Patents Assigned to Eagle Pharmaceuticals, Inc.
  • Publication number: 20110184036
    Abstract: Long term storage stable bendamustine-containing compositions are disclosed. The compositions can include bendamustine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable fluid which can include in some embodiments PEG, PG or mixtures thereof and an antioxidant or chloride ion source. The bendamustine-containing compositions have less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 223 nm, after at least about 15 months of storage at a temperature of from about 5° C. to about 25° C.
    Type: Application
    Filed: January 28, 2011
    Publication date: July 28, 2011
    Applicant: EAGLE PHARMACEUTICALS, INC.
    Inventors: Nagesh R. Palepu, Philip Christopher Buxton
  • Publication number: 20110172167
    Abstract: Long term storage stable daptomycin-containing compositions are disclosed. The compositions include daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, a buffer having an acidic functional group and have a pH of from about 6.0 to about 7. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin and the ?-isomer of daptomycin after storage periods of at least about 18 months.
    Type: Application
    Filed: September 17, 2010
    Publication date: July 14, 2011
    Applicant: EAGLE PHARMACEUTICALS, INC.
    Inventors: Nagesh R. Palepu, Bulusu Bhanu Teja
  • Publication number: 20110124551
    Abstract: Long term storage stable daptomycin-containing compositions are disclosed. The compositions include a pharmacologically acceptable fluid including daptomycin or a pharmaceutically acceptable salt thereof at a concentration of less than or equal to about 25 mg/mL, and a calcium source. The formulations are surprisingly free of degradation products such as the hydrolysis product of daptomycin, the ?-isomer of daptomycin and anhydro daptomycin after storage periods of at least about 18 months under refrigerated conditions.
    Type: Application
    Filed: September 17, 2010
    Publication date: May 26, 2011
    Applicant: EAGLE PHARMACEUTICALS, INC.
    Inventors: Nagesh R. Palepu, Bulusu Bhanu Teja
  • Patent number: 7803762
    Abstract: Ready-to-use bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use bivalirudin compositions. The ready-to-use bivalirudin compositions comprise bivalirudin and one or more stabilizing agents. The one or more stabilizing agents may be buffering agents having a pKa of about 2.5 to about 6.5, pH-adjusting agents, polymers, preservatives, antioxidants, sugars or polyols, or a combination thereof. The ready-to-use bivalirudin compositions may also comprise [9-10]-cycloimido bivalirudin, [11-12]-cycloimido bivalirudin, or a combination thereof. The method of using the ready-to-use bivalirudin compositions comprises administering the ready-to-use compositions to a patient in need thereof. Further, the method of preparing the ready-to-use bivalirudin compositions comprises mixing bivalirudin with one or more stabilizing agents.
    Type: Grant
    Filed: August 20, 2009
    Date of Patent: September 28, 2010
    Assignees: The Medicines Company, Eagle Pharmaceuticals, Inc.
    Inventors: Nagesh Palepu, Rajeshwar Motheram, Praful Shah, Gopal Krishna
  • Patent number: 7713928
    Abstract: Ready-to-use bivalirudin compositions, methods of using the ready-to-use bivalirudin compositions, and methods of preparing the ready-to-use bivalirudin compositions. The ready-to-use bivalirudin compositions comprise bivalirudin and one or more stabilizing agents. The one or more stabilizing agents may be buffering agents having a pKa of about 2.5 to about 6.5, pH-adjusting agents, polymers, preservatives, antioxidants, sugars or polyols, or a combination thereof. The ready-to-use bivalirudin compositions may also comprise [9-10]-cycloimido bivalirudin, [11-12]-cycloimido bivalirudin, or a combination thereof. The method of using the ready-to-use bivalirudin compositions comprises administering the ready-to-use compositions to a patient in need thereof. Further, the method of preparing the ready-to-use bivalirudin compositions comprises mixing bivalirudin with one or more stabilizing agents.
    Type: Grant
    Filed: September 21, 2009
    Date of Patent: May 11, 2010
    Assignees: The Medicines Company, Eagle Pharmaceuticals, Inc.
    Inventors: Nagesh Palepu, Rajeshwar Motheram, Praful Shah, Gopal Krishna
  • Patent number: 7687516
    Abstract: An aqueous formulation of argatroban and of related compounds is disclosed along with a reconstitutable formulation, each of which is substantially, if not totally alcohol free. The formulations are also substantially free, if not totally free, of mono-, di-, and oligo-saccharides. An especially preferred embodiment is a ready-to-administer 1 mg/ml injectable dosage form having argatroban, lactobionic acid, and methionine.
    Type: Grant
    Filed: October 9, 2007
    Date of Patent: March 30, 2010
    Assignee: Eagle Pharmaceuticals, Inc.
    Inventor: Nageswara R. Palepu
  • Publication number: 20100076019
    Abstract: An aqueous formulation of argatroban and of related compounds is disclosed along with a reconstitutable formulation, each of which is substantially, if not totally alcohol free. The formulations are also substantially free, if not totally free, of mono-, di-, and oligo-saccharides. An especially preferred embodiment is a ready-to-use 1 mg/ml injectable dosage form having argatroban, lactobionic acid, and methionine.
    Type: Application
    Filed: October 9, 2007
    Publication date: March 25, 2010
    Applicant: EAGLE PHARMACEUTICALS, INC.
    Inventor: Nageswara R. Palepu
  • Patent number: 7589106
    Abstract: An aqueous formulation of argatroban and of related compounds is disclosed along with a reconstitutable formulation, each of which is substantially, if not totally alcohol free. The formulations are also substantially free, if not totally free, of mono-, di-, and oligo-saccharides. An especially preferred embodiment is a ready-to-administer 1 mg/ml injectable dosage form having argatroban, lactobionic acid, and methionine.
    Type: Grant
    Filed: September 26, 2007
    Date of Patent: September 15, 2009
    Assignee: Eagle Pharmaceuticals, Inc.
    Inventor: Nageswara R. Palepu
  • Publication number: 20090221622
    Abstract: Aqueous-based, ready to use topotecan-containing formulations for parenteral use having extended stability are disclosed. The formulations are surprisingly free of precipitated degradation products such as 10-hydroxycamptothecin (10-HCPT) after periods of up to 1 year or greater.
    Type: Application
    Filed: February 27, 2009
    Publication date: September 3, 2009
    Applicant: EAGLE PHARMACEUTICALS, INC.
    Inventors: Bulusu Bhanu TEJA, Philip Christopher BUXTON, Nagesh R. PALEPU