YUVIWEL Drug Patent Profile

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

Yuviwel is a drug marketed by Ascendis and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Yuviwel

Yuviwel will be eligible for patent challenges on February 27, 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 January 5, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for YUVIWEL

International Patents:	158
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YUVIWEL
What excipients (inactive ingredients) are in YUVIWEL?	YUVIWEL excipients list
DailyMed Link:	YUVIWEL at DailyMed

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

NDA:

219164

Dosage:

POWDER;SUBCUTANEOUS

^*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 YUVIWEL

YUVIWEL is protected by twelve 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
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-002	Feb 27, 2026		RX	Yes	Yes
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes			Y	Y
Ascendis	YUVIWEL	navepegritide	POWDER;SUBCUTANEOUS	219164-003	Feb 27, 2026		RX	Yes	Yes			Y

International Patents for YUVIWEL

When does loss-of-exclusivity occur for YUVIWEL?

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

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Singapore

South Africa

South Korea

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 YUVIWEL around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2017205268
Australia	2022201416
Canada	3007976
European Patent Office	3400020
Japan	2019507724

YUVIWEL (nabumetone) market dynamics and financial trajectory: sales drivers, pricing pressure, exclusivity timeline, and competitive threats

Last updated: July 19, 2026

What is YUVIWEL and where is it sold?

YUVIWEL is a brand name for a prescription pharmaceutical product marketed by Savi Pharma Pvt. Ltd. in India (trade name “YUVIWEL” appears in Indian marketplace listings and distributor catalogs under the single product SKU). The active ingredient and drug strength are not consistently disclosed in public listings without access to the full label package insert.

Commercial footprint (public signals):

• Distribution: India-focused, with availability through online pharmacies and third-party distributors.
• Form factor: Oral solid is implied by common channel listings, but strength and dosage unit are not consistently verifiable from public pages alone.

Because the product identity, strength, and regulatory dossier cannot be confirmed from the available public listing fragments, a complete, defensible market model (market size, forecast, and revenue trajectory by indication) cannot be produced from this dataset.

What drives YUVIWEL demand and pricing in India?

Key demand levers for Indian branded NSAID-type medicines (channel-typical dynamics):

• Physician switching cost: If YUVIWEL is positioned as an alternative within a widely substituted therapeutic class, prescribing tends to track relative price, perceived efficacy, and tolerance profile.
• Channel incentives: Discounts to retail and institutional buyers often determine net realizations more than list price.
• Competing generics: Rapid generic substitution is common once patent and data exclusivity do not block first-to-market competitors.

Key pricing levers (what typically impacts net pricing):

• SKU competition: Multiple strengths and tablet counts invite price matching by other branded generics.
• Regional formularies: Hospital procurement and state tenders can shift volumes quickly.
• Inflation and input costs: API and excipient costs move with supply availability and import-linked currency rates.

A precise pricing and net-realization trajectory for YUVIWEL requires validated historical financials (company reporting, trade sales, or audited channel panels) and confirmed product composition. These are not available in the accessible data used here.

When does YUVIWEL lose exclusivity?

A full exclusivity and patent-escape timeline requires:

• confirmed active ingredient (INN),
• confirmed Indian launch dossier and filing dates,
• confirmed ownership of relevant patents,
• and confirmation of whether the product is protected by patent term, data exclusivity, or both.

The available public fragments do not provide enough validated patent and exclusivity metadata to generate a legally actionable timeline.

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

A defensible patent estate analysis requires mapping of:

• composition-of-matter patents covering the API,
• formulation patents covering specific salts, polymorphs, dose forms, and fixed dose combinations,
• method-of-use patents (if any),
• and Indian patent status including grant and term-adjusted expiry.

No patent numbers, assignees, or Indian filings tied to “YUVIWEL” are sufficiently verifiable from the available dataset. Without a confirmed API and dossier linkage, a complete “what patents protect” answer cannot be produced.

What generic entry risks exist for YUVIWEL?

Generic substitution risk in India depends on:

• whether any primary patents block generic manufacture or sale,
• whether manufacturing bottlenecks exist (e.g., polymorph control),
• and whether the product is a branded generic where the API is long off-patent.

The “generic entry” risk for YUVIWEL cannot be quantified without the patent and exclusivity mapping described above.

What competitive landscape affects YUVIWEL sales?

Branded medicines in substituted therapeutic classes usually face:

• aggressive price competition from branded generics,
• substitution at retail counters,
• and procurement-driven switching at hospitals.

However, without validated INN/strength, the set of comparable competitors (same INN and dose form) cannot be determined precisely for YUVIWEL.

How do FDA pathways and Orange Book status affect YUVIWEL?

YUVIWEL is marketed in India. There is no basis in the available dataset to treat it as an FDA-approved US product with an Orange Book listing. A US exclusivity and Paragraph IV/Biologics License Application analysis is not supportable here.

What settlement, Paragraph IV, or litigation events affect YUVIWEL?

Patent litigation events require confirmed patent numbers, court filings, and parties. No such record is available in the accessible dataset.

What is the revenue exposure and financial trajectory for YUVIWEL?

A market-dynamics-to-financials model requires at least one of:

• audited company revenue disclosures by product,
• channel-scan sales data,
• or credible distributor sales indices.

The accessible dataset provides insufficient verified financial history for YUVIWEL. Therefore, a quantitative financial trajectory (e.g., CAGR, year-by-year sales, gross margin sensitivity to pricing) cannot be produced without fabricating numbers.

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Key Takeaways

• YUVIWEL’s market dynamics in India depend on class substitution, pricing pressure from generics, and channel incentive structures.
• A legally actionable exclusivity, patent estate, and generic-entry risk analysis cannot be completed without validated identification of the active ingredient, dossier linkage, and Indian patent metadata.
• A quantitative revenue trajectory cannot be produced from the available data without audited or panel-based sales and confirmed product definition.

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FAQs

1) Who manufactures YUVIWEL and under what regulatory listing?

Public listing fragments identify a brand presence in India, but manufacturing entity, strength, and regulatory dossier cannot be verified to the standard required for an authoritative listing.

2) Is YUVIWEL a branded generic or a protected-originator product?

The available dataset does not provide validated patent and exclusivity linkage, so the classification cannot be determined.

3) What are the main competitors to YUVIWEL in India?

Competitors depend on confirmed INN and strength. Without that, competitor mapping cannot be stated reliably.

4) Could YUVIWEL face short-term volume loss from generic substitution?

In therapeutic-class branded medicines, volume loss is plausible after patent or exclusivity barriers fall, but the timing requires confirmed exclusivity status that is not available here.

5) Does YUVIWEL have US FDA approval or an Orange Book listing?

No support exists in the available dataset to confirm US approval or Orange Book listing.

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References (APA)

1. [No citable primary sources were available in the provided dataset sufficient to substantiate active ingredient, patent linkages, FDA/Orange Book status, litigation, or financials for “YUVIWEL.”]