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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 twelve patents protecting this drug.

This drug has three hundred and twenty-six patent family members in forty-four 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.

Indicators of Generic Entry

Summary for GIVLAARI

International Patents:	326
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information 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 twelve US patents and two FDA Regulatory Exclusivities.

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	10,273,477			Y
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	11,028,392		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	9,708,615
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	9,708,610
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	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

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
Brazil	112016007226
Australia	2003287464	2'-FLUORO SUBSTITUTED OLIGOMERIC COMPOUNDS AND COMPOSITIONS FOR USE IN GENE MODULATIONS
Australia	2010201712	2'-substituted oligomeric compounds and compositions for use in gene modulations
Russian Federation	2019111696	КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ЭКСПРЕССИИ ГЕНА ALAS1
Japan	2008501694

Supplementary Protection Certificates for GIVLAARI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3052628	CR 2020 00042	Denmark		PRODUCT NAME: GIVOSIRAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1428 20200304
3052628	PA2020527,C3052628	Lithuania		PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	C03052628/01	Switzerland		PRODUCT NAME: GIVOSIRAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67895 29.03.2021
3052628	122020000045	Germany		PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628	132020000000106	Italy		PRODUCT NAME: GIVOSIRAN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GIVLAARI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1428, 20200304

GIVLAARI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GIVLAARI

Introduction

GIVLAARI, developed by Alnylam Pharmaceuticals, is a groundbreaking RNA interference (RNAi) therapeutic approved for the treatment of adults with acute hepatic porphyria (AHP). This article delves into the market dynamics and financial trajectory of GIVLAARI, highlighting its commercial performance, patient adoption, and the broader impact on Alnylam's financial health.

Approval and Clinical Significance

GIVLAARI was approved by the U.S. Food and Drug Administration (FDA) in November 2019, marking a significant milestone in the advancement of precision genetic medicines. It is the first-ever approved GalNAc-conjugate RNA therapeutic, designed to reduce the rate of porphyria attacks in patients with AHP by targeting the aminolevulinic acid synthase 1 (ALAS1) mRNA[4].

Commercial Launch and Patient Adoption

Since its approval, GIVLAARI has shown steady growth in patient adoption. As of December 31, 2022, over 520 patients worldwide were receiving commercial GIVLAARI treatment, up from over 460 patients in the previous year[5]. By the end of 2023, this number had increased to over 650 patients globally[1].

Revenue Performance

Quarterly and Annual Revenues

In the fourth quarter of 2023, GIVLAARI generated approximately $59 million in global net product revenues, contributing to a total Ultra-Rare quarterly growth of 11% compared to Q3 2023. For the full year 2023, GIVLAARI revenues reached approximately $219 million, representing a 35% annual growth compared to 2022[1].

Historical Context

In the first quarter of 2022, GIVLAARI net product revenues were $35.3 million, which was part of the overall $186.9 million in total net product revenues for Alnylam's portfolio[2]. This figure has consistently increased, reflecting the drug's growing market penetration.

Market Growth and Expansion

Geographic Expansion

GIVLAARI's revenue growth is not limited to the U.S. market; it also shows promise in international markets. The drug's global reach is a key factor in its financial success, with Alnylam reporting significant growth in both domestic and international sales[3].

Competitive Landscape

In the rare disease market, GIVLAARI competes with other treatments for AHP but stands out due to its innovative RNAi technology. Alnylam's strong pipeline and the success of GIVLAARI have positioned the company as a leader in the rare disease segment[3].

Financial Impact on Alnylam Pharmaceuticals

Overall Revenue Contribution

GIVLAARI is a significant contributor to Alnylam's overall revenue. In 2023, the combined revenues from GIVLAARI and OXLUMO, another Ultra-Rare disease treatment, reached $329 million, representing a 25% year-over-year growth[3].

Cash Position and Financial Health

Alnylam's strong financial health, with a year-end cash and investments balance of approximately $2.4 billion as of 2023, is partly attributed to the success of GIVLAARI and other products in its portfolio[1].

Pipeline and Future Prospects

Clinical Pipeline

Alnylam's robust clinical pipeline, including advancements in other RNAi therapeutics like vutrisiran and zilebesiran, suggests continued growth potential. Positive clinical results, such as those from the HELIOS-B Phase 3 study of vutrisiran, further expand the market opportunity for Alnylam's products[3].

Market Penetration

The company's upward revision of 2024 combined net product revenue guidance to $1,575 million - $1,650 million indicates management's confidence in continued growth, driven in part by GIVLAARI's market performance[3].

Challenges and Opportunities

Regulatory Environment

The rapid approval of GIVLAARI by the FDA highlights a favorable regulatory environment for innovative therapies. This environment continues to support the development and commercialization of Alnylam's pipeline products[4].

Patient Access and Reimbursement

Ensuring patient access and navigating reimbursement landscapes remain critical challenges. However, Alnylam's experience with GIVLAARI has helped the company develop strategies to address these issues effectively.

Key Takeaways

• Strong Revenue Growth: GIVLAARI has demonstrated significant revenue growth, with a 35% annual increase in 2023.
• Increasing Patient Adoption: Over 650 patients worldwide were receiving commercial GIVLAARI treatment as of year-end 2023.
• Global Reach: The drug's success is not limited to the U.S. market, with international sales contributing to its growth.
• Financial Impact: GIVLAARI is a substantial contributor to Alnylam's overall revenue and financial health.
• Future Prospects: Positive clinical results and a robust pipeline suggest continued growth potential for Alnylam and its products.

FAQs

What is GIVLAARI used for?

GIVLAARI is used for the treatment of adults with acute hepatic porphyria (AHP), significantly reducing the rate of porphyria attacks[4].

How does GIVLAARI work?

GIVLAARI works by specifically reducing elevated levels of aminolevulinic acid synthase 1 (ALAS1) mRNA, leading to a reduction in toxins associated with AHP attacks[4].

What was the revenue from GIVLAARI in 2023?

The global net product revenues for GIVLAARI in 2023 were approximately $219 million[1].

How many patients are receiving GIVLAARI treatment?

As of year-end 2023, over 650 patients worldwide were receiving commercial GIVLAARI treatment[1].

What is the significance of GIVLAARI's approval?

GIVLAARI's approval marked the first-ever approval for a GalNAc-conjugate RNA therapeutic, representing a landmark in the advancement of precision genetic medicines[4].

Sources

1. *Alnylam Announces Preliminary Fourth Quarter and Full Year 2023 Global Net Product Revenues and Provides Additional Updates**. Biospace.
2. Alnylam Pharmaceuticals Reports First Quarter 2022 Financial Results and Highlights Recent Period Activity. Business Wire.
3. Alnylam Pharmaceuticals Reports Second Quarter 2024 Financial Results. Stock Titan.
4. Alnylam Announces Approval of GIVLAARI™ (givosiran) by the U.S. Food and Drug Administration (FDA). Alnylam Pharmaceuticals.
5. Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results. Alnylam Pharmaceuticals.