Patents by Inventor Hanimi Reddy BAPATU
Hanimi Reddy BAPATU has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20240122858Abstract: Modified-release pharmaceutical compositions of ruxolitinib or a pharmaceutically acceptable salt thereof are disclosed. Preferably, the invention relates to oral modified-release pharmaceutical compositions of ruxolitinib, which enable once-daily administration. Oral modified-release compositions of ruxolitinib, methods for their administration, processes for their preparation, and use of these compositions for treatment of diseases treatable by ruxolitinib are also described.Type: ApplicationFiled: December 7, 2023Publication date: April 18, 2024Applicant: SLAYBACK PHARMA LLCInventors: Paras P. JAIN, Krishna Mohan LAKSHMIPATHULA, Somnath Devidas NAVGIRE, Hanimi Reddy BAPATU, Sandeep JAIN, Sumitra Ashokkumar PILLAI, Praveen Kumar SUBBAPPA
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Publication number: 20240009188Abstract: Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: ApplicationFiled: September 15, 2023Publication date: January 11, 2024Applicant: SLAYBACK PHARMA LLCInventors: Paras P. JAIN, Ajay Kumar SINGH, Keerthi PRIYA, Girish Kumar JAIN, Girish G. KORE, Sandeep JAIN, Hanimi Reddy BAPATU
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Patent number: 11793809Abstract: Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: GrantFiled: November 20, 2020Date of Patent: October 24, 2023Assignee: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Sandeep Jain, Hanimi Reddy Bapatu
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Publication number: 20230248742Abstract: Stable pharmaceutical compositions are provided, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g.Type: ApplicationFiled: April 12, 2023Publication date: August 10, 2023Applicant: SLAYBACK PHARMA LLCInventors: Umangi K. SONI, Prem Prakash SINGH, Hanimi Reddy BAPATU, Praveen Kumar SUBBAPPA, Ajay Kumar SINGH
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Publication number: 20230172863Abstract: The present invention relates to modified-release pharmaceutical compositions of ruxolitinib or its pharmaceutically acceptable salts thereof. Preferably, the invention relates to oral modified-release pharmaceutical compositions of ruxolitinib, which enable once-daily administration. The present invention further relates to oral modified-release compositions of ruxolitinib, methods for their administration, processes for their preparation, and use of these compositions for treatment of diseases treatable by ruxolitinib.Type: ApplicationFiled: December 5, 2022Publication date: June 8, 2023Inventors: Paras P. JAIN, Krishna Mohan LAKSHMIPATHULA, Somnath Devidas NAVGIRE, Hanimi Reddy BAPATU, Sandeep Jain, Sumitra Ashokkumar PILLAI, Praveen Kumar SUBBAPPA
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Patent number: 11642355Abstract: The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g.Type: GrantFiled: March 16, 2022Date of Patent: May 9, 2023Assignee: SLAYBACK PHARMA LLCInventors: Umangi K. Soni, Prem Prakash Singh, Hanimi Reddy Bapatu, Praveen Kumar Subbappa, Ajay Kumar Singh
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Publication number: 20220202830Abstract: The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, as well as methods of using such pharmaceutical compositions for hormone replacement therapy, e.g.Type: ApplicationFiled: March 16, 2022Publication date: June 30, 2022Applicant: SLAYBACK PHARMA LLCInventors: Umangi K. SONI, Prem Prakash SINGH, Hanimi Reddy BAPATU, Praveen Kumar SUBBAPPA, Ajay Kumar SINGH
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Patent number: 11311554Abstract: The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g.Type: GrantFiled: March 25, 2019Date of Patent: April 26, 2022Assignee: SLAYBACK PHARMA LLCInventors: Umangi K. Soni, Prem Prakash Singh, Hanimi Reddy Bapatu, Praveen Kumar Subbappa, Ajay Kumar Singh
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Patent number: 11103502Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: GrantFiled: November 27, 2019Date of Patent: August 31, 2021Assignee: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Praveen Kumar Subbappa, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Hanimi Reddy Bapatu, Sandeep Jain
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Patent number: 11103503Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: GrantFiled: January 28, 2020Date of Patent: August 31, 2021Assignee: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Praveen Kumar Subbappa, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Hanimi Reddy Bapatu, Sandeep Jain
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Publication number: 20210121480Abstract: The present application relates to stable pharmaceutical compositions for oral administration comprising a progesterone alone, or optionally in combination with an estradiol. The pharmaceutical compositions may further include a solubilizing agent, a surfactant and optionally other pharmaceutical acceptable excipients. Preferably, the estradiol does not precipitate for at least 12 months, and the pharmaceutical compositions are stable for at least 12 months under normal storage conditions at room temperature. Also, when the pharmaceutical compositions are stored for 6 months at 40° C./75% relative humidity (RH), the level of Impurity-M in the composition is less than about 0.2% (w/w) as measured by HPLC. The pharmaceutical compositions may be used for the treatment of moderate to severe vasomotor symptoms due to menopause in post-menopausal women.Type: ApplicationFiled: October 23, 2020Publication date: April 29, 2021Applicant: SLAYBACK PHARMA LLCInventors: Vijayabhanu Prattipati, Venkateshwar Reddy Keesara, Naga Venkata Durga Prasad Ketha, Hanimi Reddy Bapatu
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Publication number: 20210077485Abstract: Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: ApplicationFiled: November 20, 2020Publication date: March 18, 2021Applicant: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Sandeep Jain, Hanimi Reddy Bapatu
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Patent number: 10874671Abstract: Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: GrantFiled: February 18, 2020Date of Patent: December 29, 2020Assignee: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Sandeep Jain, Hanimi Reddy Bapatu
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Publication number: 20200261449Abstract: Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: ApplicationFiled: February 18, 2020Publication date: August 20, 2020Applicant: SLAYBACK PHARMA LLCInventors: Paras P. JAIN, Ajay Kumar SINGH, Keerthi PRIYA, Girish Kumar JAIN, Girish G. KORE, Sandeep JAIN, Hanimi Reddy BAPATU
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Publication number: 20200222395Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: ApplicationFiled: January 28, 2020Publication date: July 16, 2020Applicant: SLAYBACK PHARMA LLCInventors: Paras P. JAIN, Ajay Kumar SINGH, Praveen Kumar SUBBAPPA, Keerthi PRIYA, Girish Kumar JAIN, Girish G. KORE, Hanimi Reddy BAPATU, Sandeep JAIN
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Publication number: 20200222394Abstract: Solid dispersions of lurasidone or a pharmaceutically acceptable salt thereof are described, as well as pharmaceutical formulations thereof, and methods for making such formulations. Preferably, the solid dispersions are prepared by hot-melt extrusion or spray-drying, and comprise lurasidone with a pharmaceutically acceptable carrier (e.g., hydroxypropyl methyl cellulose acetate succinate (HPMC-AS), polyvinyl pyrrolidine vinyl acetate (PVP/VA) copolymer, hydroxypropyl methylcellulose phthalate (HPMCP), or mixtures thereof). The pharmaceutical composition may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Tmax, Cmax, AUC0-t and/or AUC0-infinity) of lurasidone, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.Type: ApplicationFiled: November 27, 2019Publication date: July 16, 2020Applicant: SLAYBACK PHARMA LLCInventors: Paras P. Jain, Ajay Kumar Singh, Praveen Kumar Subbappa, Keerthi Priya, Girish Kumar Jain, Girish G. Kore, Hanimi Reddy Bapatu, Sandeep Jain
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Publication number: 20190307772Abstract: The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of benzyl alcohol, for example, about 1% to 3% weight/volume of benzyl alcohol. The present invention also provides a process for stabilizing testosterone-containing pharmaceutical compositions by ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the shelf life of the product, without exhibiting crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for hormone replacement therapy, e.g.Type: ApplicationFiled: March 25, 2019Publication date: October 10, 2019Applicant: SLAYBACK PHARMA LLCInventors: Umangi K. SONI, Prem Prakash SINGH, Hanimi Reddy BAPATU, Praveen Kumar SUBBAPPA, Ajay Kumar SINGH