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-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
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:

11,028,392

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 patent 11,028,392.

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

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	8,546,143
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	9,708,615

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
Canada	2538252	4'-THIONUCLEOSIDES ET COMPOSES D'OLIGOMERES (4'-THIONUCLEOSIDES AND OLIGOMERIC COMPOUNDS)
Australia	2018203098	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE
European Patent Office	2216407	Compositions thérapeutiques (Therapeutic compositions)

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2020C/532	Belgium		PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1428 20200304
3052628	20C1040	France		PRODUCT NAME: GIVOSIRAN OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1428 20200304; FIRST REGISTRATION: - EU/1/20/1428 20200304

GIVLAARI (givosiran): Market dynamics and financial trajectory

Last updated: April 23, 2026

What is the commercial footprint of GIVLAARI?

GIVLAARI (givosiran) is a targeted RNA interference therapy approved for acute hepatic porphyria (AHP). Commercial adoption is driven by two market realities: (1) a defined, relatively small patient population with frequent acute attacks; and (2) specialist-led prescribing concentrated in porphyria centers.

Indication and positioning

• Indication: GIVLAARI is used in adults with acute hepatic porphyria.
• Mechanism: RNA interference targeting ALA synthase 1 (ALAS1) to reduce hepatic ALA/PBG production (core value proposition: attack reduction vs. reactive therapies).

Demand generation dynamics

• Enrollment and identification: Growth depends on diagnosis and referral to centers. In AHP, underdiagnosis and misclassification can cap near-term demand even when pricing is accepted.
• Physician workflow: Adoption typically follows a pathway from acute-management settings to long-term prophylaxis decisions, where clinicians weigh attack history and hospitalization frequency.
• Payer acceptance: Like most orphan-leaning specialty biologics, uptake is shaped by prior authorization, step therapy rules where applicable, and formulary placement at large regional payers.

How is pricing and reimbursement shaping the revenue curve?

GIVLAARI’s revenue trajectory is constrained and amplified by reimbursement mechanics typical for rare disease therapies:

• High list pricing with outcomes-based pressure: Payers increasingly tie coverage to documented attack frequency and prior treatment response.
• Restricted net price realization: Rebates and discounts depend on formulary tier, patient volume commitments, and contracting discipline by major pharmacy benefit managers (PBMs).
• Dose intensity as revenue denominator: Revenue is sensitive to adherence to dosing schedules and persistence. For prophylactic therapies, persistence is a key determinant of sustained revenue rather than initial market entry alone.

What market forces influence competition and share capture?

GIVLAARI’s market dynamics are shaped by both direct and indirect competitive forces:

Direct competitive landscape

• In AHP prophylaxis, competitive pressure centers on therapies that reduce hepatic heme precursor production or provide attack reduction with acceptable safety and logistics.
• Competitive share tends to shift when efficacy differentiators and real-world tolerability improve relative to alternatives, or when payers create tighter preferred positions in a limited formulary slot.

Indirect competitive forces

• Switching friction: Once a patient stabilizes, clinicians often maintain prophylaxis unless efficacy or tolerability falls below threshold.
• Hospitalization avoidance economics: Payers evaluate overall cost offsets from reduced ER visits and admissions; this creates a continued incentive for prophylaxis uptake when budget impact models are favorable.

How do historical financial signals translate into a trajectory for GIVLAARI?

GIVLAARI’s financial trajectory is governed by three levers: (1) new patient starts, (2) persistence (duration on therapy), and (3) net pricing (post-rebate realization).

What tends to happen as adoption matures

• Early period: Faster growth is driven by conversion from uncontrolled attack history to prophylaxis.
• Mid period: Growth normalizes as eligible patients become increasingly identified and routed through a smaller number of specialty sites.
• Late period: Total category growth slows; revenue growth becomes increasingly dependent on share gains from competitors, persistence, and incremental penetration into regional payer networks.

What to watch in the revenue path

• Patient starts vs. churn: In rare disease, revenue can plateau if patient starts slow while discontinuations rise.
• Net price stability: Category contracting cycles and PBM re-anchors can cause volatility in revenue even with stable volumes.
• Safety-driven persistence: Tolerability and adherence patterns directly affect continuation rates, which drive recurring revenue.

Financial trajectory: how it typically reads in rare disease specialty

While exact quarterly financials and revenue line items for GIVLAARI are reported by the manufacturer in filings and earnings releases, the trajectory logic for a prophylactic rare disease therapy is consistent and measurable through a few indicators:

• Growth rate of starts: Drives top-line acceleration.
• Persistence over 12 to 24 months: Determines sustainability.
• Net price trends: Captures contracting and rebate evolution.
• Geographic payer penetration: Explains uneven quarter-to-quarter patterns.

Market sizing mechanics: why revenue can cap even with strong clinical demand

For GIVLAARI, the effective addressable market is smaller than the total AHP diagnosed population because:

• not all AHP patients need prophylaxis
• prophylaxis eligibility often requires frequent attack history and documented severity
• specialist centers and referral pathways limit the speed of patient capture These constraints create a revenue ceiling unless the product expands eligibility, wins additional payer coverage, or gains share from alternative prophylaxis.

Strategic implications for investors and commercial planners

• Commercial scaling depends on diagnosis and referral velocity, not only marketing spend.
• Contracting strength is central: stable net price and favorable formulary positioning can sustain revenue even when category growth slows.
• Medical access quality matters: real-world data generation and support programs that help physicians document eligibility can improve patient starts.
• Persistence is the second-order growth engine: adherence and discontinuation patterns have outsized effect on revenue durability in small patient populations.

Key takeaways

• GIVLAARI’s market dynamics are defined by a rare, specialist-centered AHP population where growth depends on diagnosis, eligibility documentation, and payer access.
• The revenue curve is driven by patient starts, persistence, and net price realization more than by headline market expansion.
• Competitive outcomes in AHP prophylaxis will hinge on payer contracting, switching friction once patients stabilize, and safety-driven continuation.
• In mature adoption scenarios, category growth slows and revenue increasingly reflects share gains and persistence rather than incremental penetration.

FAQs

1. What drives GIVLAARI demand in acute hepatic porphyria?
   Patient identification, specialist referral velocity, documented attack history, and payer coverage decisions for prophylaxis.

2. What matters most for revenue in rare disease prophylaxis like GIVLAARI?
   The combination of new patient starts, 12- to 24-month persistence, and net pricing after rebates and contracting.

3. How does payer policy influence GIVLAARI’s financial trajectory?
   Prior authorization, step edits, formulary tiering, and rebate structures determine realized net price and covered volumes.

4. What competitive factors can shift share in AHP prophylaxis?
   Relative efficacy in real-world outcomes, tolerability, administration logistics, and preferred formulary placement by large payers.

5. Why can revenue plateau even if clinical uptake is strong?
   Because the eligible prophylaxis population is capped by diagnosis rates, severity thresholds, and specialist access constraints.

References

[1] European Medicines Agency. Givlaari (givosiran) product information / EPAR documentation. EMA.
[2] U.S. Food and Drug Administration. Givlaari (givosiran) prescribing information and approval documentation. FDA.
[3] Bloomberg Intelligence / company filings cited in public earnings and annual reports covering GIVLAARI commercialization (where applicable).
[4] Clinical literature on ALAS1-targeted RNAi in acute hepatic porphyria (mechanism and efficacy basis for payer value assessments).