Table 3 Market availability status of orphan drugs for 14 rare diseases in the U.S., EU, Japan and China
From: The availability and affordability of orphan drugs for rare diseases in China
ATC Code | Generic name (Brand name) | Indication | Year marketing authorization received | Delay of release in China (in years) Compared to the earliest time | |||
|---|---|---|---|---|---|---|---|
China | U.S.a | EUa | Japana | ||||
A16AB02 | Imiglucerase (Cerezyme)b P | GD | 2008 | 1994 | d | 1998 | 14 |
A16AX07 | Sapropterin Dihydrochloride (Kuvan)b P | PKU | 2010 | 2007 | 2008 | -- | 3 |
B02BD02 | Human coagulation factor VIIIe | HEM | 2002 | -- D | -- | -- | -- |
B02BD02 | Recombinant coagulation factor VIII (Kogenate FS) | 2010 | -- D | -- D | -- | -- | |
-- | Human prothrombin complex concentrate (e, Kcentra) | 2002 | 2013 | -- | -- | −11 | |
B02BD04 | Coagulation factor IX ( Benefix)c | 2012 | 1997 | D, d | 2009 | 15 | |
B02BD05 | Coagulation factor VIIa ( Novoseven) | 2010 | 1999 | D, d | 2000 | 11 | |
H01BA02 | Desmopressin acetate spray (e, Stimste) | 2001 | 1994 | -- | -- | 7 | |
C02KX01 | Bosentan (Tracleer)b | PAH | 2011 | 2001 | 2002 | 2005 | 10 |
B01AC19 | Beraprost sodium (Dorner) | 2008 | -- D | -- D | 1999 | 9 | |
B01AC11 | Iloprost inhalational solution (Ventavis)b | 2007 | 2004 | 2003 | -- | 5 | |
C02KX02 | Ambrisentan (Volibris/Letairis)b | 2010 | 2007 | 2008 | 2010 | 3 | |
B01AC21 | Treprostinil (Remodulin)b P | 2014 | 2002 | -- | -- | 12 | |
G04BE08 | Tadalafil (Cialis® / Adcirca®) | 2009 | 2009 | d | -- | 0 | |
G03XA01 | Danazol e | HAE | 2002 | -- | -- | -- | -- |
H01AC01 | RDNA origin somatropin (e,Norditropin SimpleXx/Norditropin) | GHD | 1999 | 2000 | -- | 1997 | 2 |
H01AC01 | Somatropin (Saizen) | 2000 | 1996 | -- | -- | 4 | |
H01AC01 | Somatropin (Genotropin) | 2000 | 1997 | -- | 1997 | 3 | |
H01AC01 | Somatropin (Humatrope) P | 2002 | 1987 | -- | -- | 15 | |
-- | Recombinant human growth hormonee | 2006 | -- | d | -- | -- | |
L01AB01 | Busulfan (Busulfex/Busilvex ) P | CML | 2002 | 1999 | 2003 | 2006 | 3 |
L01XE01 | Imatinib (e, Glivec/Gleevec)b P | 2010 | 2001 | d | 2001 | 9 | |
L01XE06 | Dasatinib (e, Sprycel)b P | 2011 | 2006 | 2006 | 2009 | 5 | |
L01XE08 | Nilotinib (Tasigna)b | 2009 | 2007 | 2007 | 2009 | 2 | |
-- | Meisoindigo | 2010 | -- | -- | -- | -- | |
L01BB02 | Mercaptopurine (e, Xaluprine) | ALL | 2002 | 2014 | 2012 | -- | - 10 |
L01AA01 | Cyclophosphamide (e, Endoxan) | 2001 | -- D | -- | 2003 | - 2 | |
L01CB02 | Teniposide (e, Vumon)b P | 1999 | 1992 | -- | -- | 7 | |
L01XX24 | Pegaspargase (e, Oncaspar)c | 2013 | 1994 | -- | -- | 19 | |
L01XE01 | Imatinib (e, Gleevec / Glivec) | 2010 | 2006 | d | 2001 | 9 | |
L01XE06 | Dasatinib (e, Sprycel) | 2011 | 2006 | 2006 | 2009 | 5 | |
L01DB07 | Mitoxantrone HCl (e, Novantrone)b | AML | 2001 | 1987 | -- | -- | 14 |
L01DB06 | Idarubicin HCl (e, Zavedos/Idamycin)b P | 2002 | 1990 | -- | -- | 12 | |
L01BC01 | Cytarabine (e, Cylocide N) | 2000 | -- | -- | 2000 | 0 | |
-- | Homoharringtonine | 2002 | -- D | -- D | -- | -- | |
-- | Arsenious Acid (Yitaida) | APL | 2010 | -- | -- | -- | -- |
L01XX27 | Arsenic Trioxide (e,Trisenox)b P | 2008 | 2000 | d | -- | 8 | |
L01XX14 | Tretinoin (e,Vesanoid) P | 2002 | 1995 | -- | 1995 | 7 | |
-- | Homoharringtonine | 2002 | -- D | -- D | -- | -- | |
L01XC02 | Rituximab (MabThera/Rituxan)c | NHL | 2000 | 1997 | d | 2001 | 3 |
L01XE05 | Sorafenib (Nexavar)b P | RCC | 2011 | 2005 | 2006 | -- | 6 |
L01XC07 | Bevacizumab (Avastin) | 2012 | 2009 | d | -- | 3 | |
N07XX02 | Riluzole (e, Rilutek)b P | ALS | 2010 | 1995 | d | 1998 | 15 |
R07AA | Poractant alfa (Curosurf)b | PIRDS | 2000 | 1999 | -- | -- | 1 |
-- | Calf pulmonary surfactant (Kelisu) | 2010 | -- | -- | -- | -- | |