Claims for Patent: 7,495,030

Summary for Patent: 7,495,030

Title:	(5-(2-hydroxy-4-chlorobenzoyl) aminovaleric acid and salts thereof and compositions containing the same for delivering active agents
Abstract:	(5-(2-hydroxy-4-chlorobenzoyl) aminovaleric acid, salts thereof, and compositions containing the same for the delivery of active agents are provided. Methods of administration, treatment of disease and preparation are provided as well.
Inventor(s):	Gschneidner; David (Stamford, CT)
Assignee:	Emisphere Technologies, Inc. (Cedar Knolls, NJ)
Application Number:	10/363,726
Patent Claims:	1. A compound selected from the group consisting of ##STR00002## and salts thereof. 2. A composition comprising: (A) a biologically active agent; and (B) a compound selected from the group consisting of ##STR00003## salts thereof, and mixtures thereof. 3. The composition of claim 2, wherein the biologically active agent is at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 4. The composition of claim 2, wherein the biologically active agent is selected from the group consisting of: growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor(IGF), IGF-1, heparin, unfractionated heparin, heparinoids, dermatans, chondroitins, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, salmon calcitonin, eel calcitonin, human calcitonin; erytliropojetin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, fligrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof. 5. The composition of claim 2, wherein the biologically active agent is selected from the group consisting of interferon, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, and daptomycin, or a combination thereof. 6. The composition of claim 2, wherein the biologically active agent is interferon. 7. The composition of claim 2, wherein the biologically active agent is cromolyn sodium. 8. The composition of claim 2, wherein the biologically active agent is daptomycin. 9. A dosage unit form comprising: (A) the composition of claim 2; and (B) (a) an excipient (b) a diluent, (c) a disintegrant, (d) a lubricant, (e) a plasticizer, (f) a colorant, (g) a dosing vehicle, or (h) any combination thereof. 10. The dosage unit form of claim 9, wherein the biologically active agent is a protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 11. The dosage unit form of claim 9, wherein the biologically active agent is selected from the group consisting of: growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor(IGF), IGF-1, heparin, unfractionated heparin, heparinoids, dermatans, chondroitins, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, salmon calcitonin, eel calcitonin, human calcitonin; erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof. 12. The dosage unit form of claim 9, wherein the biologically active agent is selected from the group consisting of interferon, cromolyn sodium, sodium chromoglycate, disodium chromoglycate and daptomycin, or a combination thereof. 13. The dosage unit form of claim 9, wherein the biologically active agent is interferon. 14. The dosage unit form of claim 9, wherein the biologically active agent is cromolyn sodium. 15. The dosage unit form of claim 9, wherein the biologically active agent is daptomycin. 16. The dosage unit form of claim 9, wherein the dosage unit form is in the form of a tablet, a capsule, a particle, a powder, a sachet, or a liquid. 17. The dosage unit form of claim 9, wherein the dosing vehicle is liquid selected from the group consisting of water, 25% aqueous propylene glycol, phosphate buffer, 1,2-propane diol, ethanol, and any combination thereof. 18. A method for preparing a composition comprising mixing: (A) at least one biologically active agent; (B) the compound of claim 1; and (C) optionally, a dosing vehicle. 19. The method according to claim 18, wherein the biologically active agent is at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 20. The method according to claim 19, wherein the biologically active agent is selected from the group consisting of: growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor(IGF), IGF-1, heparin, unfractionated heparin, heparinoids, dermatans, chondroitins, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, salmon calcitonin, eel calcitonin, human calcitonin; erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof.

Details for Patent 7,495,030

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2020-09-06
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2020-09-06
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2020-09-06
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2020-09-06
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2020-09-06
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2020-09-06