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Last Updated: December 12, 2025

Claims for Patent: 10,973,795

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Summary for Patent: 10,973,795

Title:	Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Abstract:	Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.
Inventor(s):	Claire Megret, Herve Guillard, Jean-Francois Dubuisson
Assignee:	Flamel Ireland Ltd
Application Number:	US16/419,616
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,973,795
Patent Claims:	1. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g or 6.0 g approximately two hours after a standardized evening meal as depicted in FIG. 12 for the corresponding dose. 2. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g approximately two hours after a standardized evening meal as depicted in FIG. 22. 3. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof, wherein the once-nightly formulation yields a dissolution profile as depicted in: FIG. 7 and FIG. 8; FIG. 20 and FIG. 21; FIG. 3; or FIG. 16. 4. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3, wherein the once-nightly formulation yields a dissolution profile as depicted in FIG. 7 and FIG. 8. 5. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3, wherein the once-nightly formulation yields a dissolution profile as depicted in FIG. 20 and FIG. 21. 6. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3, wherein the once-nightly formulation yields a dissolution profile as depicted in FIG. 3. 7. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3, wherein the once-nightly formulation yields a dissolution profile as depicted in FIG. 16. 8. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 3, wherein the once-nightly formulation yields a dissolution profile as depicted in any one of FIGS. 29 through 89. 9. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof, wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in: FIG. 25 and FIG. 26; FIG. 27 and FIG. 28; or FIG. 26 and FIG. 28. 10. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 9, wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in FIG. 25 and FIG. 26. 11. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 9, wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in FIG. 27 and FIG. 28. 12. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 1, wherein the once-nightly formulation yields a dissolution profile between the minimum and maximum values depicted in FIG. 26 and FIG. 28. 13. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g, 7.5 g or 9.0 g approximately two hours after a standardized evening meal as depicted in FIG. 90 for the corresponding dose. 14. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g, 6.0 g or 7.5 g approximately two hours after a standardized evening meal as depicted in FIG. 13 for the corresponding dose. 15. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g or 6.0 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in FIG. 12 for the corresponding dose. 16. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in FIG. 22. 17. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions for a human subject in need thereof, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in: FIG. 7 and FIG. 8; FIG. 20 and FIG. 21; FIG. 3; or FIG. 16. 18. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in FIG. 7 and FIG. 8. 19. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in FIG. 20 and FIG. 21. 20. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in FIG. 3. 21. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in FIG. 16. 22. The once-nightly modified release formulation of gamma-hydroxybutyrate of claim 17, wherein the once-nightly formulation yields a dissolution profile bioequivalent to the profile as depicted in any one of FIGS. 29 through 89. 23. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g, 7.5 g or 9.0 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in FIG. 90 for the corresponding dose. 24. A once-nightly modified release formulation of gamma-hydroxybutyrate comprising immediate release and modified release portions, wherein the once-nightly formulation yields a plasma concentration versus time curve when administered once-nightly in a human subject at a dose of 4.5 g, 6.0 g or 7.5 g approximately two hours after a standardized evening meal that is bioequivalent to the plasma concentration versus time curve depicted in FIG. 13 for the corresponding dose.

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