LIFYORLI (COPACKAGED) Drug Patent Profile

When do Lifyorli (copackaged) patents expire, and when can generic versions of Lifyorli (copackaged) launch?

Lifyorli (copackaged) is a drug marketed by Corcept Therap and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and fifteen patent family members in twenty-five countries.

The generic ingredient in LIFYORLI (COPACKAGED) is relacorilant. One supplier is listed for this compound. Additional details are available on the relacorilant profile page.

DrugPatentWatch^® Generic Entry Outlook for Lifyorli (copackaged)

Lifyorli (copackaged) will be eligible for patent challenges on March 25, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2040. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LIFYORLI (COPACKAGED)

International Patents:	115
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIFYORLI (COPACKAGED)
DailyMed Link:	LIFYORLI (COPACKAGED) at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LIFYORLI (COPACKAGED)

Constraining patent/regulatory exclusivity:

11,464,764

NDA:

220641

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for LIFYORLI (COPACKAGED)

LIFYORLI (COPACKAGED) is protected by twenty US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,464,764.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	11,285,145
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	11,925,626		Y
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	10,456,392
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	12,514,849		Y
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	12,589,094
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	8,859,774		Y	Y
Corcept Therap	LIFYORLI (COPACKAGED)	relacorilant	CAPSULE;ORAL	220641-001	Mar 25, 2026		RX	Yes	Yes	11,576,907		Y	Y

International Patents for LIFYORLI (COPACKAGED)

When does loss-of-exclusivity occur for LIFYORLI (COPACKAGED)?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Denmark

European Patent Office

Finland

Israel

Japan

Mexico

New Zealand

Philippines

Poland

Portugal

Singapore

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LIFYORLI (COPACKAGED) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013266110	Heteroaryl-ketone fused azadecalin glucocorticoid receptor modulators
Brazil	112014028857	Moduldores de receptor de glucocorticóide de azadecalina fundida com heteroaril-cetona
Brazil	112015022109	dispositivo para determinar um sinal vital de um indivíduo, método para determinar um sinal vital de um indivíduo, e, programa de computador
Brazil	112015022112	dispositivo para determinar os sinais vitais de um indivíduo, método para determinar os sinais vitais de um indivíduo, programa de computador, e sistema para determinar os sinais vitais de um indivíduo
Canada	2872260	MODULATEURS DES RECEPTEURS DE GLUCOCORTICOIDES CONSISTANT EN AZADECALINES A HETEROARYLE CETONE FUSIONNE (HETEROARYL-KETONE FUSED AZADECALIN GLUCOCORTICOID RECEPTOR MODULATORS)
Chile	2014003173	Moduladores del receptor de glucocorticoides de azadecalina fusionada de heteroaril-cetona
China	104619328	杂芳基-酮稠合的氮萘烷糖皮质激素受体调节剂 (Heteroaryl-ketone fused azadecalin glucocorticoid receptor modulators)

Last updated: May 9, 2026

LIFYORLI (COPACKAGED): Market Dynamics and Financial Trajectory

LIFYORLI (copackaged) is a branded, copackaged pharmaceutical product with distribution and commercialization mechanics that depend on the branded label holder’s supply chain, wholesaler placement, payer contracting, and channel mix (acute vs. retail). The market outcome and financial trajectory hinge on three variables: (1) formulary access and rebate structure, (2) net price realization vs list price, and (3) supply stability and claim risk tied to copackaging execution. Without audited commercial figures and explicit payer/net price data, the financial trajectory cannot be computed from first principles from the patent record alone.

What market dynamics govern LIFYORLI (copackaged) commercialization?

Key dynamics that determine uptake, persistence, and revenue capture for a copackaged brand:

Dynamic	What it changes	What drives it for copackaged products
Formulary access	Patient volume and prescription fill	Restrictive access or tiering raises effective cost and delays penetration
Net price realization	Revenue per prescription	Rebates and discounts tied to channel and volume drive the gap vs list price
Channel mix	Revenue stability vs cyclicality	Hospital/IDN contracting vs outpatient retail changes pacing of demand
Supply execution	Continuity of therapy and claim denials	Packaging/labeling readiness and GMP release timing affect fills and substitution risk
Competition timing	Share erosion and price pressure	Follow-on entrants, label expansions, or payer switching policies reduce demand share

For copackaged offerings, payer contracting and distribution execution tend to be more sensitive than for single-component SKUs because copackaging requires matching supply of components, coordinated lot release, and packaging logistics that can create short-cycle shortages or shipping constraints. That translates into revenue volatility during supply shocks and during transitions between lot runs.

What does the competitive landscape typically do to pricing and share?

For branded pharmaceuticals with ongoing exclusivity through patent life and regulatory data protection, the competitive vector usually unfolds in layers:

• Direct label competitors (same indication, same patient population) constrain share via step-therapy, prior authorization, and tier placement.
• Therapeutic alternatives (same clinical endpoint through different mechanisms) cap net price realization by shifting payer leverage.
• Biosimilar or generic pressure (if applicable to product components or equivalent mechanisms) compresses pricing rapidly once exclusivity expires.

For copackaged brands, competition effects often show up first as changes in payer policy rather than immediate unit share loss. Net price typically declines earlier than unit volume because payers negotiate deeper discounts to maintain access.

Financial trajectory: what can be concluded from IP-driven commercialization signals?

A complete financial trajectory requires: revenue history by quarter, prescription volume, net price vs list price, rebate rate, and channel distribution. Those are not present in the patent-style data provided here, and there is no audited financial time series for LIFYORLI (copackaged) in the information available in this session.

Can a revenue path be modeled without revenue and net price inputs?

No. A drug’s revenue trajectory cannot be derived accurately from patent status alone because financial outcomes depend on commercialization execution and payer economics that are not inferable from IP records. The only robust “directional” statements that can be made without financial inputs are structural:

• Revenue is typically front-loaded when:
  • formulary access is broad,
  • the product avoids supply interruptions,
  • and prescribers adopt quickly.
• Revenue typically flattens when:
  • payer restrictions tighten,
  • rebate pressure increases,
  • and competition begins to displace share.
• Revenue typically declines when:
  • exclusivity ends or competitive entries expand,
  • or supply disruption causes missed fills and plan losses.

Those are general market laws, not an LIFYORLI-specific financial forecast.

Business implications: how to interpret market dynamics for investment/R&D decisions

Where value is created (and lost) in copackaged brands

Profit driver	Upside scenario	Downside scenario
Net price	Higher realized price through favorable formulary position and stable payer contracts	Rebate escalation and tier movement drive down net price even if gross demand holds
Volume	Stable supply and clinician adoption drive sustained prescriptions	Supply constraints or claim friction reduce fills and trigger payer switching
Retention	Low disruption sustains persistence	Dose interruption increases discontinuation and switches to alternatives

What to monitor to map trajectory to real-time signals

Even without revenue numbers, trajectory can be triangulated using leading indicators:

• Formulary list changes (tier movements, PA requirements, step therapy).
• Channel inventory and wholesaler fill rates (implied demand vs backorder-driven volatility).
• Supply continuity (GMP release timing, lot availability, and copackaged-kit readiness).
• Contracting behavior (rebate intensity and payer preferencing).

For LIFYORLI (copackaged), copackaging adds an extra checkpoint: whether the copackaged configuration remains continuously available at the pharmacy and hospital point of dispense.

Key Takeaways

• LIFYORLI (copackaged) market performance depends on formulary access, net price realization, channel mix, and supply execution, with copackaging logistics increasing sensitivity to continuity and claim risk.
• A specific financial trajectory (revenue curve, margin trajectory, or unit-to-net conversion) cannot be computed from the information available in this session because audited commercial and payer-economics data for LIFYORLI are not included.
• The actionable path is to track leading indicators tied to contracting, dispense continuity, and channel placement to infer whether demand is growing, stabilizing, or eroding.

FAQs

1. What makes copackaged drugs more sensitive to commercialization execution?
   They require coordinated component supply and packaging readiness, so disruptions can directly reduce fills and increase switching risk.

2. Do formulary actions usually impact unit volume or net price first?
   Net price often moves first as payers tighten contracting terms to maintain access before unit share erodes.

3. What are the highest-impact indicators of trajectory for a branded pharmaceutical without relying on revenue reports?
   Formulary tiering/PA changes, supply continuity, and channel fill rates provide the earliest market signals.

4. How does competition typically change the economics of branded therapy?
   It increases payer leverage for discounts and shifts patients to alternatives, compressing net price and eventually unit share.

5. What is the main reason financial trajectory cannot be inferred from patent status alone?
   Patent status does not determine net pricing, rebate structure, channel placement, or supply execution, which drive revenue outcomes.

References

[1] Bloomberg Law. (n.d.). Drug commercialization and market dynamics overview. Bloomberg.
[2] FDA. (n.d.). Prescription drug marketing and related regulatory information. U.S. Food and Drug Administration.
[3] CMS. (n.d.). Medicare Part D formulary and coverage policy guidance. Centers for Medicare & Medicaid Services.