Last Updated: June 9, 2026

H-CORT Drug Patent Profile


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When do H-cort patents expire, and what generic alternatives are available?

H-cort is a drug marketed by Pharm Assoc and Torch and is included in three NDAs.

The generic ingredient in H-CORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for H-cort

A generic version of H-CORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Questions you can ask:
  • What is the 5 year forecast for H-CORT?
  • What are the global sales for H-CORT?
  • What is Average Wholesale Price for H-CORT?
Summary for H-CORT
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,465
DailyMed Link:H-CORT at DailyMed

US Patents and Regulatory Information for H-CORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc H-CORT hydrocortisone CREAM;TOPICAL 086823-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharm Assoc H-CORT hydrocortisone LOTION;TOPICAL 086824-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Torch H-CORT hydrocortisone POWDER;FOR RX COMPOUNDING 087834-001 Mar 29, 1982 DISCN 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

EU/EMA Drug Approvals for H-CORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185Treatment of adrenal insufficiency in adults. Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal
Last updated: June 7, 2026

H-CORT market dynamics and financial trajectory (pricing, volume, revenue, and competitive pressure)

H-CORT is a corticosteroid product with market dynamics dominated by (1) formulary positioning across hospital and outpatient channels, (2) competitive pressure from established steroid generics and branded alternatives, and (3) reimbursement volatility driven by payer preferred-lists and substitution policies. A reliable financial trajectory cannot be produced from the information provided because H-CORT is a non-unique drug name used across multiple jurisdictions and dosage forms, with potentially different products, manufacturers, and supply chains.

What is H-CORT and what drug product is it (active ingredient, dosage form, strength)?

No market-sizing or financial trajectory can be stated without an unambiguous identification of the exact H-CORT product, including active ingredient, strength, dosage form (oral, injectable, topical, ophthalmic, inhaled), route of administration, and manufacturer. “H-CORT” is not uniquely tied to a single FDA/NDA/BLA listing, an Orange Book entry, or a single global marketed product.

Which corticosteroid products are commonly confused with H-CORT?

Common categories that can be conflated under nonproprietary or brand-like labels include hydrocortisone, prednisolone, methylprednisolone, triamcinolone, and dexamethasone, each with distinct market pricing, utilization patterns, and payer behavior.

Why formulation and route drive the financial curve

A steroid’s financial trajectory varies materially by:

  • Site of care: emergency/hospital IV use vs outpatient oral vs chronic topical
  • Clinical role: acute anti-inflammatory vs maintenance therapy
  • Competitive base: branded originator vs generic-heavy classes
  • Regulatory status: FDA-listed drug approvals vs non-U.S. distribution

What patents and exclusivity affect H-CORT pricing power?

A patent/exclusivity view is required to model pricing durability, but a complete patent estate cannot be mapped because the exact H-CORT product identity is not specified. Without the precise active ingredient and dosage form, Orange Book status, exclusivity periods, and likely generic entry timing cannot be derived.

When does H-CORT lose exclusivity, and what does that do to revenue?

Exclusivity loss timing is product-specific, driven by:

  • NDA approval date and 5-year/3-year exclusivity triggers
  • Patent expiration and any relevant 505(b)(2) or ANDA exclusivity
  • Patent litigation/settlements that can shift launch dates

No exclusivity timeline can be established without the correct H-CORT regulatory record.

How many generics can launch H-CORT, and what are the generic entry risks?

Generic entry risk depends on:

  • Whether the product is protected by formulation or method-of-use patents
  • Whether there are FDA Orange Book listings that create Paragraph IV exposure
  • Whether the dosage form is formulation-sensitive (suspensions, ophthalmics, injectables)

No defensible count of launch-ready competitors can be provided without the exact H-CORT listing.

What is the Orange Book status of H-CORT?

Orange Book status requires an unambiguous FDA product identifier (active ingredient, dosage form, strength, applicant, and NDA/ANDA linkage). The provided prompt does not include these identifiers, so Orange Book mapping cannot be completed.

What FDA regulatory pathway does H-CORT use (NDA, ANDA, 505(b)(2))?

Regulatory pathway drives:

  • approval pathway barriers for new entrants
  • interchangeability and substitution in pharmacy reimbursement
  • post-approval safety and labeling changes that affect demand

No pathway can be assigned without the correct application record.

Which companies manufacture and distribute H-CORT, and how does that shape supply and pricing?

Manufacturing base and distribution agreements determine:

  • procurement leverage by group purchasing organizations
  • national vs regional availability
  • exposure to shortages or supplier concentration

No manufacturing/distribution network can be compiled without the exact product.

How does H-CORT compare with competing corticosteroids on cost, access, and utilization?

A comparative market model requires:

  • the specific comparator set (e.g., hydrocortisone vs prednisolone vs methylprednisolone)
  • route-of-administration comparability
  • strength equivalence rules used by formularies

The prompt does not identify H-CORT’s active ingredient or route.

What drives demand for H-CORT (indications, site-of-care, and clinical substitution)?

Corticosteroid demand shifts with:

  • guideline position by indication
  • substitution rules between steroid agents and formulations
  • hospital protocol standardization
  • payer coverage policies and step edits

No indication mapping can be completed without the exact product label.

How does reimbursement affect H-CORT margins (payer preferred lists, substitution rules, tender behavior)?

Reimbursement dynamics for generics are typically shaped by:

  • contracting with wholesalers and IDNs
  • PBM formulary status
  • tender purchasing cycles
  • competitive bidding at the national and local levels

A margin trajectory cannot be produced without verified channel-level pricing and payer mix for the exact product.

What is the financial trajectory for H-CORT (revenue, growth rate, unit sales, price changes)?

A financial trajectory requires at least one of:

  • manufacturer-reported sales by product and period
  • reliable third-party sales estimates by NDC/strength/formulation
  • public filings tying product revenue to the correct identity

Because H-CORT is not uniquely identified here, no revenue or unit-sales series can be compiled without risking conflating multiple different products that share the same label.

Key Takeaways

  • H-CORT’s market dynamics are governed by corticosteroid competitive structure, formulary access, and reimbursement-driven substitution.
  • A credible financial trajectory requires unambiguous product identity (active ingredient, route, strength, dosage form, and regulatory listing).
  • The provided prompt does not contain enough information to produce accurate market sizing, pricing benchmarks, or revenue timelines.

FAQs

  1. How can I determine whether H-CORT is hydrocortisone, prednisolone, or another corticosteroid from the label?
  2. What data fields (NDC, NDA/ANDA, dosage form) are required to pull H-CORT sales estimates accurately?
  3. Do hospital tender cycles or PBM preferred lists typically drive corticosteroid price declines faster?
  4. How do formulation-specific hurdles (injectable sterility, ophthalmic viscosity) affect generic entry for steroid products?
  5. What indicators show an impending generic launch or settlement for a corticosteroid product like H-CORT?

References

No sources were cited because the exact identity of H-CORT (active ingredient, dosage form, strength, manufacturer, and regulatory record) is not provided.

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