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 nine patents protecting this drug.

This drug has two hundred and seventy-nine patent family members in forty-five 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 October 3, 2034. 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:	279
US Patents:	9
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:

10,119,143

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 nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,119,143.

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
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	9,133,461		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	10,273,477
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	9,150,605
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	11,530,408
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	9,708,615

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
Japan	2015146823	特定遺伝子の発現を抑制するための方法および薬剤 (METHOD AND MEDICAMENT FOR INHIBITING EXPRESSION OF GIVEN GENE)
Japan	6215284
Australia	2004274021	4'-thionucleosides and oligomeric compounds
Canada	2504701	MOTIFS STRUCTURELS, COMPOSES OLIGOMERIQUES ET UTILISATION DECEUX-CI DANS LA MODULATION DE GENE (STRUCTURAL MOTIFS AND OLIGOMERIC COMPOUNDS AND THEIR USE IN GENE MODULATION)
Cyprus	1122975
Australia	2004233092	Modified iRNA agents
World Intellectual Property Organization (WIPO)	2005120230

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	SPC/GB20/042	United Kingdom		PRODUCT NAME: GIVOSIRAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/20/1428 (NI) 20200304; UK PLGB 50597/0004 20200304
3052628	2020029	Norway		PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306
3052628	132020000000106	Italy		PRODUCT NAME: GIVOSIRAN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GIVLAARI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1428, 20200304
3052628	2020/038	Ireland		PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/20/1428 20200304; FIRST REGISTRATION NO/DATE: EU/1/20/1428 04/03/2020
3052628	PA2020527	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	C202030043	Spain		PRODUCT NAME: GIVOSIRAN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1428; DATE OF AUTHORISATION: 20200302; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1428; DATE OF FIRST AUTHORISATION IN EEA: 20200302
3052628	301061	Netherlands		PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1428 20200304

Market Dynamics and Financial Trajectory for GIVLAARI (Givosiran)

Last updated: December 29, 2025

Executive Summary

GIVLAARI (givosiran) is a novel RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals, approved by the FDA in November 2019 for the treatment of acute hepatic porphyria (AHP). Since its approval, GIVLAARI has reshaped the therapeutic landscape for rare porphyric disorders, leveraging the burgeoning RNAi platform that positions Alnylam as a frontrunner in nucleic acid therapies. This report delineates the current market dynamics—encompassing competitive landscape, reimbursement policies, and patient demographics—and projects the financial trajectory, considering sales, market penetration, and pipeline developments.

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What Are the Market Drivers for GIVLAARI?

Driver	Description	Impact
Rare Disease Focus	AHP affects an estimated 5,000-10,000 people globally; high unmet need.	Drives physician adoption, niche market premium.
Regulatory Approvals and Expanding Labels	FDA approval (Nov 2019), plus EMA and other agencies’ approvals; label extensions for pre-symptomatic use (2021).	Broaden patient eligibility, increase sales potential.
RNAi Therapeutics Growth	Rapid advancement of RNAi platforms; Alnylam's leadership consolidates market confidence.	Attracts investment, accelerates drug adoption.
Health Economic Value	Demonstrated reduction in hospitalization and attack frequency reduces overall healthcare costs.	Supports favorable reimbursement negotiations.
Limited Competition in Niche Indication	Few approved options, primarily off-label or supportive care.	Enhances market share for GIVLAARI.

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What Is the Current Market Size and Revenue Clarity?

Parameter	Details	Implications
Global AHP Patient Population	Estimated 5,000-10,000, predominantly in North America and Europe.	Provides initial target market scope.
Peak Sales Estimates	Industry analysts project peak sales ranging from $500 million to over $1 billion globally.	Indicates significant growth potential.
Quarterly and Yearly Sales (2022-2023)	Alnylam reported sales of approximately $100 million in FY2022.	Reflects rapid growth trajectory.
Pricing Structure	Approximately $575,000 per year per patient; varies by region.	Critical for revenue and reimbursement calculations.

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How Does GIVLAARI Compare with Competitors?

Parameter	GIVLAARI	Competitors/Alternatives	Notes
Mechanism of Action	RNA interference (RNAi) targeting ALAS1 mRNA	Supportive care, off-label therapies	Differentiates as targeted, disease-specific therapy.
Approved Indication	Acute hepatic porphyria (AHP)	Supportive therapies; no direct competitors in approval yet	First FDA-approved RNAi for this indication.
Administration Route	Subcutaneous injection weekly	Variable; supportive care may be oral or infrequent	Enhances patient compliance and healthcare delivery ease.
Safety Profile	Generally well-tolerated; transient injection-site reactions.	Supportive care risks vary; no direct comparators.	Favorable safety profile supports broader adoption.
Market Differentiation	Disease-targeted, disease-modifying; reduced attack frequency	Symptomatic treatments; no disease modification	Positions GIVLAARI as first-mover in this niche.

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What Are the Key Market Challenges?

Challenge	Details	Implications
Pricing and Reimbursement Hurdles	High annual cost ($575,000) may face scrutiny; reimbursement depends on healthcare policies.	Potential delays in adoption; influence on market penetration.
Limited Patient Pool	Niche indication limits sales volume; growth hinges on expanding indications or label extensions.	Necessitates pipeline expansion or label updates.
Market Penetration Delays	Limited clinician familiarity; logistical barriers for patients.	Requires robust educational efforts and patient support programs.
Pipeline Competition	Emergence of other RNAi therapeutics or small molecules.	Threats from future, more efficacious, or cost-effective options.

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What Is the Financial Trajectory?

Year	Estimated Sales (USD Million)	Key Assumptions	Comments
2023	$180–$250	Continued uptake, expanding label, and reimbursement support.	Early market penetration, patient awareness initiatives.
2024	$300–$oon	Greater geographic expansion; new indications.	Pipeline progress and increased physician familiarity.
2025	$500–$1,000	Peak sales with broader adoption, possibly in pre-symptomatic patients.	Reflects mature market with optimized access strategies.

Note: These estimates are contingent on factors such as pipeline success, competition, and healthcare policy shifts.

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How Will GIVLAARI’s Sales Be Impacted by Pipeline and Label Expansions?

Development Area	Expected Impact	Timeline
Pre-symptomatic Use Expansion	Larger patient population, increased sales.	2024-2025
Other Porphyric Indications	Potential approval for porphyria-related conditions, expanding market share.	2024–2026
Combination Therapy Potential	Synergistic regimes with other treatments could boost revenues.	Long-term (post-2025)

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What Is the Future Outlook for GIVLAARI and Its Market?

Growth Potential

• The RNAi platform's maturation is expected to catalyze broader adoption.
• Potential label expansion and pipeline progression open avenues to multiply revenue streams.
• Strategic partnerships and enhanced patient access could accelerate growth.

Risks

• Pricing pressures, especially in countries with stringent healthcare budgets.
• Competition from emerging RNAi or gene therapies targeting AHP or related rare diseases.
• Regulatory and reimbursement landscape variability across regions.

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Summary of Key Data and Metrics

Attribute	Details
Market Size	5,000–10,000 global patients
Peak Sales Forecast	$500 million to over $1 billion
Current Revenue (2022)	~$100 million
Pricing	~$575,000 annually per patient
Regulatory Status	Approved in US, EU; additional indications under review
Competitors	None directly approved; supportive care options are main competitors

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Key Takeaways

• Growth Catalysts: GIVLAARI benefits from its first-mover status, disease specificity, and RNAi platform robustness, positioning it for considerable future growth.
• Market Dynamics: The niche AHP market is expanding through label extensions and geographic penetration, although sales are limited by the small patient population.
• Financial Outlook: Anticipated to reach peak sales between $500 million and $1 billion over the next 3-5 years, driven by increased adoption and pipeline expansion.
• Challenges: Pricing policies, reimbursement hurdles, and competition will shape the pace of growth.
• Strategic Implications: Stakeholders should focus on patient access, evidence generation for economic value, and pipeline diversification to maximize financial potential.

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FAQs

1. How does GIVLAARI’s mechanism of action differ from traditional therapies?
GIVLAARI employs RNA interference, specifically silencing the ALAS1 gene, thereby reducing neurotoxic precursors in porphyria, providing a targeted and disease-modifying approach unlike symptomatic supportive treatments.

2. What are the primary barriers to GIVLAARI’s wider adoption?
Barriers include high costs, reimbursement inconsistencies across regions, limited awareness among clinicians, and the small size of the target population.

3. How does GIVLAARI compare economically to alternative management options?
Modeling indicates GIVLAARI can reduce emergency hospitalizations and attack frequency, potentially lowering overall healthcare costs, though initial drug costs remain high.

4. What is the outlook for GIVLAARI’s pipeline expansion?
Alnylam is exploring label extensions for pre-symptomatic patients and additional indications within porphyric disorders, which could significantly broaden the market.

5. How is GIVLAARI’s market share expected to evolve?
As awareness and access increase, market share should grow steadily within the niche space; eventual competition or pipeline innovations could influence this trajectory.

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References

[1] FDA Approval Letter for GIVLAARI (Nov 2019).
[2] Alnylam Pharmaceuticals Annual Reports 2022.
[3] Industry Analyst Reports on RNAi Market (2022-2023).
[4] European Medicines Agency Label Extension Data (2021).
[5] Global Rare Disease Data from Orphanet (2022).