ONPATTRO Drug Patent Profile

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

Onpattro is a drug marketed by Alnylam Pharms Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has two hundred and fifty patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Onpattro

Onpattro was eligible for patent challenges on August 10, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 15, 2029. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ONPATTRO

International Patents:	250
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for ONPATTRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ONPATTRO
What excipients (inactive ingredients) are in ONPATTRO?	ONPATTRO excipients list
DailyMed Link:	ONPATTRO at DailyMed

See drug prices for ONPATTRO

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

Constraining patent/regulatory exclusivity:

8,058,069

NDA:

210922

Dosage:

SOLUTION;INTRAVENOUS

^*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.

Recent Clinical Trials for ONPATTRO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Austin Neuromuscular Center	Early Phase 1
Alnylam Pharmaceuticals	Early Phase 1

See all ONPATTRO clinical trials

Pharmacology for ONPATTRO

Drug Class	Small Interfering RNA Transthyretin-directed RNA Interaction
Physiological Effect	Decreased RNA Integrity Increased Protein Breakdown

US Patents and Regulatory Information for ONPATTRO

ONPATTRO is protected by thirteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,058,069.

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
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes	8,802,644		Y
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes	8,741,866
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes	8,168,775		Y	Y
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes	8,492,359		Y
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes	11,079,379		Y	Y
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018		RX	Yes	Yes

Expired US Patents for ONPATTRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	8,552,171
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	9,943,539
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	8,895,718
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	8,334,373
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	8,372,968
Alnylam Pharms Inc	ONPATTRO	patisiran sodium	SOLUTION;INTRAVENOUS	210922-001	Aug 10, 2018	9,943,538

International Patents for ONPATTRO

When does loss-of-exclusivity occur for ONPATTRO?

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

Australia

Canada

China

Denmark

European Patent Office

Hungary

Israel

Japan

New Zealand

Poland

Portugal

Spain

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 ONPATTRO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009307677	Compositions and methods for inhibiting expression of transthyretin
Australia	2015249072	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN
Australia	2017225110	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN
Australia	2019216630	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN
Australia	2021203272
Australia	2023248138	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF TRANSTHYRETIN

Supplementary Protection Certificates for ONPATTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2937418	122018000133	Germany		PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180827
2937418	300965	Netherlands		PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 20180829
2937418	PA2019501	Lithuania		PRODUCT NAME: PATISIRANAS; REGISTRATION NO/DATE: EU/1/18/1320 20180827
2937418	2019C/501	Belgium		PRODUCT NAME: PATISIRAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829
2937418	3/2019	Austria		PRODUCT NAME: PATISIRAN; REGISTRATION NO/DATE: EU/1/18/1320 (MITTEILUNG) 20180829
2937418	LUC00098	Luxembourg		PRODUCT NAME: PATISIRAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (ONPATTRO ); AUTHORISATION NUMBER AND DATE: EU/1/18/1320 20180829

ONPATTRO (patisiran) market dynamics and financial trajectory: exclusivity, competition, payer adoption, and revenue outlook

Last updated: June 26, 2026

Executive summary: ONPATTRO (patisiran) is an approved RNAi therapy for hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy. Since launch, growth has been driven by expansion of eligible patient segments, label refreshes tied to broader disease presentations, and payer acceptance in the U.S. and select ex-U.S. markets. Competitive pressure is emerging from alternative mechanism products in hATTR (notably VYNDAMAX/VYNDAQUEL and inotersen-era dynamics), with biosimilar-style competition not applicable. The financial trajectory has been characterized by high base revenue with volatility around payer coverage, channel mix, and regional penetration, rather than by generic erosion. The relevant risk framework is therefore: (1) pricing and contracting pressure, (2) substitution by competing TTR-directed agents and evolving treatment algorithms, and (3) life-cycle IP/regulatory timing rather than patent cliff-to-generic.

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How has ONPATTRO performed financially since launch and what revenue trend matters most?

What drives the ONPATTRO revenue curve: ONPATTRO has followed a “high-value specialty drug” pattern: steep post-approval ramp, then a plateau punctuated by periodic step-ups tied to label expansions, clinical evidence updates, and improved access channels. The main near-to-mid-term variables are not manufacturing scale but access: formulary placement, prior authorization throughput, patient identification, and site-of-care dynamics.

Key financial trajectory themes investors track

• Patient mix and penetration: market growth depends on how many diagnosed and eligible patients initiate and persist, not on incremental demand from generic substitution.
• Net price vs. list price: payer contracting, rebates, and outcomes-based terms typically determine margin profile.
• Geographic expansion cadence: ex-U.S. reimbursement can lag the U.S., creating step-change revenue in subsequent quarters/years.
• Switching behavior: competing TTR therapies can limit incremental uptake even when ONPATTRO remains clinically used.

Featured snippet answer: ONPATTRO’s financial trajectory is driven primarily by payer access and patient penetration in hATTR neuropathy, with competition affecting growth rates more than causing abrupt revenue loss.

What benchmark metrics show whether ONPATTRO is growing or losing share?

• New patient starts per quarter (or proxy using units dispensed and treatment duration assumptions)
• Persistency (dose continuity through neuropathy disease course)
• Channel mix (specialty pharmacy vs. hospital/clinic administered)
• U.S. vs. ex-U.S. revenue split and its quarterly stability

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What market dynamics shape ONPATTRO demand in hereditary ATTR amyloidosis with polyneuropathy?

Demand is a function of diagnosis, eligibility, and clinician treatment algorithms. hATTR amyloidosis remains underdiagnosed. Growth depends on identification and referral networks, not simply drug availability.

Which patient segments decide ONPATTRO adoption?

• Disease stage: early vs. advanced neuropathy affects willingness to initiate and insurance authorization probability.
• Baseline neuropathy severity and progression velocity: drives “benefit per decision” arguments in payer reviews.
• Comorbidities: influences suitability versus competing TTR therapies.
• Prior therapy: ONPATTRO uptake can be higher in therapy-naive patients or those who fail/stop prior agents.

How do treatment guidelines and clinical practice affect prescribing?

Clinicians tend to match therapy selection to:

• Neuropathy involvement and progression risk
• Side-effect tolerability and monitoring burden
• Route-of-administration preferences and patient capability for infusion and supportive care

Even when competitors exist, ONPATTRO can keep share if prescribers view it as a strong option for neuropathy outcomes, particularly when tolerability and neurologic endpoints matter.

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Which competitive therapies most influence ONPATTRO pricing and uptake?

Competitive set in hATTR is mechanism- and administration-defined rather than “same class generic.” Key pressure sources come from TTR stabilizers and competing disease-modifying approaches.

How does ONPATTRO compare with VYNDAMAX/VYNDAQUEL (tafamidis/tafamidis meglumine) in market dynamics?

• Mechanism difference: ONPATTRO targets hepatic TTR production via RNAi; tafamidis stabilizes TTR.
• Access profile: payer decisions often weigh outcomes evidence, safety monitoring burden, and patient eligibility.
• Switch risk: patients eligible for tafamidis may be prioritized for simplicity, while ONPATTRO may gain share among those seeking neuropathy-focused disease modification or who cannot tolerate other options.

How does inotersen affect the ONPATTRO landscape historically?

Inotersen (an earlier antisense TTR approach) created the first wave of TTR-targeted therapy experience. Its market presence influenced clinician familiarity, patient pathway creation, and payer precedent for TTR therapies. Over time, ONPATTRO’s label and convenience relative to monitoring requirements can shift treatment selection.

How does competition translate into financial outcomes?

• Competition typically pressures net pricing through contracting rather than collapsing demand.
• It can cap incremental patient growth, especially where payer formularies narrow preferred options.

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What is ONPATTRO’s payer and reimbursement exposure in the U.S. and Europe?

Payer behavior is the primary determinant of net revenue. For specialty infusion drugs, payers evaluate clinical criteria (diagnosis verification, baseline measures), treatment response expectations, and safety monitoring plans.

What coverage criteria tend to matter most for ONPATTRO?

• Confirmed hATTR amyloidosis with polyneuropathy diagnosis
• Disease stage or symptom criteria used as enrollment gates
• Prior therapy requirements (where used)
• Monitoring evidence for concomitant care

Where do bottlenecks emerge?

• Time-to-authorization for initiation
• Documentation requirements for eligibility
• Site-of-care reimbursement structures that influence adoption

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What is ONPATTRO’s IP and exclusivity timeline risk profile for commercialization?

No generic “cliff-to-competition” dynamic drives ONPATTRO like small-molecule drugs with multiple ANDA entries. Instead, risk comes from long-tail life-cycle patent expiry (formulations, dosing regimen, use patents) and settlement outcomes around Paragraph IV-type litigation for biosimilars is irrelevant because ONPATTRO is not a biologic.

How does exclusivity map to market competitiveness?

• U.S. regulatory exclusivity can delay approval of competing RNAi drugs even after patent expiry, depending on labeling and regulatory exclusivity eligibility.
• Patent estates shape whether competitors can enter by changing formulations, routes, or indications.
• Settlement dynamics can prevent or delay market entry.

Featured snippet answer: ONPATTRO’s competitive risk is paced by IP and regulatory exclusivity on a multi-year horizon, not by rapid generic substitution.

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What is the Orange Book status of ONPATTRO and what patents are most relevant to entry barriers?

ONPATTRO is listed in FDA’s Orange Book for U.S. marketing authorization and patent-protected claims. The relevant analysis for entry barriers is the set of patents covering:

• Composition of matter (if any still active)
• Methods of use tied to hATTR polyneuropathy
• Formulation or delivery system claims

Patent landscape impact: any challenger must navigate claim scope and expiration dates by geography and claim type. Where settlements occur, they usually fix entry timing by agreed dates rather than claim invalidation.

(Note: the Orange Book listing content is jurisdiction-specific and must match the exact NDA/strength/form (and patent list) to enumerate specific patent numbers and dates.)

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How do settlement agreements and patent litigation affect ONPATTRO’s competitive timeline?

Litigation affects timing and market structure by:

• Defining an agreed “launch date” for future entrants
• Narrowing what claims can be used in future marketing applications
• Shaping whether competitors choose to launch “at-risk” versus waiting

For ONPATTRO, the key commercial question is whether any RNAi or TTR-targeted competitor has a litigation strategy to obtain earlier market access. Market impacts are typically realized through delayed or accelerated uptake and contracting renegotiations.

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What generic entry risks exist for ONPATTRO and why does “generic” look different here?

Because ONPATTRO is not a traditional small-molecule with ANDA generics, “generic entry” risk is not a straightforward ANDA event. Competing RNAi products would face distinct development and regulatory pathways and would require their own regulatory approval package and IP workarounds.

Market impact pattern:

• If an alternative RNAi mechanism enters, it can drive share shift and pricing pressure.
• If substitutes are TTR stabilizers, ONPATTRO faces algorithmic competition rather than direct replacement at the pharmacy level.

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How does ONPATTRO administration logistics (infusion, monitoring, concomitant care) influence commercialization?

ONPATTRO is administered via infusion with associated premedication considerations and in-clinic administration processes. These operational factors:

• Affect site readiness and treatment scheduling
• Influence patient and physician willingness
• Impact payer justification processes tied to health system throughput

Commercial consequence: even if clinical outcomes are strong, adoption can lag if real-world administration friction increases prior authorization or infusion capacity bottlenecks.

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What is ONPATTRO’s revenue sensitivity to price concessions and contracting?

Specialty drugs with high unit cost are highly sensitive to:

• Rebate rates and payer-specific net price reductions
• Outcomes or utilization-based contracts (where used)
• Competitive tender outcomes at hospital systems

Revenue sensitivity mechanism:

• Small list price changes can be partially offset by rebates.
• Competitive entry (even indirect) can strengthen payer leverage to push net price down.

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How does ONPATTRO compare with competing hATTR drugs on market access and expected substitution?

Substitution is rarely automatic. It depends on eligibility criteria, toxicity/monitoring preferences, and payer alignment to clinical endpoints.

Relative positioning (commercially)

• ONPATTRO (RNAi): often viewed as a targeted option aligned to neuropathy disease modification.
• TTR stabilizers (tafamidis pathway): competitive for broader simplicity and established payer comfort in many settings.
• Other TTR-targeting approaches (e.g., earlier-generation agents): can reduce “blank slate” market growth because patients are already on a TTR pathway.

Featured snippet answer: ONPATTRO’s competitive exposure is share-taking through clinical algorithm choices and payer preference shifts, not through generic replacement.

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What does ONPATTRO’s regional expansion pattern suggest for future financial performance?

Regional performance typically evolves in phases:

• initial U.S. access and patient identification
• subsequent ex-U.S. reimbursement launches or expansion to additional indications/eligibility criteria
• slower European reimbursement maturation due to health technology assessment cycles and budget impact deliberations

Financial implication: revenue growth can be “lumpy” around reimbursement wins and label-eligible expansion waves.

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Key Takeaways

• ONPATTRO’s financial trajectory is primarily access-driven: diagnosis pipeline, payer approval speed, and net price/contracting terms.
• Competitive pressure in hATTR is mechanism-based, dominated by TTR stabilizers and treatment algorithm selection, rather than generic substitution.
• The main downside risk is not a generic cliff but pricing leverage and formulary preference shifts as competing options gain traction.
• IP and regulatory exclusivity set the long-term competitive timeline; litigation and settlements shape the cadence of any alternative entry.

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FAQs

1. How does payer prior authorization criteria affect ONPATTRO treatment initiation rates?
2. What clinical endpoints most influence formulary decisions for ONPATTRO in hATTR polyneuropathy?
3. How do infusion center capacity and site-of-care reimbursement impact ONPATTRO adoption?
4. Does ONPATTRO face competition from TTR stabilizers on a patient-by-patient substitution basis?
5. What financial signals indicate ONPATTRO is gaining or losing share in the U.S. specialty channel?

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA: ONPATTRO (patisiran) prescribing information and approvals. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. (n.d.). Patisiran studies in hereditary transthyretin-mediated amyloidosis. National Library of Medicine.
4. EMA. (n.d.). Onpattro (patisiran) EPAR. European Medicines Agency.

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