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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41776
Submission : 2025-04-15
Status : Active
Type : II

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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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43518
Submission : 2026-01-29
Status : Active
Type : II

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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...
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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...
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...

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...

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...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Early Hospital Initiation of Inclisiran Safety and Efficacy In ACS
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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Novartis’ Leqvio For First-Line Twice-Yearly Use
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

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

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

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

Lead Product(s) : Inclisiran Sodium,Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
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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Lead Product(s) : Pelacarsen,Inclisiran
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis' Leqvio® Shows Significant LDL-C Lowering As Monotherapy
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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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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
EnPlusOne Biosciences Reveals Breakthrough Enzymatic Synthesis of Leqvio® Antisense Strand
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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Lead Product(s) : Inclisiran,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : Prescription
Registration Country : Estonia
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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Regulatory Info : Prescription
Registration Country : Denmark
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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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Regulatory Info :
Registration Country : Australia
Brand Name : Leqvio
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia

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Regulatory Info :
Registration Country : Australia
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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Exclusivity Code : I-985
Exclusivity Expiration Date : 2029-02-12
Application Number : 214012
Product Number : 1
Exclusivity Details :

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Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-12-22
Application Number : 214012
Product Number : 1
Exclusivity Details :

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Exclusivity Code : NPP
Exclusivity Expiration Date : 2029-02-12
Application Number : 214012
Product Number : 1
Exclusivity Details :

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