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12 US Patents, 1 US Exclusivities

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12 US Patents
1 US Exclusivities

Difelikefalin Acetate

Synopsis

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0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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USP

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FDA Orange Book

Europe

Canada

Australia

South Africa

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DRUG PRODUCT COMPOSITIONS

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US Patents

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Chemistry

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Also known as: Cr845 acetate, Cr-845 acetate, 1024829-44-4, Unii-0p70ar5byb, 0p70ar5byb, Korsuva

Molecular Formula

C₃₈H₅₇N₇O₈

Molecular Weight

739.9 g/mol

InChI Key

MZWHRPKAHCWTOI-KGURMGBCSA-N

FDA UNII

0P70AR5BYB

DIFELIKEFALIN ACETATE is a Protein drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2021 and is indicated for chronic kidney disease and pruritus.

1 2D Structure

Difelikefalin Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;4-amino-1-[(2R)-6-amino-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid

2.1.2 InChI

InChI=1S/C36H53N7O6.C2H4O2/c1-24(2)21-29(32(45)40-28(15-9-10-18-37)34(47)43-19-16-36(39,17-20-43)35(48)49)42-33(46)30(23-26-13-7-4-8-14-26)41-31(44)27(38)22-25-11-5-3-6-12-25;1-2(3)4/h3-8,11-14,24,27-30H,9-10,15-23,37-39H2,1-2H3,(H,40,45)(H,41,44)(H,42,46)(H,48,49);1H3,(H,3,4)/t27-,28-,29-,30-;/m1./s1

2.1.3 InChI Key

MZWHRPKAHCWTOI-KGURMGBCSA-N

2.2 Other Identifiers

2.2.1 UNII

0P70AR5BYB

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 4-piperidinecarboxylic Acid, 4-amino-1-((2r)-6-amino-2-(((2r)-2-(((2r)-2-(((2r)-2-amino-1-oxo-3-phenylpropyl)amino)-1-oxo-3-phenylpropyl)amino)-4-methyl-1-oxopentyl)amino)-1-oxohexyl)-

2. Difelikefalin

3. Korsuva

4. N-((2r)-1-(((2r)-1-(((2r)-6-amino-1-(4-amino-4-carboxy-1-piperidinyl)-1-oxo-2-hexanyl)amino)-4-methyl-1-oxo-2-pentanyl)amino)-1-oxo-3-phenyl-2-propanyl)-d-phenylalaninamide

2.3.2 Depositor-Supplied Synonyms

1. Cr845 Acetate

2. Cr-845 Acetate

3. 1024829-44-4

4. Unii-0p70ar5byb

5. 0p70ar5byb

6. Korsuva

7. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysl)-piperidine-4-carboxylic Acid, Acetate Salt

8. Acetic Acid;4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic Acid

9. Difelikefalin (acetate)

10. Chembl5315123

11. Hy-17609c

12. 1024828-77-0 , Difelikefalin

13. Difelikefalin Acetate [who-dd]

14. Ac-38232

15. Ts-10624

16. Difelikefalin Acetate [orange Book]

17. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)piperidine-4-carboxylic Acid Acetate

18. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:)

19. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:?)

2.3.3 Other Synonyms

1. Difelikefalin

2.4 Create Date

2015-09-11

3 Chemical and Physical Properties

Molecular Formula	C₃₈H₅₇N₇O₈
Molecular Weight	739.9 g/mol
Hydrogen Bond Donor Count	8
Hydrogen Bond Acceptor Count	11
Rotatable Bond Count	18
Exact Mass	Da
Monoisotopic Mass	Da
Topological Polar Surface Area	260
Heavy Atom Count	53
Formal Charge	0
Complexity	1110
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

API SUPPLIERS

01

Neuland Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

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Neuland Laboratories- A dedicated 100% API provider.

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India

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Vtides Life Sciences Pvt. Ltd

India

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INTERPHEX Week

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Chunghwa Chemical Synthesis & Biot...

Taiwan

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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Omgene Life Sciences Pvt. Ltd

India

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Hospitalar

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

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MSN Laboratories

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Cipla

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ALP Pharm

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Sandoo Pharmaceuticals and Chemcia...

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Jiangsu Sinopep Allsino Biopharmac...

China

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Changzhou Pharmaceutical Factory

China

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USDMF

01

Neuland Laboratories Ltd

India

CPhI WW Frankfurt

Booth #6.1D6

Neuland Laboratories- A dedicated 100% API provider.

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India

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DIFELIKEFALIN ACETATE

GDUFA

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Rev. Date :

Pay. Date :

DMF Number : 41503

Submission : 2025-03-26

Status : Active

Type : II

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02

Chunghwa Chemical Synthesis And Biot...

Taiwan

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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Taiwan

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DIFELIKEFALIN ACETATE

GDUFA

DMF Review : N/A

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Pay. Date :

DMF Number : 38511

Submission : 2023-06-19

Status : Active

Type : II

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03

Alp Pharm Beijing Co Ltd

China

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04

Cipla Ltd

India

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Msn Life Sciences Private Ltd

India

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06

Wisdom Pharmaceutical Co Ltd

China

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JDMF

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PolyPeptide Laboratories France SAS

Switzerland

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NDC API

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Listed Suppliers

01

Neuland Laboratories

India

CPhI WW Frankfurt

Booth #6.1D6

Neuland Laboratories- A dedicated 100% API provider.

Contact Supplier

India

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Digital Content

Difelikefalin

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.

Product Web Link

02

Vtides Life Sciences Pvt. Ltd

India

INTERPHEX Week

Attending

New Global Pharma Company With State-of-the-art GMP Facility for Peptide API Development and Manufacturing, Launched in 2024.

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India

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Digital Content

Difelikefalin Acetate

About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis. T...

Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis. The company is equipped with state-of-the-art GMP facilities, including automated peptide synthesizers (Microwave peptide synthesizer), preparative HPLC systems, lyophilizers, and advanced analytical instruments. We use science and technology to provide affordable Active Pharmaceutical Ingredients (APIs) to Pharmaceutical companies to produce best quality of Medicines.

03

Chunghwa Chemical Synthesis & Biote...

Taiwan

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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Taiwan

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Difelikefalin

About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.

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04

Omgene Life Sciences Pvt. Ltd

India

Hospitalar

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

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India

Virtual Booth

Digital Content

Difelikefalin

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

Omgene Life Sciences Private Limited 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.

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