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    Also known as: Rilpivirine hcl, 700361-47-3, Tmc278 hydrochloride, Edurant, Rilpivirine hydrochloride [usan], 212wax8kdd
    Molecular Formula
    C22H19ClN6
    Molecular Weight
    402.9  g/mol
    InChI Key
    KZVVGZKAVZUACK-BJILWQEISA-N
    FDA UNII
    212WAX8KDD
    Rilpivirine Hydrochloride
    A diarylpyrimidine derivative and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 that is used in the treatment of HIV INFECTIONS. It is also used in combination with other ANTI-HIV AGENTS, since ANTIVIRAL DRUG RESISTANCE emerges rapidly when it is used alone.
    1 2D Structure

    Rilpivirine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[[4-[4-[(E)-2-cyanoethenyl]-2,6-dimethylanilino]pyrimidin-2-yl]amino]benzonitrile;hydrochloride
    2.1.2 InChI
    InChI=1S/C22H18N6.ClH/c1-15-12-18(4-3-10-23)13-16(2)21(15)27-20-9-11-25-22(28-20)26-19-7-5-17(14-24)6-8-19;/h3-9,11-13H,1-2H3,(H2,25,26,27,28);1H/b4-3+;
    2.1.3 InChI Key
    KZVVGZKAVZUACK-BJILWQEISA-N
    2.1.4 Canonical SMILES
    CC1=CC(=CC(=C1NC2=NC(=NC=C2)NC3=CC=C(C=C3)C#N)C)C=CC#N.Cl
    2.1.5 Isomeric SMILES
    CC1=CC(=CC(=C1NC2=NC(=NC=C2)NC3=CC=C(C=C3)C#N)C)/C=C/C#N.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    212WAX8KDD
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 278, Tmc

    2. Hcl, Rilpivirine

    3. Hydrochloride, Rilpivirine

    4. R278474

    5. Rilpivirine

    6. Rilpivirine Hcl

    7. Tmc 278

    8. Tmc-278

    9. Tmc278

    2.3.2 Depositor-Supplied Synonyms

    1. Rilpivirine Hcl

    2. 700361-47-3

    3. Tmc278 Hydrochloride

    4. Edurant

    5. Rilpivirine Hydrochloride [usan]

    6. 212wax8kdd

    7. Rilpivirine (as Hydrochloride)

    8. 700361-47-3 (hcl)

    9. Chebi:68602

    10. (e)-4-((4-((4-(2-cyanovinyl)-2,6-dimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile Hydrochloride

    11. Benzonitrile, 4-((4-((4-((1e)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)

    12. 4-[[4-[4-[(e)-2-cyanoethenyl]-2,6-dimethylanilino]pyrimidin-2-yl]amino]benzonitrile;hydrochloride

    13. Unii-212wax8kdd

    14. Endurant

    15. Edurant (tn)

    16. Rilpivirine Monohydrochloride

    17. Tmc-278 Hydrochloride

    18. Schembl1831067

    19. Tmc-278-la

    20. Tmc 278. Trade Name Edurant

    21. Chembl1628504

    22. Dtxsid80220320

    23. Bcp13350

    24. Rilpivirine Hydrochloride (jan/usan)

    25. Rilpivirine Hydrochloride [mi]

    26. Akos025149454

    27. Rilpivirine Hydrochloride [jan]

    28. 4-((4-((4-((1e)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)pyrimidin-2- Yl)amino)benzonitrile

    29. Rilpivirine Hydrochloride [vandf]

    30. Ac-30620

    31. Rilpivirine Hydrochloride [who-dd]

    32. D09958

    33. Rilpivirine Hydrochloride [orange Book]

    34. Juluca Component Rilpivirine Hydrochloride

    35. Eviplera Component Rilpivirine Hydrochloride

    36. Odefsey Component Rilpivirine Hydrochloride

    37. Rilpivirine Hydrochloride Component Of Juluca

    38. Q27137040

    39. Rilpivirine Hydrochloride Component Of Eviplera

    40. Rilpivirine Hydrochloride Component Of Odefsey

    41. 4-[[4-[[4-[(e)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile Monohydrochloride

    42. 4-{[4-({4-[(e)-2-cyanoethenyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile Hydrochloride

    43. 4-{[4-({4-[(e)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile Hydrochloride

    44. Benzonitrile, 4-((4-((4-((1e)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2- Pyrimidinyl)amino)-, Hydrochloride (1:1)

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 402.9 g/mol
    Molecular Formula C22H19ClN6
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass402.1359723 g/mol
    Monoisotopic Mass402.1359723 g/mol
    Topological Polar Surface Area97.4 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity607
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameEdurant
    PubMed HealthRilpivirine (By mouth)
    Drug ClassesAntiretroviral Agent
    Active IngredientRilpivirine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 25mg base
    Market StatusPrescription
    CompanyJanssen Prods

    2 of 2  
    Drug NameEdurant
    PubMed HealthRilpivirine (By mouth)
    Drug ClassesAntiretroviral Agent
    Active IngredientRilpivirine hydrochloride
    Dosage FormTablet
    RouteOral
    Strengtheq 25mg base
    Market StatusPrescription
    CompanyJanssen Prods

    4.2 Drug Indication

    Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV1) infection in antiretroviral treatmentnave patients 12 years of age and older with a viral load 100,000 HIV1 RNA copies/ml.

    As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-HIV Agents

    Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS. (See all compounds classified as Anti-HIV Agents.)

    Reverse Transcriptase Inhibitors

    Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template. (See all compounds classified as Reverse Transcriptase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Non-Nucleoside Analog [EXT]; Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]; Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    5.3 ATC Code

    J05AG05

    API Reference Price

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    DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;300...DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;300MG

    USFDA APPLICATION NUMBER - 202123

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    DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;EQ ...DOSAGE - TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE

    USFDA APPLICATION NUMBER - 208351

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    01

    GILEAD SCIENCES INC

    EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

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    GILEAD SCIENCES INC

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    ABOUT THIS PAGE

    Edurant Manufacturers

    A Edurant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edurant, including repackagers and relabelers. The FDA regulates Edurant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edurant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Edurant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Edurant Suppliers

    A Edurant supplier is an individual or a company that provides Edurant active pharmaceutical ingredient (API) or Edurant finished formulations upon request. The Edurant suppliers may include Edurant API manufacturers, exporters, distributors and traders.

    click here to find a list of Edurant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Edurant USDMF

    A Edurant DMF (Drug Master File) is a document detailing the whole manufacturing process of Edurant active pharmaceutical ingredient (API) in detail. Different forms of Edurant DMFs exist exist since differing nations have different regulations, such as Edurant USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Edurant DMF submitted to regulatory agencies in the US is known as a USDMF. Edurant USDMF includes data on Edurant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edurant USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Edurant suppliers with USDMF on PharmaCompass.

    Edurant JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Edurant Drug Master File in Japan (Edurant JDMF) empowers Edurant API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Edurant JDMF during the approval evaluation for pharmaceutical products. At the time of Edurant JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Edurant suppliers with JDMF on PharmaCompass.

    Edurant KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Edurant Drug Master File in Korea (Edurant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Edurant. The MFDS reviews the Edurant KDMF as part of the drug registration process and uses the information provided in the Edurant KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Edurant KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Edurant API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Edurant suppliers with KDMF on PharmaCompass.

    Edurant WC

    A Edurant written confirmation (Edurant WC) is an official document issued by a regulatory agency to a Edurant manufacturer, verifying that the manufacturing facility of a Edurant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Edurant APIs or Edurant finished pharmaceutical products to another nation, regulatory agencies frequently require a Edurant WC (written confirmation) as part of the regulatory process.

    click here to find a list of Edurant suppliers with Written Confirmation (WC) on PharmaCompass.

    Edurant NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Edurant as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Edurant API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Edurant as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Edurant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Edurant NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Edurant suppliers with NDC on PharmaCompass.

    Edurant GMP

    Edurant Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Edurant GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Edurant GMP manufacturer or Edurant GMP API supplier for your needs.

    Edurant CoA

    A Edurant CoA (Certificate of Analysis) is a formal document that attests to Edurant's compliance with Edurant specifications and serves as a tool for batch-level quality control.

    Edurant CoA mostly includes findings from lab analyses of a specific batch. For each Edurant CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Edurant may be tested according to a variety of international standards, such as European Pharmacopoeia (Edurant EP), Edurant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Edurant USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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