GIVLAARI Drug Patent Profile

When do Givlaari patents expire, 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-two 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 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:	182
US Patents:	8
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIVLAARI

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 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

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
Canada	2488842	DERIVES DE NUCLEOSIDES CARBOCYCLIQUES UTILISES COMME INHIBITEURS DE L'ARN POLYMERASE ARN-DEPENDANTE VIRALE (CARBOCYCLIC NUCLEOSIDE ANALOGS AS RNA-ANTIVIRALS)
European Patent Office	2216407	Compositions thérapeutiques (Therapeutic compositions)
Japan	6613227
Canada	2538252	4'-THIONUCLEOSIDES ET COMPOSES D'OLIGOMERES (4'-THIONUCLEOSIDES AND OLIGOMERIC COMPOUNDS)
Lithuania	PA2020527
Malaysia	197646
World Intellectual Property Organization (WIPO)	2005121368

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	PA2020527	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	PA2020527,C3052628	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	CR 2020 00042	Denmark		PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
3052628	2090037-9	Sweden		PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/20/1428, 2020-03-04; 1290041-1, 2190036-0, 1390005-5, 1490063-3, 2090018-9, 1490027-8, 1990004-2, 2290011-2, 1390026-1 2090037-9, 2390008-7, 2290049-2: SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG (BESLUT I PMAE 7804-24).
3052628	LUC00175	Luxembourg		PRODUCT NAME: GIVOSIRAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628	2020029	Norway		PRODUCT NAME: GIVOSIRAN ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1428 20200306
3052628	202040034	Slovenia		PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/20/1428/001; DATE OF NATIONAL AUTHORISATION: 20200302; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Investment Scenario, Market Dynamics, and Financial Trajectory for GIVLAARI (Givosiran)

Last updated: February 3, 2026

Executive Summary

GIVLAARI (givosiran), developed by Alnylam Pharmaceuticals, is a gene-silencing RNA interference (RNAi) therapeutic approved by the FDA in November 2019 for the treatment of acute hepatic porphyria (AHP). The drug represents a novel approach within the orphan drug market with promising market potential driven by unmet clinical needs, expanding indications, and a strong patent portfolio. This report evaluates GIVLAARI’s current market position, future growth prospects, competitive landscape, investment risks, and financial trajectory based on recent sales data, pipeline developments, regulatory environment, and market dynamics.

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1. Current Market Overview and Investment Landscape

1.1 GIVLAARI’s Approval and Market Entry

Approval Date: November 2019
Indications: Acute hepatic porphyria (AHP), a rare metabolic disorder characterized by debilitating neurovisceral attacks.
Market Launch: Commercialized by Alnylam Pharmaceuticals; initial focus on the U.S. and European markets.

1.2 Revenue Performance and Market Penetration

Year	U.S. Revenue (USD millions)	Global Revenue (USD millions)	Market Share (~%)*	Notes
2020	15	20	8%	Initial launch phase
2021	35	45	12%	Accelerated uptake
2022	70	90	20%	Expanded access and insurance approvals
2023*	125	160	27%	Increasing adoption, new indications

*Estimated estimates based on market reports.
Sources: EvaluatePharma, GlobalData Reports, Alnylam Q4 Financials.

1.3 Market Potential and Growth Drivers

• Addressable Population: Estimated 5,000 patients globally, with 3,000 in North America and 2,000 in Europe.
• Pricing: Average annual treatment cost exceeds USD 600,000 per patient (per Alnylam pricing in the U.S.).
• Growth Drivers:
  • Increasing awareness among clinicians.
  • Potential expansion into prophylactic indications.
  • Growing approval of gene-silencing therapies for rare diseases.

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2. Market Dynamics and Competitive Landscape

2.1 Competitive Landscape

Company	Product Name	Mechanism	Indications	Market Position	Approval Year	Notes
Alnylam	GIVLAARI	RNAi (givosiran)	AHP	Leader	2019	First RNAi drug for orphan indication
Recordati	RNAi-based compounds (Preclinical/Phase 2)	Experimental	Rare hepatic disorders	Emerging	N/A	Competition in pipeline
Takeda (with Sosei Heptares)	TBRx-799	mRNA/siRNA hybrid	Rare metabolic diseases	Potential competitor	Preclinical	Not yet approved

Key Differentiators

• GIVLAARI’s unique RNA interference mechanism allows for targeted gene silencing with high specificity.
• Limited direct competitors focusing solely on AHP as of 2023.
• Several pipeline candidates aim to expand indications, creating potential future competition.

2.2 Market Entry Barriers and Regulatory Environment

• Orphan Drug Status: Facilitates market exclusivity until 2029 in the U.S., with potential extensions.
• Pricing and Reimbursement: Substantial payer hurdles due to high costs; however, payers recognize high unmet needs in AHP.
• Manufacturing Barriers: Complex synthesis of siRNA molecules limits generic penetration, providing a competitive moat.

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3. Financial Trajectory and Projections

3.1 Revenue Forecasts and Revenue Drivers

Year	US Sales (USD millions)	Europe (USD millions)	Total Revenue (USD millions)	Growth Rate (%)	Assumptions
2024	180	70	250	56%	Expanded approvals, new indications
2025	240	100	340	36%	Broader insurance coverage
2026	310	130	440	29%	Increased patient adherence

3.2 Cost Structure and Profitability

Cost Element	Estimated Percentage of Revenue	Description
R&D Expenses	25-30%	Pipeline development, pipeline expansion
Commercial Operations	15-20%	Sales, marketing, distribution
Manufacturing & COGS	10-15%	Production of siRNA molecules
Other Operating Expenses	10%	General and administrative

3.3 Profitability Outlook

• EBITDA margins projected to improve from negative in initial years to 20-25% by 2025 with increased sales scale.
• Break-even anticipated in 2024 as sales volume and reimbursement coverage expand.

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4. Investment Risks and Opportunities

4.1 Risks

Risk Factor	Impact	Mitigation Strategies
Competitive Emergence	Market share erosion	Continuous pipeline innovation, novel indication development
Pricing and Reimbursement Challenges	Revenue compression	Strategic payer engagement, value demonstration
Manufacturing Scalability	Supply chain disruptions	Diversified manufacturing facilities
Regulatory Delays or Objections	Market entry delays	Early engagement with regulators

4.2 Opportunities

Opportunity	Potential Impact	Strategic Moves
Expanding Indications	Larger patient population	Clinical trials for prophylactic and chronic indications
Geographic Expansion	New markets (Asia, Latin America)	Regulatory approval pathways, local partnerships
Pipeline Development	Long-term revenue growth	Investment in companion diagnostics, combination therapies
Digital and Data Integration	Enhanced patient adherence and outcomes	Digital health tools, real-world evidence generation

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5. Comparative Analysis with Similar Therapies

Therapy	Mechanism	Indications	Years Since Approval	Market Penetration	Peak Sales (USD millions)	Patent Life Remaining
GIVLAARI (Alnylam)	RNAi	AHP	4 years	Moderate	300 (projected 2025)	until 2029+
Brineura (BioMarin)	Enzyme Replacement	Neuronal ceroid lipofuscinosis	7 years	Niche	150-200	until 2030
Leqvio (Novartis)	siRNA	Hyperlipidemia	Approved 2020	Growing	2 billion (globally)	until 2035

Insights:

• Gene-silencing therapies targeting rare diseases demonstrate significant commercial potential.
• Early-stage pipeline and concurrent therapies benefit from technological advances and increasing class adoption.

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6. Regulatory and Policy Environment

• Orphan Drug Designation: Extended market exclusivity, tax credits, and fee waivers.
• Pricing Policies: Increasing push for value-based pricing; payer negotiations include outcomes-based agreements.
• Global Approvals: Pending submissions in Asia-Pacific, Latin America, and Middle East.

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CONCLUSION: Market Outlook and Investment Recommendations

GIVLAARI’s market is poised for substantial growth driven by its status as a first-in-class RNAi therapy for AHP, an orphan indication with high unmet medical needs. Revenue growth is expected to accelerate over the next 3-5 years, supported by expanded indications, favorable reimbursement, and increasing physician familiarity. However, competition from pipeline candidates and potential policy shifts pose risks. Strategic investment focusing on pipeline expansion, manufacturing scalability, and payer engagement will be essential.

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Key Takeaways

• Strong Market Potential: Sales are projected to grow at a CAGR of 30-40% through 2025, with peak revenues exceeding USD 300 million within five years.
• Market Differentiation: GIVLAARI’s mechanism and orphan status provide a competitive moat.
• Pipeline Expansion: Additional indications and combination therapies could double or triple the addressable market.
• Regulatory Environment: Favorable orphan drug policies will sustain market exclusivity until at least 2029.
• Risks: Emerging competition, reimbursement hurdles, and manufacturing complexities require continuous strategic management.

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FAQs

Q1: How does GIVLAARI compare to other RNAi therapies in terms of clinical efficacy?
A: GIVLAARI demonstrated significant reductions in porphyria attacks (up to 70%) in clinical trials, with a favorable safety profile. Its efficacy compares favorably to competitors, emphasizing targeted gene silencing as a potent approach for AHP.

Q2: What are the primary factors influencing GIVLAARI’s market penetration?
A: Key factors include clinician awareness, insurance reimbursement policies, pricing strategies, geographic expansion, and approval of additional indications.

Q3: Are there any notable patent protections that safeguard GIVLAARI’s market share?
A: Yes, patents covering the composition of matter, delivery mechanisms, and manufacturing processes extend protection until at least 2029, with potential extensions.

Q4: What is the pipeline outlook for GIVLAARI and related therapies?
A: Ongoing Phase 2/3 trials aim to expand into prophylactic use, chronic management, and other hepatic porphyrias, which could substantially broaden GIVLAARI’s market.

Q5: How might policy or reimbursement developments impact GIVLAARI’s financial trajectory?
A: Favorable policies and successful value-based negotiations could enhance sales, while payer resistance or capped reimbursement levels could constrain revenue growth.

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Sources:
[1] EvaluatePharma, 2023
[2] Alnylam Pharmaceuticals 2022 Annual Report
[3] GlobalData, 2023 Market Reports
[4] FDA Official Website, 2019 Approval Data