LYNAVOY Drug Patent Profile

Which patents cover Lynavoy, and what generic alternatives are available?

Lynavoy is a drug marketed by Glaxosmithkline and is included in one NDA. There is one patent protecting this drug.

This drug has forty-two patent family members in thirty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Lynavoy

Lynavoy will be eligible for patent challenges on March 17, 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 March 17, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LYNAVOY

International Patents:	42
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	LYNAVOY at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF CHOLESTATIC PRURITUS ASSOCIATED WITH PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULT PATIENTS

NDA:

220295

Dosage:

TABLET;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.

Pharmacology for LYNAVOY

Drug Class	Ileal Bile Acid Transporter Inhibitor
Mechanism of Action	Ileal Bile Acid Transporter Inhibitors

US Patents and Regulatory Information for LYNAVOY

LYNAVOY is protected by one US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF CHOLESTATIC PRURITUS ASSOCIATED WITH PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULT PATIENTS.

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
Glaxosmithkline	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes			Y	Y
Glaxosmithkline	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes
Glaxosmithkline	LYNAVOY	linerixibat	TABLET;ORAL	220295-001	Mar 17, 2026		RX	Yes	Yes

International Patents for LYNAVOY

When does loss-of-exclusivity occur for LYNAVOY?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Ukraine

Uruguay

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 LYNAVOY around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	081337	DERIVADOS DE 1,4-BENZOTIAZEPINAS, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y SU USO EN LA PREPARACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE TRASTORNOS METABOLICOS
Australia	2011245393
Brazil	112012026767	composto, sal farmaceuticamente aceitável de um composto, composição farmacêutica, método para tratar ou previnir distúrbios, e, uso de um composto ou sal
Canada	2795543	COMPOSES CHIMIQUES (CHEMICAL COMPOUNDS)
Chile	2012003009	Acido3-(((3-butil-3-etil-(metiloxi)-1-1-dioxido-5-fenil-2,3,4,5-tetrahidro-1,4benxotiazepin-8-il)-metil)-amino)-pentanodioco; composicion farmaceutica que lo comprende; y su uso en un tastorno metabolico. pct.
China	102858159	Chemical compounds

LYNAVOY: Market Dynamics and Financial Trajectory

Last updated: May 2, 2026

What is LYNAVOY and what market category does it occupy?

LYNAVOY is a branded prescription pharmaceutical product. Public, investment-grade market and financial trajectory depends on two variables: (1) its legal/regulatory status (launch date, approvals, indications) and (2) whether it is a small-molecule, biologic, or gene/cell therapy, since reimbursement and pricing dynamics differ by modality.

No reliable, citable data on LYNAVOY’s regulatory history, launch timeline, indications, modality, manufacturer, pricing, or revenue is provided in the prompt. Without those specifics, a complete and accurate market and financial analysis cannot be produced under the required citation and proof standard.

How do market dynamics typically shape LYNAVOY’s uptake?

A defensible market-dynamics map requires at least: the therapeutic area and target, the approved indications and line-of-therapy, the comparator landscape, payer positioning (formulary status, prior authorization prevalence), and evidence strength (endpoints, durability). For prescription drugs, uptake is primarily driven by:

• Clinical differentiation (outcomes vs standard of care)
• Channel access (starter kits, distribution model, specialty pharmacy coverage)
• Reimbursement mechanics (WAC vs net price, PBM rebates, copay assistance policy)
• Competitive intensity (same-class agents, mechanism competitors, and near-substitutes)
• Exclusivity and patent runway (market protection duration affects price tolerance and investor outlook)

No indication/comparator or claims-level pricing/reimbursement facts for LYNAVOY are included, so the uptake pathway cannot be tied to actual market events.

What is the financial trajectory path investors track for a drug like LYNAVOY?

For branded pharmaceuticals, the financial trajectory typically follows this observable sequence:

1. Launch ramp: prescriptions grow as payer access stabilizes (often volatile early)
2. Net revenue stabilization: gross-to-net discounts settle after contracting and formulary placement
3. Peak sales and decline risk: driven by competition entry, label expansion, or loss of exclusivity
4. Cash flow shape: influenced by COGS, rebates, promotional spend, and specialty distribution economics

To build this into an LYNAVOY-specific trajectory, the analysis requires:

• reported or charted revenue by quarter/year
• unit sales, TRx, or equivalent demand metrics
• gross-to-net drivers (rebates, patient assistance, chargebacks)
• competitive and lifecycle events (new entrants, label changes, switching)

None of those inputs are present.

Is there evidence of adoption, pricing power, or competitive pressure for LYNAVOY?

Evidence-based market pressure requires at least one of:

• formulary tiers and coverage changes over time
• payer policy updates (PA criteria, step edits)
• competitor pipeline timelines
• realized net pricing versus WAC
• prescription share movements by region/plan

No such evidence is supplied, so the market pressure profile cannot be quantified for LYNAVOY.

What would a proof-based financial model for LYNAVOY look like (if data were available)?

A standard model links demand and net revenue:

Component	How it’s modeled	What’s required for LYNAVOY
Demand (units)	market share x treated population x adherence	indication, incidence/prevalence, prescriber behavior
Net price	WAC minus rebates/discounts/fees	WAC, contracting, PBM/bid effects
Revenue	units x net price	historical revenue and/or unit trajectory
Margin	revenue minus COGS and commercialization	COGS class economics, sales force and promo
Risk events	exclusivity expiry, competitor entry, label changes	patent list, trial outcomes, pipeline entrants

Because no LYNAVOY-specific inputs are included, no LYNAVOY-specific financial trajectory can be calculated or justified.

Key Takeaways

• LYNAVOY’s market dynamics and financial trajectory cannot be determined from the information provided.
• A credible analysis requires LYNAVOY’s therapeutic area/indication, regulatory and launch timeline, modality, pricing and payer access evidence, and revenue/demand metrics.
• Without those facts, any quantified trajectory would be speculative and non-actionable.

FAQs

1. What metrics best forecast a branded drug’s revenue ramp?
   Net price trajectory (gross-to-net), prescription growth (TRx), and payer access (formulary tier and PA/step edit rules).

2. How do payer policies typically affect early sales?
   Payer coverage delays, prior authorization requirements, and step edits slow adoption and create uneven quarter-to-quarter demand.

3. What drives peak sales timing and decline risk?
   Competitive entry, loss of exclusivity, label expansion or reversal, and net pricing compression as contracting matures.

4. How does the drug’s modality change market dynamics?
   Biologics and specialty modalities often face different distribution channels, monitoring costs, and payer design compared with small molecules.

5. What role does patent life play in financial trajectory?
   Patent and exclusivity duration strongly shape the pricing tolerance window and the speed of competitive substitution after launch.

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References