Generic Name: trametinib and dabrafenib
Trade Name: Mekinist And Tafinlar
Indication: Treatment of Stage IIb through IV melanoma
Marketing Approval Date: 01-08-2014/01-09-2014
Exclusivity End Date: 01-08-2021/01-09-2021
Sponsor: GlaxoSmithKline
Generic Name: tasimelteon
Trade Name: Hetlioz
Indication: Non-24-hour sleepwake disorder in blind individuals without light perception
Marketing Approval Date: 01-31-2014
Exclusivity End Date: 01-31-20121
Sponsor: Vanda Pharmaceuticals
Generic Name: ibrutinib
Trade Name: Imbruvica
Indication: Treatment of chronic lymphocytic leukemia (CLL)
Marketing Approval Date: 02-12-2014
Exclusivity End Date: 02-12-2021
Sponsor: Pharmacyclics
Generic Name: elosulfase alfa
Trade Name: Vimizim
Indication: Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)
Marketing Approval Date: 02-14-2014
Exclusivity End Date: 02-14-2021
Sponsor: BioMarin
Generic Name: droxidopa
Trade Name: Northera
Indication: Treatment of neurogenic symptomatic orthostatic hypotension in patients with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.
Marketing Approval Date: 02-18-2014
Exclusivity End Date: 02-18-2021
Sponsor: Lundbeck
Generic Name: metreleptin
Trade Name: Myalept
Indication: Treatment of metabolic disorders secondary to lipodystrophy
Marketing Approval Date: 02-24-2014
Exclusivity End Date: N/A
Sponsor: Amylin Pharmaceuticals
Generic Name: propranolol
Trade Name: Hemangeol
Indication: Treatment of proliferating infantile hemangiomas requiring systemic therapy
Marketing Approval Date: 03-14-2014
Exclusivity End Date: N/A
Sponsor: Pierre Fabre Dermatologie
Generic Name: Impavido
Trade Name: miltefosine
Indication: Treatment of leishmaniasis.
Marketing Approval Date: 03-19-2014
Exclusivity End Date: 03-19-2021
Sponsor: Knight Therapeutics
Generic Name: Coagulation factor IX (recombinant), Fc fusion protein
Trade Name: Alprolix
Indication: Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)
Marketing Approval Date: 03-28-2014
Exclusivity End Date: 03-28-2021
Sponsor: Biogen Idec
Generic Name: ecallantide
Trade Name: Kalbitor
Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older
Marketing Approval Date: 03-28-2014
Exclusivity End Date: 03-28-2021
Sponsor: Dyax Corp.
Generic Name: ethiodized oil injection
Trade Name: Lipiodol
Indication: Selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma
Marketing Approval Date: 04-04-2014
Exclusivity End Date: 04-04-2021
Sponsor: Guerbet LLC
Generic Name: ofatumumab
Trade Name: Arzerra
Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Marketing Approval Date: 04-17-2014
Exclusivity End Date: 04-17-2021
Sponsor: Glaxo Group Limited d/b/a GlaxoSmithKline
Generic Name: ramucirumab
Trade Name: Cyramza
Indication: Treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, as a single agent or in combination with paclitaxel, after prior fluoropyrimidine- or platinium-containing chemotherapy.
Marketing Approval Date: 11-05-2014
Exclusivity End Date: N/A
Sponsor: Eli Lilly and Company
Generic Name: siltuximab
Trade Name: Sylvant
Indication: Treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Marketing Approval Date: 04-23-2014
Exclusivity End Date: 04-23-2021
Sponsor: Janssen Biotech
Generic Name: mercaptopurine oral solution
Trade Name: Purixan
Indication: Treatment of patients with acute lymphoblastic leukemia as part of a combination regimen.
Marketing Approval Date: 04-28-2014
Exclusivity End Date: 04-28-2021
Sponsor: Nova Laboratories Limited
Generic Name: ceritinib
Trade Name: Zykadia
Indication: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Marketing Approval Date: 04-29-2014
Exclusivity End Date: 04-29-2021
Sponsor: Novartis Pharmaceuticals Corp.
Generic Name: antihemophilic factor (recombinant), Fc fusion protein
Trade Name: Eloctate
Indication: Treatment of adults and children with Hemophilia A (congenital Factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Marketing Approval Date: 06-06-2014
Exclusivity End Date: 06-06-2021
Sponsor: Biogen Idec Inc.
Generic Name: technetium Tc 99m tilmanocept
Trade Name: Lymphoseek
Indication: Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
Marketing Approval Date: 06-13-2014
Exclusivity End Date: 06-13-2021
Sponsor: Navidea Biopharmaceuticals
Generic Name: coagulation factor VIIa (recombinant)
Trade Name: Novoseven Rt
Indication: Treatment of bleeding episodes and peri-operative management in adults and children with Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.
Marketing Approval Date: 07-02-2014
Exclusivity End Date: 07-02-2021
Sponsor: Novo Nordisk Inc.
Generic Name: Belinostat
Trade Name: Beleodaq
Indication: Treatment of peripheral T-cell lymphoma (PTCL).
Marketing Approval Date: 07-03-2014
Exclusivity End Date: 07-03-2021
Sponsor: Spectrum Pharmaceuticals, Inc.
Generic Name: C1-esterase inhibitor (recombinant)
Trade Name: Ruconest
Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Marketing Approval Date: 07-16-2014
Exclusivity End Date: 07-16-2021
Sponsor: Santarus, Inc.
Generic Name: dantrolene sodium suspension for injection
Trade Name: Ryanodex
Indication: Treatment of malignant hyperthermia in conjunctin with appropriate supportive measures.
Marketing Approval Date: 07-22-2014
Exclusivity End Date: N/A
Sponsor: Eagle Pharmaceuticals, Inc.
Generic Name: idelalisib
Trade Name: Zydelig
Indication: (1) Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities; and (2) Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies.
Marketing Approval Date: 07-23-2014
Exclusivity End Date: 07-23-2021
Sponsor: Gilead Sciences, Inc
Generic Name: ibrutinib
Trade Name: Imbruvica
Indication: Treatment of chronic lymphocytic leukemia with 17p deletion
Marketing Approval Date: 07-28-2014
Exclusivity End Date: 07-28-2021
Sponsor: Pharmacyclics, Inc.
Generic Name: Recombinant human acid alpha-glucosidase; alglucosidase alfa
Trade Name: 1. Myozyme 2. Lumizyme
Indication: (Lumizyme) Patients with Pompe disease (acid alpha-glucosidase (GAA deficiency)).
Marketing Approval Date: 08-01-2014
Exclusivity End Date: 08-01-2021
Sponsor: Genzyme Corporation
Generic Name: eliglustat
Trade Name: Cerdelga
Indication: Long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.
Marketing Approval Date: 08-19-2014
Exclusivity End Date: 08-19-2021
Sponsor: Genzyme Corporation
Generic Name: eltrombopag
Trade Name: Promacta
Indication: Treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
Marketing Approval Date: 08-26-2014
Exclusivity End Date: 08-26-2021
Sponsor: GlaxoSmithKline LLC
Generic Name: pembrolizumab
Trade Name: Keytruda
Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Marketing Approval Date:
Exclusivity End Date:
Sponsor: Merck, Sharp & Dohme Corp.
Generic Name: adalimumab
Trade Name: Humira
Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. (Orphan approval for patients from 6 through 16 years of age.)
Marketing Approval Date: 09-23-2014
Exclusivity End Date: 09-23-2021
Sponsor: AbbVie Inc.
Generic Name: adalimumab
Trade Name: Humira
Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Marketing Approval Date: 09-30-2014
Exclusivity End Date: 09-30-2021
Sponsor: AbbVie Inc.
Generic Name: bortezomib
Trade Name: Velcade For Injection
Indication: Treatment of patients with mantle cell lymphoma
Marketing Approval Date: 10-08-2014
Exclusivity End Date: N/A
Sponsor: Millennium Pharmaceuticals, Inc.
Generic Name: nintedanib
Trade Name: Ofev
Indication: Treatment of idiopathic pulmonary fibrosis
Marketing Approval Date: 10-15-2014
Exclusivity End Date: 10-15-2021
Sponsor: Boehringer Ingelheim Pharmaceuticals, Inc.
Generic Name: pirfenidone
Trade Name: Esbriet
Indication: Treatment of idiopathic pulmonary fibrosis
Marketing Approval Date: 10-15-2014
Exclusivity End Date: 10-15-2021
Sponsor: Intermune
Generic Name: antihemophilic factor (recombinant), porcine sequence
Trade Name: Obizur
Indication: Treatment of bleeding episodes in adults with acquired hemophilia A.
Marketing Approval Date: 10-23-2014
Exclusivity End Date: 10-23-2021
Sponsor: Baxter Healthcare Corporation
Generic Name: ramucirumab
Trade Name: Cyramza
Indication: Treatment of advanced gastric or gastro-esophageal junction adenocarcinoma, as a single agent or in combination with paclitaxel, after prior fluoropyrimidine- or platinium-containing chemotherapy.
Marketing Approval Date: 11-05-2014
Exclusivity End Date: 11-05-2021
Sponsor: Eli Lilly and Company
Generic Name: bevacizumab
Trade Name: Avastin
Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
Marketing Approval Date: 11-14-2014
Exclusivity End Date: 11-14-2021
Sponsor: Genentech, Inc
Generic Name: cinacalcet
Trade Name: Sensipar
Indication: Treatment of hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.
Marketing Approval Date: 11-21-2014
Exclusivity End Date: 11-21-2021
Sponsor: Amgen, Inc.
Generic Name: blinatumomab
Trade Name: N/A
Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Marketing Approval Date: 12-03-2014
Exclusivity End Date: 12-03-2021
Sponsor: Amgen, Inc.
Generic Name: ruxolitinib
Trade Name: Jakafi
Indication: Treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.
Marketing Approval Date: 12-04-2014
Exclusivity End Date: 12-04-2021
Sponsor: Incyte Corporation
Generic Name: denosumab
Trade Name: Xgeva
Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.
Marketing Approval Date: 12-05-2014
Exclusivity End Date: 12-05-2021
Sponsor: Amgen, Inc.
Generic Name: nivolumab
Trade Name: Opdivo
Indication: treatment for patients with unresectable or metastatic (advanced) melanoma who no longer respond to other drugs.
Marketing Approval Date: 12-22-2014
Exclusivity End Date: N/A
Sponsor: Bristol-Myers Squibb
Generic Name: bedaquiline
Trade Name: Sirturo
Indication: Indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. See sections 4.2, 4.4 and 5.1.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Approval Date: 03-05-2014
Conditional Approval: YES
Sponsor: Janssen-Cilag International N.V.
Generic Name: cabozantinib
Trade Name: Cometriq
Indication: Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma
Marketing Approval Date: 03-21-2014
Conditional Approval: YES
Sponsor: TMC Pharma Services Ltd
Generic Name: riociguat
Trade Name: Adempas
Indication: Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with
inoperable CTEPH,
persistent or recurrent CTEPH after surgical treatment,
to improve exercise capacity (see section 5.1). Pulmonary arterial hypertension (PAH) Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity. Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1).
Marketing Approval Date: 03-27-2014
Conditional Approval: NO
Sponsor: Bayer Pharma AG
Generic Name: cholic acid
Trade Name: Kolbam (previously Cholic Acid FGK)
Indication: Kolbamis indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or a-) methylacyl-CoA racemase (AMACR) deficiency or Cholesterol 7a-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Marketing Approval Date: 04-04-2014
Conditional Approval: NO
Sponsor: FGK Representative Service GmbH
Generic Name: para-aminosalicylic acid
Trade Name: Granupas (previously Para-aminosalicylic acid Lucane)
Indication: Granupas is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Approval Date: 04-07-2014
Conditional Approval: NO
Sponsor: Lucane Pharma
Generic Name: elosulfase alfa
Trade Name: Vimizim
Indication: Vimizim is indicated for the treatment of mucopolysaccharidosis, type IVA (Morquio A Syndrome, MPS IVA) in patients of all ages.
Marketing Approval Date: 04-28-2014
Conditional Approval: NO
Sponsor: BioMarin Europe Ltd
Generic Name: delamanid
Trade Name: Deltyba
Indication: Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Approval Date: 04-28-2014
Conditional Approval: YES
Sponsor: Otsuka Novel Products GmbH
Generic Name: siltuximab
Trade Name: Sylvant
Indication: Sylvant is indicated for the treatment of adult patients with multicentric Castlemans disease (MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Marketing Approval Date: 05-22-2014
Conditional Approval: NO
Sponsor: Janssen-Cilag International NV
Generic Name: obinutuzumab
Trade Name: Gazyvaro
Indication: Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy
Marketing Approval Date: 07-23-2014
Conditional Approval: NO
Sponsor: Roche Registration Ltd
Generic Name: ataluren
Trade Name: Translarna
Indication: Translarna is indicated for the treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 5 years and older.
Marketing Approval Date: 07-31-2014
Conditional Approval: YES
Sponsor: PTC Therapeutics International Limited
Generic Name: ibrutinib
Trade Name: Imbruvica
Indication: Imbruvica is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Imbruvicais indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo immunotherapy.
Marketing Approval Date: 10-21-2014
Conditional Approval: NO
Sponsor: Janssen-Cilag International NV
Generic Name: olaparib
Trade Name: Lynparza
Indication: Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Marketing Approval Date: 12-16-2014
Conditional Approval: NO
Sponsor: AstraZeneca AB
