HAILEY FE 1/20 Drug Patent Profile

Which patents cover Hailey Fe 1/20, and what generic alternatives are available?

Hailey Fe 1/20 is a drug marketed by Glenmark Pharms Ltd and is included in one NDA.

The generic ingredient in HAILEY FE 1/20 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.

Summary for HAILEY FE 1/20

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	206
DailyMed Link:	HAILEY FE 1/20 at DailyMed

Recent Clinical Trials for HAILEY FE 1/20

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

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

See all HAILEY FE 1/20 clinical trials

US Patents and Regulatory Information for HAILEY FE 1/20

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 FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	206597-001	Nov 21, 2017	AB	RX	No	No

Hailey Fe 1/20 Market Dynamics, Patent Status, Competition and Financial Trajectory

Last updated: August 3, 2026

Hailey Fe 1/20 is a low-dose combined oral contraceptive containing norethindrone acetate 1 mg, ethinyl estradiol 20 micrograms, and ferrous fumarate placebo tablets. The product is a generic equivalent of Microgestin Fe 1/20 and competes in a highly commoditized U.S. oral contraceptive market. Its commercial value depends primarily on formulary access, pharmacy distribution, pricing, manufacturing cost and supply reliability rather than patent exclusivity.

Public filings do not disclose standalone revenue, prescription volume or gross margin for Hailey Fe 1/20. The product is reported within broader pharmaceutical portfolios, so its financial trajectory cannot be isolated from company-level disclosures.

What is Hailey Fe 1/20 and how does it work?

Hailey Fe 1/20 is an oral contraceptive indicated for the prevention of pregnancy. Each active tablet contains:

Component	Amount
Norethindrone acetate	1 mg
Ethinyl estradiol	20 mcg
Ferrous fumarate tablets	75 mg each, inactive reminder tablets

The standard package contains 21 active tablets followed by seven ferrous fumarate tablets. The iron tablets do not provide contraceptive activity. Their principal commercial function is to maintain a daily tablet-taking routine during the hormone-free interval. The FDA-approved labeling identifies the product as an oral contraceptive and includes the class warnings associated with combined estrogen-progestin contraception, including thromboembolic, cardiovascular and smoking-related risks.[1]

Hailey Fe 1/20 is a low-estrogen formulation compared with products containing 30 or 35 micrograms of ethinyl estradiol. Its main competitive attributes are established clinical use, generic pricing and availability through retail and mail-order pharmacies.

Who manufactures Hailey Fe 1/20?

Hailey Fe 1/20 has been marketed in the United States by Mayne Pharma Inc. The product has been listed under Mayne Pharma’s U.S. prescription portfolio and is distributed through the U.S. pharmaceutical supply chain.

The product should be distinguished from similarly named products:

Product	Hormonal ingredients	Form
Hailey Fe 1/20	Norethindrone acetate 1 mg / ethinyl estradiol 20 mcg	21 active plus seven ferrous fumarate tablets
Hailey 24 Fe	Norethindrone acetate 1 mg / ethinyl estradiol 20 mcg	24 active plus four ferrous fumarate tablets
Hailey 1.5/30	Norethindrone acetate 1.5 mg / ethinyl estradiol 30 mcg	Higher-dose combined oral contraceptive
Microgestin Fe 1/20	Norethindrone acetate 1 mg / ethinyl estradiol 20 mcg	Reference product historically associated with the formulation

The 21/7 regimen and the 24/4 regimen are not interchangeable from a packaging or dosing perspective, even though both contain the same estrogen and progestin strengths in certain products.

What is the FDA regulatory status of Hailey Fe 1/20?

Hailey Fe 1/20 is an FDA-approved prescription drug marketed as a generic oral contraceptive. It is approved through the abbreviated new drug application pathway, which requires the applicant to demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug rather than repeat the full clinical development program required for a new chemical entity.[2]

The regulatory profile is mature:

Regulatory element	Status
FDA pathway	Abbreviated New Drug Application
Prescription status	Prescription-only
Therapeutic category	Combined hormonal contraceptive
Active ingredients	Norethindrone acetate and ethinyl estradiol
Ferrous fumarate	Inactive reminder tablets
Reference-product relationship	Generic equivalent to Microgestin Fe 1/20
Biosimilar pathway	Not applicable
New chemical entity exclusivity	Expired or not applicable
Pediatric exclusivity	No product-specific strategic relevance identified

Because Hailey Fe 1/20 is a small-molecule generic, biosimilar competition is not relevant. Competitive entry occurs through abbreviated applications and generic substitutions rather than through the biosimilar licensing pathway.

What patents protect Hailey Fe 1/20?

No meaningful active patent moat protects the basic Hailey Fe 1/20 formulation. The active ingredients, norethindrone acetate and ethinyl estradiol, have been used in oral contraceptive products for decades. The product’s commercial protection is therefore based on regulatory approval, manufacturing capability, customer contracts and distribution rather than composition-of-matter patent rights.

A current Orange Book review is the controlling source for listed patents and exclusivity associated with FDA-approved products.[3] The relevant commercial conclusions are:

Patent question	Assessment
Active-ingredient patent	Expired historical technology
Formulation patent	No material active patent barrier identified for the basic 1/20 21/7 product
Method-of-use patent	No meaningful product-specific barrier identified
Orange Book patent leverage	Limited
Paragraph IV risk	Low strategic significance because the product is already generic
Patent-based launch blocking	Not a principal market risk

What formulation patents protect the product?

The product’s formulation is commercially important but not strongly differentiated from competing generic oral contraceptives. Its relevant technical elements are:

• A low-dose estrogen and progestin combination.
• Conventional oral tablets.
• A 21-day active-tablet regimen.
• Seven ferrous fumarate reminder tablets.
• Standard packaging and labeling for daily contraceptive use.

These features are generally reproducible by other generic manufacturers. A company could seek protection for a novel delivery system, dosage regimen or manufacturing process, but the conventional Hailey Fe 1/20 product does not depend on those protections.

When does Hailey Fe 1/20 lose exclusivity?

Hailey Fe 1/20 did not have a durable period of branded market exclusivity comparable to a new chemical entity. Its economic exclusivity was effectively absent once multiple FDA-approved generic equivalents entered the norethindrone acetate/ethinyl estradiol market.

The exclusivity timeline is best understood as follows:

Period	Market condition
Historical branded era	Oral contraceptive ingredients developed and commercialized decades ago
Generic entry period	Multiple abbreviated applications became possible after reference-product protections expired
Current period	Mature generic market with limited patent-based protection
Future outlook	Continued price and access competition; no patent cliff expected

A generic launch scenario for a new entrant would not require overcoming a substantial active patent estate. The key constraints would be FDA approval, manufacturing validation, supplier qualification, inventory availability, pharmacy-channel access and payer contracting.

Which companies compete with Hailey Fe 1/20?

Hailey Fe 1/20 competes with both direct generic equivalents and therapeutic alternatives. The relevant competitive set includes products containing the same hormonal ingredients, different norethindrone/ethinyl estradiol strengths, other combined oral contraceptives and nonoral methods.

Direct generic competition

Direct competitors may include generic versions marketed under manufacturer or distributor labels for:

• Norethindrone acetate and ethinyl estradiol 1 mg/20 mcg.
• Norethindrone acetate and ethinyl estradiol 1 mg/20 mcg with ferrous fumarate.
• Microgestin Fe 1/20-equivalent products.
• Blisovi Fe 1/20-equivalent products.
• Junel Fe 1/20-equivalent products.

The precise set of currently available suppliers can change through product discontinuations, NDC changes, wholesaler decisions and temporary shortages. FDA’s Orange Book and DailyMed provide the controlling product-level records.[2][3]

Therapeutic competition

Hailey Fe 1/20 also competes with:

• Levonorgestrel/ethinyl estradiol products.
• Desogestrel/ethinyl estradiol products.
• Norgestimate/ethinyl estradiol products.
• Drospirenone/ethinyl estradiol products.
• Progestin-only pills.
• Transdermal patches, vaginal rings, injectables, implants and intrauterine systems.

Long-acting reversible contraceptives compete for clinical preference and prescription budgets, while low-cost oral contraceptives compete for price-sensitive patients and payer formularies.

How strong is the patent estate for Hailey Fe 1/20?

The patent estate is weak from a business-protection perspective. The product has three structural characteristics that limit patent value:

1. The active ingredients are old.
2. The dosage form is a conventional tablet.
3. Generic substitution is permitted once FDA therapeutic-equivalence requirements are met.

The defensible assets are operational rather than patent-based. These include supplier relationships, validated manufacturing processes, packaging capacity, quality systems, pharmacovigilance records and customer access. Those assets can delay or complicate entry, but they do not prevent a capable generic company from competing.

What is the Orange Book status of Hailey Fe 1/20?

The Orange Book is relevant because it identifies FDA-approved products, therapeutic-equivalence evaluations, listed patents and exclusivity information. For Hailey Fe 1/20, the commercial interpretation is that Orange Book status supports generic substitution and does not establish a significant product-specific patent barrier.[3]

A Paragraph IV certification would matter mainly for a new abbreviated applicant challenging a listed patent connected to a reference product. It is not a central litigation issue for an established generic such as Hailey Fe 1/20 unless a later entrant confronts a newly listed patent covering a specific formulation, labeling approach or manufacturing process.

What patent litigation affects Hailey Fe 1/20?

No major product-specific patent litigation is a central driver of Hailey Fe 1/20’s market outlook. The product is not an innovative branded medicine with a high-value patent estate, and no major settlement structure is publicly associated with the basic formulation.

Litigation risk is more likely to arise from:

• Generic manufacturing disputes.
• Trademark or trade-dress claims.
• Product liability claims.
• Supply and distribution contracts.
• Patent disputes involving a competing formulation or delivery system.
• Regulatory enforcement or manufacturing-quality issues.

These risks differ from the patent litigation profile of high-revenue specialty drugs, where Paragraph IV challenges can determine billions of dollars in launch timing.

What is the financial trajectory for Hailey Fe 1/20?

Standalone financial data are not publicly reported. Mayne Pharma’s public disclosures report revenue by broader business segments and product portfolios rather than providing a separate income statement for Hailey Fe 1/20.[4]

The product’s financial trajectory can nevertheless be characterized:

Financial driver	Expected effect
Generic price erosion	Negative
Prescription volume	Supports recurring demand
Contraceptive category demand	Positive
Formulary access	Critical
Manufacturing scale	Important for margin retention
Product differentiation	Limited
Patent protection	Minimal
Supply reliability	Can create temporary upside
Retail and mail-order distribution	Necessary for volume
Promotional spending	Typically modest relative to branded drugs

Hailey Fe 1/20 is more likely to generate stable, low-to-moderate portfolio revenue than high-margin growth. Demand for oral contraception is recurring, but generic pricing limits revenue expansion. Unit growth can be offset by lower net prices, wholesaler discounts, payer rebates and pharmacy substitution.

The strongest financial scenario is a supply-constrained market in which a reliable manufacturer maintains availability while competitors experience shortages or discontinuations. The weakest scenario is a fully supplied market with several therapeutically equivalent products competing for the same formulary position.

What licensing deals affect Hailey Fe 1/20?

No major publicly disclosed licensing transaction appears to define the economics of the basic Hailey Fe 1/20 product. Generic oral contraceptives are commonly commercialized through manufacturer, distributor and private-label arrangements, but those agreements may not be separately disclosed.

Potential commercial arrangements include:

• Contract manufacturing.
• Product supply agreements.
• Wholesale distribution agreements.
• Private-label marketing.
• Pharmacy-benefit and payer arrangements.
• Portfolio acquisitions involving multiple products.

These arrangements can affect net revenue and margins without changing the product’s FDA approval or patent status.

What generic entry risks exist for Hailey Fe 1/20?

Generic entry risk is high because the product has limited differentiation and no substantial patent barrier. A new entrant could compete through lower pricing, broader wholesaler coverage, more reliable supply or preferred payer placement.

The principal risks are:

• Additional ANDA approvals.
• Price compression.
• Loss of formulary positions.
• Pharmacy substitution toward lower-cost equivalents.
• Manufacturing interruptions.
• Active-ingredient or excipient supply constraints.
• Product discontinuation by the marketer.
• Regulatory action tied to quality or labeling.

The main barrier is execution. Oral contraceptive tablets require consistent pharmaceutical quality, validated processes, reliable packaging and compliance with FDA current good manufacturing practices. These are meaningful requirements but are common capabilities among established generic manufacturers.

How does Hailey Fe 1/20 compare with branded contraceptives?

Factor	Hailey Fe 1/20	Branded oral contraceptive
Price	Generally lower	Generally higher
Patent protection	Limited or expired	May be active
Promotion	Limited	Potentially significant
Formulary role	Cost-control option	Differentiation-dependent
Revenue durability	Volume-driven	Price and exclusivity-driven
Generic substitution	Expected	Depends on product status
Litigation exposure	Usually lower	Can be substantial
Margin profile	Sensitive to competition	Higher if protected

Hailey Fe 1/20’s commercial position is strongest when payers prioritize low acquisition cost and patients prefer a familiar combined oral contraceptive. Its position is weaker when a pharmacy benefit manager has several equivalent norethindrone/ethinyl estradiol products available at lower net prices.

What geographic markets matter for Hailey Fe 1/20?

The product is primarily a U.S. market asset. FDA approval, Orange Book listing, NDC distribution and U.S. pharmacy substitution rules determine its domestic commercial position.

International revenue should not be assumed. Other countries may use different brand names, regulatory dossiers, labeling requirements, reimbursement systems and contraceptive guidelines. The U.S. market remains the relevant jurisdiction for assessing Hailey Fe 1/20’s FDA status, Orange Book position and generic-entry exposure.

Key Takeaways

• Hailey Fe 1/20 is a generic combined oral contraceptive containing norethindrone acetate 1 mg and ethinyl estradiol 20 mcg, followed by ferrous fumarate reminder tablets.
• Its principal commercial reference is Microgestin Fe 1/20.
• The product has no meaningful composition-of-matter or formulation patent moat.
• Paragraph IV litigation, biosimilar competition and patent settlements are not major drivers of its current outlook.
• Revenue and profit are not publicly disclosed on a standalone basis.
• The market is mature, price-sensitive and dependent on formulary access, distribution and supply reliability.
• The most important risks are additional generic entry, price erosion, manufacturing disruption and product-level portfolio rationalization.
• The likely financial profile is stable recurring demand with limited pricing power and modest growth potential.

FAQs

Is Hailey Fe 1/20 the same as Microgestin Fe 1/20?

It is a generic equivalent with the same core hormonal strengths: norethindrone acetate 1 mg and ethinyl estradiol 20 mcg. The FDA-approved labeling, inactive ingredients, packaging and manufacturer can differ.

Does Hailey Fe 1/20 have an authorized generic competitor?

Generic equivalents may be marketed under several manufacturer or distributor labels. An authorized-generic determination requires product-specific FDA and manufacturer records and should not be inferred from similar brand names.

Can Hailey Fe 1/20 be substituted automatically at the pharmacy?

Substitution depends on state law, the product’s FDA therapeutic-equivalence rating, prescriber instructions and payer or pharmacy policies.

Is Hailey Fe 1/20 vulnerable to a patent-based generic launch?

The basic product has limited patent-based protection. A new entrant’s principal hurdles are FDA approval, manufacturing, supply and commercial access.

Does the ferrous fumarate in Hailey Fe 1/20 treat iron deficiency?

No. The ferrous fumarate tablets are reminder tablets in the contraceptive regimen and are not intended to function as a therapeutic iron-replacement product.

References

1. U.S. Food and Drug Administration. (n.d.). Hailey Fe 1/20: Norethindrone acetate and ethinyl estradiol, and ferrous fumarate tablets prescribing information. DailyMed.

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

4. Mayne Pharma Group Limited. (2024). Annual report 2024. Mayne Pharma Group Limited.