Patents Assigned to ANI Pharmaceuticals, Inc.
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Patent number: 12233105Abstract: A method of storing a sterile corticotropin composition at a temperature of 2° to 8° C., warming the sterile corticotropin composition to a temperature of 18° to 26° C., injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject, wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2.Type: GrantFiled: August 29, 2024Date of Patent: February 25, 2025Assignee: ANI Pharmaceuticals, Inc.Inventors: Edward M. DeSimone, III, Weijun Cheng, Zachary Holcomb
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Patent number: 12133831Abstract: A sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.Type: GrantFiled: October 27, 2023Date of Patent: November 5, 2024Assignee: ANI Pharmaceuticals, Inc.Inventors: Edward M. DeSimone, III, Weijun Cheng, Zachary Holcomb
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Patent number: 12102662Abstract: A method of warming a vial containing a sterile corticotropin composition from a temperature of 2° to 8° C. to a temperature of 18° to 26° C., withdrawing the sterile corticotropin composition from the vial with a first needle having a first gauge size with a first diameter, replacing the first needle with a second needle having a second gauge size with a second diameter that is different from the first diameter, and injecting 80 (United States Pharmacopeia) USP units of the sterile corticotropin composition into a human subject.Type: GrantFiled: April 12, 2024Date of Patent: October 1, 2024Assignee: ANI Pharmaceuticals, Inc.Inventors: Edward M. DeSimone, III, Weijun Cheng, Zachary Holcomb
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Publication number: 20240189229Abstract: Liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof are described. More specifically, stable liquid pharmaceutical compositions of baclofen at concentrations of 2 mg/mL or more are provided. Preferably, the liquid pharmaceutical compositions are suitable for oral administration, and stable at pH ranges of 3-8 over a variety of storage conditions, including long-term storage for extended periods of time. Various methods for preparing stable liquid pharmaceutical compositions of baclofen are described. Methods of treating spasticity using the inventive pharmaceutical compositions are also provided.Type: ApplicationFiled: February 27, 2023Publication date: June 13, 2024Applicant: ANI Pharmaceuticals, Inc.Inventors: Sushant Omprakash Dube, Suprit Dilip Saoji, Girish G. Kore, Abhijit Balaji Pawar, Purushottam Sakhahari Pattewar, Pankaj Kisan Chatki, Sumitra Ashokkumar Pillai, Praveen Kumar Subbappa
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Publication number: 20240173282Abstract: The present invention relates to stable liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof including baclofen at concentrations of equal to or more than 2 mg/ml or more. Preferably, the liquid pharmaceutical compositions of baclofen are suitable for oral administration and are stable at wider pH ranges over a variety of storage conditions, including long-term storage for extended periods of time. Methods of treating various disorders using the inventive pharmaceutical compositions are also provided.Type: ApplicationFiled: February 9, 2024Publication date: May 30, 2024Applicant: ANI Pharmaceuticals, Inc.Inventors: Sushant Omprakash Dube, Purushottam Sakhahari Pattewar, Pankaj Kisan Chatki, Sumitra Ashokkumar Pillai
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Patent number: 11975047Abstract: A method of storing and warming a sterile corticotropin composition by storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and warming the vial to a temperature of 18° to 26° C., wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units.Type: GrantFiled: October 27, 2023Date of Patent: May 7, 2024Assignee: ANI Pharmaceuticals, Inc.Inventors: Edward M. DeSimone, III, Weijun Cheng, Zachary Holcomb
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Publication number: 20240016771Abstract: The present invention relates to stable liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof. More specifically, stable oral suspensions of baclofen at concentrations of equal to or more than 2 mg/mL or more are provided. Preferably, the liquid pharmaceutical compositions of baclofen are suitable for oral administration and are stable at wider pH ranges over a variety of storage conditions, including long-term storage for extended periods of time. Methods of treating various disorders using the inventive pharmaceutical compositions are also provided. The invention further relates to various methods for preparing stable suspension of baclofen.Type: ApplicationFiled: September 26, 2023Publication date: January 18, 2024Applicant: ANI Pharmaceuticals, Inc.Inventors: Sushant Omprakash Dube, Purushottam Sakhahari Pattewar, Pankaj Kisan Chatki, Sumitra Ashokkumar Pillai
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Patent number: 11857524Abstract: The present invention relates to stable liquid pharmaceutical compositions of baclofen or a pharmaceutically acceptable salt thereof. More specifically, stable oral suspensions of baclofen at concentrations of equal to or more than 2 mg/mL or more are provided. Preferably, the liquid pharmaceutical compositions of baclofen are suitable for oral administration and are stable at wider pH ranges over a variety of storage conditions, including long-term storage for extended periods of time. Methods of treating various disorders using the inventive pharmaceutical compositions are also provided. The invention further relates to various methods for preparing stable suspension of baclofen.Type: GrantFiled: April 4, 2023Date of Patent: January 2, 2024Assignee: ANI Pharmaceuticals, Inc.Inventors: Sushant Omprakash Dube, Purushottam Sakhahari Pattewar, Pankaj Kisan Chatki, Sumitra Ashokkumar Pillai