Claims for Patent: 10,016,407

Summary for Patent: 10,016,407

Title:	Pharmaceutical compositions and methods of using the same
Abstract:	Novel pharmaceutical compositions including cocaine hydrochloride and methods of treating patients using those pharmaceutical compositions are described.
Inventor(s):	Moshal; Jeffrey M. (Allentown, PA), Libman; Michael (Allentown, PA)
Assignee:	GENUS LIFESCIENCES INC. (Allentown, PA)
Application Number:	15/849,575
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,016,407
Patent Claims:	1. A method of administering a local anesthetic prior to performing a diagnostic or surgical procedure on a subject with hepatic or renal impairment comprising: soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising: about 3.6% to about 4.4% cocaine hydrochloride; about 0.07% to about 0.20% sodium benzoate; an acidulant; optionally, at least one coloring additive; and water, contacting each pledget on a nasal mucous membrane of the subject for up to 20 minutes, and removing each pledget. 2. The method of claim 1, wherein the subject has hepatic impairment. 3. The method of claim 2, wherein the hepatic impairment leads to increased systemic exposure of the cocaine hydrochloride. 4. The method of claim 2, wherein the subject has a Child-Pugh Grade of Grade B. 5. The method of claim 2, wherein the subject has a Child-Pugh Grade of Grade C. 6. The method of claim 1, wherein the subject has renal impairment. 7. The method of claim 6, wherein the renal impairment leads to increased systemic exposure of the cocaine hydrochloride. 8. The method of claim 6, wherein the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 15 mL/min/1.73 m.sup.2 to about 29 mL/min/1.73 m.sup.2. 9. The method of claim 1, wherein, the procedure is a nasal endoscopy. 10. The method of claim 1, wherein the acidulant is citric acid. 11. A method of administering a local anesthetic prior to performing a diagnostic or surgical procedure on a subject with hepatic or renal impairment comprising: soaking one or more pledgets in about 4 mL of a ready-to-use composition comprising: about 3.6% to about 4.4% cocaine hydrochloride; a preservative; about 0.01% to about 1.0% citric acid; optionally, at least one coloring additive; and water, contacting each pledget on a nasal mucous membrane of the subject for up to 20 minutes, and removing each pledget. 12. The method of claim 11, wherein the subject has hepatic impairment. 13. The method of claim 11, wherein the hepatic impairment leads to increased systemic exposure of the cocaine hydrochloride. 14. The method of claim 12, wherein the subject has a Child-Pugh Grade of Grade B. 15. The method of claim 12, wherein the subject has a Child-Pugh Grade of Grade C. 16. The method of claim 11, wherein the subject has renal impairment. 17. The method of claim 11, wherein the renal impairment leads to increased systemic exposure of the cocaine hydrochloride. 18. The method of claim 16, wherein, the renally impaired subject has an estimated glomerular filtration rate (eGFR) of about 15 mL/min/1.73 m.sup.2 to about 29 mL/min/1.73 m.sup.2. 19. The method of claim 11, wherein, the procedure is a nasal endoscopy. 20. The method of claim 11, wherein the preservative is sodium benzoate.