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ACTIVE PHARMA INGREDIENTS

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CEP/COS

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JDMF

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EU WC

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VMF

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

FINISHED DOSAGE FORMULATIONS

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South Africa

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Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

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Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

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Regulatory FDF Prices

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MARKET PLACE

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FDF

DIGITAL CONTENT

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

Chemistry

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API SUPPLIERS

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USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41776

Submission : 2025-04-15

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2025-10-23

Pay. Date : 2025-09-25

DMF Number : 42095

Submission : 2025-09-24

Status : Active

Type : II

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03

Suzhou Olipharma Co Ltd

Country

USDMF

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03

Suzhou Olipharma Co Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 43518

Submission : 2026-01-29

Status : Active

Type : II

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KDMF

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sodium inclisiran

Registrant Name : Novartis Korea

Registration Date : 2026-02-25

Registration Number : Su196-34-ND

Manufacturer Name : Novartis Pharma Schweizerhal...

Manufacturer Address : Rothausstrasse, 4133, Pratteln, Switzerland

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ST Pharma

South Korea
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ST Pharma

South Korea
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sodium inclisiran

Registrant Name : Novartis Korea

Registration Date : 2024-06-20

Registration Number : Su196-29-ND

Manufacturer Name : ST Pharm Co., Ltd.

Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do

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NDC API

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INCLISIRAN

NDC Package Code : 70596-1002

Start Marketing Date : 2021-12-27

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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INCLISIRAN SODIUM

NDC Package Code : 42931-712

Start Marketing Date : 2024-11-26

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ST Pharm Co., Ltd.

South Korea
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ST Pharm Co., Ltd.

South Korea
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INCLISIRAN SODIUM

NDC Package Code : 73675-006

Start Marketing Date : 2025-12-18

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Flag France
Digital Content Digital Content

Inclisiran

About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...

EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
EUROAPI Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

Flag U.S.A
Digital Content Digital Content

Inclisiran

About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...

Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and acts as a sourcing and regulatory marketing agent for API manufacturers. Transo-Pharm assists with DMF setup, GMP consulting, and regulatory activities, supported by a regulatory team, warehouse facilities, proprietary API process IPs, and laboratory partnerships, with offices in Shanghai, Hong Kong, Singapore, and the US. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Transo Pharm USA Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Inclisiran

About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...

Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Omgene Company Banner

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Inclisiran

About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...

Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuzhou, within the Nanjing metropolitan area, Ribobay Pharmaceutical specializes in the therapeutic oligonucleotides CXO field. This strategic focus aligns with General Biol's broader expansion plans for its CXO business, making Ribobay a crucial component of the company's ventures in this domain.
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Inclisiran

About the Company : For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacture...

For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacturers who rely on our integrity, expertise, and follow-through have been with us for three, four, and even five decades.
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Inclisiran

About the Company : Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and effici...

Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and efficient manufacturing technologies, Sinopep ensures global compliance with advanced process development. Their CRDMO services span peptides, oligonucleotides, and synthetic conjugates, making them a trusted partner worldwide in pharmaceutical and healthcare solutions.
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Drugs in Development

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Details:

Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Acute Coronary Syndrome.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 04, 2025

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PEGS Boston Summit
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PEGS Boston Summit
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Details : Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Acute Coronary Syndrome.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 04, 2025

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Details:

Leqvio (inclisiran) is a siRNA directed to PCSK9 mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 31, 2025

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Leqvio (inclisiran) is a siRNA directed to PCSK9 mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

July 31, 2025

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  • Development Update

Details:

Inclisiran Sodium is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.


Lead Product(s): Inclisiran Sodium,Inclisiran

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Oligonucleotide

Sponsor: Novartis Pharmaceuticals Corporation | Colorado Prevention Center | Mount Sinai Hospital, New York

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 03, 2025

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Duke University

Country
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Duke University

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Lead Product(s) : Inclisiran Sodium,Inclisiran

Therapeutic Area : Undisclosed

Highest Development Status : Phase IV

Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation | Colorado Prevention Center | Mount Sinai Hospital, New York

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Inclisiran Sodium is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

April 03, 2025

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  • Development Update

Details:

Inclisiran Sodium is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Metabolic Syndrome.


Lead Product(s): Inclisiran Sodium,Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Oligonucleotide

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 10, 2025

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University of California, San Diego

Country
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University of California, San Diego

Country
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Details : Inclisiran Sodium is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Metabolic Syndrome.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

March 10, 2025

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Details:

Pelacarsen is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Atherosclerosis.


Lead Product(s): Pelacarsen,Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 07, 2025

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Pelacarsen is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Atherosclerosis.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

February 07, 2025

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Details:

Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Homozygous Familial Hypercholesterolemia.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Genetic Disease Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 19, 2024

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Homozygous Familial Hypercholesterolemia.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

September 19, 2024

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Details:

Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Heterozygous Familial Hypercholesterolemia.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 19, 2024

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07

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Heterozygous Familial Hypercholesterolemia.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

September 19, 2024

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Details:

Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 28, 2024

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 28, 2024

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Details:

Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2024

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

July 09, 2024

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Details:

Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hypercholesterolemia.


Lead Product(s): Inclisiran,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 26, 2024

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Inclisiran is a Oligonucleotide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hypercholesterolemia.

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

April 26, 2024

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FDF Dossiers

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INCLISIRAN SODIUM

Brand Name : LEQVIO

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Packaging :

Approval Date : 2021-12-22

Application Number : 214012

Regulatory Info : RX

Registration Country : USA

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Inclisiran

Brand Name : Leqvio

Dosage Form : Solution For Injection

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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Inclisiran

Brand Name : Leqvio

Dosage Form : Solution For Injection

Dosage Strength : 284mg

Packaging :

Approval Date : 09-12-2020

Application Number : 28106393820

Regulatory Info : Prescription

Registration Country : Denmark

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INCLISIRAN (INCLISIRAN SODIUM)

Brand Name : LEQVIO

Dosage Form : SOLUTION

Dosage Strength : 284MG/1.5ML

Packaging :

Approval Date :

Application Number : 2518376

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Patents & EXCLUSIVITIES

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US Patents

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01

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 8222222

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-4249

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-12-29

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 10851377

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-4414

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-08-25

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 9370582

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-4413

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-12-04

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 8106022

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-4249

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-12

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 10131907

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-4413

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-08-24

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 8222222

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-4413

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-12-29

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 10125369

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-4249

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2034-08-18

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 9370582

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-4414

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-12-04

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 8222222

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-4414

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-12-29

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 10851377

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-4249

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-08-25

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US Exclusivities

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01

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

Exclusivity Code : I-985

Exclusivity Expiration Date : 2029-02-12

Application Number : 214012

Product Number : 1

Exclusivity Details :

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

Exclusivity Code : NCE

Exclusivity Expiration Date : 2026-12-22

Application Number : 214012

Product Number : 1

Exclusivity Details :

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

Exclusivity Code : NPP

Exclusivity Expiration Date : 2029-02-12

Application Number : 214012

Product Number : 1

Exclusivity Details :

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