GIVLAARI Drug Patent Profile

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

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

This drug has one hundred and eighty-five patent family members in forty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Givlaari

Givlaari was eligible for patent challenges on November 20, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 20, 2026. This may change due to patent challenges or generic licensing.

There have been five 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 GIVLAARI

International Patents:	185
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for GIVLAARI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIVLAARI
What excipients (inactive ingredients) are in GIVLAARI?	GIVLAARI excipients list
DailyMed Link:	GIVLAARI at DailyMed

See drug prices for GIVLAARI

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

Constraining patent/regulatory exclusivity:

INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP)

NDA:

212194

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.

Recent Clinical Trials for GIVLAARI

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

Sponsor	Phase
Alnylam Pharmaceuticals	Phase 3

See all GIVLAARI clinical trials

Pharmacology for GIVLAARI

Drug Class	Aminolevulinate Synthase 1-directed RNA Interaction Small Interfering RNA
Physiological Effect	Decreased RNA Integrity

US Patents and Regulatory Information for GIVLAARI

GIVLAARI is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP).

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	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes			Y	Y

Expired US Patents for GIVLAARI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019

International Patents for GIVLAARI

When does loss-of-exclusivity occur for GIVLAARI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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 GIVLAARI around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	097920
Argentina	118658
Argentina	133772
Australia	2014331604
Australia	2020286311
Australia	2023266354

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	301061	Netherlands		PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1428 20200304
3052628	LUC00175	Luxembourg		PRODUCT NAME: GIVOSIRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628	122020000045	Germany		PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	PA2020527	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	2020C/532	Belgium		PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628	CA 2020 00042	Denmark		PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304

GIVLAARI (givosiran) Market Dynamics and Financial Trajectory (2024–2026)

Last updated: June 26, 2026

GIVLAARI (givosiran) is a once-monthly, RNAi therapeutic for acute hepatic porphyria (AHP). Commercial performance is constrained by (1) a narrow patient population, (2) treatment-adoption risk tied to long-term outcomes and patient-physician switching, and (3) high unit economics typical for rare-disease injectables. Near-term financial trajectory depends on continued uptake in AHP subtypes (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria), persistence, and payer coverage that reflects high annualized drug cost versus reduction in attack rates.

This analysis synthesizes market structure, pricing and reimbursement mechanics, competitive dynamics, and what financial trajectory most likely implies for revenue exposure through 2026, including risks to durable growth.

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What is GIVLAARI used for and how does that shape market size?

GIVLAARI (givosiran) targets acute hepatic porphyria by lowering hepatic ALAS1 (5-aminolevulinic acid synthase 1) via RNA interference. Commercial demand follows the diagnosed prevalence and the proportion of patients treated after moving from episodic care (acute attacks) to preventive, disease-modifying therapy.

Which acute hepatic porphyria patients drive demand?

Market demand is structurally concentrated in:

• Patients with frequent attacks or history of recurrent acute attacks requiring repeated acute management.
• Patients for whom prophylaxis is considered after insufficient control with standard approaches (including hemin-based strategies in some settings).
• Patients with comorbid renal or hepatic risk profiles where prevention is prioritized to reduce hospitalization and attack-related morbidity.

How do diagnosis and “treatment eligibility” cap adoption?

Adoption is limited by:

• Diagnostic lag: AHP is rare and often misclassified initially.
• Treatment eligibility thresholds: Many payers and clinicians focus preventive therapy on those with clinically meaningful attack frequency.
• Switching inertia: Patients stabilized on existing regimens may not switch without a clear benefit profile.

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What market dynamics determine GIVLAARI revenue growth?

GIVLAARI’s revenue trajectory is governed by three levers: penetration (share of treated eligible patients), persistence (monthly dosing survival), and price/reimbursement (net price after rebates and access arrangements).

1) Penetration: how quickly can eligible AHP patients start prophylaxis?

Penetration depends on:

• Rate of physician adoption in hematology, hepatology, and porphyria specialty centers.
• Proactive identification programs in specialty clinics.
• Evidence-based reassurance on long-term tolerability of RNAi in a chronic dosing model.

2) Persistence: how much of the treated base stays on therapy?

Persistence risk typically comes from:

• Adverse events leading to discontinuation.
• Dose timing adherence and logistics for monthly injections.
• Physician preference shifts if competing prophylaxis (including other RNAi or upstream pathway drugs) gains traction.

3) Net price: how payers set access for high-cost orphan medicines

Net revenue is shaped by:

• Coverage criteria and step edits (attack frequency, prior hemin exposure, documented AHP subtype).
• Rebate structures tied to formulary inclusion.
• Limits on quantity or duration via prior authorization.

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What is the financial trajectory of GIVLAARI and what does it imply for future revenue?

GIVLAARI’s financial trajectory should be evaluated as a rare-disease, high-cost prophylaxis product where year-over-year change is mainly driven by treated patient counts rather than volume elasticity. In this model:

• Revenue grows when net-treated patients increase and persistence holds.
• Price growth is usually modest versus access pressure.
• Any abrupt revenue step-change is usually associated with formulary expansion, payer coverage revisions, or a pipeline-driven confidence boost that accelerates uptake.

Key metrics that track GIVLAARI’s trajectory

• Treated patient counts (with monthly dosing persistence)
• Prescription demand vs. new starts
• Proportion of spend under commercial versus specialty pharmacy channels
• Net-to-gross ratio (rebates and discounts)
• Geographic mix where coverage is strongest

How revenue typically behaves for rare prophylaxis RNAi

For RNAi rare-disease agents:

• Early growth phase is patient identification plus specialty conversion.
• Mid phase stabilizes on persistence and payer consolidation.
• Late phase relies on incremental uptake and life-cycle extensions (new indications or dosing improvements).

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When does GIVLAARI face exclusivity and competitive entry pressure?

Revenue pressure in the US is driven by patent and regulatory exclusivity, then shifts to generic/biosimilar substitution risk only if an equivalent becomes authorized. For small-molecule drugs, substitution is straightforward; for RNAi modalities, “generic” pathways are still constrained by delivery chemistry, oligonucleotide composition, and manufacturing/IP barriers.

How to think about exclusivity in RNAi rare disease

• Regulatory exclusivity can extend beyond initial approval for certain milestones, but competition is more dependent on patent estate strength than exclusivity alone.
• The practical risk is usually “similar product” or next-generation mechanism, not true generic substitutability.

What to watch for in 2024–2026

• Evidence of next-generation ALAS1-directed therapies (RNAi or alternative mechanisms) entering late-stage development.
• US payer behavior shifting toward preferred prophylaxis if a competitor demonstrates equal or better outcomes.
• Any FDA label expansion that broadens eligible populations (increases addressable market).

(A full exclusivity and patent-by-patent expiration timetable requires the underlying Orange Book and patent family data for givosiran; without it, an accurate date-specific exclusivity schedule cannot be stated.)

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Which competitors affect GIVLAARI demand and how does each shift market share?

Competition typically comes from:

• Other AHP prophylaxis options with different mechanisms (upstream heme pathway modulation, liver-targeted approaches).
• Next-generation RNAi products with improved delivery or tolerability.
• Non-pharmacologic or supportive strategies, which limit physician willingness to switch when attacks are controlled.

How patient selection changes when a competitor launches

When a new prophylaxis arrives, physicians often:

• Start new patients on the preferred product.
• Convert only the most attack-prone or least controlled on current therapy.

So even a modest competitor advantage can cause disproportionate displacement by capturing new starts.

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What is GIVLAARI’s payer and reimbursement profile in the US?

Access for rare disease is usually “center-of-excellence” and “prior authorization” heavy, with specialty pharmacy distribution.

Typical reimbursement dynamics

• Formularies: Often included after evidence of coverage criteria and outcomes.
• PA documentation: Frequency of AHP attacks, prior therapies, diagnosis confirmation.
• Specialty pharmacy: Net price is determined by rebate structures, patient assistance, and contracting.

Revenue impact pathways

• Positive: Broadening coverage criteria or lowering administrative burden increases new starts.
• Negative: Tightening prior authorization during budget pressure reduces treatment initiation and slows growth.

(A precise US payer mix and net pricing table requires company-reported revenue disclosure and claims-level access data, which are not provided here.)

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How strong is GIVLAARI’s commercialization compared with other rare-disease RNAi products?

Relative performance in rare-disease RNAi depends on:

• Patient population size and diagnosable prevalence.
• Clinician comfort with long-term RNAi dosing.
• Demonstrated reduction in attack rates and healthcare utilization.
• Uptake speed after launch (sales force penetration plus KOL prescribing).

GIVLAARI’s narrow indication usually means growth is slower than in broader chronic disorders, but persistence can be strong when patients experience meaningful attack reduction.

What drives durable market share

• Real-world persistence.
• Reduced hospitalization and acute-care utilization.
• Consistent tolerability over time.

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What risks could slow GIVLAARI revenue growth in 2025–2026?

Common headwinds for orphan prophylaxis include:

• Administrative tightening of coverage (PA, step edits).
• Discontinuation from adverse events or patient dissatisfaction with monthly injection logistics.
• Competitive displacement in new starts.
• Label restrictions if post-marketing safety signals appear.

For RNAi specifically, payer and clinician concerns can also arise around:

• Long-term safety interpretation as more patients move into multi-year use.
• Any signal that prompts physicians to delay initiation.

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What upside drivers could accelerate GIVLAARI revenue in 2025–2026?

• Increased identification of AHP patients via specialty networks.
• Expanded payer coverage and improved formulary positioning.
• Any evidence (trial or real-world) supporting stronger outcomes, including reduced healthcare resource use.
• Potential label expansion that broadens patient eligibility (if approved).

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How does GIVLAARI compare on market access versus other rare medicines?

Rare-disease medicines often share:

• High per-patient annual cost.
• Access bottlenecks centered on payer criteria and specialty distribution.
• A need for documentation-intensive prior authorization.

GIVLAARI’s differentiation for market access is linked to:

• The clarity of eligibility tied to attack frequency and prophylaxis need.
• The magnitude and durability of attack reduction in clinical practice.

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Key Takeaways

• GIVLAARI demand is structurally capped by the diagnosed acute hepatic porphyria population and clinical eligibility for prophylaxis.
• Revenue growth is primarily a function of treated-patient penetration and persistence, not broad market expansion.
• Net revenue in the US is sensitive to formulary inclusion, prior authorization criteria, and rebate dynamics typical of orphan high-cost injectables.
• Competitive pressure is most likely to shift new starts rather than instantly displace stable patients.
• The 2025–2026 outlook hinges on real-world persistence, payer coverage stability, and the competitive landscape for ALAS1-targeting or alternative AHP prophylaxis.

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FAQs

1. How does prior authorization impact GIVLAARI net revenue?
   It reduces new starts when documentation thresholds tighten, and it increases net revenue when criteria are standardized and formulary access improves.

2. What real-world metrics best forecast GIVLAARI revenue persistence?
   Continued monthly dosing rates, discontinuation reasons, and documented attack reduction translating into fewer acute-care episodes.

3. Is GIVLAARI growth more driven by new starts or by price increases?
   Primarily by new starts and persistence; price increases are typically limited by payer pressure for high-cost rare medicines.

4. How would a new AHP prophylaxis approval affect GIVLAARI revenue?
   It usually reallocates new start share first, with slower displacement of existing patients unless outcomes or tolerability strongly favor the competitor.

5. What signals in FDA labeling or safety updates would most affect GIVLAARI adoption?
   Changes impacting dosing, eligibility language, or safety monitoring that raise physician uncertainty or payer scrutiny.

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References (APA)

1. No sources were cited because no specific financial, regulatory, pricing, payer, patent, or Orange Book data for GIVLAARI were provided in the input.

DrugChatter Q&A for GIVLAARI

What are the side effects of the drug Givlaari?