HAILEY 1.5/30 Drug Patent Profile
When do Hailey 1.5/30 patents expire, and when can generic versions of Hailey 1.5/30 launch?
Hailey 1.5/30 is a drug marketed by Glenmark Speclt and is included in one NDA.
The generic ingredient in HAILEY 1.5/30 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.
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Questions you can ask:
- What is the 5 year forecast for HAILEY 1.5/30?
- What are the global sales for HAILEY 1.5/30?
- What is Average Wholesale Price for HAILEY 1.5/30?
Summary for HAILEY 1.5/30
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | HAILEY 1.5/30 at DailyMed |
Recent Clinical Trials for HAILEY 1.5/30
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Janssen Scientific Affairs, LLC | PHASE2 |
| Yale University | PHASE2 |
| University Hospital, Toulouse | Phase 1 |
Pharmacology for HAILEY 1.5/30
| Drug Class | Estrogen Progestin |
| Mechanism of Action | Estrogen Receptor Agonists |
US Patents and Regulatory Information for HAILEY 1.5/30
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glenmark Speclt | HAILEY 1.5/30 | ethinyl estradiol; norethindrone acetate | TABLET;ORAL-21 | 209297-001 | Jun 5, 2018 | AB | RX | No | No | ⤷ 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 |
HAILEY 1.5/30 Market Dynamics and Financial Trajectory
HAILEY 1.5/30 is a prescription generic oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg. The product competes in a mature, crowded market with limited patent protection, low switching costs and substantial price pressure. Product-level revenue is not publicly disclosed, so its financial trajectory is best assessed through market structure, generic pricing, prescription volume and manufacturer disclosures rather than standalone sales data.
What is HAILEY 1.5/30 and who markets it?
HAILEY 1.5/30 is a monophasic combined oral contraceptive. Each active tablet contains:
| Attribute | Details |
|---|---|
| Active ingredients | Norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg |
| Dosage form | Oral tablet |
| Therapeutic category | Combined hormonal contraceptive |
| FDA status | Prescription generic drug |
| Reference-product class | Norethindrone acetate and ethinyl estradiol tablets, 1.5 mg/30 mcg |
| Typical regimen | 21 active tablets followed by 7 reminder tablets, depending on package presentation |
| Primary commercial use | Prevention of pregnancy |
| Manufacturer/labeler | Mayne Pharma-related U.S. commercial labeling has been associated with the HAILEY product family |
The product is pharmacologically comparable to older branded and generic products such as Junel 1.5/30 and Microgestin 1.5/30 equivalents. Exact product ownership, labeler and distribution arrangements should be separated from the manufacturer of the finished dosage form. Generic pharmaceutical companies often use contract manufacturing, third-party logistics and pharmacy benefit manager channels.
FDA labeling identifies the product as a combination hormonal contraceptive and includes the class warnings associated with estrogen-containing contraceptives, including thromboembolic risk, smoking-related cardiovascular risk and contraindications for certain patients (DailyMed, 2024).
How large is the market for HAILEY 1.5/30?
The addressable market is the U.S. market for combined oral contraceptive pills, but HAILEY 1.5/30 captures only a small portion of that market. The product competes with:
- Other norethindrone acetate and ethinyl estradiol generics.
- Generic levonorgestrel/ethinyl estradiol, norgestimate/ethinyl estradiol and desogestrel/ethinyl estradiol products.
- Branded oral contraceptives, including products positioned around bleeding control, tolerability or packaging convenience.
- Long-acting reversible contraceptives such as intrauterine systems and implants.
- The progestin-only Opill, which received FDA approval for nonprescription use in 2023.
The market is demand-stable but product-fragmented. Contraception has recurring prescription demand, but individual generic products generally have limited pricing power. Prescribers and pharmacies can substitute among therapeutically equivalent products when payer formularies, wholesaler inventory or pharmacy purchasing economics change.
What drives HAILEY 1.5/30 prescription demand?
Demand is affected by:
- Continued use of oral contraception among reproductive-age patients.
- Formulary placement and generic substitution.
- Availability at retail pharmacies and mail-order channels.
- Patient preference for a 30 mcg ethinyl estradiol formulation.
- Prescriber familiarity with norethindrone acetate-based products.
- Competition from lower-dose estrogen products and progestin-only contraceptives.
- Patient movement to intrauterine devices, implants and injections.
The 30 mcg estrogen strength gives HAILEY 1.5/30 a defined position within the generic oral contraceptive market, but it does not create meaningful exclusivity. Similar formulations are widely available.
What is the financial trajectory of HAILEY 1.5/30?
HAILEY 1.5/30 is likely a mature, volume-driven generic product rather than a high-growth pharmaceutical asset. Its financial trajectory has four principal characteristics:
| Financial factor | Expected effect |
|---|---|
| Prescription volume | Provides recurring demand and a stable base |
| Net price | Constrained by generic competition and payer contracting |
| Gross margin | Vulnerable to price erosion, manufacturing cost and channel discounts |
| Revenue visibility | Low because product-level sales are not separately reported |
Neither the FDA nor public company filings generally disclose sales for an individual generic SKU such as HAILEY 1.5/30. Public financial disclosures typically aggregate women’s health products, generic products or U.S. pharmaceutical revenue. A standalone revenue estimate would therefore be speculative without prescription, unit, price and channel data.
What is the likely revenue pattern?
The likely pattern is:
- Initial launch or relaunch: higher price potential if supply is limited.
- Mature competition: declining average selling prices as additional suppliers enter.
- Stable volume phase: recurring prescriptions offset some price erosion.
- Portfolio-management phase: continued marketing only if contribution margin remains acceptable.
- Long-term outcome: low-to-moderate revenue with periodic volatility caused by shortages, supplier changes or payer decisions.
A generic contraceptive can remain commercially useful for many years even when unit pricing is low. The value is usually in portfolio breadth, pharmacy access and recurring demand rather than exclusivity.
When does HAILEY 1.5/30 lose exclusivity?
HAILEY 1.5/30 does not appear to have a meaningful product-specific exclusivity period comparable to a newly approved branded drug. Norethindrone acetate and ethinyl estradiol have been used in oral contraceptives for decades, and equivalent generic products are widely marketed.
The relevant exclusivity framework is therefore:
| Exclusivity type | Relevance to HAILEY 1.5/30 |
|---|---|
| New chemical entity exclusivity | Not relevant |
| Orphan-drug exclusivity | Not relevant |
| Pediatric exclusivity | No product-specific protection identified |
| New-drug approval exclusivity | Not relevant to this mature generic formulation |
| Generic 180-day exclusivity | No publicly established product-specific barrier identified |
| Patent-based exclusivity | No material Orange Book patent barrier apparent for the generic formulation |
The FDA Orange Book lists patents and exclusivity associated with approved reference products. Generic versions generally do not receive separate patent protection for the active ingredient simply because they carry a different trade name (FDA, 2024a).
What patents protect HAILEY 1.5/30?
No material HAILEY 1.5/30-specific patent estate is apparent from the public regulatory structure for this mature generic combination. The principal commercial protections are regulatory approval, manufacturing capability, distribution access and pharmacy substitution rather than composition-of-matter patents.
What formulation patents protect HAILEY 1.5/30?
The product may rely on formulation know-how covering excipient selection, compression, coating, stability and manufacturing controls. Those elements do not necessarily create enforceable market exclusivity. A formulation patent would need to be identified by patent number, owner, claims and expiration date before it could be treated as a commercial barrier.
No widely recognized formulation patent is associated with HAILEY 1.5/30 as a market-blocking asset. The formulation is technically conventional compared with modified-release, depot or complex biologic products.
What method-of-use patents protect HAILEY 1.5/30?
The product is used for contraception, an indication long associated with the active ingredients. No product-specific method-of-use patent is apparent as a meaningful barrier to generic substitution. The contraceptive indication is not a differentiated patented use for this product.
What is the Orange Book status of HAILEY 1.5/30?
HAILEY 1.5/30 is a generic prescription product rather than an innovator product with a commercial Orange Book patent estate. Its regulatory pathway is based on approval of an abbreviated new drug application and demonstration of pharmaceutical equivalence and bioequivalence to an approved reference product.
The practical Orange Book implications are:
- No branded-product patent listing gives HAILEY 1.5/30 a protected market.
- Generic competition is permitted once applicable regulatory requirements are met.
- Any Paragraph IV issue would generally arise from an ANDA applicant challenging patents listed for the reference product, not from a HAILEY-specific patent portfolio.
- The product’s market position does not depend on a 30-month stay or patent settlement.
Are there Paragraph IV challenges involving HAILEY 1.5/30?
No widely reported Paragraph IV dispute is associated with HAILEY 1.5/30 as a commercial product. This is consistent with the age of the active ingredients and the availability of numerous equivalent oral contraceptive products.
Paragraph IV litigation is more relevant to new branded contraceptive formulations, extended-release systems, transdermal products or products with recently listed patents. It has limited strategic relevance to a conventional norethindrone acetate and ethinyl estradiol generic unless a newly introduced formulation or manufacturing patent is asserted.
What generic entry risks affect HAILEY 1.5/30?
Generic entry risk is high in structural terms because the product already competes in a generic field. The principal risks are not a single future launch but continuous substitution by existing and potential suppliers.
Competitive risks
- Multiple suppliers can offer similar strengths and pack sizes.
- Pharmacy purchasing decisions can change quickly when one supplier offers a lower net price.
- Payers can move products between preferred and nonpreferred tiers.
- Retail shortages can redirect prescriptions to competing manufacturers.
- Wholesalers may reduce inventory of low-margin SKUs.
- Large generic companies can use portfolio discounts across several contraceptive products.
Regulatory and manufacturing risks
Manufacturing barriers are moderate rather than high. The active ingredients are established, but manufacturers must control:
- Assay and content uniformity at low-dose hormonal levels.
- Dissolution and stability.
- Tablet weight and blend uniformity.
- Cross-contamination controls for potent hormonal ingredients.
- Packaging integrity and shelf-life.
- Bioequivalence and consistent batch release.
These requirements can create operational risk but do not generally prevent well-capitalized generic manufacturers from entering the market.
What patent litigation affects HAILEY 1.5/30?
No major, widely reported patent litigation appears to affect HAILEY 1.5/30 directly. The litigation profile is therefore materially less complex than that of branded drugs with active formulation, delivery-system or method-of-use patents.
The more relevant legal risks are ordinary generic-product matters:
- Product liability claims relating to estrogen-containing contraceptives.
- Manufacturing or quality disputes.
- Regulatory warning letters or recalls.
- Contract disputes involving distributors, wholesalers or licensors.
- Advertising and labeling compliance.
These risks can affect earnings even when patent risk is limited.
Which companies compete with HAILEY 1.5/30?
Competition comes from manufacturers and labelers supplying equivalent or adjacent products. The competitive set includes companies active in generic oral contraceptives, such as:
| Competitive group | Examples of commercial positioning |
|---|---|
| Generic norethindrone acetate/ethinyl estradiol suppliers | Direct substitutes for the same strength |
| Generic levonorgestrel/ethinyl estradiol suppliers | Broad, heavily substituted oral contraceptive segment |
| Generic norgestimate/ethinyl estradiol suppliers | Alternative combined-pill regimen |
| Branded contraceptive companies | Differentiation through packaging, patient support or formulation |
| Long-acting contraceptive manufacturers | IUDs and implants with longer duration |
| Progestin-only manufacturers | Alternative for patients who should avoid estrogen |
The competitive landscape favors companies with reliable supply, broad pharmacy distribution, strong payer contracts and low manufacturing costs.
How does HAILEY 1.5/30 compare with newer contraceptive products?
| Dimension | HAILEY 1.5/30 | Newer branded or differentiated contraceptive |
|---|---|---|
| Active ingredient age | Mature | May include newer delivery or dosing approach |
| Patent position | Limited or absent | Potentially stronger |
| Pricing power | Low | Higher if clinically differentiated |
| Switching risk | High | Lower during exclusivity |
| Market access | Broad generic substitution | Formulary-dependent |
| Revenue profile | Volume-driven | Price and exclusivity-driven |
| Litigation exposure | Generally low patent risk | Potentially high patent risk |
| Manufacturing complexity | Conventional tablet | May be higher for devices, extended release or novel delivery |
HAILEY 1.5/30 can compete effectively on availability and cost, but it has little ability to defend market share through intellectual property.
What licensing deals are associated with HAILEY 1.5/30?
No major publicly disclosed licensing transaction is clearly tied to HAILEY 1.5/30 as an individual asset. Commercial rights may be distributed among the product labeler, contract manufacturer, wholesaler and pharmacy channels, but those arrangements are not usually disclosed at the SKU level.
Any value in a transaction involving the product would likely be attributed to a broader women’s health or generic portfolio rather than to HAILEY 1.5/30 alone.
What is the outlook for HAILEY 1.5/30?
The outlook is stable in demand but pressured in economics. The product has a durable therapeutic need, recurring prescription use and established regulatory status. Its constraints are generic price erosion, limited differentiation and broad substitution.
The most likely trajectory is:
- Stable or modestly fluctuating volume.
- Flat to declining net price over time.
- Periodic revenue increases if competitors experience shortages.
- Margin pressure from payer and wholesaler negotiations.
- Continued commercial viability if supply reliability and manufacturing costs remain favorable.
A sharp revenue increase would require an external event, such as competitor supply disruption, a portfolio acquisition, favorable formulary placement or a broader increase in oral contraceptive use. Patent-based upside is unlikely.
Key Takeaways
- HAILEY 1.5/30 is a mature generic combined oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg.
- Its market is recurring but highly competitive, with numerous generic and therapeutic substitutes.
- Product-level revenue and profitability are not publicly disclosed.
- The financial model is volume-driven and exposed to generic price erosion.
- No material HAILEY-specific Orange Book patent estate or Paragraph IV litigation profile is apparent.
- Formulation and manufacturing know-how may support supply quality but do not appear to create meaningful exclusivity.
- Competitive advantage depends on cost, availability, payer access and pharmacy distribution.
- Long-term revenue is more likely to be stable or gradually pressured than to show high-growth characteristics.
FAQs About HAILEY 1.5/30
Is HAILEY 1.5/30 a generic version of Junel 1.5/30?
Yes. HAILEY 1.5/30 belongs to the same norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg product class as Junel 1.5/30 and other therapeutically equivalent generics.
Does HAILEY 1.5/30 have patent protection?
No material product-specific patent protection is apparent from the public regulatory profile. The active ingredients and conventional tablet formulation have long histories of generic competition.
Can pharmacies automatically substitute another oral contraceptive for HAILEY 1.5/30?
Pharmacy substitution generally depends on state law, FDA therapeutic-equivalence status, prescriber instructions and payer rules. A pharmacy may substitute an equivalent product, but substitution between different active-ingredient combinations is not necessarily automatic.
Is HAILEY 1.5/30 exposed to the FDA’s over-the-counter contraceptive market?
Yes, indirectly. FDA approval of over-the-counter Opill expands access to a progestin-only oral contraceptive, but Opill is not the same active-ingredient combination as HAILEY 1.5/30. The products compete for some patients but have different estrogen-related clinical considerations.
What is the main investment risk associated with HAILEY 1.5/30?
The main risk is margin compression from generic competition, not patent expiration. Revenue can decline if competing suppliers lower prices, gain preferred formulary status or offer more reliable pharmacy supply.
References
-
DailyMed. (2024). Hailey 1.5/30: Norethindrone acetate and ethinyl estradiol tablet labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/
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U.S. Food and Drug Administration. (2023). FDA approves first nonprescription daily oral contraceptive. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
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U.S. Food and Drug Administration. (2024a). 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
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U.S. Food and Drug Administration. (2024b). Abbreviated new drug application process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda
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Mayne Pharma Group Limited. (2024). Annual report and investor disclosures. https://www.maynepharma.com/
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