WAINUA Drug Patent Profile

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

Wainua is a drug marketed by Astrazeneca Ab and is included in one NDA. There are four patents protecting this drug.

This drug has two hundred and sixty-three patent family members in forty countries.

The generic ingredient in WAINUA is eplontersen sodium. One supplier is listed for this compound. Additional details are available on the eplontersen sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Wainua

Wainua will be eligible for patent challenges on December 21, 2027. 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, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for WAINUA

International Patents:	263
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for WAINUA

WAINUA is protected by three US patents.

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
Astrazeneca Ab	WAINUA	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-002	Apr 15, 2026		RX	Yes	Yes			Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes			Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes			Y	Y
Astrazeneca Ab	WAINUA (AUTOINJECTOR)	eplontersen sodium	SOLUTION;SUBCUTANEOUS	217388-001	Dec 21, 2023		RX	Yes	Yes

International Patents for WAINUA

When does loss-of-exclusivity occur for WAINUA?

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

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Ukraine

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 WAINUA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014259750
Australia	2014259755
Australia	2014259756
Australia	2014259757

Supplementary Protection Certificates for WAINUA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2991656	C20260001	Finland
3524680	CA 2025 00027	Denmark		PRODUCT NAME: EPLONTERSEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1875 20250307
3524680	28/2025	Austria		PRODUCT NAME: EPLONTERSEN, OPTIONAL IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/24/1875 (MITTEILUNG) 20250307
3524680	2025C/700	Belgium		PRODUCT NAME: EPLONTERSEN, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/24/1875 20250306

Last updated: June 15, 2026

WAINUA (fostemsavir) Investment Scenario and Patent/Regulatory Fundamentals Analysis

WAINUA (fostemsavir, prodrug of temsavir) is a branded antiretroviral for heavily treatment-experienced HIV-1 patients with multidrug resistance. Investment upside is tied to (1) continued label uptake in the “compromised options” segment, (2) defensible pricing and payer access versus next-line agents, and (3) timeline risk from generic entry and any label-expansion-driven demand. Core downside is concentrated in patent and regulatory exclusivity barriers that determine when lower-cost competition can land, plus ongoing competitive pressure from modern HIV regimens with higher barriers to resistance.

What to anchor the investment case on

• Market position: niche, high-acuity segment. Forecast sensitivity is driven by clinician adoption, payer restrictions, and new guideline positioning.
• IP and exclusivity: value density depends on whether meaningful patent coverage blocks generics for the branded fostemsavir product and/or key regimens.
• Regulatory status: the drug’s FDA approval pathway and existing exclusivities determine the earliest credible generic timing.
• Competition: alternatives that can replace fostemsavir in the same patient profile reduce both volume and pricing power.

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What is WAINUA (fostemsavir) and where does it fit in HIV treatment?

WAINUA is fostemsavir, an HIV-1 attachment inhibitor prodrug converted in vivo to temsavir, which binds the HIV-1 envelope glycoprotein gp120 to block viral attachment to CD4 cells. It is positioned for patients with HIV who have multidrug resistance and limited treatment options.

Clinical placement (investment relevance)

• Usage is concentrated in patients where standard regimen construction is constrained by resistance.
• Adoption depends on physicians’ willingness to use a drug that targets a different step in the viral lifecycle, often when resistance profiles limit regimen durability.

Formulation and dosing relevance

• Revenue and access analysis should treat WAINUA as a branded oral therapy where pharmacy benefit design, prior authorization hurdles, and step therapy constraints can materially impact net pricing.

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What patents protect WAINUA (fostemsavir) and how strong is the patent estate?

No complete, citeable patent estate for WAINUA can be produced from the information provided in the prompt. A defensible investment and licensing/litigation view requires the exact FDA Orange Book listings, patent numbers, assignee chain, expiration dates, and whether protection is composition, formulation, method-of-use, or manufacturing.

Investment implication of missing estate detail

• Without a patent-by-patent map, the model cannot calculate probability-weighted generic entry windows, design-around paths, or litigation leverage in a way that is suitable for high-stakes R&D, licensing, regulatory strategy, or valuation.

(If the WAINUA Orange Book record and relevant patents are not specified, any patent-strength assessment would be incomplete and non-actionable.)

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When does WAINUA lose exclusivity? What is the Orange Book status of fostemsavir?

No complete Orange Book status for WAINUA is provided in the prompt, so exclusivity timing (patent term, non-patent exclusivity, pediatric exclusivity, and any exclusivity tied to supplements) cannot be determined.

Investment implication

• Exclusivity timing is a primary driver of valuation. Without the FDA-listed patent and exclusivity structure, there is no credible earliest generic launch date to anchor a scenario analysis.

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What generic entry risks exist for WAINUA (fostemsavir) and what would a Paragraph IV pathway look like?

A Paragraph IV scenario cannot be mapped without the Orange Book patent list and the specific patent(s) most likely to be challenged.

Investment implication

• Generic entry risk is not generic “HIV drug” risk. It is specific to each Orange Book-listed patent (and the strength and scope of those claims). Without that list, any “generic risk” estimate would not support investment decision-making.

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What patent litigation affects WAINUA and how do settlements shape timing and market share?

No litigation docket details for WAINUA are included in the prompt. A credible litigation-and-settlement view requires:

• whether any ANDA filings exist,
• whether Paragraph IV suits were filed,
• case captions, filing dates, jurisdiction, asserted patents, and outcomes,
• any settlement dates and negotiated “carve-outs” or launch dates.

Investment implication

• Settlement terms can materially shift generic launch timing. Without case details, a scenario analysis would be structurally incomplete.

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What formulations are protected by WAINUA patents?

No formulation patent details are provided. For HIV products, formulation protection can include polymorphs, crystalline forms, prodrug stabilization, tablet composition, and manufacturing parameters.

Investment implication

• A formulation gap can enable a faster, less defended generic design-around. Without patent granularity, the formulation barrier cannot be scored.

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What method-of-use (indication) patents might cover fostemsavir for multidrug-resistant HIV?

No method-of-use or indication-specific patent information is included in the prompt.

Investment implication

• Method-of-use patents can protect prescriber behavior even if composition patents weaken, depending on whether generics are permitted to market “skinny-label” and whether the remaining claims are enforceable.

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How does WAINUA compare with competing antiretrovirals for multidrug-resistant HIV?

Without additional source data on current competing branded and generic options, the comparison can only be framed at a high level.

Competitive vectors that typically drive market share in this segment

• Resistance profile fit: whether the product is used as a salvage anchor.
• Convenience: dosing schedule and pill burden relative to alternatives.
• Payer coverage: prior authorization and formulary placement.
• Clinical guideline status: placement in guideline algorithms for multidrug-resistant HIV with limited options.

Investment implication

• If payer policies tighten for off-preferred agents, WAINUA’s volume can compress even if clinical efficacy is strong.

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What is WAINUA’s FDA regulatory status and what does it imply for market timing?

No FDA approval letter details, approval date, labeling language, or exclusivity periods are provided. Those elements are required to connect regulatory pathway to:

• the length and type of exclusivity (patent term and non-patent exclusivity),
• supplement exclusivity impacts,
• and the most plausible generic entry windows.

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Commercial fundamentals: How should an investor model WAINUA revenue and margin drivers?

Because the prompt provides no financials, patient counts, or pricing/net sales history, the model can only identify drivers, not quantify them.

Revenue drivers

• Patient conversion: eligible patients who start WAINUA in salvage regimens.
• Persistence: treatment continuity and discontinuation rate.
• Net price: rebates, contracting, and utilization management constraints.
• Geographic mix: US vs ex-US royalties or direct sales impacts.
• Formulary changes: coverage expansions or restrictions.

Margin drivers

• Cost of goods and manufacturing complexity for a prodrug antiretroviral.
• Sales force intensity and patient support expense.
• Any inventory build risk ahead of competitive shifts.

Investment implication

• In niche, high-acuity segments, net price protection and payer access can matter as much as gross demand.

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What are the geographic and payer-access dynamics for WAINUA?

No geography or payer policy data is included. For investment use, a complete analysis would map:

• US commercial strategy versus ex-US licensing,
• major payer formularies and prior authorization burdens,
• and government reimbursement constraints.

Without data, a country-by-country exposure assessment cannot be executed.

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What licensing or partnership opportunities exist for fostemsavir?

No licensing deal terms, partners, or territories are provided. An investment-grade licensing view requires:

• who holds global rights,
• whether there are manufacturing or commercialization milestones,
• and how those terms interact with exclusivity and generic timelines.

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Key risks and scenario framework for WAINUA (fostemsavir)

Core upside scenarios

• Sustained uptake in multidrug-resistant patient cohorts with limited alternatives.
• Continued favorable payer access and stable net pricing.
• IP durability that delays or limits generic entry and maintains brand economics.

Core downside scenarios

• Earlier-than-expected loss of meaningful IP/exclusivity coverage.
• Payer restriction or guideline changes that reduce salvage-channel utilization.
• Generic entry via design-around or carve-outs that preserve low-cost availability.

What must be verified to make the scenario decision-grade

• Orange Book patent list and expiration dates.
• Any exclusivity periods (including pediatric).
• Current generic filing and litigation posture.
• FDA label scope changes that could affect remaining protection.

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Key Takeaways

• WAINUA is an HIV attachment inhibitor for multidrug-resistant, heavily treatment-experienced patients, making demand sensitive to payer access and salvage-channel adoption rather than broad population scale.
• Investment valuation is primarily driven by exclusivity timing and patent strength, which must be anchored to the Orange Book listing and any litigation/litigation settlements.
• The prompt does not include the required patent, exclusivity, litigation, or financial data to quantify entry timelines or to score patent durability for fostemsavir.
• A correct investment model for WAINUA must link clinical positioning to payer net price, then overlay probability-weighted generic entry based on patent-by-patent barriers.

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FAQs

1) Is WAINUA (fostemsavir) used as a first-line or salvage HIV regimen?

WAINUA is used for heavily treatment-experienced patients with multidrug resistance and limited options, so it functions as a salvage-line therapy in clinical practice.

2) What is the mechanism of action of fostemsavir?

Fostemsavir is a prodrug that yields temsavir, an HIV-1 attachment inhibitor that blocks viral attachment via gp120.

3) How do payer and prior authorization policies typically affect niche HIV drugs like WAINUA?

They can materially impact net demand by restricting access to eligible patients, increasing treatment initiation friction, and lowering utilization at the pharmacy benefit level.

4) What factors determine generic launch timing for a branded HIV drug?

Orange Book patent expirations, FDA exclusivity periods, and whether ANDAs file Paragraph IV challenges with litigation or settlements.

5) What kind of competitive products most threaten WAINUA in multidrug-resistant HIV?

Newer antiretrovirals that can be constructed into durable regimens for resistant virus profiles, plus any agents that reduce the clinician need to rely on salvage attachment inhibition.

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References

No sources were provided in the prompt.