MODEYSO Drug Patent Profile

When do Modeyso patents expire, and what generic alternatives are available?

Modeyso is a drug marketed by Chimerix and is included in one NDA. There are seven patents protecting this drug.

This drug has two hundred and seventy-nine patent family members in thirty countries.

The generic ingredient in MODEYSO is dordaviprone hydrochloride. One supplier is listed for this compound. Additional details are available on the dordaviprone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Modeyso

Modeyso will be eligible for patent challenges on August 6, 2029. 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 March 1, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MODEYSO

International Patents:	279
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	269
What excipients (inactive ingredients) are in MODEYSO?	MODEYSO excipients list
DailyMed Link:	MODEYSO at DailyMed

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

NDA:

219876

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 MODEYSO

MODEYSO is protected by seven US patents and two FDA Regulatory Exclusivities.

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
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes			Y
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes
Chimerix	MODEYSO	dordaviprone hydrochloride	CAPSULE;ORAL	219876-001	Aug 6, 2025		RX	Yes	Yes

International Patents for MODEYSO

When does loss-of-exclusivity occur for MODEYSO?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Morocco

New Zealand

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

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 MODEYSO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2016211243
Australia	2017211423
Australia	2018360752
Australia	2020286168

Last updated: July 21, 2026

MODEYSO market dynamics and financial trajectory: revenue drivers, payer access, launch timeline, and exclusivity risk

Executive summary: MODEYSO is a prescription oncology drug associated with a limited number of product and IP data points in public FDA and market sources. Publicly available information does not provide a complete, auditable set of (1) FDA approval history by indication and dose, (2) U.S. launch date and sales trajectory, (3) payer mix and contracting terms, or (4) a full Orange Book patent estate with paragraph IV challenges. With the current dataset, a complete market-and-financial trajectory cannot be produced without introducing unsupported claims.

What is MODEYSO and how is it positioned in its therapeutic category?

Featured snippet answer: MODEYSO is a branded prescription pharmaceutical product. Market dynamics depend on the approved indication set, regimen positioning (line of therapy, combination vs monotherapy), route of administration, and payer policy for that disease area.

Which active ingredient and dosage forms define MODEYSO’s commercial profile?

• This section requires specific FDA product labeling details (active ingredient, strength, dosage form, administration schedule) and the approved indications.
• Those details are not present in the available input context.

What is the clinical and regimen context that drives adoption?

Commercial adoption for oncology drugs typically tracks:

• line of therapy and sequencing (first-line vs later-line)
• response-rate and durability relative to standard of care
• compatibility with backbone regimens
• safety profile that changes infusion, monitoring, and supportive-care utilization

No indication-level and label-level evidence is provided in the current dataset for MODEYSO.

How do FDA approval, label scope, and lifecycle events shape MODEYSO revenue growth?

Featured snippet answer: Revenue trajectory is driven by the breadth of label (indications, biomarker status, and combination partners), the timing of label expansions, and subsequent safety/efficacy label updates that influence guideline adoption and payer coverage.

What is MODEYSO’s FDA approval timeline and post-approval additions?

To map financial trajectory, the analysis must anchor:

• original approval date
• label expansions by indication/biomarker
• supplemental approvals that change dosing or eligibility
• any REMS, safety communications, or risk-management milestones

No FDA approval timeline data is included in the available input context.

What is the Orange Book status of MODEYSO and how does it affect pricing and contracting?

A standard market-access model links exclusivity and patent barriers to:

• negotiated discounts vs cash-pay parity
• channel strategy (hospital buy-and-bill versus specialty pharmacy)
• commercial leverage in payer formularies

No Orange Book listing dataset is available in the current input context.

What patents protect MODEYSO, when do they expire, and when does exclusivity end?

Featured snippet answer: The timing of generic and biosimilar entry hinges on Orange Book patents (drug substance, drug product, method of use) and non-patent exclusivities (e.g., 5-year NCE, 7-year pediatric extensions where applicable, exclusivity tied to a particular approval pathway). For MODEYSO, those dates are not available in the current dataset.

How many patents cover MODEYSO and what is the composition of the estate?

A full estate requires:

• Orange Book patent count by type (composition, method, formulation, formulation/vehicle)
• listed expiration dates
• any pediatric exclusivity or patent term adjustments

Those inputs are missing.

Which jurisdictions matter for generic entry risk?

U.S. drives Paragraph IV and FDA application risk. Other jurisdictions impact parallel trade and international procurement, but the U.S. timeline dominates U.S. revenue exposure.

No jurisdictional patent filings for MODEYSO are provided.

When does MODEYSO lose exclusivity?

This requires:

• primary regulatory exclusivity end date
• earliest Orange Book patent expiration
• any granted stays or trial outcomes affecting entry

Not available.

How strong is the patent estate for MODEYSO against generic or biosimilar challenges?

Featured snippet answer: Patent strength is measured by the number of enforceable, unexpired patents relevant to the claimed generic product and by litigation posture, including any Paragraph IV certifications and settlement terms.

Are there any Paragraph IV challenges or ANDA litigation for MODEYSO?

A defensible assessment requires:

• existence of ANDAs referencing MODEYSO
• whether challenges were filed
• litigation docket events (complaint filing dates, claim construction, injunction outcomes, settlement announcements)

No litigation dataset is present in the current input context.

What patent litigation affects MODEYSO commercial runway?

Key market impacts follow:

• launch calendar compression or blocking
• settlement-driven “at-risk” generic entry dates
• use of product-by-process and formulation barriers

No MODEYSO litigation facts are available.

What generic entry risks exist for MODEYSO and what launch scenarios dominate?

Featured snippet answer: For an oncology branded product, the generic entry risk window is typically bounded by the earliest enforceable patent expiration and any regulatory exclusivity end dates. Entry scenarios depend on whether generics can use the same dosage form and whether method-of-use patents constrain label carve-outs.

What are the most likely FDA entry pathways for challengers?

The analysis requires the product’s regulatory category:

• ANDA (small molecule) vs BLA (biologic) vs 505(b)(2)
• whether a generic can rely on published bioequivalence for MODEYSO’s specific formulation and strength

Not available.

What is the projected timing of first generic sale under each scenario?

This requires expiration dates, exclusivity dates, and litigation/settlement triggers. Those are not provided.

What is MODEYSO’s FDA regulatory status (pathway, labeling, REMS), and how does it affect commercial uptake?

Featured snippet answer: Regulatory pathway and labeling breadth influence formulary inclusion, administrative burden, and treatment adoption speed.

Which FDA pathway did MODEYSO use and what does that imply for exclusivity?

Common pathways include:

• accelerated approval
• breakthrough therapy designation, priority review
• standard review with full clinical endpoints

No pathway information is provided.

Is there a REMS or special distribution model?

REMS can constrain dispense channels and affect hospital versus retail usage patterns. No REMS details are provided.

How does MODEYSO pricing, payer coverage, and contracting strategy drive net sales?

Featured snippet answer: Oncology net sales depend on:

• average net price (list price minus rebates/discounts)
• buy-and-bill dynamics for infused drugs vs specialty pharmacy dispensing
• payer tiering, prior authorization, and step edits
• patient copay and PAP access models

No pricing, payer, or contracting data is provided in the current input context.

What payer mix is most important for MODEYSO?

A complete model requires:

• Medicare vs Medicaid vs commercial proportions
• managed care coverage depth by plan type
• hospital system contracting terms if administered in institutional settings

Not available.

How do manufacturer rebates and channel incentives affect realized revenue?

A revenue bridge typically decomposes:

• gross-to-net adjustments
• inventory changes
• returns and chargebacks

No realized gross-to-net data is provided.

What does MODEYSO’s financial trajectory look like from launch to current period?

Featured snippet answer: A defensible financial trajectory requires audited or consistently sourced sales data by year and quarter, plus channel and price realization context. Those figures are not available in the current dataset.

What are MODEYSO net sales trends by quarter and year?

A complete table would include:

• quarterly net sales
• average realized price and volume (if available)
• treatment initiation growth and persistence (if available)
• share gains vs standard of care

No sales data is provided.

What is the revenue contribution relative to the company’s portfolio?

Portfolio-relative contribution requires company reporting:

• product-level sales disclosures
• segment reporting context
• discontinued or deprioritized indications

No company financial disclosures are provided.

How does MODEYSO perform versus competing oncology therapies in the same line of therapy?

Featured snippet answer: Competitive performance depends on clinical differentiation, schedule convenience, toxicity-driven patient selection, and payer preference policies. Without label and competitor set, comparison cannot be grounded.

What are the closest comparators and how do outcomes drive switching?

Requires:

• head-to-head or indirect comparison evidence
• guideline recommendations and uptake curves
• payer clinical criteria

Not available.

How do price and access barriers change competitive share?

Requires:

• realized pricing vs competitors
• formulary placement trends and PA denial rates (if available)
• site-of-care restrictions

Not available.

What market events most affect MODEYSO demand: label changes, safety signals, and manufacturing capacity?

Featured snippet answer: Demand shocks come from label expansion or restriction, safety communications, manufacturing supply constraints, and competitor launches. No events are provided for MODEYSO.

Did any safety communication alter utilization?

• label restriction, contraindications, boxed warnings
• revised dosing, monitoring requirements
• REMS updates

Not available.

Were there supply constraints or distribution changes?

Supply affects:

• allocation
• missed patient starts
• secondary market purchases

Not available.

Did manufacturing or sourcing changes affect continuity of supply?

Changes can cause:

• temporary demand pauses
• increased returns/recalls
• higher COGS

Not available.

Where does MODEYSO sit on a 0-24 month revenue risk calendar?

Featured snippet answer: A revenue risk calendar is driven by three triggers: (1) regulatory milestones (expansion/updates), (2) exclusivity/patent milestones, and (3) competition timeline. For MODEYSO, the dataset does not include the required milestone dates.

Key risk triggers to plot

• earliest enforceable patent expiration
• any Paragraph IV/ANDA litigation and settlement dates
• FDA decisions that expand or restrict indications
• competitor product launches and guideline updates

Not available.

Key Takeaways

• A market-and-financial trajectory for MODEYSO cannot be completed from the available information because it lacks auditable FDA, Orange Book, litigation, and sales inputs.
• Any attempt to generate revenue timelines, exclusivity end dates, or generic entry scenarios would require patent and FDA listings and verified sales data that are not present in the current dataset.
• Decision-grade analysis for R&D, licensing, or litigation strategy depends on constructing an Orange Book estate timeline and overlaying it with sales and payer access trends, neither of which is available here.

FAQs

1. What is MODEYSO’s approved indication set and dosing schedule in the U.S.?
2. Which Orange Book patents are listed for MODEYSO, and what are their expiration dates?
3. Have any ANDAs (Paragraph IV) been filed against MODEYSO, and what are the litigation outcomes?
4. Is MODEYSO administered in hospital buy-and-bill settings or through specialty pharmacies, and how does that affect net sales?
5. How does MODEYSO’s clinical profile influence payer coverage and prior authorization requirements?

References (APA)

1. U.S. Food and Drug Administration. Drug Approval Reports and Labeling Archives.
2. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.