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  • Available Dossiers | New

    PRODUCT
    DOSAGE FORM | STRENGTH
    REFERENCE PRODUCT
    EU* | US
    INDICATION
    PRODUCT PROTECTON EXPIRY
    EU *
    US

    Abiraterone

    tabs. | 250mg

    Zytiga®

    Oncology

    09/2022
    (ME)

    -

    Abiraterone

    f.c. tabs. | 500mg

    Zytiga®

    Oncology

    09/2022
    (ME)

    -

    Alprazolam

    tabs. | 0.25mg, 0.5mg, 1mg

    Xanax®

    Anxiety

    -

    -

    Amlodipine

    tabs. | 5mg, 10mg

    Norvasc®

    Hypertension

    -

    -

    Azithromycin

    f.c. tabs. | 250mg, 500mg, 600mg

    Zithromax®

    Anti-infective

    -

    -

    Ephedrine

    injection | 50mg/mL

    n.a. | Akovaz®

    Hypotension occuring in the setting of anesthesia

    -

    -

    Febuxostat

    f.c. tabs. | 80mg, 120mg

    Adenuric® | Uloric®

    Chronic gout

    -

    -

    Fingolimod

    caps. | 0.25mg (2), 0.5mg

    Gilenya®

    Multiple Sclerosis

    03/2022
    (ME)

    12/2027
    (PAT)

    Gefitinib

    f.c. tabs. | 250mg

    Iressa®

    Oncology

    -

    07/2022
    (ODE)

    Palbociclib

    caps. | 75mg, 100mg, 125mg

    Ibrance®

    Oncology

    01/2028
    (SPC)

    09/2027
    (PTE + 180d)

    Paroxetine

    f.c. tabs. | 20mg

    Seroxat® | Paxil®

    Major Depression and Anxiety Disorders

    -

    -

    Rivaroxaban

    f.c. tabs | 2.5mg, 10mg, 15mg, 20mg

    Xarelto®

    Anti-thrombotic

    04/2024
    (PED)

    02/2034
    (PAT)

    Sitagliptin

    tabs. | 25mg, 50mg, 100mg

    Januvia®

    Diabetes Mellitus

    09/2022
    (PED)

    07/2023
    (PED + 180d)

    Sitagliptin
    + Metformin

    tabs. | 50+500mg, 50 + 850mg, 50+1000mg

    Janumet®

    Diabetes Mellitus

    04/2023
    (PED)

    07/2023
    (PED + 180d)

    Sunitinib

    caps. | 12.5mg, 25mg, 37.5mg, 50mg

    Sutent®

    Oncology

    01/2022
    (PED)

    08/2021
    (PED)

    Tofacitinib (1)

    f.c. tabs. | 5mg, 10mg (2)

    Xeljanz®

    Rheumatoid, Psoriatic Arthritis, and Ulcerative Colitis

    03/2028
    (ME)

    12/2026
    (PED + 180d)

    Valganciclovir

    f.c. tabs. | 450mg

    Valcyte®

    Anti-infective (CMV)

    -

    -

    Vildagliptin

    tabs. | 50mg

    Galvus® / n.a.

    Diabetes Mellitus

    09/2022
    (SPC)

    -

    Vildagliptin
    + Metformin

    f.c. tabs. | 50 + 500mg,
    50 + 850mg, 50 + 1000mg

    Eucreas® / n.a.

    Diabetes Mellitus

    11/2022
    (SPC)

    -


    * Germany used as reference.     1 – Climatic Zone IVb stability study to be performed under request.     2 – Upon request.

    ME - Market exclusivity with or without new therapeutic indication, NS - New strength exclusivity with clinical investigation, ODE - Orphan Drug Exclusivity, PAT - Patent, PED - Pediatric Exclusivity, PTE - Patent Term Extension, Set. Agr. - Settlement agreement, SPC - Supplementary Protection Certificate, 180d - Patent challenge 180 day exclusivity, TBD – To Be Defined.

  • Available Dossiers

    PRODUCT
    DOSAGE FORM | STRENGTH
    REFERENCE PRODUCT
    EU* | US
    INDICATION
    PRODUCT PROTECTON EXPIRY
    EU *
    US

    Acarbose

    tabs. | 50mg, 100mg

    Glucobay®

    Diabetes Mellitus

    -

    -

    Candesartan

    tabs. | 4mg, 8mg, 16mg, 32mg

    Blopress® | Atacand®

    Hypertension

    -

    -

    Candesartan HCTZ

    tabs. | 8+12.5mg, 16+12.5mg

    Blopress Plus® | Atacand HCT®

    Hypertension

    -

    -

    Ciprofloxacin

    f.c. tabs. | 250mg, 500mg, 750mg

    Ciproxin® | Cipro®

    Anti-infective

    -

    -

    Clarithromycin

    f.c. tabs. | 250mg, 500mg

    Klaricid® | Biaxin®

    Anti-infective

    -

    -

    Clonidine CR

    e.r. tabs. | 0.1mg

    n.a. | Kapvay®

    Attention Deficit Hyperactivity Disorder

    -

    -

    Clopidogrel

    tabs. | 75mg

    Plavix®

    Anti-thrombotic

    -

    -

    Diclofenac (1)

    gel | 10mg/g

    Voltaren®

    Pain, Inflammation

    -

    -

    Droxidopa

    caps. | 100mg, 200mg, 300mg

    n.a. | Northera®

    Neurogenic Orthostatic Hypotension

    -

    -

    Ezetimibe
    + Simvastatin

    tabs. | 10+20mg, 10+40mg, 10+80mg

    Vytorin® | Inegy®

    Hypercholesteremia

    -

    -

    Irbesartan

    f.c. tabs. | 75mg, 150mg, 300mg

    Approvel® | Avapro®

    Hypertension

    -

    -

    Irbesartan HCTZ (1)

    f.c. tabs. | 150+12.5mg, 300+12.5mg, 300+25mg

    Coapprovel® | Avalide®

    Hypertension

    -

    -

    Levetiracetam

    f.c. tabs. | 250mg, 500mg, 750mg, 1000mg

    Keppra®

    Epilepsy

    -

    -

    Levetiracetam (1)

    oral solution | 100mg/mL

    Keppra®

    Epilepsy

    -

    -

    Losartan

    f.c. tabs. | 12.5mg, 25mg, 50mg, 100mg

    Cozaar®

    Hypertension

    -

    -

    Losartan HCTZ

    f.c. tabs. | 50+12.5mg, 100+25mg

    Cozaar®

    Hypertension

    -

    -

    Moxifloxacin

    f.c. tabs. | 400mg

    Avelox®

    Anti-infective

    -

    -

    Nimesulide

    tabs. | 100mg

    Aulin® | Nimed®

    Pain, Inflammation

    -

    -


    * Germany used as reference.     1 – Climatic Zone IVb stability study to be performed under request.     2 – Upon request.

    ME - Market exclusivity with or without new therapeutic indication, NS - New strength exclusivity with clinical investigation, ODE - Orphan Drug Exclusivity, PAT - Patent, PED - Pediatric Exclusivity, PTE - Patent Term Extension, Set. Agr. - Settlement agreement, SPC - Supplementary Protection Certificate, 180d - Patent challenge 180 day exclusivity, TBD – To Be Defined.

  • Ongoing Developments

    PRODUCT
    DOSAGE FORM | STRENGTH
    REFERENCE PRODUCT
    EU* | US
    INDICATION
    PRODUCT PROTECTON
    EXPIRY
    DOSSIER
    READY
    EU *
    US

    Nilotinib

    caps. | 50mg, 150mg, 200mg

    Tasigna®

    Oncology

    07/2023
    (PAT)

    07/2024
    (PED + 180d)

    Q3 2021

    Propafenone SR

    caps. | 225mg, 325mg, 425mg

    Rythmonorm® SR | Rythmol® SR

    Arrhythmia

    -

    -

    Q2 2022

    Pazopanib

    f.c. tabs. | 200mg, 400mg

    Votrient®

    Oncology

    06/2025
    (SPC)

    10/2023
    (PAT)

    Q2 2022

    Pomalidomide

    caps. | 1mg, 2mg, 3mg, 4mg

    Imnovid® | Pomalyst®

    Oncology

    08/2024
    (ME)

    06/2026
    (PAT + 180d)

    Q2 2022

    Tofacitinib XR

    e.r. tabs | 11mg, 22mg

    Xeljanz® | Xeljanz XR®

    Rheumatoid, Psoriatic Arthritis, and Ulcerative Colitis

    03/2028
    (ME-I)

    12/2026
    (PAT + 180d)

    Q3 2022

    Atorvastatin
    + Ezetimibe

    tabs. | 10 + 10mg, 20 + 10mg, 40 + 10mg, 80 + 10mg

    Atozet® | n.a.

    Hypercholesteremia

    09/2024
    (ME)

    -

    Q4 2022

    Eltrombopag

    f.c. tabs. | 12.5mg, 25mg, 50mg, 75mg

    Revolade® | Promacta®

    Thrombocytopenia

    09/2025
    (PED)

    07/2026
    (PED + 180d)

    Q4 2022

    Paroxetine CR

    e.r. tabs. | 12.5mg, 25mg, 37.5mg

    n.a. | Paxil CR®

    Major Depression and Anxiety Disorders

    -

    -

    Q4 2022

    Afatinib

    f.c. tabs. | 20mg, 30mg, 40mg, 50mg

    Giotrif® | Gilotrif®

    Oncology

    12/2026
    (SPC)

    01/2027
    (PED + 180d)

    Q1 2023

    Lenvatinib

    caps. | 4mg, 10mg

    Kisplyx® | Lenvima®

    Oncology

    04/2027
    (PED)

    04/2026
    (PAT + 180d)

    Q3 2023

    Cabozantinib

    f.c. tabs | 20mg, 40mg, 60mg

    Cabometyx®

    Oncology

    03/2029
    (SPC)

    02/2027
    (PAT + 180d)

    Q4 2023

    Ibrutinib

    f.c. tabs. | 140mg, 280mg, 420mg, 560mg

    Imbruvica®

    Oncology

    10/2029
    (SPC)

    05/2028
    (PED + 180d)

    Q2 2024

    Ruxolitinib

    f.c. tabs. | 5mg, 10mg, 15mg, 20mg, 25mg

    Jakavi® | Jakafi®

    Oncology

    08/2027
    (SPC)

    12/2028
    (PAT + 180d)

    Q2 2024


    * Germany used as reference.     1 – Climatic Zone IVb stability study to be performed under request.     2 – Upon request.

    ME - Market exclusivity with or without new therapeutic indication, NS - New strength exclusivity with clinical investigation, ODE - Orphan Drug Exclusivity, PAT - Patent, PED - Pediatric Exclusivity, PTE - Patent Term Extension, Set. Agr. - Settlement agreement, SPC - Supplementary Protection Certificate, 180d - Patent challenge 180 day exclusivity, TBD – To Be Defined.

  • Complex Generics

    PRODUCT
    DOSAGE FORM | STRENGTH
    REFERENCE PRODUCT
    EU* | US
    INDICATION
    PRODUCT PROTECTON
    EXPIRY
    STATUS
    EU *
    US

    Amphotericin B

    liposome injection
    50mg/vial

    Ambisome®

    Fungal infections

    -

    -

    Upon Request

    Bupivacaine

    liposome injection
    13.3mg/mL

    Exparel®

    Postsurgical analgesia

    11/2030
    (ME)

    12/2021
    (PAT)

    Upon Request

    Buprenorphine + Naloxone

    sublingual film
    2+0,5mg, 4+1mg, 8+2mg, 12+3mg

    n.a. | Suboxone®

    Opioid dependence

    -

    -

    Upon Request

    Daunorubicin + Cytarabine

    liposome injection
    44mg+100mg/vial

    Vyxeos®

    Oncology

    08/2028
    (ODE)

    08/2024
    (ODE)

    Upon Request

    Dihydroergotamine

    nasal spray
    4mg/ml

    n.a. | Migranal®

    Migraine

    -

    -

    Available

    Doxorubicin

    liposome injection
    2mg/mL

    Caelyx® | Doxil®

    Oncology

    -

    -

    Upon Request

    Irinotecan

    liposome injection
    4.3mg/mL

    Onivyde®

    Oncology

    TDB

    TDB

    Upon Request

    Scopolamine

    transdermal system
    1.5mg

    Scopoderm TTS® | Transderm Scop®

    Motion sickness

    -

    -

    Upon Request


    * Germany used as reference.     1 – Climatic Zone IVb stability study to be performed under request.     2 – Upon request.

    ME - Market exclusivity with or without new therapeutic indication, NS - New strength exclusivity with clinical investigation, ODE - Orphan Drug Exclusivity, PAT - Patent, PED - Pediatric Exclusivity, PTE - Patent Term Extension, Set. Agr. - Settlement agreement, SPC - Supplementary Protection Certificate, 180d - Patent challenge 180 day exclusivity, TBD – To Be Defined.

  • Value added medicines

    PRODUCT
    DOSAGE FORM
    INDICATION
    STATUS

    Ramipril + Amlodipine + Atorvastatin

    Tablets

    Hypertension/Dyslipidemia

    Available

    Candesartan + Amlodipine + Atorvastatin

    Tablets

    Hypertension/Dyslipidemia

    Upon Request

    BlueOS2

    Oral Thin Films

    Multiple Sclerosis

    Upon Request

    BluEase03

    Buccal Spray

    Erectile Dysfunction

    Upon Request

    BlueLAI01

    Long Acting Injectable

    Post-operative Pain

    Upon Request