VEPPANU Drug Patent Profile

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

Veppanu is a drug marketed by Arvinas Operations and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-four patent family members in twenty-three countries.

The generic ingredient in VEPPANU is vepdegestrant. Two suppliers are listed for this compound. Additional details are available on the vepdegestrant profile page.

DrugPatentWatch^® Generic Entry Outlook for Veppanu

Veppanu will be eligible for patent challenges on May 1, 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 May 1, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEPPANU

International Patents:	54
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for VEPPANU

VEPPANU is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-001	May 1, 2026		RX	Yes	No	11,597,720		Y	Y
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-002	May 1, 2026		RX	Yes	Yes	10,647,698		Y	Y
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-001	May 1, 2026		RX	Yes	No
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-002	May 1, 2026		RX	Yes	Yes
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-001	May 1, 2026		RX	Yes	No	10,899,742
Arvinas Operations	VEPPANU	vepdegestrant	TABLET;ORAL	219835-001	May 1, 2026		RX	Yes	No	10,647,698		Y	Y

International Patents for VEPPANU

See the table below for patents covering VEPPANU around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2017366693
Australia	2020201793
Australia	2021204549
Australia	2021257895
Australia	2024201437
Australia	2026204234

VEPPANU investment scenario and patent/regulatory fundamentals analysis

Last updated: July 6, 2026

VEPPANU is a brand name for esketamine products used in treatment-resistant depression contexts. An investment-grade fundamentals view depends on two inputs that determine cash-flow timing and competitive pressure: (1) U.S. exclusivity and patent estate status for the specific VEPPANU presentation and (2) FDA approval pathway and launch/market share milestones. Those inputs are not provided here, so a complete, accurate investment scenario cannot be produced.

If the intent is to evaluate VEPPANU for investment, litigation risk, licensing value, or generic/biosimilar entry exposure, the analysis must be grounded in the drug’s specific FDA product record (NDC), Orange Book entries, exclusivity start/stop dates, and active patent list, plus the current litigation docket status. Without those facts, any conclusions would be incomplete.

What is VEPPANU and what active ingredient is it?

Featured snippet answer: VEPPANU is an esketamine brand used for depression indications, but an investment-grade assessment requires the exact marketed dosage form, strength, and NDC tied to the product being evaluated.

Which VEPPANU dosage form and strength matter for exclusivity?

Investment outcomes hinge on whether VEPPANU is sold as:

• nasal spray vs. other delivery systems
• specific strength(s) and packaging
• combination products (if any)

Each presentation can map to distinct Orange Book records and patent claims.

What patents protect VEPPANU and how strong is the patent estate?

Featured snippet answer: Patent protection is product-specific. A full VEPPANU estate requires the Orange Book patent list by active ingredient, dosage form, and formulation/method-of-use claims.

How many patents cover VEPPANU in the US Orange Book?

A complete answer requires:

• Orange Book listed U.S. patents
• patent types (composition, formulation, method-of-use, device, manufacturing)
• claim coverage scope by presentation

Which companies hold the VEPPANU patents?

A complete answer requires:

• patent assignees
• licensing status and any prior consent judgments

What formulations and delivery-system claims are protected?

For esketamine brands, formulation and device-related claims can materially affect generic design-around pathways.

When does VEPPANU lose exclusivity (patent expiration and exclusivity windows)?

Featured snippet answer: Exclusivity depends on the first approved product date and patent expiration schedule for the exact marketed presentation. A full timeline requires Orange Book and FDA exclusivity records.

What are the latest patent expiration dates for VEPPANU?

To model revenue cliff risk, you need:

• non-extendable earliest expiration
• any pediatric exclusivity or patent term adjustments (PTA)
• listed method-of-use vs. composition expiration

When does exclusivity start and end for VEPPANU?

You need:

• approval date per FDA label
• exclusivity end date per FDA determination (e.g., NCE/223, 7/5 rules if applicable to the specific active ingredient record)

What Orange Book status does VEPPANU have and which patents are listed for each product?

Featured snippet answer: Orange Book status must be checked per NDC and dosage form to determine which patents attach to which formulation.

What is the Orange Book listing for the VEPPANU marketed dosage form?

A proper listing requires:

• Orange Book patent numbers
• patent expiration dates
• exclusivity codes
• reference to NDA/BLA record

Do VEPPANU patents include method-of-use and dosing regimen claims?

Method-of-use patents can delay “at-risk” generic entry even when composition claims expire.

What generic entry risks exist for VEPPANU and what happens after Paragraph IV?

Featured snippet answer: Generic risk is driven by the number and type of unexpired patents and whether any Paragraph IV challenges have been filed to those patents.

Has any Paragraph IV ANDA been filed against VEPPANU?

A complete answer requires:

• ANDA filer names
• paragraph IV vs. carve-out details
• settlement terms if any

Which patents would likely be challenged first for VEPPANU?

A defensible ranking requires the patent claim structure:

• formulation/composition claims (hard to design around)
• method-of-use claims (may be carve-out-able)
• device/manufacturing claims (often create process barriers)

What patent litigation affects VEPPANU (and what are the likely outcomes)?

Featured snippet answer: Litigation materially changes generic timelines via injunctions and settlement-driven entry dates, but outcomes require docket-level facts for VEPPANU’s specific patents and filings.

Which VEPPANU patents are asserted in recent cases?

A complete answer requires:

• asserted patent numbers
• court, case caption
• filing and scheduled trial dates

Have settlements been reached and what are the entry dates?

Settlement terms determine:

• “effective date” for generic launch
• non-infringement carve-outs
• additional royalties or agreements

How does VEPPANU compare with other esketamine products on IP and exclusivity?

Featured snippet answer: Comparisons must be built on each product’s Orange Book estate and FDA label/delivery system, which can differ materially across brands.

How do patent estates differ across esketamine brands?

A comparative model requires:

• per-brand patent counts by category
• expiration timelines
• litigation and settlement history

Which competitors pose the largest pricing and share risk?

A complete answer requires:

• current competitors (brand and generic/OTC substitutes if any)
• payer coverage and formulary status (if available)
• channel and segment mix

What is the FDA regulatory status of VEPPANU (approvals, labeling, and postmarketing milestones)?

Featured snippet answer: FDA status depends on whether VEPPANU is the reference brand, a supplement, or a changed formulation, and on any REMS or postmarketing commitments.

What is VEPPANU’s approval history and label scope?

A complete answer requires:

• initial approval date and indication list
• label changes by supplement type
• REMS requirements and compliance milestones

Is VEPPANU under any ongoing FDA actions that affect sales risk?

A complete answer requires:

• safety communications
• warning letters or compliance issues (if any)

Commercial fundamentals: what drives VEPPANU revenue and margin?

Featured snippet answer: Revenue timing and durability depend on exclusivity length, competitive entry probability, payer uptake, and uptake in the target clinical setting. Margin is driven by manufacturing cost, distribution terms, and product-level pricing.

What are the key revenue drivers for VEPPANU?

For a drug like esketamine, revenue is typically driven by:

• number of treated patients in the approved indication
• persistence and treatment cadence
• reimbursement rates and net price

A complete analysis requires VEPPANU-specific financial disclosures, payer mix, and prescribing trends, none of which are provided.

What are the key cost and execution risks?

Key drivers typically include:

• REMS operational costs (if applicable)
• supply continuity and manufacturing yield
• inventory and returns management

A complete answer requires VEPPANU’s operational and cost structure data.

Investment scenario: base case, bull case, and bear case

Featured snippet answer: Scenario construction requires VEPPANU’s exact exclusivity end date, the likelihood of generic/competing entry, and current sales trajectory. Those inputs are not provided, so an investment scenario cannot be stated accurately.

Base case scenario (what must be true)

Would require:

• exclusivity/patent protection holds through the modeled window
• no adverse FDA action
• market uptake stays on plan

Bull case scenario (what must be true)

Would require:

• longer protection via litigation outcomes or delayed entry
• faster patient uptake or broader payer adoption
• favorable label expansion (if any)

Bear case scenario (what must be true)

Would require:

• earlier-than-modeled generic entry due to carve-outs or invalidation
• REMS or safety issues impacting prescribing
• price compression from competitors

Key Takeaways

No investment-grade VEPPANU scenario or patent/regulatory fundamentals analysis can be completed from the provided information. A correct high-stakes assessment requires the exact VEPPANU FDA product record (NDC/dosage form), Orange Book patent list with expiration dates, and the current status of any Paragraph IV filings and litigation tied to those patents.

FAQs

1. How do you value VEPPANU patent life for an exclusivity-based investment model?
2. What Orange Book patents typically determine generic entry timing for esketamine brands?
3. How do settlement agreements after Paragraph IV affect VEPPANU launch dates?
4. What FDA labeling scope changes most often impact VEPPANU sales risk?
5. How should investors compare VEPPANU versus competing esketamine products on IP durability?

References (APA)

1. Not available.