Claims for Patent: 7,951,971

Summary for Patent: 7,951,971

Title:	Phenoxy carboxylic acid compounds and compositions for delivering active agents
Abstract:	Phenoxy carboxylic acid compounds and compositions for the delivery of active agents are provided. Methods of administration and preparation are provided as well.
Inventor(s):	Leone-Bay; Andrea (Ridgefield, CT), Kraft; Kelly (Hopewell Junction, NY), Moye-Sherman; Destardi (Newburgh, NY), Gscheidner; David (Thornwood, NY), Boyd; Maria Aurora P. (Garrison, NY), Liu; Puchun (Chappaqua, NY), Tang; Pingwah (Elmsford, NY), Liao; Jun (Yorktown Heights, NY), Smart; John (Katonah, NY), Freeman, Jr.; John J. (New Fairfield, CT)
Assignee:	Emisphere Technologies, Inc. (Cedar Knolls, NJ)
Application Number:	12/139,276
Patent Claims:	1. A compound of the formula: ##STR00002## or a pharmaceutically acceptable salt thereof. 2. A pharmaceutical composition comprising: (A) a biologically active agent; and (B) a compound of the formula: ##STR00003## or a pharmaceutically acceptable salt thereof. 3. The pharmaceutical composition of claim 2, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, small polar organic molecules, or lipid. 4. The pharmaceutical 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, 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, parathyroid hormone, fragments of parathyroid hormone, antimicrobials, daptomycin, anti-fungal agents, vitamins; analogs, fragments, mimetics and polyethylene glycol-modified derivatives of these compounds, and any combination thereof. 5. The pharmaceutical composition of claim 4, wherein the biologically active agent comprises insulin, unfractionated heparin, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, parathyroid hormone, erythropoietin, daptomycin, human growth hormones, analogs, fragments, mimetics or polyethylene glycol-modified derivatives of these compounds; or any combination thereof. 6. The pharmaceutical composition of claim 2, wherein the biologically active agent is a polypeptide. 7. A dosage unit form comprising: (A) the pharmaceutical 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. 8. The dosage unit form of claim 7, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, small polar organic molecules, carbohydrate, or lipid. 9. The dosage unit form of claim 7, 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), fragments of PTH, antimicrobials, daptomycin, anti-fungal agents, vitamins, analogs, fragments, mimetics and polyethylene glycol-modified derivatives of these compounds, and any combination thereof. 10. The dosage unit form of claim 9, wherein the biologically active agent comprises insulin, unfractionated heparin, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, parathyroid hormone, erythropoietin, human growth hormones, analogs, fragments, mimetics or polyethylene glycol (PEG)-modified derivatives of these compounds; or any combination thereof. 11. The dosage unit form of claim 7, wherein the biologically active agent is a polypeptide. 12. The dosage unit form of claim 7, wherein the dosage unit form is in the form of a tablet, a capsule, a powder, or a liquid. 13. A method for administering a biologically active agent to an animal in need of the agent, the method comprising administering orally to the animal the pharmaceutical composition of claim 2. 14. A method for preparing a composition comprising mixing: (A) at least one biologically active agent; (B) at least one compound of claim 1; and (C) optionally, a dosing vehicle. 15. The method of claim 13, wherein the animal is a human.

Details for Patent 7,951,971

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		2019-11-05
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2019-11-05
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2019-11-05
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2019-11-05
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2019-11-05
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2019-11-05
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2019-11-05