REDEMPLO Drug Patent Profile

When do Redemplo patents expire, and when can generic versions of Redemplo launch?

Redemplo is a drug marketed by Arrowhead and is included in one NDA. There are five patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Redemplo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 7, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REDEMPLO

International Patents:	233
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in REDEMPLO?	REDEMPLO excipients list
DailyMed Link:	REDEMPLO at DailyMed

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

NDA:

219947

Dosage:

SOLUTION;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 REDEMPLO

REDEMPLO is protected by five US patents and one FDA Regulatory Exclusivity.

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
Arrowhead	REDEMPLO	plozasiran sodium	SOLUTION;SUBCUTANEOUS	219947-001	Nov 18, 2025		RX	Yes	Yes			Y	Y
Arrowhead	REDEMPLO	plozasiran sodium	SOLUTION;SUBCUTANEOUS	219947-001	Nov 18, 2025		RX	Yes	Yes			Y	Y
Arrowhead	REDEMPLO	plozasiran sodium	SOLUTION;SUBCUTANEOUS	219947-001	Nov 18, 2025		RX	Yes	Yes			Y	Y
Arrowhead	REDEMPLO	plozasiran sodium	SOLUTION;SUBCUTANEOUS	219947-001	Nov 18, 2025		RX	Yes	Yes			Y	Y
Arrowhead	REDEMPLO	plozasiran sodium	SOLUTION;SUBCUTANEOUS	219947-001	Nov 18, 2025		RX	Yes	Yes

International Patents for REDEMPLO

When does loss-of-exclusivity occur for REDEMPLO?

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

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 REDEMPLO around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	104754
Argentina	106227
Argentina	108217
Argentina	121850
Australia	2016233364

REDEMPLO market dynamics and financial trajectory: demand drivers, pricing pressure, payer adoption, and revenue risk profile

Last updated: July 27, 2026

What is REDEMPLO and what market does it address?

REDEMPLO is a pharmaceutical product name used in commercial markets; however, no drug-specific facts are available in the provided input to identify the active ingredient, strength/dosage form, route, indication, manufacturer, or jurisdictions. Without those specifics, a precise market and financial analysis cannot be constructed.

How do REDEMPLO’s sales and revenue typically progress after launch?

A reliable revenue trajectory requires at minimum the product’s:

• launch date (country and channel)
• FDA/EMA status and launch pathway (NDA/BLA, generic, biosimilar)
• initial pricing and list-to-net discounting pattern
• payer coverage and formulary placement timing
• acquisition or distribution structure (who invoices and who discounts)

No such launch and commercial data are present for REDEMPLO in the provided input.

What market dynamics drive REDEMPLO adoption and utilization?

Key market drivers for a branded or specialty pharmaceutical generally include:

• clinical differentiation: outcomes, safety profile, dosing convenience
• payer stance: step edits, prior authorization, quantity limits
• competitive intensity: same-class molecules, generics/biosimilars, substitution rules
• site-of-care: inpatient vs outpatient vs specialty pharmacy
• manufacturing supply stability and inventory allocation

No drug-specific attributes, payer results, or competitor set are provided for REDEMPLO.

Which competitors pressure REDEMPLO pricing and share?

A competitor landscape requires identification of:

• same active ingredient competitors (if any)
• class comparators (mechanism-of-action)
• formulary substitutes (including generics/biosimilars)
• geography-specific competition

No active ingredient or indication details are available to determine who competes with REDEMPLO.

How does REDEMPLO pricing evolve under US commercial and Medicaid dynamics?

Pricing trajectory depends on:

• WAC vs ASP and negotiated rebates
• PBM position and rebate bands
• AMP/Best Price outcomes
• Medicaid coverage rules and managed-care contracting

The input includes no indication for US pricing datasets, no AMP/ASP or rebate history, and no payer contracting details for REDEMPLO.

What is the REDEMPLO revenue exposure to formulary restriction risk?

Exposure can be mapped by:

• historical formulary status and change cadence
• prior authorization frequency and approval rates
• step therapy triggers
• volume shifts after negative evidence, safety communications, or competitor launches

No formulary change history or utilization data are present.

When does REDEMPLO face exclusivity and patent-driven revenue risk?

Revenue risk timing requires patent and exclusivity data:

• patent expiration dates for composition, formulation, and method-of-use
• regulatory exclusivities (NCE, orphan, pediatric, 5-year, 3-year, exclusivity extensions)
• FDA Orange Book listing status
• any Paragraph IV filings and settlement terms

No Orange Book, exclusivity, or patent information is available in the provided input, so exclusivity-driven revenue inflection cannot be established.

What generic or biosimilar entry scenarios threaten REDEMPLO?

To model entry risk:

• determine whether REDEMPLO is small molecule or biologic
• locate ANDA/ BLA biosimilar candidates and legal status
• identify launch-date assumptions and design-around feasibility
• assess label/carve-out constraints and switching barriers

No product class or legal/regulatory status is provided for REDEMPLO.

How does REDEMPLO’s net revenue bridge look from gross sales to operating income?

A financial bridge needs:

• gross-to-net components (rebates, discounts, returns)
• SKU mix and channel split (specialty vs retail)
• COGS drivers and supply costs
• SG&A and distribution economics
• milestones, royalties, and amortization impacts

No financial statements, segment reporting, or deal terms are supplied for REDEMPLO.

What is the likely profit sensitivity of REDEMPLO to volume vs price?

Profit sensitivity is typically decomposed into:

• demand elasticity by payer and patient access
• price erosion pace tied to competitor entry and formulary moves
• gross margin impact from rebate pressure and COGS inflation
• manufacturing utilization changes and inventory write-down risk

No REDEMPLO volume history or price performance data are available here.

Which licensing or commercialization deals shape REDEMPLO’s financial trajectory?

Commercial trajectory depends on:

• licensing partner economics (upfront, milestones, royalty rate)
• territory rights (US/ROW, ex-US carveouts)
• co-promotion vs distributor margins
• step-up royalties tied to sales thresholds

No licensing or partner structure is provided for REDEMPLO.

What FDA/EMA milestones affect REDEMPLO market growth and revenue timing?

A milestone map requires:

• approvals timeline
• label expansion or indication-specific approvals
• REMS or postmarketing requirements
• safety communications that alter prescribing or access

No regulatory timelines or label scope are included for REDEMPLO.

How does REDEMPLO compare with peer drugs on time-to-peak and durability?

Time-to-peak and durability require:

• historical quarter-by-quarter sales for REDEMPLO
• comparable peer drug cohorts by indication and class
• common payer dynamics in those cohorts

No sales history or peer set is available.

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Key Takeaways

• A market and financial trajectory analysis for REDEMPLO cannot be produced from the provided input because the drug’s active ingredient, indication, product form, launch geography, regulatory status, and financial dataset identifiers are not specified.
• Without those identifiers, competitor mapping, exclusivity/patent timing, generic/biosimilar entry risk, and net revenue modeling cannot be grounded in verifiable facts.

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FAQs

1. What information is required to build a revenue forecast for REDEMPLO?
2. How do formulary restrictions typically change utilization patterns for specialty drugs like REDEMPLO?
3. What are the standard drivers of gross-to-net erosion in branded pharmaceuticals, and how would they apply to REDEMPLO?
4. How is exclusivity loss timing calculated for an FDA-approved drug like REDEMPLO?
5. What evidence is used in Paragraph IV and settlement outcomes to predict launch timing for a competing generic or biosimilar against REDEMPLO?

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References

(No sources cited because REDEMPLO drug-specific identity, regulatory record, and financial disclosures were not provided in the input.)