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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Medtronic
Colorcon
Fish and Richardson
Federal Trade Commission
Accenture

Generated: September 18, 2019

DrugPatentWatch Database Preview

Regulatory Exclusivity: NEW INDICATION

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Drugs with New Indication Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes   Try a Free Trial REVISED INDICATION FOR USE IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY.
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   Try a Free Trial AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-001 Jul 20, 2012 RX Yes Yes   Try a Free Trial AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
Onyx Therap KYPROLIS carfilzomib POWDER;INTRAVENOUS 202714-002 Jun 3, 2016 RX Yes No   Try a Free Trial REVISED INDICATION FOR USE IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY.
Eisai Inc HALAVEN eribulin mesylate SOLUTION;INTRAVENOUS 201532-001 Nov 15, 2010 RX Yes Yes   Try a Free Trial TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-001 Jul 24, 2015 DISCN Yes No   Try a Free Trial EXPANSION OF THE PATIENT POPULATION TO INCLUDE PATIENTS WITH RECURRENCE OF HEPATITIS C VIRUS (HCV) GENOTYPE 1 OR 3 AFTER LIVER TRANSPLANTATION
Bristol-myers Squibb DAKLINZA daclatasvir dihydrochloride TABLET;ORAL 206843-002 Jul 24, 2015 DISCN Yes No   Try a Free Trial EXPANSION OF THE PATIENT POPULATION TO INCLUDE PATIENTS WITH RECURRENCE OF HEPATITIS C VIRUS (HCV) GENOTYPE 1 OR 3 AFTER LIVER TRANSPLANTATION
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
McKesson
Colorcon
Citi
Mallinckrodt
Johnson and Johnson

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