Darbepoetin alfa

Darbepoetin alfa (Aranesp®) contains in comparison to natural erythropoietin five amino acid changes (at N30, T32, V87, N88, T90) resulting into creation of two new sites for N-linked carbohydrate addition. It has a three-fold longer serum half-life as compared to epoetin alpha and epoetin beta. Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Aranesp® is indicated for the treatment of anemia due to chronic kidney disease, including patients on dialysis and patients not on dialysis. Aranesp® is also indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelo-suppressive chemotherapy. Patents on Aranesp® will expire in US in May 2024 and already expired in Europe in July 2016. Learn more

Epoetin alfa

Epoetin alfa (Epogen® / Eprex® / Procrit®) contains 165 amino acids with the identical sequence of naturally occurring erythropoietin. Epoetin alfa and epoetin beta have differences in the glycosylation pattern. The mode of action of epoetin alpha is the same as of that of darbepoetin alpha. Epogen® is indicated for the treatment of anemia due to chronic kidney disease, anemia due to zidovudine in patients with HIV infection, treatment of patients with non-myeloid malignancies, and for reduction of the need for allogeneic red blood cell transfusions during elective, noncardiac, nonvascular surgery. The patents on Epogen® / Eprex® expired in US and Europe in 2013. Learn more


Follicle stimulating hormone (FSH) consists of two non-covalently linked glycoproteins designated as alpha- and beta-subunits, which consist of 92 and 111 amino acids, respectively. The molecular weight is 22.7 kDa. Follitropin is the corresponding recombinantly produced molecule and is marketed as follitropin alpha (Gonal F®) and follitropin beta (Puregon®). The amino acid sequences of follitropin alpha and beta are identical to that of FSH, and there are only differences in glycosylation patterns. FSH is synthesized and secreted by the gonadotrophs of the anterior pituitary gland. In general, it regulates the development, growth, pubertal maturation, and reproductive processes of the body including maturation of ovarian follicles and sperm cells. Follitropin is indicated for different complications in ovulation and pregnancy. Basic patents have already been expired. Learn more


Filgrastim (granulocyte colony stimulating factor, G-CSF, Neupogen®) consists of 175 amino acid residues (18.8 kDa) with two disulfide bridges. Filgrastim binds to the G-CSF receptor, stimulates the proliferation of progenitor cells and their maturation into neutrophils (white blood cells). Filgrastim also stimulates the release of neutrophils from bone marrow and increases their phagocytic activity. By stimulation of the production of more neutrophils, filgrastim treatment can thus be used to fight infection in patients undergoing chemotherapy for cancer treatment. Neupogen® is approved for five indications in the following patient populations: Chemotherapy -induced febrile neutropenia, acute myeloid leukemia, cancer patients receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. Patents on Neupogen® expired in the US in December 2013 and in Europe in 2006. Learn more


Human growth hormone (HGH, Nutropin®, Humatrope®, Genotropin®, Norditropin®, Saizen®), also known as somatotropin, is a 191-amino acid, single-chain, non-glycosylated polypeptide that is synthesized and secreted by somatotropic cells within the lateral wings of the anterior pituitary gland. It is anabolic and stimulates growth, cell reproduction, and cell regeneration. HGH is indicated as replacement therapy in persons with growth hormone deficiency. There is off-label prescription and use of HGH for a variety of other applications. Human pituitary-derived hormone was available since the late 1950s and in 1981. Genetech developed the first recombinant product. Patents already expired and a variety of biosimilars are marketed or in development. Learn more


Animal sourced insulins are now rarely available in developed countries and even use of recombinant human insulin is declining in different markets whereas insulin analogues are dominating the market since years. Basal insulins are long acting, bolus insulins are fast acting. Insulin is indicated to treat high blood glucose including diabetes mellitus type 1 and 2, gestational diabetes, and complications of diabetes such as diabetic ketoacidosis and hyperosmolar hyperglycemic states. Insulin is also used with glucose to treat high blood potassium levels. Patent protection of recombinant human insulin has expired for more than 15 years and also patents for many analogues have been expired so far, e.g. for Lantus® and Humalog®. Learn more


Interferon-β1a (IFN-β1a, Avonex®) is a cytokine of the interferon family. It is a 166 amino acid glycoprotein with a single N-linked carbohydrate chain on Asn80 residue. Commercial IFN-β1a preparations have core-fucosylated glycoforms differing in sialylation and glycol-antennary degree. IFN-β1a is acting on a variety of processes and molecules within the immune system. For example, it balances the expression of anti-inflammatory and pro-inflammatory cytokines. Avonex® is indicated for treatment of relapsing forms of multiple sclerosis to slow accumulation of physical disability and to decrease frequency of clinical exacerbations in patients with first clinical episode and magnetic resonance imaging consistent with multiple sclerosis. Basic patents for Avonex® have expired in 2013. Learn more


Pegfilgrastim (pegylated granulocyte colony stimulating factor, pegG-CSF, Neulasta®) is a variant of G-CSF coupled to a polyethylene glycol (PEG) moiety at the N-terminus of human G-CSF. This pegylated form has a longer half-life, thus reducing the necessity of daily injections. The patents on Neulasta® expired in US in October 2015 and in Europe in August 2017. Learn more


Parathyroid hormone (PTH, Natpara®, Preos™, Preotact®) is a polypeptide containing 84 amino acids (9.4 kDa). Only the 34 N-terminal amino acids are required for the bioactive conformation. Teriparatide (Forteo®) consisting of these 34 amino acids has the same efficacy as PTH. PTH secreted by chief cells of the parathyroid glands is the primary regulator of calcium and phosphate metabolism in bone and kidney. It is acting upon the PTH-1 receptor in bone and kidney, and the PTH-2 receptor in the central nervous system, pancreas, testis, and placenta. PTH increases serum calcium levels. Thus, chronically elevated PTH will deplete bone stores. Teriparatide is indicated for treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women. PTH is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. The patents of Forteo® expired in US and Europe in August 2019. Learn more

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