Last Updated: May 11, 2026

HAILEY 1.5/30 Drug Patent Profile


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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 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.

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  • What is the 5 year forecast for HAILEY 1.5/30?
  • What are the global sales for HAILEY 1.5/30?
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Summary for HAILEY 1.5/30
Recent Clinical Trials for HAILEY 1.5/30

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

SponsorPhase
Yale UniversityPHASE2
Janssen Scientific Affairs, LLCPHASE2
University Hospital, ToulousePhase 1

See all HAILEY 1.5/30 clinical trials

Pharmacology for HAILEY 1.5/30
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen 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 Analysis and Financial Projection

Last updated: May 5, 2026

HAILEY 1.5/30: Market dynamics and financial trajectory

What is HAILEY 1.5/30 and how is it positioned?

No complete, verifiable public dossier details were provided in the prompt for “HAILEY 1.5/30” (e.g., generic name, active ingredients, strength basis, dosage form, marketing authorization holder, territories, launch dates, NDC/ATC codes, or sales figures). Without those identifiers, a market dynamics and financial trajectory analysis cannot be produced accurately.

Which product economics inputs are required to model market dynamics?

A defensible financial trajectory requires, at minimum, product-specific identifiers and the market context inputs below. These were not included and cannot be reliably inferred from the label alone.

Input needed Why it drives dynamics Typical sources
Active ingredient(s) and drug class Determines demand drivers, reimbursement tier, and competitive set Regulatory labels, ATC/INN listings
Dosage form and regimen (including “1.5/30” meaning) Determines target patient population and interchangeability SmPC/label, prescribing info
Authorization geography (country/region) Determines pricing controls, tender dynamics, and uptake EMA/FDA/other regulators
Launch timeline and switches (brand to generic, reformulation) Drives unit growth and price erosion Launch announcements, payer policies
Pricing and reimbursement (list price, net price, rebate structure) Determines revenue and margin trajectory National tariffs, payer formularies
Market size and share by channel Determines distribution-driven growth vs substitution IMS/other market audits
Competitive landscape and patent status Determines premium vs erosion timing Patent registers, legal filings
Substitution rules (generic/biosimilar, interchangeability) Governs volume share shifts Pharmacy benefit rules
Sales history (units and value) Enables trend, seasonality, and forecast calibration Company reports, market data vendors

What market dynamics typically move revenue for branded pharma products?

Absent the drug identity and geography, the only accurate statement is that HAILEY 1.5/30’s revenue path will be governed by the interaction of:

  • Net price vs. volume (rebates, tender discounts, payer step edits)
  • Channel mix (institutional vs retail; private vs public procurement)
  • Competitive replacement pressure (therapeutic alternatives, generics, class competition)
  • Formulary access timing (initial inclusion vs subsequent tier migration)
  • Safety and adherence effects (label limitations, persistence)
    These are universal dynamics, but mapping them to HAILEY 1.5/30 requires the missing product-specific facts.

Can a financial trajectory be calculated for HAILEY 1.5/30 from available information?

No. A financial trajectory requires numeric baseline sales, pricing, and market-share evidence by geography and time. The prompt does not provide any of those figures, and the product cannot be uniquely identified to pull authoritative sales data.

What would a complete financial trajectory deliver for an investment/R&D decision?

A complete deliverable would include, by territory and channel:

  • Revenue curve (annual and quarterly) with unit and price decomposition
  • Margin and rebate sensitivity (net sales vs gross, reimbursement changes)
  • Share and penetration (new starts, persistence, substitution impacts)
  • Milestone timeline (launch, formulary wins/losses, competitor entries)
  • Regulatory or legal inflection points (label expansions, patent cliffs, ANDA/Biosimilar events)
  • Forecast tied to explicit drivers and constraints (capacity, distribution, payer rules)

Key Takeaways

  • A market dynamics and financial trajectory analysis for “HAILEY 1.5/30” cannot be produced accurately because the product is not uniquely identifiable from the information provided.
  • Reliable revenue modeling requires drug identity, authorization geography, launch history, pricing/reimbursement, and historical sales data. None are present in the prompt.

FAQs

  1. What does “HAILEY 1.5/30” refer to?
    The prompt does not specify the active ingredient(s), dosage form, or regulatory identity.

  2. Which markets should be analyzed?
    The prompt does not specify countries or regions where HAILEY 1.5/30 is marketed.

  3. How do pricing and rebates affect the financial trajectory?
    Net revenue depends on reimbursement rules and rebate/tender structures, which are not provided.

  4. What competitive factors typically drive share loss or growth?
    Therapeutic alternatives, generics, and formulary access determine share shifts, but the competitive set cannot be identified without the drug’s specifics.

  5. What inputs are required to forecast revenue?
    Historical units, net price, market size, payer penetration, and competitor entry timing are required, and none are supplied.

References

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