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-three 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:	183
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	9,631,193
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	8,828,956		Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	8,106,022		Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	11,028,392		Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	10,131,907		Y	Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	10,125,364		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	9,150,605
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	9,708,615
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	10,273,477
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	8,546,143
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	9,708,610
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	11,530,408

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

Last updated: May 26, 2026

GIVLAARI (givosiran) market dynamics and financial trajectory: exclusivity, pricing, uptake, and revenue path

Givlaari (givosiran) is a tie-up specialty RNAi therapy for acute hepatic porphyria (AHP) that targets the HBV? no, HMO? pathway: it reduces hepatic ALAS1 via RNA interference against ALAS1 mRNA. Commercial trajectory is driven by (1) patient identification in AHP, (2) payer coverage and infusion-setting adoption for subcutaneous dosing, (3) outcomes evidence tied to annualized attack rates, and (4) the durability of regulatory exclusivity and the strength of the patent estate supporting the branded product. The financial profile is characterized by high launch-year pricing relative to treatment frequency, concentrated demand in a defined patient population, and revenue sensitivity to real-world persistence and reimbursement policy.

Source-controlled market dynamics hinge on one question: how fast does Givlaari convert incident AHP patients and switchers from standard-of-care to long-term RNAi treatment, under restrictive payer criteria that commonly require prior attack burden and documented diagnosis.

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What is GIVLAARI (givosiran) used for, and how does indication breadth affect market size?

Which acute hepatic porphyria patients does Givlaari cover

Givlaari is approved for the treatment of adults with acute hepatic porphyria (AHP) who have recurrent attacks. The addressable market depends on:

• Confirmed AHP phenotype (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria).
• “Recurrent attack” definitions used by clinicians and payers.
• Exclusions that narrow eligibility, such as comorbidities that limit chronic therapy and regional differences in diagnostic practices.

Why recurrence status matters for payer coverage

Payers typically tie coverage to:

• Documented frequency of acute attacks before initiation.
• Failure or inadequate control on prior prophylaxis approaches (common in real-world pathways).
• Prescriber specialty confirmation (porphyria centers, hepatology, hematology, genetics).

Market impact: Givlaari revenue grows with both diagnosis rate and the number of eligible patients who remain on therapy across multiple treatment cycles.

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How does GIVLAARI dosing and administration shape adoption and cost of treatment?

Dosing schedule and persistence dynamics

Givlaari is administered by subcutaneous injection using a standardized regimen with defined initiation and maintenance phases. Adoption depends less on complex infusion logistics and more on:

• Training and nurse support at specialty pharmacies and outpatient infusion or office settings.
• Patient adherence to a chronic injection plan.
• Monitoring burden driven by known safety considerations from pivotal trials and label requirements.

Commercial drivers tied to administration

• Lower administration friction than IV biologics supports site-of-care flexibility.
• Patient persistence is a key determinant because annualized attack reductions show strongest alignment when therapy is sustained.

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How strong is the GIVLAARI exclusivity position, and when does it lose exclusivity?

Regulatory exclusivity timeline: what determines branded lock

For a small, specialty drug, exclusivity is typically reinforced by:

• New molecular entity (NME) exclusivity.
• Potential pediatric exclusivity extensions if applicable.
• Patent term and any regulatory patent extensions tied to US regulatory events.

Commercial effect: exclusivity determines the horizon of safe pricing and avoids early generic pressure, but market share can still erode via payer preferencing, channel displacement, and competitors within the same AHP prophylaxis category.

What to watch for

Even with exclusivity intact, revenue can shift through:

• Formulary tiering changes.
• Step therapy restrictions tightened over time.
• Narrowing criteria around “recurrent attacks” or biomarker requirements.

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What patents protect GIVLAARI, and how many are in the estate?

Patent estate composition by type

Givlaari’s patent protection (typical for RNAi therapeutics) usually spans:

• Composition-of-matter (active ingredient and salt/chemical variants).
• Formulation patents (stability, delivery system parameters).
• Method-of-use patents (prophylaxis, recurrence reduction, specific AHP subpopulations).
• Manufacturing process patents (oligonucleotide synthesis/assembly steps, purification, QA controls).

Why this matters financially: the strength and number of enabling and blocking patents drive whether challengers can find a defensible route to generic or biosimilar-like entry. For RNAi, regulatory and technical hurdles tend to be higher, which can keep pricing power longer even if some patents expire earlier.

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Are there Paragraph IV challenges or generic entry risks for GIVLAARI?

Timing risks

Generic or competing RNAi entrants depend on:

• The earliest patent expiration in the relevant Orange Book listings (if applicable).
• The scope of method-of-use and formulation patents that could be infringed by a “carve-out” generic.

Reality check for competitive pressure

For drugs with complex delivery and manufacturing, real-world competition often comes later via:

• Authorized or licensed competitors.
• Next-generation products with improved safety or convenience.
• Payer-favored rebates or contract pricing rather than true generic entry.

Financial linkage: unless a challenger succeeds in forcing a legal entry, the branded revenue trajectory is mostly a function of penetration and persistence, not substitution.

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What is the Orange Book status of GIVLAARI (givosiran) in the US?

Orange Book listings drive launch timelines

The US market exclusivity and challenge risk are anchored in:

• Listed drug records.
• Patent numbers mapped to expiration dates.
• Patent use codes and claim scope.

Commercial effect: any early narrow expiration on formulation or method-of-use could create leverage for lower-priced competitors even if composition-of-matter remains protected.

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What patent litigation affects GIVLAARI, and what settlements changed market access?

Litigation signals that affect revenue

Patent suits change the commercial outlook when they:

• Create a risk of earlier market entry.
• Lead to stay/settlement timelines that define generic entry dates.
• Change how payers plan contracting (risk-based contracting and pricing).

What investors and licensing teams track

• Court decisions affecting claim construction.
• Settlement dates that create predictable “switch” windows for payers.
• Any cross-licensing that creates “competition without generics,” such as supply agreements.

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How does GIVLAARI compare with other AHP therapies on market adoption and payer preference?

Competitor set

In AHP prophylaxis, the competitive landscape typically includes:

• Therapies used for attack prevention or symptom management.
• Standards that may include hemin-based approaches or off-label prophylaxis where permitted.
• Liver-directed or supportive regimens used at specialty centers.

Comparison dimensions that translate into revenue

• Reduction in annualized attack rates and symptom burden.
• Safety profile relative to existing chronic regimens.
• Ease of long-term administration.
• Evidence strength for recurrent attack populations.

Financial linkage: Givlaari’s market share is most sensitive to outcomes evidence that matches payer criteria for continued reimbursement.

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How do pricing, rebates, and payer coverage rules drive GIVLAARI revenue?

Net pricing vs list pricing

Specialty drugs in small populations often have:

• High list price.
• Contracted net price shaped by outcomes, volume tiers, and formulary placement.
• Pharmacy benefit manager (PBM) negotiations that influence patient access.

Coverage constraints that delay uptake

Common restrictions include:

• Confirmation of AHP diagnosis.
• Attack frequency thresholds.
• Prior therapy requirements.
• Prescriber or specialty center requirements.

Commercial effect: these controls convert pent-up need into slower, uneven uptake that flattens revenue growth rates after initial launch.

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What is the financial trajectory for GIVLAARI in terms of growth stages?

Stage 1: Launch to early penetration

• Sales typically rise as centers learn workflows, prescribers build confidence, and payers finalize coverage templates.
• Revenue can remain below modeled peaks if patient identification lags or if reimbursement criteria are tightened.

Stage 2: Expansion through persistence

• For chronic therapies, the largest revenue lift often comes from retention.
• Real-world persistence influences year-over-year revenue more than initial prescribing.

Stage 3: Contracting and payer competition

• Even without generic entry, net price can decline through broader payer negotiation.
• Patient steering can occur through formulary positioning, preferred contracting among PBMs, and rebate renegotiations.

Net result: branded revenue is typically “stable-to-growth” if persistence stays high and access broadens, “flat” if criteria tighten, and “down” if contracting pressure accelerates.

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How do safety and monitoring considerations affect ongoing demand for GIVLAARI?

Risk management impacts on discontinuation

If label-driven monitoring or adverse events lead to discontinuations, that mechanically reduces:

• Patient count on drug.
• Revenue retention.
• Reimbursement continuation approvals.

Clinical confidence affects payer continuation

Payers often require continued treatment justification if patients worsen, have serious adverse events, or fail to meet outcomes thresholds.

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Which geographic markets have the highest leverage for GIVLAARI expansion?

US vs ex-US dynamics

Givlaari’s revenue path can differ due to:

• National health system negotiation practices.
• Diagnostic capacity for AHP.
• Differences in payer authority and coverage rules for specialty drugs.
• Availability of specialized centers to administer RNAi therapies.

Financial linkage: the strongest markets tend to be those with higher diagnosis rates and less restrictive reimbursement criteria for recurrent attack prophylaxis.

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What business levers can a sponsor use to improve GIVLAARI financial performance?

Commercial levers that impact revenue most

• Tightening center-of-excellence referral pathways to increase eligible patient identification.
• Payer-specific contracting that aligns net price to clinically meaningful outcomes.
• Persistence programs that reduce treatment discontinuation through injection training and monitoring adherence.
• Evidence generation in real-world settings that supports payer authorization renewals.

Licensing and partnership levers

• Authorized distribution arrangements or specialty pharmacy expansion can widen access without requiring additional manufacturing capacity.
• Co-marketing and payer education can reduce time-to-coverage.

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Key Takeaways

• Givlaari’s revenue trajectory is dominated by patient identification, reimbursement criteria for recurrent AHP attacks, and long-term persistence on chronic subcutaneous therapy.
• The financial profile should be modeled as specialty “penetration plus retention,” not as broad market expansion.
• Exclusivity and patent estate strength primarily reduce generic substitution risk, shifting competitive pressure to payer contracting and non-generic alternatives within AHP prophylaxis.
• Net revenue is sensitive to formulary tiering, step-edit controls, and outcomes-linked reimbursement renewals.
• Safety, monitoring, and treatment discontinuation rates directly affect patient-level revenue retention.

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FAQs

1. How quickly do payers approve GIVLAARI for recurrent acute hepatic porphyria attacks?
2. What outcomes endpoints do insurers use to justify ongoing GIVLAARI reimbursement?
3. How do porphyria center referral patterns influence GIVLAARI patient conversion rates?
4. What manufacturing or supply constraints could affect GIVLAARI continuity of treatment and revenue?
5. What factors would accelerate competitive pressure to GIVLAARI short of generic entry?

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots: GIVLAARI (givosiran). FDA.
2. U.S. Food and Drug Administration. (n.d.). GIVLAARI (givosiran) Prescribing Information. FDA.
3. U.S. Patent and Trademark Office / FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.

DrugChatter Q&A for GIVLAARI

What are the side effects of the drug Givlaari?