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    Also known as: Dabigatran etexilate mesylate, 872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966
    Molecular Formula
    C35H45N7O8S
    Molecular Weight
    723.8  g/mol
    InChI Key
    XETBXHPXHHOLOE-UHFFFAOYSA-N
    Dabigatran Etexilate Mesylate
    A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.
    1 2D Structure

    Dabigatran Etexilate Mesylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    ethyl 3-[[2-[[4-[(Z)-N'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
    2.1.2 InChI
    InChI=1S/C34H41N7O5.CH4O3S/c1-4-6-7-10-21-46-34(44)39-32(35)24-12-15-26(16-13-24)37-23-30-38-27-22-25(14-17-28(27)40(30)3)33(43)41(20-18-31(42)45-5-2)29-11-8-9-19-36-29;1-5(2,3)4/h8-9,11-17,19,22,37H,4-7,10,18,20-21,23H2,1-3H3,(H2,35,39,44);1H3,(H,2,3,4)
    2.1.3 InChI Key
    XETBXHPXHHOLOE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCCCOC(=O)N=C(C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)N.CS(=O)(=O)O
    2.1.5 Isomeric SMILES
    CCCCCCOC(=O)/N=C(/C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)\N.CS(=O)(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bibr 1048

    2. Dabigatran

    3. Dabigatran Etexilate

    4. Dabigatran Etexilate Mesylate

    5. Etexilate Mesylate, Dabigatran

    6. Etexilate, Dabigatran

    7. Mesylate, Dabigatran Etexilate

    8. N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-beta-alanine

    9. Pradaxa

    2.2.2 Depositor-Supplied Synonyms

    1. Dabigatran Etexilate Mesylate

    2. 872728-81-9

    3. Pradaxa

    4. Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic Acid

    5. Dtxsid20236248

    6. Ex-a1966

    7. Mfcd25424070

    8. S5960

    9. Ccg-213236

    10. Cs-w004358

    11. (z)-ethyl 3-(2-(((4-(n'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-n-(pyridin-2-yl)-1h-benzo[d]imidazole-5-carboxamido)propanoate Methanesulfonate

    12. 728p819

    2.3 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 723.8 g/mol
    Molecular Formula C35H45N7O8S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count17
    Exact Mass723.30503259 g/mol
    Monoisotopic Mass723.30503259 g/mol
    Topological Polar Surface Area217 Ų
    Heavy Atom Count51
    Formal Charge0
    Complexity1100
    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 NamePradaxa
    PubMed HealthDabigatran (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
    Active IngredientDabigatran etexilate mesylate
    Dosage FormCapsule
    RouteOral
    Strengtheq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    2 of 2  
    Drug NamePradaxa
    PubMed HealthDabigatran (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
    Active IngredientDabigatran etexilate mesylate
    Dosage FormCapsule
    RouteOral
    Strengtheq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    4.2 Drug Indication

    Pradaxa 75 mg

    - Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

    Pradaxa 110 mg

    - Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

    - Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

    - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    Pradaxa 150 mg

    - Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

    - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antithrombins

    Endogenous factors and drugs that directly inhibit the action of THROMBIN, usually by blocking its enzymatic activity. They are distinguished from INDIRECT THROMBIN INHIBITORS, such as HEPARIN, which act by enhancing the inhibitory effects of antithrombins. (See all compounds classified as Antithrombins.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Thrombin Inhibitors [MoA]; Direct Thrombin Inhibitor [EPC]
    5.3 ATC Code

    B01AE07

    API Reference Price

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C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"OMAN PHARM PRODUCTS","supplierCountry":"INDIA","foreign_port":"NA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"149.42","actualQuantity":"149.42303","unit":"KGS","unitRateFc":"600","totalValueFC":"93780.3","currency":"USD","unitRateINR":"51435.5","date":"13-Apr-2023","totalValueINR":"7685651.78","totalValueInUsd":"93780.3","indian_port":"HYDERABAD AIR","hs_no":"29333919","bill_no":"5501463","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694457000,"product":"DABIGATRAN ETEXILATE MESYLATE (RE-IMP VIDE SB.NO:5135663 DT07.10.2021)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"CHEMO","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1000","totalValueFC":"103054","currency":"USD","unitRateINR":"85543.3","date":"12-Sep-2023","totalValueINR":"8554332.27","totalValueInUsd":"103054","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7787428","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"MANUEL POMBO ANGULO,3RD FLOORMADRID-28050 SPAINSDNF ES","customerAddress":"MSN HOUSE, PLOT NO. C-24,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694457000,"product":"DABIGATRAN ETEXILATE MESYLATE (RE-IMP VIDE SB.NO:5941445 DT12.11.2021)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"CHEMO","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1000","totalValueFC":"103054","currency":"USD","unitRateINR":"85543.3","date":"12-Sep-2023","totalValueINR":"8554332.27","totalValueInUsd":"103054","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7787428","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"MANUEL POMBO ANGULO,3RD FLOORMADRID-28050 SPAINSDNF ES","customerAddress":"MSN HOUSE, PLOT NO. C-24,"}]
    12-Jan-2021
    30-Sep-2024
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    Average Price (USD/KGS)

    Number of Transactions

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DOSAGE - CAPSULE;ORAL - EQ 110MG BASE

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    APIs

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    india-flag.png
    Ph. Eur. Grade Dabigatran Etexilate Mesylate API needed in India [ENA20892]
    A company that focuses on research, development & manufacturing of pellets, micro-pellets and granules is looking for suppliers of Dabigatran Etexilate Mesylate API. The initial required quantity is 1 kg - 2 kg & later 250 kg - 300 kg for commercial purposes. The suppliers must support this enquiry with ODMF & CoA.
    18 Oct 2024

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    18 Oct 2024

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    18 Oct 2024

    United_States_of_America.png
    Dabigatran API needed in the U.S.A [ENA20791]
    A company that focuses on development of various drugs, biologics and natural products is looking for suppliers of Dabigatran API for development purposes. The suppliers must support this enquiry with USFDA & CoA.
    08 Oct 2024

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    08 Oct 2024

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    08 Oct 2024

    india-flag.png
    Dabigatran Etexilate Mesylate API needed in India [ENA20447]
    A company that focuses on manufacturing and exporting various finished formulations is looking for suppliers of Dabigatran Etexilate Mesylate API for development purposes. The suppliers must support this enquiry with ODMF & CoA.
    04 Sep 2024

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    04 Sep 2024

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    04 Sep 2024

    india-flag.png
    Dabigatran (20 kg) API needed in India [ENA16359]
    A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Dabigatran (20 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    13 Feb 2023

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    13 Feb 2023

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    13 Feb 2023

    turkeypng-1602828403png-1622460951png-1622462103.png
    Dabigatran API needed in Turkey [ENA14946]
    A company that focuses on the development and manufacturing of a wide range of finished formulations is looking for suppliers of Dabigatran API. The suppliers must support this enquiry with DMF/ CEP, GMP & CoA.
    06 Sep 2022

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    06 Sep 2022

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    06 Sep 2022

    india-flag.png
    Various APIs needed in India [ENA11572]
    A leading company that deals in the discovery and development of a wide range of lyophilized products, liquid orals, ophthalmics, tablets & capsules is looking for suppliers of Various APIs for Vietnam market. The required quantity is MOQ for each. The suppliers must support this enquiry with DMF. 1. Sorafenib API 2. Carbidopa and Levodopa API 3. Dabigatran Etexilate API 4. Afatinib API 5. Bismuth Subcitrate Potassium API 6. Metronidazole API 7. Tetracycline HCl API
    06 Oct 2021

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    06 Oct 2021

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    06 Oct 2021

    Belarus.png
    Dabigatran Etexilate Mesylate (40%) Pellets needed in Belarus [ENA10443]
    A dynamically developing science-intensive state pharmaceutical enterprise for the production and sale of medicines and dietary supplements of high quality is looking for suppliers of Dabigatran Etexilate Mesylate (40%) Pellets for commercial purposes. The required quantity is 75 kg - 120 kg/ annum. The suppliers must support this enquiry with GMP and CoA.
    19 May 2021

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    19 May 2021

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    19 May 2021

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    Fenticonazole Nitrate (100 kg) & Dabigatran Etexilate (35 kg) APIs needed in Vietnam [ENA09931]
    One of the fastest growing organizations in the pharmaceutical industry is looking for suppliers of Fenticonazole Nitrate (100 kg) & Dabigatran Etexilate (35 kg) APIs for commercial manufacturing purposes. The suppliers must support this enquiry with GMP and DMF.
    12 Mar 2021

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    12 Mar 2021

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    12 Mar 2021

    Russia-big.png
    Various APIs needed in Russia [ENA09605]
    A top Russian pharmaceutical company that is a leader in the spheres of the synthesis of innovative substances and modern dosage forms is looking for suppliers of Various APIs for development purposes. The required quantity is 100 g and 1 kg for each. The suppliers must support this enquiry with CoA. 1. Iloprost API 2. Nadroparin Calcium API 3. Ambrisentan API 4. Dabigatran Etexilate API 5. Riociguat API 6. Eltrombopag API 7. Rivaroxaban API 8. Ticagrelor API 9. Macitentan API
    29 Jan 2021

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    29 Jan 2021

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    29 Jan 2021

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    Dabigatran Etexilate Mesylate (35%, 40%, 50% & 75%) Pellets needed in India [ENA08814]
    A fast-growing pharmaceutical manufacturing company is looking for suppliers of Dabigatran Etexilate Mesylate (35%, 40%, 50% & 75%) Pellets. The required quantity is 5 kg for development purposes & 50 kg/ month for commercial purposes. The final market is India & ROW (non-regulated).
    15 Oct 2020

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    15 Oct 2020

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    15 Oct 2020

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    FDF DOSSIERS

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    Tender// Various Finished Dosage Formulations needed in Croatia [ENA15254]
    Klinicka bolnica Dubrava is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 7-Nov-2022. 1. Rivaroxaban (15 mg) Film-Coated Tablets. The required quantity is 2,800 units. 2. Dabigatran Etexilate (110 mg) Capsules. The required quantity is 1,500 units.
    08 Oct 2022

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    08 Oct 2022

    Uzbekistan.png
    In-licensing with Supply of Dabigatran Capsules needed in Uzbekistan [ENA14059]
    A company that manufactures generic and original medicines in such forms as injections in vials, tablets, capsules, ointments, gels, and suspensions is looking for suppliers of In-Licensing of Dabigatran (75 mg, 110 mg & 150 mg) Capsules with supply for commercial purpose. The suppliers must support this enquiry with CTD dossier, EU GMP/ USFDA/ Australian GMP/ Japan GMP/ South Korea GMP. The final market is Kazakhstan and Uzbekistan.
    22 Jun 2022

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    22 Jun 2022

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    22 Jun 2022

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    Various Finished Dosage Formulations needed in Brazil [ENA12556]
    A company that deals in the research, development & trading of health products is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The suppliers must support this enquiry with CTD Dossier, ANVISA, DMF & PIC/s GMP. 1. Infliximab (100 mg & 10 mg) Lyophilized Vials. 2. Bevacizumab (25 mg in 4 ml & 25 mg in 16 ml) Infusions. 3. Duloxetine HCl (60 mg & 30 mg) Slow release Capsules. The required quantity is 50 million units & 10 million units respectively. 4. Dabigatran (110 mg & 150 mg) Capsules. The required quantity is 28 million units & 10 million units respectively.
    31 Jan 2022

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    31 Jan 2022

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    31 Jan 2022

    Bulgaria.png
    Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA10678]
    Hospital for Active Treatment "Sv. Panteleymon" - Yambol AD is looking for supplies of Various Finished Dosage Formulations. The deadline is 19-July-2021. 1. Propofol (10 mg/ ml in 20 ml (1%)) Ampoules. The required quantity is 1,600 units. 2. Fentanyl (0.25 mg/ 5 ml) Ampoules. The required quantity is 1,500 units. 3. Atracurium (50 mg/ 5 ml) Ampoules. The required quantity is 1,000 units. 4. Dexketoprofen (50 mg/ 2 ml) Solution for Injection. The required quantity is 15,000 units. 5. Sodium Chloride (0.9%) + Glucose (5%) Solution for Infusion. The required quantity is 50,000 units. 6. Sodium Chloride (0.009) Solution for Infusion. The required quantity is 2,000 units. 7. Dabigatran Etexilate (150 mg) Capsules. The required quantity is 5,000 units. 8. Heparin Sodium (25000 IU) Solution for Injection. The required quantity is 8,000 units. 9. Azithromycin (500 mg) Tablets. The required quantity is 1,250 units. 10. Enoxaparin (40 mg/ 0.4 ml and 60 mg/ 0.6 ml) Solution for Injection. The required quantity is 3,500 units for each.
    19 Jun 2021

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    19 Jun 2021

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    19 Jun 2021

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    Patents & EXCLUSIVITIES

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    US Patents

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    01

    BOEHRINGER INGELHEIM

    DABIGATRAN ETEXILATE MESYLATE

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    SupplySide West 2024
    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2031-01-20

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 9034822

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code : U-1759

    Delist Requested :

    Patent Use Description : METHOD OF REVERSING TH...

    Patent Expiration Date : 2031-01-20

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    BOEHRINGER INGELHEIM

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    SupplySide West 2024
    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2026-03-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-03-07

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    03

    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2026-03-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 214358

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-03-07

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2031-01-20

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 9034822

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code : U-1759

    Delist Requested :

    Patent Use Description : METHOD OF REVERSING TH...

    Patent Expiration Date : 2031-01-20

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    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2026-03-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 214358

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-03-07

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    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2026-03-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-03-07

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    07

    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2031-01-20

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 9034822

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code : U-1759

    Delist Requested :

    Patent Use Description : METHOD OF REVERSING TH...

    Patent Expiration Date : 2031-01-20

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    BOEHRINGER INGELHEIM

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    BOEHRINGER INGELHEIM

    Germany
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2026-03-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 214358

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2026-03-07

    blank

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    09

    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
    arrow
    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2031-07-20

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 9034822*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22512

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2031-07-20

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    BOEHRINGER INGELHEIM

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    Not Confirmed

    BOEHRINGER INGELHEIM

    Germany
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    SupplySide West 2024
    Not Confirmed

    Patent Expiration Date : 2025-09-07

    DABIGATRAN ETEXILATE MESYLATE

    US Patent Number : 7932273

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 214358

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-09-07

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