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  • Anti-infectives for Systemic Use
  • Cardiovascular System
  • Central Nervous System
  • Complex Injectables
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Oncology
  • Oromucosal Delivery
  • Anti-infectives for Systemic Use

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Azithromycin f.c. tabs. / 250mg, 500mg, 600mg Zithromax®
    -
    -
    available 1
    Ciprofloxacin f.c. tabs. / 250mg, 500mg, 750mg Ciproxin®/Cipro®
    -
    -
    available 1
    Clarithromycin f.c. tabs. / 250mg, 500mg Klaricid®/Biaxin®
    -
    -
    available 1
    Moxifloxacin f.c. tabs. / 400mg Avelox®
    -
    -
    available 1
    Valganciclovir f.c. tabs. / 450mg Valcyte®
    -
    -
    available 1
  • Cardiovascular System

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Amlodipine tabs. / 5mg, 10mg Norvasc®
    -
    -
    available 1
    Apixaban f.c. tabs. / 2.5mg, 5mg Eliquis® 
    2026
    (SPC)
    2026
    (PTE)
    Q4 2019
    Candesartan tabs. / 4mg, 8mg, 16mg, 32mg Blopress®/Atacand® 
    -
    -
    available 1
    Candesartan HCTZ tabs. / 8+12.5mg, 16+12.5mg Blopress Plus®/Atacand HCT®
    -
    -
    available 1
    Clopidogrel tabs. / 75mg Plavix®
    -
    -
    available 1
    Dofetilide caps. / 0,125mg, 0,25mg, 0,5mg Tykosin®
    NA
    2020
    (PAT)
    Q1 2019
    Ezetimibe + Simvastatine tabs. / 10+20mg, 10+40mg, 10+80mg Vytorin® / Inegy®
    2019
    (SPC)
    -
    available 1
    (tech package available)
    Irbesartan f.c. tabs. / 75mg, 150mg, 300mg Approvel®/Avapro®
    -
    -
    available 1
    Irbesartan HCTZ f.c. tabs. / 150+12.5mg, 300+12.5mg, 300+25mg Co-approvel®/Avazide®
    -
    -
    available 1
    Losartan f.c. tabs. / 12.5mg, 25mg, 50mg, 100mg Cozaar®
    -
    -
    available 1
    Losartan HCTZ f.c. tabs. / 50+12.5mg, 100+25mg Cozaar Plus®/Hyzaar®
    -
    -
    available 1
    Propafenone SR caps. / 225mg, 325mg, 425mg Rythmonorm® SR/Rythmol® SR
    -
    -
    Q3 2019
    Ramipril tabs. / 1.25mg, 2.5mg, 5mg, 10mg Triatec®/Tritace®
    -
    -
    available
    Rivaroxaban f.c. tabs. / 10mg, 15mg, 20mg Xarelto®
    2023
    (SPC)
    2024
    (PTE)
    Q2 2019
  • Central Nervous System

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Alprazolam tabs. / 0.25mg, 0.5mg, 1mg Xanax® 
    -
    -
    available 1
    Clonidine ER e.r. tabs. / 0.1mg Kapvay®
    -
    -
    available 1
    Droxidopa caps. / 100mg, 200mg, 300mg Northera®
    NA
    2021
    (ODE)
    Q2 2019
    Fluoxetine caps. / 20mg Prozac®
    -
    -
    available 1
    Levetiracetam f.c.tabs / 250mg, 500mg, 750mg, 1000mg Keppra®
    -
    -
    available 1
    Levetiracetam oral solution / 100mg/ml Keppra®
    -
    -
    available
    Paroxetine tabs. / 20mg Paxil®
    -
    -
    available 1
    Paroxetine CR c.r. tabs. / 12.5mg, 25mg, 37.5mg Paxil CR®
    -
    -
    available 1
    Pramipexole f.c.tabs. / 0,125mg, 0,25mg, 0,5mg, 1mg, 1,5mg Mirapex®
    -
    -
    available
  • Complex Injectables

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Amphotericin B Liposome injection / 50 mg/vial Ambisome®
    -
    2021
    (PAT)
    Q3 2020
    Bupivacaine Liposome injection / 13.3 mg/mL Exparel®
    -
    2021
    (PAT)
    Q3 2020
    Doxorubicine Liposome injection / 2 mg/mL Doxil®
    -
    -
    Q4 2020
    Irinotecan Liposome injection / 4.3 mg/mL Onivyde®
    2026
    (ODE)
    2022
    (ODE)
    Q2 2020
  • Metabolic Disorders

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Acarbose tabs. / 50mg, 100mg Glucobay®
    -
    -
    available 1
    Febuxostat f.c. tabs. / 80mg, 120mg Adenuric®/Uloric®
    2019
    (Mkt. Ex.)
    2019
    (PAT)
    available 1
    Gliclazide tabs. / 80mg Diamicron® 
    -
    -
    available 1
    Sitagliptin tabs./ 25mg, 50mg, 100mg Januvia® 
    2022
    (PAT)
    2022
    (PAT)
    Q1 2019
    Sitagliptin + Metformin tabs./ 50 + 850mg, 50+1000mg Janumet® 
    2023
    (SPC)
    2022
    (PAT)
    Q1 2019
    Vildagliptin tabs. / 50mg Galvus® 
    2022
    (SPC)
    -
    available 1
    Vildagliptin + Metformin tabs. / 50 + 850mg, 50 + 1000mg Eucreas® 
    2022
    (SPC)
    -
    available 1
  • Musculoskeletal Disorders

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Diclofenac gel / 10mg/g Voltaren® 
    -
    -
    available
    Fingolimod caps. / 0.5mg Gilenya®
    2022
    (Mkt. Ex.)
    2019
    (PED)
    available 1
    Nimesulide tabs. / 100mg Aulin®/Nimed®
    -
    -
    available 1
    Tofacitinib f.c. tabs. / 5mg Xeljanz®
    2027
    (Mkt. Ex.)
    2026
    (PED)
    available 1
    Tofacitinib XR f.c. tabs. / 5mg Xeljanz XR®
    2027
    (Mkt. Ex.)
    2026
    (PED)
    Q2 2020
  • Oncology

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Abiraterone tabs. / 250mg Zytiga®
    2022
    (Mkt. Ex.)
    -
    available 1
    Abiraterone f.c. tabs. / 500mg Zytiga®
    2022
    (Mkt. Ex.)
    -
    Q2 2019
    Dasatinib f.c.tabs / 20mg, 50mg, 70mg, 80mg, 100mg, 140mg Sprycel®
    2021
    (SPC)
    2024
    (Set. Agr.)
    Q3 2019
    Ibrutinib caps. / 70mg Imbruvica®
    2029
    (SPC)
    2027
    (PTE)
    Q1 2020
    Ibrutinib tabs. / 140mg, 280mg, 420mg, 560mg Imbruvica®
    2029
    (SPC)
    2027
    (PTE)
    Q1 2020
    Nilotinib caps. / 50mg, 150mg, 200mg Tasigna®
    2023
    (PAT)
    2023
    (PAT)
    Q3 2019
    Palbociclib caps. / 75mg, 100mg, 125mg Ibrance®
    2028
    (SPC)
    2028
    (PED)
    Q1 2019
    Pazopanib f.c.tabs. / 200mg, 400mg Votrient®
    2025
    (SPC)
    2023
    (PED)
    Q1 2021
    Sunitinib caps. / 12.5mg, 25mg, 37.5mg, 50mg Sutent®
    2021
    (SPC)
    2021
    (PAT)
    Q2 2019
  • Oromucosal Delivery

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT EU/US
    PRODUCT PROTECTON EXPIRY
    DOSSIER
    READY
    EU *
    US
    Buprenorphine + Naloxone oral thin films / 2 + 0,5mg, 4 + 1 mg, 8 + 2 mg, 12 + 3 mg Suboxone®
    NA
    2022
    (Set. Agr.)
    Q4 2019
    Buprenorphine buccal film / 0.075mg, 0.150mg, 0.300mg, 0.400mg, 0.600mg, 0.750mg, 0.900mg Belbuca®
    NA
    TBD
    Q1 2020

* Protection status in Germany was used as reference. | 1 - Climatic Zone IVb data available

All dossiers are available in eCTD format. Products cannot be offered for countries where patents may apply.