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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
    07/09/2022
    (ME-I)
    -
    Abiraterone f.c. tabs. / 500mg Zytiga® Oncology
    07/09/2022
    (ME-I)
    -
    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
    -
    -
    Febuxostat f.c. tabs. / 80mg, 120mg Adenuric® / Uloric® Chronic gout
    -
    -
    Fingolimod caps. / 0.5mg Gilenya® Multiple Sclerosis
    21/03/2022
    (ME-I)
    25/12/2027
    (PED)
    Gefitinib f.c. tabs. / 250mg Iressa® Oncology
    -
    13/07/2022
    (ODE)
    Palbociclib caps. / 75mg, 100mg, 125mg Ibrance® Oncology
    10/01/2028
    (SPC)
    28/06/2028
    (PTE + 180d)
    Paroxetine f.c. tabs. / 20mg Seroxat® / Paxil® Major Depression and
    Anxiety disorders
    -
    -
    Rivaroxaban f.c. tabs. / 10mg, 15mg, 20mg Xarelto® Anti-thrombotic
    01/04/2024
    (PED)
    17/02/2034
    (PAT)
    Sitagliptin tabs. / 25mg, 50mg, 100mg Januvia® Diabetes Mellitus
    23/09/2022
    (SPC)
    22/01/2023
    (PAT + 180d)
    Sitagliptin + Metformin tabs. / 50+500mg, 50 + 850mg, 50+1000mg Janumet® Diabetes Mellitus
    23/09/2022
    (SPC)
    22/01/2023
    (PAT + 180d)
    Sunitinib caps. / 12.5mg, 25mg, 37.5mg, 50mg Sutent® Oncology
    24/01/2022
    (PED)
    15/08/2021
    (PED)
    Tofacitinib 1 f.c. tabs. / 5mg Xeljanz® Rheumatoid and
    Psoriatic Arthritis
    24/03/2028
    (ME-I)
    06/12/2026
    (PED + 180d)
    Valganciclovir f.c. tabs. / 450mg Valcyte® Anti-infective (CMV)
    -
    -
    Vildagliptin tabs. / 50mg Galvus® / n.a. Diabetes Mellitus
    28/09/2022
    (SPC)
    -
    Vildagliptin + Metformin f.c. tabs. / 50 + 500mg, 50 + 850mg, 50 + 1000mg Eucreas® / n.a. Diabetes Mellitus
    16/11/2022
    (SPC)
    -

    * Germany used as reference | 1 - Climatic Zone IVb stability study to be performed under request

    ME-I - Market exclusivity with 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
  • 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 ER 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
    -
    18/02/2021
    (ODE)
    Ezetimibe + Simvastatine 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
    -
    -
    Ramipril + Amlodipin + Atorvastatin tabs. / 5+5+10mg, 5+10+20mg, 10+10+40mg, 5+5+20mg, 10+10+20mg Delix® / Novarsc® / Sortis® Hypertension/Dyslipidemia
    -
    -

    * Germany used as reference | 1 - Climatic Zone IVb stability study to be performed under request

    ME-I - Market exclusivity with 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
  • Ongoing Developments

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT
    EU* / US
    INDICATION
    PRODUCT PROTECTON
    EXPIRY
    DOSSIER
    READY
    EU *
    US
    Ephedrine injection / 50mg/ml n.a. / Akovaz® Hypotension occuring in the setting of anesthesia
    -
    -
    Q1 2021
    Nilotinib caps. / 50mg, 150mg, 200mg Tasigna® Oncology
    04/07/2023
    (PAT)
    03/07/2024
    (PED + 180d)
    Q2 2021
    Fingolimod caps. / 0.25mg Gilenya® Multiple Sclerosis
    21/03/2022
    (ME-I)
    11/11/2021
    (NS + PED)
    Q4 2021
    Paroxetine CR e.r. tabs. / 12.5mg, 25mg, 37.5mg n.a. / Paxil CR® Major Depression and Anxiety disorders
    -
    -
    Q4 2021
    Propafenone SR e.r. caps. / 225mg, 325mg, 425mg Rythmonorm® SR / Rythmol® SR Arrhythmia
    -
    -
    Q4 2021
    Tofacitinib f.c. tabs. / 10mg Xeljanz® Rheumatoid, Psoriatic Arthritis, Ulcerative Colitis
    24/03/2028
    (ME-I)
    06/12/2026
    (PED + 180d)
    Q4 2021
    Pazopanib f.c. tabs. / 200mg, 400mg Votrient® Oncology
    16/06/2025
    (SPC)
    19/10/2023
    (PAT)
    Q1 2022
    Pomalidomide caps. / 1mg, 2mg, 3mg, 4mg Imnovid® / Pomalyst® Oncology
    08/08/2024
    (ME-I)
    14/12/2025
    (PAT + 180d)
    Q2 2022
    Tofacitinib XR e.r. tabs. / 11mg, 22mg n.a. / Xeljanz XR® Rheumatoid, Psoriatic Arthritis
    24/03/2028
    (ME-I)
    06/12/2026
    (PED + 180d)
    Q2 2022
    Eltrombopag f.c. tabs. / 12.5mg, 25mg, 50mg, 75mg Revolade® Q3 / Promacta® Thrombocytopenia
    15/09/2025
    (PED)
    13/07/2026
    (PED + 180d)
    Q3 2022
    Ibrutinib f.c. tabs. / 140mg, 280mg, 420mg, 560mg n.a. / Imbruvica® Oncology
    21/10/2029
    (SPC)
    30/05/2032
    (PED + 180d)
    Q4 2022
    Afatinib f.c. tabs. / 20mg, 30mg, 40mg, 50mg Giotrif® / Gilotrif® Oncology
    12/12/2026
    (SPC)
    08/01/2027
    (PED + 180d)
    Q1 2023
    Ruxolitinib tabs. / 5mg, 10mg, 15mg, 20mg, 25mg Jakavi® / Jakafi® Oncology
    28/08/2027
    (SPC)
    09/12/2028
    (PAT + 180d)
    Q2 2023
    Dapagliflozin f.c. tabs. / 5mg, 10mg Forxiga® / Farxiga® Diabetes Mellitus
    14/05/2028
    (PED)
    02/04/2026
    (PAT + 180d)
    Q3 2023
    Dapagliflozin + Metformin f.c. tabs. / 5 + 850 mg, 5 + 1000mg Xigduo® / n.a. Diabetes Mellitus
    14/05/2028
    (PED)
    -
    Q3 2023

    * Germany used as reference | 1 - Climatic Zone IVb stability study to be performed under request

    ME-I - Market exclusivity with 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
  • Complex Generics

    PRODUCT
    DOSAGE FORM / STRENGTH
    REFERENCE PRODUCT
    EU* / US
    INDICATION
    PRODUCT PROTECTON
    EXPIRY
    STATUS
    EU *
    US
    Amphotericin B liposome injection / 50 mg/vial Ambisome® Fungal infections
    -
    -
    Upon Request
    Bupivacaine liposome injection / 13.3 mg/mL n.a. / Exparel® Postsurgical analgesia
    -
    24/12/2021
    (PAT)
    Upon Request
    Buprenorphine + Naloxone sublingual film / 2 + 0,5mg,
    4 + 1 mg, 8 + 2 mg, 12 + 3 mg    		 n.a. / Suboxone® Opioid dependence
    -
    -
    Upon Request
    Daunorubicin + Cytarabine liposome injection / 44 mg + 100mg/vial Vyxeos® Oncology
    27/08/2028
    (ODE)
    03/08/2024
    (ODE)
    Upon Request
    Dihydroergotamine nasal spray / 4 mg/ml n.a. / Migranal® Migraine
    -
    -
    Upon Request
    Doxorubicin liposome injection / 2 mg/mL Caelyx® / Doxil® Oncology
    -
    -
    Upon Request
    Irinotecan liposome injection / 4.3 mg/mL Onivyde® Oncology
    18/10/2026
    (ODE)
    22/10/2022
    (ODE)
    Upon Request
    Scopolamine transdermal system / 1,5 mg Scopoderm TTS® / Transderm Scop® Motion sickness
    -
    -
    Upon Request

    * Germany used as reference | 1 - Climatic Zone IVb stability study to be performed under request

    ODE - Orphan Drug Exclusivity | PAT - Patent | TBD - To Be Defined