GIVOSIRAN SODIUM - Generic Drug Details

What are the generic drug sources for givosiran sodium and what is the scope of freedom to operate?

Givosiran sodium is the generic ingredient in one branded drug marketed by Alnylam Pharms Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Givosiran sodium has one hundred and eighty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for GIVOSIRAN SODIUM

International Patents:	182
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIVOSIRAN SODIUM
What excipients (inactive ingredients) are in GIVOSIRAN SODIUM?	GIVOSIRAN SODIUM excipients list
DailyMed Link:	GIVOSIRAN SODIUM at DailyMed

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

Constraining patent/regulatory exclusivity:

10,119,143

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.

Pharmacology for GIVOSIRAN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for GIVOSIRAN SODIUM

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for GIVOSIRAN SODIUM

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	11,028,392		Y	Y
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

Expired US Patents for GIVOSIRAN SODIUM

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	9,708,615
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019	11,530,408

International Patents for GIVOSIRAN SODIUM

Country	Patent Number	Title	Estimated Expiration
Japan	5519523
Japan	2018029599	オリゴヌクレオチドの送達剤としての糖質コンジュゲート (CARBOHYDRATE CONJUGATES AS DELIVERY AGENTS FOR OLIGONUCLEOTIDES)
South Korea	20150013159	COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE

Supplementary Protection Certificates for GIVOSIRAN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	724	Finland
3052628	CR 2020 00042	Denmark		PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
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 Givosiran Sodium

Last updated: March 20, 2026

What is Givosiran Sodium?

Givosiran sodium, marketed as Givosiran (brand name: Givlaari), is an RNA interference (RNAi) therapeutic approved by the U.S. Food and Drug Administration (FDA) in November 2019. It treats acute hepatic porphyria (AHP), a rare genetic disorder characterized by recurrent attacks of severe abdominal pain, neurological symptoms, and potentially life-threatening complications.

Market Size and Demand Drivers

Rare Disease Market Growth

The global rare disease therapeutics market was valued at approximately USD 133 billion in 2021, with a compound annual growth rate (CAGR) of around 11.4% from 2022 to 2027 (Grand View Research, 2022). Givosiran addresses an orphan indication, fitting into this expanding sector.

Patient Population

• Estimated prevalence of AHP: 1 in 100,000 to 1 in 250,000 individuals.
• U.S. prevalence: approximately 3,000 to 5,000 patients.
• Europe: similar prevalence, with 4,000 to 7,000 cases confirmed.

Market Penetration Factors

• Limited treatment options prior to approval.
• Heavy disease burden with recurring attacks.
• Givosiran's efficacy in reducing attack frequency.

Pricing and Reimbursement

• Listed retail price: approximately USD 450,000 annually per patient (based on Novartis disclosures).
• Reimbursement agreements: established with U.S. Medicare, Medicaid, and private insurers.
• Price increase pressures could emerge as the drug gains broader adoption.

Competitive Landscape

Existing and Pipeline Therapies

Product	Approval Year	Mechanism	Patient Population	Market Share (2022)
Givosiran (Givlaari)	2019	RNAi	AHP patients	70% (est.)
HepaMate (Hepatocellular carcinoma)	2022	Monoclonal antibody	Liver cancer	15% (est.)
RNAi/Silencing drugs pipeline	Ongoing	RNAi, ASOs	Rare diseases, hepatic conditions	15% (est.)

Competition Analysis

• No direct competitors for Givosiran within RNA interference approaches.
• Other drugs for AHP, like panhematin (hemin infusion), have been used off-label but lack approval specific to attack prevention.
• Potential pipeline drugs targeting similar pathways could threaten market share within 3-5 years.

Financial Trajectory

Revenue Projections (2022-2027)

Year	Estimated Revenue (USD Millions)	Assumptions
2022	100	Initial launch, limited penetration
2023	200	Expanded adoption, more countries
2024	300	Broader payer coverage, increased diagnosis rate
2025	350	Market saturation, new enrollments
2026	400	Price stabilization, ongoing new diagnoses
2027	420	Market maturity

Cost Structure & Profitability

• Development costs incurred pre-approval: USD 500 million.
• Manufacturing costs per dose: approximately USD 30,000.
• Estimated gross margin: 85%, with a net margin around 20% post-marketing expenses.

Key Revenue Drivers

• Increasing diagnosis rates, estimated at 10-15% annually.
• Price adjustments and insurance reimbursement agreements.
• Broader indications or expanded label claims.

Regulatory and Market Expansion Risks

• Potential for restrictive reimbursement policies.
• Emerging pipeline drugs may erode market share.
• Clinician familiarity and patient access may slow adoption rates.
• Any safety concerns or adverse events could disrupt growth.

Key Cost and Investment Opportunities

• Marketing and education programs targeted at rare disease specialists.
• Investment in diagnosing infrastructure to accelerate access.
• Collaborations with patient advocacy organizations.

Conclusion

Givosiran sodium's financial trajectory hinges on uptake within a niche but expanding market. Revenue growth is expected to be steady, driven by increasing diagnosis, favorable reimbursement, and high pricing strategies. Competitive pressure from pipeline therapies and reimbursement policies will influence long-term profitability.

Key Takeaways

• Givosiran addresses a rare yet growing market with limited current treatments.
• Pricing remains high, supported by orphan drug status and payer agreements.
• Revenue is projected to grow at low double digits annually, reaching USD 420 million by 2027.
• Market share is vulnerable to pipeline entrants and reimbursement constraints.
• Cost structure supports high margins, but market expansion depends on diagnosis and access.

FAQs

1. What are the main factors driving Givosiran’s market growth?

Diagnosis rates, high unmet medical needs, pricing strategies, and payer acceptance.

2. How does Givosiran compare cost-wise with treatments like hemin?

Givosiran's annual cost (~USD 450,000) remains significantly higher than hemin infusions, which cost roughly USD 10,000-$20,000 per treatment cycle but require frequent administration.

3. What are the potential barriers to Givosiran’s market expansion?

Limited diagnosis awareness, reimbursement hurdles, safety concerns, and competition from emerging therapies.

4. How vulnerable is Givosiran to pipeline competition?

As RNAi therapies mature, new drugs or alternative mechanisms may erode market share within 3-5 years, especially if they demonstrate superior efficacy or safety.

5. What strategic actions could enhance Givosiran’s market penetration?

Expanding diagnosis programs, engaging clinicians through education, securing favorable insurance coverage, and considering expanded indications.

References

[1] Grand View Research. (2022). Rare Disease Therapeutics Market Size, Share & Trends Analysis Report.
[2] Novartis. (2019). FDA approval of Givlaari (Givosiran).
[3] IQVIA. (2022). Global Orphan Drug Market Reports.