalone patent estate is publicly associated with Hailey 24 Fe as a generic product. The likely patent categories are those historically associated with the reference formulation:

• Composition patents covering the active hormonal combination.
• Formulation patents covering the 24-active-tablet regimen.
• Method-of-use patents covering contraception or premenstrual dysphoric disorder, where applicable.
• Packaging or dosing-regimen patents.
• Manufacturing patents involving tablet production, coating, or stability.

For a mature norethindrone acetate/ethinyl estradiol product, composition and basic method-of-use patents are less likely to provide durable protection than formulation, regimen, or manufacturing claims. Even where patents exist, their commercial value depends on claim scope, expiration, Orange Book listing, enforceability, and the number of non-infringing generic design-around options.

What formulations are protected by Hailey 24 Fe?

The product’s formulation has two commercial characteristics:

• Twenty-four hormonal tablets containing norethindrone acetate and ethinyl estradiol.
• Four ferrous fumarate tablets used as non-hormonal reminder tablets.

This regimen can support formulation or dosing claims, but it is not technically difficult to reproduce compared with extended-release systems, transdermal delivery, long-acting injectables, or drug-device combinations.

Potential manufacturing barriers include:

• Consistent low-dose hormone content uniformity.
• Control of tablet dissolution and stability.
• Prevention of cross-contamination during production.
• Packaging that protects tablet integrity and supports a 28-day regimen.
• Reliable sourcing of active pharmaceutical ingredients.

These requirements create quality-control obligations but are unlikely to produce a high barrier to entry for established oral-solid-dose manufacturers.

How strong is the patent estate for Hailey 24 Fe?

The patent estate is weak from Hailey 24 Fe’s perspective because the product is an ANDA generic rather than an innovator product with an independent patent portfolio.

Patent-strength factor	Assessment
Composition protection	Low for the generic product
Formulation protection	Possible at the reference-product level, but likely narrow or expired for core concepts
Method-of-use protection	Potentially relevant to reference products, not a durable Hailey asset
Manufacturing protection	Limited unless proprietary process claims apply
Biosimilar-style complexity	None
Design-around difficulty	Low to moderate
Litigation leverage	Limited absent an active patent dispute
Long-term exclusivity	Low

The product’s defensibility is commercial rather than patent-based. Supply contracts, pharmacy relationships, manufacturing economics, and product availability are more important than exclusivity rights.

Which companies compete with Hailey 24 Fe?

Hailey 24 Fe competes in a crowded oral contraceptive market. The closest competitors include other norethindrone acetate/ethinyl estradiol products with similar strengths and regimens.

Direct product competitors

• Taytulla, an innovator product associated with the same general 24-day hormonal regimen.
• Mibelas 24 Fe, a generic or authorized generic competitor.
• Blisovi 24 Fe, a widely distributed norethindrone acetate/ethinyl estradiol product.
• Other ANDA products sold through pharmacy, managed-care, specialty-distribution, and cash-pay channels.

The relevant market is broader than exact molecule-and-strength matching. Patients and prescribers may also switch to levonorgestrel/ethinyl estradiol, drospirenone/ethinyl estradiol, norgestimate/ethinyl estradiol, progestin-only pills, intrauterine systems, implants, and transdermal or vaginal delivery systems.

What is the financial trajectory for Hailey 24 Fe?

Hailey 24 Fe likely follows the standard mature-generic trajectory:

Commercial phase	Expected financial pattern
Initial launch	Higher price and potentially favorable gross margin if competition is limited
Early competition	Price reductions, rebate pressure, and share migration
Mature market	Stable but lower-margin volume business
Expanded competition	Contract losses, channel fragmentation, and possible supply rationalization
Manufacturer consolidation	Improved pricing if competitors exit or face shortages

Product-specific sales are not separately disclosed in the public financial reporting reviewed for the manufacturer. The absence of disclosed revenue means analysts should not treat company-level women’s-health or generic-pharmaceutical sales as Hailey 24 Fe revenue.

The product’s revenue exposure is likely modest relative to a branded contraceptive franchise. Generic oral contraceptives generally generate value through recurring prescriptions and distribution volume rather than high per-prescription pricing. Financial performance depends on:

• Number of approved competing products.
• Wholesale acquisition price.
• Medicaid and commercial-plan reimbursement.
• Pharmacy benefit manager contracts.
• Retail pharmacy substitution.
• Inventory availability.
• Cost of active ingredients and finished-dose manufacturing.
• Product recalls or quality events.
• Whether the manufacturer owns or outsources production.

A low-priced contraceptive can maintain strategic value even with limited revenue if it fills a portfolio gap, supports retailer relationships, or uses available manufacturing capacity. It can also become unattractive if net pricing falls below a sustainable contribution margin.

What generic entry risks exist for Hailey 24 Fe?

The main generic-entry risk is additional competition rather than a single later entrant. The product already operates as a generic, so each new approved ANDA can reduce price and volume.

Key risks include:

1. Contract displacement by a lower-cost supplier.
2. Retail substitution toward another equivalent product.
3. Formulary exclusion or preferred-tier changes.
4. Manufacturer shortages that shift demand temporarily but weaken long-term reliability.
5. API or packaging cost inflation.
6. Regulatory action involving manufacturing quality.
7. A branded competitor using copay support to retain commercially insured patients.
8. Patient switching to long-acting contraceptive methods.

The competitive risk is asymmetric. A shortage at another supplier can raise Hailey 24 Fe volume quickly, but such gains may reverse when supply normalizes.

What licensing deals affect Hailey 24 Fe?

No major publicly disclosed licensing transaction specific to Hailey 24 Fe establishes a separate revenue-sharing or royalty stream. Generic products can nevertheless involve commercial agreements covering:

• ANDA ownership and transfer.
• Contract manufacturing.
• Authorized-generic distribution.
• National pharmacy supply.
• Private-label sales.
• Product rights by territory.

Absent a disclosed product-specific agreement, the appropriate financial assumption is that Hailey 24 Fe is part of the manufacturer’s broader generic or women’s-health portfolio rather than a separately monetized licensed asset.

What patent litigation or settlement agreements affect Hailey 24 Fe?

No active, material patent litigation or settlement agreement is publicly established as a current constraint on Hailey 24 Fe commercialization. Historical disputes involving reference products or competing contraceptive formulations may have affected generic launch timing, but those proceedings should not be attributed to Hailey 24 Fe without a case-specific party, patent, and court record.

The absence of a known active case reduces legal uncertainty but does not eliminate ordinary product-liability, manufacturing-quality, regulatory, or commercial-contract exposure.

How does Hailey 24 Fe compare with branded Taytulla?

Factor	Hailey 24 Fe	Taytulla
Product type	Generic	Branded innovator
Regulatory pathway	ANDA	NDA
Price position	Lower	Higher
Patent dependence	Reference-product patent environment	Own NDA and listed-patent environment
Patient access	Substitution and formulary driven	Copay and brand-prescribing driven
Margin profile	Lower per unit, volume dependent	Higher potential price, higher commercial costs
Long-term risk	Generic price erosion	Generic substitution and patent expiry
Financial disclosure	Usually not product-specific	More likely to be included in branded portfolio reporting

Hailey 24 Fe has a structural price advantage but limited differentiation. Taytulla has stronger brand recognition and potential commercial support, while Hailey 24 Fe benefits from substitution and lower payer cost.

What is the geographic coverage of Hailey 24 Fe?

The publicly visible commercial footprint is primarily the United States. FDA approval, Orange Book status, and ANDA competition determine the U.S. market position. International rights should not be inferred from U.S. marketing.

A company may sell an equivalent formulation outside the United States under another trade name or through a separate regulatory filing. Those products can have different patent, regulatory, pricing, and reimbursement profiles.

What is the generic launch outlook for Hailey 24 Fe?

The most probable launch scenarios are:

• Base case: stable generic volume with continuing price pressure.
• Upside case: temporary share gains caused by competitor shortages, supply interruptions, or favorable payer contracting.
• Downside case: new ANDA entries, loss of a major pharmacy or managed-care contract, or manufacturing disruption.
• Strategic case: portfolio retention despite low margins because the product supports broader women’s-health distribution.

A durable price recovery would require competitor exits, supply constraints, or a meaningful change in channel economics. Patent-based price protection is unlikely to be the principal driver.

Key Takeaways

• Hailey 24 Fe is a generic combined oral contraceptive containing norethindrone acetate, ethinyl estradiol, and ferrous fumarate.
• It is exposed to generic substitution rather than biosimilar competition.
• The product has no meaningful standalone patent estate publicly associated with it.
• Orange Book and Paragraph IV issues principally concern the reference-product patent environment.
• Public filings do not disclose product-specific revenue, volume, or margin.
• Financial performance is likely driven by price, pharmacy contracts, supply reliability, and competitor count.
• The long-term trajectory is mature, recurring volume with gradual price erosion.
• Formulation and manufacturing barriers exist but are unlikely to prevent additional ANDA competition.
• The most material commercial upside is temporary share capture during competitor shortages or contract wins.
• The principal downside is further generic entry and lower net pricing.

FAQs

Is Hailey 24 Fe the same as Taytulla?

Hailey 24 Fe and Taytulla use the same general hormonal ingredients and 24-day active-tablet regimen, but they are marketed under different product identities and regulatory pathways. Hailey 24 Fe is a generic product, while Taytulla is a branded product.

Does Hailey 24 Fe have biosimilar competition?

No. Hailey 24 Fe is a conventional small-molecule oral contraceptive. Its competition comes from generic ANDA products, not biosimilars.

Can pharmacies automatically substitute Hailey 24 Fe for a branded contraceptive?

Substitution depends on FDA therapeutic-equivalence status, state pharmacy law, prescriber instructions, payer rules, and the dispensing pharmacy’s policies.

Is Hailey 24 Fe protected by a long-term patent?

No standalone long-term patent protection is publicly associated with Hailey 24 Fe as a generic product. Any relevant patent analysis must examine the reference product, listed patents, certifications, and litigation history.

What would increase the value of Hailey 24 Fe?

A shortage affecting competing products, improved payer access, a national pharmacy contract, reliable supply, or reduced generic competition could increase volume or net revenue. These effects would likely be commercial and temporary rather than patent-driven.

References

1. U.S. National Library of Medicine. (n.d.). Hailey 24 Fe: Norethindrone acetate and ethinyl estradiol tablets, ferrous fumarate tablets prescribing information. DailyMed.

2. U.S. Food and Drug Administration. (2024). Generic drug facts. FDA.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.

4. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. FDA.