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Last Updated: May 17, 2025

Givosiran sodium - Generic Drug Details


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What are the generic 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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Givosiran sodium has two hundred and seventy-three patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for givosiran sodium
International Patents:273
US Patents:9
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
Generic Entry Date for givosiran sodium*:
Constraining patent/regulatory exclusivity:
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

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 ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try for Free ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Try for Free ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Try for Free ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Try for Free ⤷  Try for Free
Alnylam Pharms Inc GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for givosiran sodium

Country Patent Number Title Estimated Expiration
European Patent Office 4074344 LIPIDES DE CIBLAGE (TARGETING LIPIDS) ⤷  Try for Free
European Patent Office 2836595 COMPOSITIONS ET PROCÉDÉS PERMETTANT D'INHIBER L'EXPRESSION DU GÈNE ALAS1 (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE) ⤷  Try for Free
Montenegro 02850 SASTAVI I METODE ZA INHIBIRANJE EKSPRESIJE ALAS1 GENA (COMPOSITIONS AND METHODS FOR INHIBITING EXPRESSION OF THE ALAS1 GENE) ⤷  Try for Free
Japan 5519523 ⤷  Try for Free
Poland 3052628 ⤷  Try for Free
Australia 2003248708 OLIGOMERIC COMPOUNDS THAT INCLUDE CARBOCYCLIC NUCLEOSIDES AND THEIR USE IN GENE MODULATION ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for givosiran sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3052628 132020000000106 Italy ⤷  Try for Free PRODUCT NAME: GIVOSIRAN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GIVLAARI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1428, 20200304
3052628 37/2020 Austria ⤷  Try for Free PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 (MITTEILUNG) 20200304
3052628 122020000045 Germany ⤷  Try for Free PRODUCT NAME: GIVOSIRAN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 2090037-9 Sweden ⤷  Try for Free PRODUCT NAME: GIVOSIRAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1428 20200304
3052628 PA2020527 Lithuania ⤷  Try for Free PRODUCT NAME: GIVOSIRANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1428 20200302
3052628 301061 Netherlands ⤷  Try for Free PRODUCT NAME: GIVOSIRAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1428 20200304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Givosiran Sodium (Givlaari)

Introduction to Givosiran Sodium (Givlaari)

Givosiran sodium, marketed as Givlaari, is a revolutionary drug developed by Alnylam Pharmaceuticals for the treatment of acute hepatic porphyria (AHP) in adults. Approved by Health Canada in 2020 and the FDA in 2019, Givlaari has marked a significant milestone in the management of this rare and debilitating genetic disorder[1][4].

Mechanism of Action and Clinical Benefits

Givosiran works by inhibiting the production of aminolevulinic acid (ALA) and porphobilinogen (PBG), key precursors in the heme biosynthesis pathway that are elevated in AHP patients. This mechanism reduces the frequency and severity of porphyria attacks, significantly improving the quality of life for patients. Clinical trials have shown that monthly dosing of 2.5 mg/kg givosiran reduces the annualized attack rate (AAR) to 2.9 attacks per year, compared to 12.5 attacks per year with placebo[1].

Market Authorization and Regulatory Approval

Health Canada granted Givlaari a Notice of Compliance in October 2020, following a thorough review of its quality, non-clinical, and clinical data. The approval was based on the drug's favourable benefit-risk profile, with appropriate warnings and precautions in place to manage identified safety concerns[1].

Financial Performance and Market Impact

Revenue and Sales

Givlaari is part of Alnylam Pharmaceuticals' robust pipeline of RNA interference (RNAi) therapies. The drug's commercial success contributes to Alnylam's overall financial performance. As of the latest financial reports, Alnylam is executing its "Alnylam P 5x25" strategy, aiming to deliver transformative medicines and achieve sustainable innovation and financial performance. This strategy includes expanding the market presence of drugs like Givlaari, which are critical to the company's revenue growth[2].

Cost-Effectiveness and Economic Impact

While Givlaari offers significant clinical benefits, its cost-effectiveness is a subject of ongoing analysis. A study published on PubMed compared the total cost of care for AHP patients treated with either hemin or givosiran. The results indicated that hemin treatment is associated with lower annual total costs of care, ranging from $311,950 to $545,219 less than givosiran, depending on the treatment regimen. This suggests that while Givlaari is clinically effective, it may face economic challenges in terms of cost savings compared to traditional treatments like hemin[5].

Investment Trends and Industry Dynamics

Biotechnology and Precision Medicine

The pharmaceutical industry is witnessing a significant shift towards biotechnology and precision medicine, with investors favoring companies that develop targeted therapies. Givlaari, as an RNAi therapy, aligns with this trend, attracting investment and interest due to its innovative approach to treating rare genetic disorders[3].

Digital Health and Advanced Manufacturing

The industry is also seeing a surge in investments in digital health technologies and advanced manufacturing processes. While Givlaari itself is not directly related to these trends, Alnylam's overall strategy and pipeline are influenced by these broader industry shifts. For instance, the company's focus on sustainable innovation and exceptional financial performance is supported by advancements in digital health and manufacturing technologies[3].

Competitive Landscape

Givlaari operates in a niche market targeting a rare disease, which limits direct competition. However, it competes indirectly with other treatments for AHP, such as hemin, in terms of cost-effectiveness and patient preference. The drug's unique mechanism of action and clinical efficacy make it a preferred choice for many patients and healthcare providers, despite the higher cost[1][5].

Safety and Monitoring

Givosiran treatment is associated with several safety considerations, including the potential for renal impairment and interactions with CYP450 enzymes. Health Canada and other regulatory bodies have mandated careful monitoring of renal function and appropriate labelling to address these safety concerns. Long-term data collection and risk management plans (RMPs) are also in place to better characterize the short- and long-term effects of Givlaari[1][4].

Future Outlook and Growth Potential

Pipeline Expansion and Strategic Partnerships

Alnylam's "Alnylam P 5x25" strategy includes expanding its pipeline and forming strategic partnerships to enhance market presence and diversify revenue streams. This strategy is expected to drive growth for Givlaari and other Alnylam products, as the company continues to innovate and deliver transformative medicines[2].

Market Expansion and Patient Access

Efforts to expand market access and improve patient outcomes are crucial for the long-term success of Givlaari. This includes working with healthcare systems, payers, and patient advocacy groups to ensure that the drug is accessible to those who need it, despite its higher cost compared to traditional treatments[3].

Key Takeaways

  • Clinical Efficacy: Givosiran sodium (Givlaari) significantly reduces the frequency and severity of porphyria attacks in AHP patients.
  • Regulatory Approval: Approved by Health Canada and the FDA, with a favourable benefit-risk profile.
  • Financial Performance: Contributes to Alnylam Pharmaceuticals' revenue growth as part of the company's "Alnylam P 5x25" strategy.
  • Cost-Effectiveness: Higher costs compared to traditional treatments like hemin, but offers significant clinical benefits.
  • Industry Trends: Aligns with trends in biotechnology, precision medicine, and digital health.
  • Safety and Monitoring: Requires careful monitoring of renal function and management of potential interactions with CYP450 enzymes.

FAQs

What is Givosiran Sodium (Givlaari) used for?

Givosiran sodium, marketed as Givlaari, is used for the treatment of acute hepatic porphyria (AHP) in adults.

How does Givosiran work?

Givosiran inhibits the production of aminolevulinic acid (ALA) and porphobilinogen (PBG), reducing the frequency and severity of porphyria attacks.

Is Givlaari cost-effective compared to other treatments?

Givlaari is associated with higher costs compared to traditional treatments like hemin, although it offers significant clinical benefits.

What are the potential safety concerns with Givlaari?

Givosiran treatment can lead to renal impairment and interactions with CYP450 enzymes, requiring careful monitoring and appropriate labelling.

What is Alnylam's strategy for Givlaari and other products?

Alnylam is executing its "Alnylam P 5x25" strategy, focusing on sustainable innovation, financial performance, and expanding market presence through strategic partnerships.

Sources

  1. Health Canada: Summary Basis of Decision for Givlaari[1].
  2. Business Wire: Alnylam to Webcast Conference Call Discussing Third Quarter 2024 Financial Results[2].
  3. PharmaSalmanac: What are the Current Investment Trends in the Pharmaceutical Industry[3].
  4. European Medicines Agency: Givlaari, INN-givosiran[4].
  5. PubMed: Cost savings with hemin versus givosiran for the treatment of acute intermittent porphyria[5].
Last updated: 2024-12-18

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