Last Updated: August 8, 2026

CORTRIL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Cortril, and when can generic versions of Cortril launch?

Cortril is a drug marketed by Pfizer, Pfizer Global, and Pfipharmecs. and is included in four NDAs.

The generic ingredient in CORTRIL 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 Cortril

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

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CORTRIL?
  • What are the global sales for CORTRIL?
  • What is Average Wholesale Price for CORTRIL?
Summary for CORTRIL
Recent Clinical Trials for CORTRIL

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

SponsorPhase
Children's Oncology GroupPhase 1
National Cancer Institute (NCI)Phase 1
EsPhALL network I-BFM Study GroupPhase 3

See all CORTRIL clinical trials

US Patents and Regulatory Information for CORTRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer CORTRIL hydrocortisone acetate INJECTABLE;INJECTION 009164-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CORTRIL hydrocortisone TABLET;ORAL 009127-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer Global CORTRIL hydrocortisone OINTMENT;TOPICAL 009176-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer Global CORTRIL hydrocortisone OINTMENT;TOPICAL 009176-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfipharmecs CORTRIL hydrocortisone TABLET;VAGINAL 009796-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CORTRIL hydrocortisone TABLET;ORAL 009127-003 Approved Prior to Jan 1, 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 CORTRIL

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 26, 2026

Cortril (prednisolone) market dynamics and financial trajectory: sales drivers, pricing moves, and exclusivity risk

Executive summary. CORTRIL is a brand of prednisolone (marketed as cor­ticosteroid tablets). The financial trajectory is governed by (1) long-running generic availability and high payer substitution, (2) low incremental innovation risk because prednisolone is off-patent in most jurisdictions, and (3) periodic reformulations and pack-size/pricing adjustments rather than pipeline-driven value creation. Current market dynamics skew toward price erosion, stable low-to-mid single digit unit demand, and intermittent competitive pressure from generic-only portfolios.

What is CORTRIL and what active ingredient drives its market position?

Featured snippet: CORTRIL is a prednisolone brand. Its commercial fate tracks the chronic and acute use patterns of systemic corticosteroids and payer tolerance for low-cost generics.

Therapeutic class and usage

Cortril (prednisolone) is used across multiple inflammatory and immune indications, typically for:

  • Autoimmune and inflammatory conditions
  • Allergic and respiratory exacerbations
  • Hematologic and oncologic supportive regimens (in combination protocols)
  • Systemic inflammatory flares where rapid anti-inflammatory action matters

Market share is more sensitive to formulary placement and tender pricing than to clinical differentiation.

Dosage forms and dosing breadth

The breadth of prednisolone dosing (multiple tablet strengths in most markets) tends to:

  • Reduce branded differentiation
  • Increase the feasibility of switching across strengths
  • Intensify unit price pressure during tender cycles

Why does CORTRIL face persistent price erosion from generics?

Featured snippet: Prednisolone is widely generic. CORTRIL’s branded revenue usually depends on remaining supply chain strength, contract retention, and brand-specific tender wins rather than on exclusivity.

Brand versus generic economics

Key dynamics that keep branded CORTRIL exposed:

  • Therapeutic equivalence: same API (prednisolone) as generics
  • Substitution ease: pharmacy and wholesaler substitution are straightforward
  • Payer behavior: formularies and tenders favor lowest acquisition cost

Pricing and contracting patterns

Commercial outcomes typically hinge on:

  • Hospital and clinic tender rounds for steroid tablets
  • National reimbursement rules that set reference pricing against generic benchmarks
  • Switching thresholds by payer type (public payer formularies vs private insurance plans)

How strong is the patent estate for CORTRIL and how does that affect revenue?

Featured snippet: Prednisolone brands generally do not retain broad primary exclusivity. Revenue trajectories are usually driven by post-approval protections (if any) and then by generic substitution.

What usually remains after primary API expiration

In markets where prednisolone is off-patent, remaining protection commonly comes from:

  • Secondary formulation patents (specific excipients, dissolution or stability improvements)
  • Manufacturing process claims
  • Packaging or dosage regimen claims

These seldom block market entry long-term for a legacy steroid unless claims are tightly scoped or litigation changes entry timing.

Practical implication for CORTRIL financial trajectory

Even where some secondary patents exist, commercial impact typically appears as:

  • Short-term retention of branded revenue
  • Gradual margin compression rather than a single-step revenue collapse
  • Contract-based losses that accelerate once reference pricing tightens

When does CORTRIL lose exclusivity and what timing drives generic entry?

Featured snippet: CORTRIL loses exclusivity when any remaining formulation protection ends. For prednisolone, that timing is typically far in the past in most major markets.

Generic entry triggers that affect the financial curve

Where entry occurs after remaining protections lapse, the revenue pattern typically shows:

  • Pre-entry: stable or slowly declining branded unit volumes while payers prepare switch
  • Entry year: sharp drop in brand share, partially offset by price cuts and contract renegotiation
  • Post-entry: long tail of branded residual demand (non-medical switching, physician preference in certain settings, or supply continuity)

How do payer formularies and reference pricing shape CORTRIL unit sales and margins?

Featured snippet: Formulary tier and reference pricing usually determine CORTRIL margin more than demand.

Public payer systems

In many countries, reference pricing compresses branded acquisition cost advantages quickly. Expected effects:

  • Faster brand-to-generic switching
  • Lower net prices versus list prices
  • Reduced branded gross margin

Private payer systems

Private markets often show:

  • Higher initial brand persistence via inertia or product familiarity
  • Event-driven declines around tender renewals and PBM formulary updates

What is the competitive landscape for CORTRIL, and who replaces it when price drops?

Featured snippet: Competitors are typically generic prednisolone brands and pack-size variants.

Competitive mechanics

  • Multiple generics can enter with minimal clinical differentiation.
  • Supply reliability matters because corticosteroids are used in episodic care and chronic regimens.
  • The lowest net-price supplier wins most tender economics.

How competition affects the financial trajectory

Competition usually produces:

  • Declining average selling price (ASP)
  • Share shifts to the lowest-cost generics
  • Reduced marketing leverage for legacy brands

How does CORTRIL compare with other systemic corticosteroids on commercial resilience?

Featured snippet: Prednisolone brands are exposed to the same switching pressure but compete in a crowded systemic steroid category.

Key differentiators that affect economics

Even within systemic corticosteroids, branded resilience can vary based on:

  • Route of administration (oral vs injectable)
  • Indication fit and dosing convenience
  • Availability in preferred tablet strengths
  • Local reimbursement rules by active ingredient

For oral prednisolone products like CORTRIL, the main resilience lever is usually cost and supply continuity, not patent protection.

What financial indicators typically track CORTRIL performance (sales, net price, and volume)?

Featured snippet: CORTRIL performance is best monitored by net price index and volume share, not by premium pricing.

Sales drivers

  • Chronic inflammation and autoimmune patient flows (stable base demand)
  • Acute flare usage (quarterly variability)
  • Supply stability and tender outcomes

Margin drivers

  • Net price vs reference pricing
  • Contract mix (hospital tenders vs retail pharmacies)
  • Introduction of lower-priced generic packs

Observed revenue shape for legacy oral corticosteroids

Typical curves in generics-dominated brands:

  • Multi-year erosion rather than abrupt collapse (unless a major market switch occurs in one tender)
  • Stable underlying units with falling branded revenue
  • Lower profitability over time due to price and procurement pressure

What generic entry risks exist for CORTRIL, and what barriers delay substitution?

Featured snippet: The main barriers are procurement and contract timing, not clinical differentiation.

Regulatory and manufacturing barriers

Generic entry is usually feasible when:

  • API and bioequivalence standards can be met
  • Manufacturing scale and stability controls are sufficient for prednisolone tablets

Barriers that can delay entry in practice:

  • Local regulatory review backlogs
  • GMP inspection issues
  • Tight supply in certain strengths or pack sizes

Market barriers

  • Existing hospital formularies may require administrative switching periods.
  • Contract negotiations can extend branded supply duration.

What does the FDA and Orange Book status imply for CORTRIL-type prednisolone products?

Featured snippet: If CORTRIL is not an FDA-listed brand with Orange Book exclusivities, FDA exclusivity is not a relevant revenue driver.

In the US, legacy oral corticosteroid brands with no meaningful exclusivity typically face routine generic substitution once approvals clear.

How do settlement agreements and Paragraph IV litigation affect CORTRIL revenue?

Featured snippet: For broadly generic APIs like prednisolone, Paragraph IV litigation is not typically the primary driver of branded revenue for a long-established product.

Where disputes exist, they are usually tied to:

  • Specific formulation patents
  • Narrow manufacturing methods
  • Rarely, new combinations or pediatric exclusivity related to label expansions

For a legacy steroid brand, litigation effects are often limited in scope and duration relative to reference pricing dynamics.

Commercial strategy for the next 12–24 months: how brands like CORTRIL defend revenue

Featured snippet: Defense is contract-led and margin-led, not innovation-led.

Tactics that matter

  • Maintain formulary presence in chronic and hospital settings
  • Optimize pack sizes and tender readiness to avoid supply loss
  • Price to reference benchmarks rather than list price

Tactics that usually underperform

  • Large promotional spend without differentiation
  • Claims that do not change payer behavior

Key Takeaways

  • CORTRIL is a prednisolone brand, so its market trajectory is dominated by generic substitution rather than patent-led exclusivity.
  • Financial performance typically follows price erosion and contract/tender dynamics more than growth.
  • Revenue resilience is usually supply and formulary retention, with margins compressing as reference pricing and lowest-cost generics prevail.
  • Generic entry risk is structurally high in most jurisdictions for oral prednisolone products, with timing driven by procurement and administrative switching rather than clinical or therapeutic differentiation.

FAQs

  1. How do reference pricing policies affect branded prednisolone tablets like CORTRIL?
  2. Do hospital tender cycles cause abrupt versus gradual revenue declines for legacy oral corticosteroids?
  3. What packaging and tablet strength factors most influence generic substitution in prednisolone?
  4. How should investors model revenue for off-patent steroid brands under generic dominance?
  5. What leading indicators best forecast branded volume loss for generic-dominated products like CORTRIL?

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
  2. IMS Institute (or IQVIA where applicable). Pharmaceutical market trends and generic penetration analyses.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.