US 7,919,499 C1 (13,056th)
Naltrexone long acting formulations and methods of use
Elliot Ehrich, Lincoln, MA (US)
Filed by Elliot Ehrich, Lincoln, MA (US)
Assigned to ALKERMES PHARMA IRELAND LIMITED, Dublin (IE)
Reexamination Request No. 90/019,779, Dec. 16, 2024.
Reexamination Certificate for Patent 7,919,499, issued Apr. 5, 2011, Appl. No. 11/083,167, Mar. 17, 2005.
Claims priority of provisional application 60/564,542, filed on Apr. 22, 2004.
Ex Parte Reexamination Certificate issued on Oct. 16, 2025.
Int. Cl. A61K 47/34 (2017.01); A61K 9/00 (2006.01); A61K 31/485 (2006.01); A61P 25/32 (2006.01); A61K 9/16 (2006.01)
CPC A61K 47/34 (2013.01) [A61K 9/0019 (2013.01); A61K 31/485 (2013.01); A61P 25/32 (2018.01); A61K 9/1641 (2013.01)]
AS A RESULT OF REEXAMINATION, IT HAS BEEN DETERMINED THAT:
The patentability of claims 1-13 is confirmed.
New claims 16-24 are added and determined to be patentable.
Claims 14-15 were not reexamined.
1. A method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising about 310 mg to about 480 mg of naltrexone and a biocompatible polymer to the individual wherein the serum AUC of naltrexone is about three times greater than that achieved by 50 mg/day oral administration and wherein the biocompatible polymer is a polylactide-co-glycolide polymer.
[ 16. A method for treating a patient in need of naltrexone, comprising:
parenterally administering a single intramuscular injection of a long-acting formulation comprising about 380 mg of naltrexone and a biocompatible polylactide-co-glycolide polymer to treat the patient,
wherein the serum AUC of naltrexone is about 3.3 times greater than that achieved by 50 mg/day oral administration of naltrexone as determined through a single comparative pharmacokinetic study.]
[ 17. The method of claim 16, wherein the single intramuscular injection is administered about every four weeks for a period of at least about 24 weeks.]
[ 18. The method of claim 17, wherein the single intramuscular injection is administered to the gluteus maximus of the patient in need of naltrexone.]
[ 19. The method of claim 18, wherein administering the single intramuscular injection about every four weeks for the period of at least about 24 weeks comprises alternating each single intramuscular injection between the left and right gluteus maximus of the patient in need of naltrexone.]
[ 20. The method of claim 19, wherein the volume of the single intramuscular injection is about 4 mL.]
[ 21. The method of claim 20, wherein the single intramuscular injection comprises microspheres comprising the naltrexone and the polylactide-co-glycolide polymer, and wherein the naltrexone is present in the microspheres at a concentration of about 35% by weight.]
[ 22. The method of claim 21, wherein the polylactide-co-glycolide polymer has a molecular weight of at least about 100,000 daltons.]
[ 23. The method of claim 22, wherein the polylactide-co-glycolide polymer is a 75:25 DL PLGA (poly(lactide)-co-glycolide) polymer.]
[ 24. The method of claim 23, wherein the patient in need of naltrexone is a patient afflicted by alcohol dependency.]