IP Library Granted Patent US 12,629,366
Granted Patent B2
US 12,629,366 · App. 18/498,553 · Granted May 19, 2026

Pharmaceutical compositions comprising sorbitan esters

Inventors: Jason M. Perry (Cambridge, MA); Daniel R. Deaver (Franklin, MA); Magali B. Hickey (Westwood, MA); Julius F. Remenar (Framingham, MA); Jennifer Vandiver (Arlington, MA)
Assignee: Alkermes Pharma Ireland Limited
A61K31/496A61K9/0019A61K9/10A61K31/4965A61K31/497A61K31/551A61K31/5513A61K47/26A61P25/00A61P25/18A61P25/24
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,629,366
App. No.
18/498,553
Granted
May 19, 2026
Kind
B2
Abstract

The present invention relates to a pharmaceutical composition comprising sorbitan esters of carboxylic acids that are useful for the delivery of anti-psychotic drugs.

Claims (16)

1 . A pharmaceutical composition comprising:

(a) compound A-7:

(b) about 0.1-2 weight percent sorbitan laurate;

(c) about 0.05-1 weight percent polysorbate 20; and

(d) an aqueous carrier,

wherein the composition forms an aqueous, flocculated, injectable suspension.

2 . The pharmaceutical composition of claim 1 , comprising about 15-35 weight percent compound A-7.

3 . The pharmaceutical composition of claim 1 , comprising about 20-30 weight percent compound A-7.

4 . The pharmaceutical composition of claim 1 , wherein the ratio of components (b) to (c) is 5:1 to 1:1, by weight.

5 . The pharmaceutical composition of claim 1 , wherein the ratio of components (b) to (c) is about 5:2, by weight.

6 . The pharmaceutical composition of claim 1 , wherein the composition comprises about 20 to about 900 mg of aripiprazole base equivalents.

7 . The pharmaceutical composition of claim 1 , wherein the composition comprises about 60 to about 800 mg of aripiprazole base equivalents.

8 . A method of treating schizophrenia in a subject in need thereof comprising administering to the subject an effective amount of the pharmaceutical composition of claim 1 .

9 . A method of treating schizophrenia in a subject in need thereof comprising administering to the subject an effective amount of the pharmaceutical composition of claim 5 .

10 . A method of treating schizophrenia in a subject in need thereof comprising administering to the subject an effective amount of the pharmaceutical composition of claim 6 .

11 . A method of treating schizophrenia in a subject in need thereof comprising administering to the subject an effective amount of the pharmaceutical composition of claim 7 .

Assignments (4)
SECURITY INTEREST Recorded Feb 13, 2026
From: ALKERMES PHARMA IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A. AS ADMINISTRATIVE AGENT
Reel/Frame 074858/0405 →
RELEASE OF SECURITY INTEREST IN PATENTS PREVIOUSLY RECORDED AT REEL/FRAME (073213/0302) Recorded Feb 13, 2026
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: ALKERMES PHARMA IRELAND LIMITED
Reel/Frame 074858/0429 →
SECURITY INTEREST Recorded Oct 23, 2025
From: ALKERMES PHARMA IRELAND LIMITED
To: JPMORGAN CHASE BANK, N.A. AS ADMINISTRATIVE AGENT
Reel/Frame 073213/0302 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 12, 2024
From: PERRY, JASON M.; DEAVER, DANIEL R.; HICKEY, MAGALI B.; REMENAR, JULIUS F.; VANDIVER, JENNIFER
To: ALKERMES PHARMA IRELAND LIMITED
Reel/Frame 066737/0731 →
Continuity (8)
Continuation 18183257 · Mar 14, 2023
Continuation 16248259 · Jan 15, 2019
Continuation 15388554 · Dec 22, 2016
Continuation 15154562 · May 13, 2016
Continuation 14688050 · Apr 16, 2015
Continuation 13423606 · Mar 19, 2012
Provisional Application 61454008 · Mar 18, 2011
Related Publication 20240131024A1 · Apr 25, 2024
References Cited (242)
US 2418499A · Burke · 1947 [cited by applicant]
US 3266984A · Kenzo et al. · 1966 [cited by applicant]
US 3523121A · Lewis et al. · 1970 [cited by applicant]
US 3573308A · Ning et al. · 1971 [cited by applicant]
US 3957808A · Miller et al. · 1976 [cited by applicant]
US 4160099A · Bodor · 1979 [cited by applicant]
US 4204065A · Bodor · 1980 [cited by applicant]
US 4260769A · Stella et al. · 1981 [cited by applicant]
US 4267326A · Ozaki et al. · 1981 [cited by applicant]
US 4428935A · Myers · 1984 [cited by applicant]
US 4443464A · Biedermann et al. · 1984 [cited by applicant]
US 4594190A · Giani et al. · 1986 [cited by applicant]
US 4694006A · Bundgaard et al. · 1987 [cited by applicant]
US 4727151A · Bodor · 1988 [cited by applicant]
US 4734416A · Banno et al. · 1988 [cited by applicant]
US 4760057A · Alexander · 1988 [cited by applicant]
US 4837337A · Murao et al. · 1989 [cited by applicant]
US 4914094A · Oshiro et al. · 1990 [cited by applicant]
US 4992550A · Hughes et al. · 1991 [cited by applicant]
US 5006528A · Oshiro et al. · 1991 [cited by applicant]
US 5206386A · Narayanan et al. · 1993 [cited by applicant]
US 5229382A · Chakrabarti et al. · 1993 [cited by applicant]
US 5236927A · Jones et al. · 1993 [cited by applicant]
US 5350747A · Howard · 1994 [cited by applicant]
US 5462934A · Goto et al. · 1995 [cited by applicant]
US 5532372A · Saji et al. · 1996 [cited by applicant]
US 5612346A · Mesens et al. · 1997 [cited by applicant]
US 5700946A · Shimasaki et al. · 1997 [cited by applicant]
US 5719303A · Yoshida et al. · 1998 [cited by applicant]
US 5783589A · Latimer et al. · 1998 [cited by applicant]
US 5945416A · Shannon et al. · 1999 [cited by applicant]
US 5985856A · Stella et al. · 1999 [cited by applicant]
US 6127357A · Cliffe et al. · 2000 [cited by applicant]
US 6133248A · Stella · 2000 [cited by applicant]
US 6169084B1 · Bunnell et al. · 2001 [cited by applicant]
US 6180095B1 · Greenwald et al. · 2001 [cited by applicant]
US 6608084B1 · Bourzat et al. · 2003 [cited by applicant]
US 6653312B1 · Auvin et al. · 2003 [cited by applicant]
US 6656932B2 · Picard et al. · 2003 [cited by applicant]
US 6977257B2 · Parab et al. · 2005 [cited by applicant]
US 7053092B2 · Jordan et al. · 2006 [cited by applicant]
US 7112603B2 · Moon et al. · 2006 [cited by applicant]
US 7115587B2 · Nerurkar et al. · 2006 [cited by applicant]
US 7160888B2 · Johnson et al. · 2007 [cited by applicant]
US 7374779B2 · Chen et al. · 2008 [cited by applicant]
US 7538121B2 · MacDonald et al. · 2009 [cited by applicant]
US 7550445B2 · Nerurkar et al. · 2009 [cited by applicant]
US 7807680B2 · Kostanski et al. · 2010 [cited by applicant]
US 7910577B2 · Liversidge et al. · 2011 [cited by applicant]
US 7981906B2 · Dull et al. · 2011 [cited by applicant]
US 8017515B2 · Marimuthu et al. · 2011 [cited by applicant]
US 8017615B2 · Bando et al. · 2011 [cited by applicant]
US 8030313B2 · Kostanski et al. · 2011 [cited by applicant]
US 8338427B2 · Brown · 2012 [cited by applicant]
US 8338428B2 · Brown · 2012 [cited by applicant]
US 8399469B2 · Bando et al. · 2013 [cited by applicant]
US 8431576B2 · Remenar et al. · 2013 [cited by applicant]
US 8518421B2 · Kothari et al. · 2013 [cited by applicant]
US 8536328B2 · Remenar et al. · 2013 [cited by applicant]
US 8580796B2 · Bando et al. · 2013 [cited by applicant]
US 8642600B2 · Jordan et al. · 2014 [cited by applicant]
US 8642760B2 · Bando et al. · 2014 [cited by applicant]
US 9034867B2 · Perry et al. · 2015 [cited by applicant]
US 9193685B2 · Perry et al. · 2015 [cited by applicant]
US 9452131B2 · Hickey et al. · 2016 [cited by applicant]
US 9993556B2 · Perry et al. · 2018 [cited by applicant]
US 9999670B2 · Perry et al. · 2018 [cited by applicant]
US 10004807B2 · Perry et al. · 2018 [cited by applicant]
US 10064859B2 · Morales, Jr. et al. · 2018 [cited by applicant]
US 10849894B2 · Cresswell et al. · 2020 [cited by applicant]
US 11273158B2 · von Moltke et al. · 2022 [cited by applicant]
US 20020146455A1 · Kundu et al. · 2002 [cited by applicant]
US 20020176841A1 · Barker et al. · 2002 [cited by applicant]
US 20030064998A1 · Francois et al. · 2003 [cited by applicant]
US 20030077297A1 · Chen et al. · 2003 [cited by applicant]
US 20040077594A1 · Nerurkar et al. · 2004 [cited by applicant]
US 20040101557A1 · Gibson et al. · 2004 [cited by applicant]
US 20050019436A1 · Burch et al. · 2005 [cited by applicant]
US 20050032811A1 · Brown · 2005 [cited by applicant]
US 20050079185A1 · Parisot et al. · 2005 [cited by applicant]
US 20050203089A1 · Starrett, Jr. et al. · 2005 [cited by applicant]
US 20050282821A1 · Lesur et al. · 2005 [cited by applicant]
US 20060040922A1 · Greco et al. · 2006 [cited by applicant]
US 20060142333A1 · MacDonald et al. · 2006 [cited by applicant]
US 20060154918A1 · Liversidge et al. · 2006 [cited by applicant]
US 20060194345A1 · Uchiyama et al. · 2006 [cited by applicant]
US 20060293217A1 · Barker et al. · 2006 [cited by applicant]
US 20070031513A1 · Kikuchi et al. · 2007 [cited by applicant]
US 20070148100A1 · Jenkins · 2007 [cited by applicant]
US 20070191611A1 · Rao et al. · 2007 [cited by applicant]
US 20080085888A1 · Breining et al. · 2008 [cited by applicant]
US 20080186971A1 · Carmichael et al. · 2008 [cited by applicant]
US 20080233053A1 · Gross et al. · 2008 [cited by applicant]
US 20080261954A1 · Maelicke · 2008 [cited by applicant]
US 20080312199A1 · Glinsky · 2008 [cited by applicant]
US 20080318905A1 · Muhammad et al. · 2008 [cited by applicant]
US 20090053329A1 · Peters et al. · 2009 [cited by applicant]
US 20090068290A1 · Bourin et al. · 2009 [cited by applicant]
US 20090118242A1 · Burch et al. · 2009 [cited by applicant]
US 20090143403A1 · Brown · 2009 [cited by applicant]
US 20090163519A1 · Vermeulen et al. · 2009 [cited by applicant]
US 20090163545A1 · Goldfarb · 2009 [cited by applicant]
US 20090169632A1 · Lu et al. · 2009 [cited by applicant]
US 20090311347A1 · Oronsky et al. · 2009 [cited by applicant]
US 20100197641A1 · Mazess et al. · 2010 [cited by applicant]
US 20100203129A1 · Andersen et al. · 2010 [cited by applicant]
US 20100286136A1 · Jones et al. · 2010 [cited by applicant]
US 20100292316A1 · Sanders et al. · 2010 [cited by applicant]
US 20100331356A1 · Legen et al. · 2010 [cited by applicant]
US 20110003828A1 · Blumberg et al. · 2011 [cited by applicant]
US 20110015156A1 · Remenar et al. · 2011 [cited by applicant]
US 20110105536A1 · Lewyn-Briscoe et al. · 2011 [cited by applicant]
US 20110166128A1 · Remenar et al. · 2011 [cited by applicant]
US 20110166156A1 · Blumberg et al. · 2011 [cited by applicant]
US 20110166194A1 · Blumberg et al. · 2011 [cited by applicant]
US 20110178068A1 · Almarsson et al. · 2011 [cited by applicant]
US 20110195095A1 · Liversidge et al. · 2011 [cited by applicant]
US 20110236478A1 · Dokou et al. · 2011 [cited by applicant]
US 20110275803A1 · Remenar et al. · 2011 [cited by applicant]
US 20110319422A1 · Blumberg et al. · 2011 [cited by applicant]
US 20120015866A1 · Blumberg et al. · 2012 [cited by applicant]
US 20130003046A1 · Izawa et al. · 2013 [cited by applicant]
US 20130096089A1 · Remenar et al. · 2013 [cited by applicant]
US 20160045495A1 · Cresswell et al. · 2016 [cited by applicant]
DE 1273533B · 1968 [cited by applicant]
EP 0925061B1 · 2005 [cited by applicant]
EP 1891956A1 · 2008 [cited by applicant]
GB 849541A1 · 1960 [cited by applicant]
GB 2017701A · 1979 [cited by applicant]
GB 2054371A · 1981 [cited by applicant]
JP S60002331A · 1985 [cited by applicant]
WO WO1990014080A1 · 1990 [cited by applicant]
WO WO1991000863A1 · 1991 [cited by applicant]
WO WO1993025197A1 · 1993 [cited by applicant]
WO WO1996012725A1 · 1996 [cited by applicant]
WO WO1997043284A1 · 1997 [cited by applicant]
WO WO1999033846A2 · 1999 [cited by applicant]
WO WO2002049573A2 · 2002 [cited by applicant]
WO WO2002096351A2 · 2002 [cited by applicant]
WO WO2004012671A2 · 2004 [cited by applicant]
WO WO2004026864A1 · 2004 [cited by applicant]
WO WO2004067546A1 · 2004 [cited by applicant]
WO WO2004089925A1 · 2004 [cited by applicant]
WO WO2005016262A2 · 2005 [cited by applicant]
WO WO2005066165A1 · 2005 [cited by applicant]
WO WO2005079807A1 · 2005 [cited by applicant]
WO WO2006037090A2 · 2006 [cited by applicant]
WO WO2006055603A2 · 2006 [cited by applicant]
WO WO2006090273A2 · 2006 [cited by applicant]
WO WO2007018943A2 · 2007 [cited by applicant]
WO WO2007052104A2 · 2007 [cited by applicant]
WO WO2007059111A2 · 2007 [cited by applicant]
WO WO2008025781A1 · 2008 [cited by applicant]
WO WO2008124030A1 · 2008 [cited by applicant]
WO WO2009052467A1 · 2009 [cited by applicant]
WO WO2009060473A2 · 2009 [cited by applicant]
WO WO2010135703A2 · 2010 [cited by applicant]
WO WO2010151689A1 · 2010 [cited by applicant]
WO WO2010151711A1 · 2010 [cited by applicant]
WO WO2011084846A1 · 2011 [cited by applicant]
WO WO2011084848A2 · 2011 [cited by applicant]
WO WO2012129156A1 · 2012 [cited by applicant]
WO WO2013142198A1 · 2013 [cited by applicant]
WO WO2013142202A1 · 2013 [cited by applicant]
WO WO2013142205A1 · 2013 [cited by applicant]
WO WO2014080285A2 · 2014 [cited by applicant]
WO WO2015143145A1 · 2015 [cited by applicant]
U.S. Appl. No. 13/423,606 / 2012-0238552 A1 / U.S. Pat. No. 9,034,867, filed Mar. 19, 2012 / Sep. 20, 2012 / May 19, 2015, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 14/714,621 / 2015-0258115 A1 / U.S. Pat. No. 9,351,976, filed May 18, 2015 / Sep. 17, 2015 / May 31, 2016, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 14/688,050 / 2016-0038508 A1, filed Apr. 16, 2015 / Feb. 11, 2016, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 15/154,562, filed May 13, 2016, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 15/388,554 / 2017-0196856 A1 / U.S. Pat. No. 10,226,458, filed Dec. 22, 2016 / Jul. 13, 2017 / Mar. 12, 2019, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 16/248,259 / 2019-0216805, filed Jan. 15, 2019 / Jul. 18, 2019, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 18/183,257 / 2024-0058327 A1, filed Mar. 14, 2023 / Feb. 22, 2024, Jason M. Perry. [cited by applicant]
*U.S. Appl. No. 18/498,553 / 2024-01317024 A1, filed Oct. 31, 2013 / Apr. 25, 2024, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 13/801,025 / 2013-0267503 A1 / U.S. Pat. No. 10,004,807, filed Mar. 13, 2013 / Oct. 10, 2013 / Jun. 26, 2018, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 13/801,167 / 2013-0267504 A1 / U.S. Pat. No. 9,993,556, filed Mar. 13, 2013 / Oct. 10, 2013 / Jun. 12, 2018, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 13/801,344 / 2013-0267504 A1 / U.S. Pat. No. 9,993,556, filed Mar. 13, 2013 / Oct. 10, 2013 / Jun. 12, 2018, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 14/031,842 / 2013-0267305 A1 / U.S. Pat. No. 9,999,670, filed Sep. 19, 2013 / Oct. 10, 2013 / Jun. 19, 2018, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 14/882,069 / 2016-0136279 A1 / U.S. Pat. No. 9,861,699, filed Oct. 13, 2015 / May 19, 2016 / Jan. 9, 2018, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 15/705,237 / 2018-0000944 A1 / U.S. Pat. No. 10,342,877, filed Sep. 14, 2017 / Jan. 4, 2018 / Jul. 9, 2019, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 16/425,150 / 2019-0275155 A1 / U.S. Pat. No. 10,639,376, filed May 29, 2019 / Sep. 12, 2019 / May 5, 2020, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 16/834,565 / 2020-0268891 A1 / U.S. Pat. No. 11,097,006, filed Mar. 30, 2020 / Aug. 27, 2020 / Aug. 24, 2021, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 17/398,801 / 2022-0072133 A1 / U.S. Pat. No. 11,969,469, filed Aug. 10, 2021 / Mar. 10, 2022 / Apr. 30, 2024, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 18/618,311, filed Mar. 27, 2024, Jason M. Perry. [cited by applicant]
U.S. Appl. No. 14/663,042 / 2015-0265529 A1 / U.S. Pat. No. 9,452,131, filed Mar. 19, 2015 / Sep. 24, 2015 / Sep. 27, 2016, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 15/164,473 / 2016-0263111 A1/ U.S. Pat. No. 9,526,726, filed May 25, 2016 / Sep. 15, 2016 / Dec. 27, 2016, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 15/349,243 / 2017-0157117 A1 / U.S. Pat. No. 10,085,980, filed Nov. 11, 2016 / Jun. 8, 2017 / Oct. 2, 2018, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 16/116,652 / 2018-0369239 A1 / U.S. Pat. No. 10,238,651, filed Aug. 29, 2018 / Dec. 27, 2018 / Mar. 26, 2019, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 16/271,248 / 2019-0167673 A1 / U.S. Pat. No. 10,813,928, filed Feb. 8, 2019 / Jun. 6, 2019 / Oct. 27, 2020, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 16/889,528 / 2020-0289504 A1 / U.S. Pat. No. 11,406,632, filed Jun. 1, 2020 / Sep. 17, 2020 / Aug. 9, 2022, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 17/809,745 / 2023-0026422 A1 / U.S. Pat. No. 11,931,355, filed Jun. 29, 2022 / Jan. 26, 2023 / Mar. 19, 2024, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 18/440,388, filed Feb. 13, 2024, Magali B. Hickey. [cited by applicant]
U.S. Appl. No. 14/833,638 / 2016-0051546 A1 / U.S. Pat. No. 10,064,859, filed Aug. 24, 2015 / Feb. 25, 2016 / Sep. 4, 2018, Wilfredo Morales. [cited by applicant]
U.S. Appl. No. 16/043,721 / 2019-0015408 A1 / U.S. Pat. No. 10,478,434, filed Jul. 24, 2018 / Jan. 17, 2019 / Nov. 19, 2019, Wilfredo Morales. [cited by applicant]
U.S. Appl. No. 16/595,608 / 2020-0108063 A1 / U.S. Pat. No. 10,973,816, filed Oct. 8, 2019 / Apr. 9, 2020 / Apr. 13, 2021, Wilfredo Morales. [cited by applicant]
U.S. Appl. No. 17/211,352 / 2021-0205302 A1 / U.S. Pat. No. 11,883,394, filed Mar. 24, 2021 / Jul. 8, 2021 / Jan. 30, 2024, Wilfredo Morales. [cited by applicant]
U.S. Appl. No. 18/543,767 / 2024-245676 A1, filed Dec. 18, 2023 / Jul. 25, 2024, Wilfredo Morales. [cited by applicant]
U.S. Appl. No. 16/291,768 / 2019-0298716 A1 / U.S. Pat. No. 11,273,158, filed Mar. 4, 2019 / Oct. 3, 2019 / Mar. 15, 2022, Lisa L. von Moltke. [cited by applicant]
U.S. Appl. No. 17/665,015 / 2022-0152021 A1, filed Feb. 4, 2022 / May 19, 2022, Lisa L. von Moltke. [cited by applicant]
U.S. Appl. No. 16/024,729 / 2018-0318293 A1 / U.S. Pat. No. 10,849,894, filed Jun. 29, 2018 / Nov. 8, 2018 / Dec. 1, 2020, Philip Cresswell. [cited by applicant]
U.S. Appl. No. 16/416,818 / 2019-0269676 A1 / U.S. Pat. No. 10,688,091, filed May 20, 2019 / Sep. 5, 2019 / Jun. 23, 2020, Philip Cresswell. [cited by applicant]
U.S. Appl. No. 16/904,246 / 2020-0316061 A1 / U.S. Pat. No. 11,154,552, filed Jun. 17, 2020 / Oct. 8, 2020 / Oct. 26, 2021, Philip Cresswell. [cited by applicant]
Akers et al., “Formulation Design and Development of Parenteral Suspensions”, [cited by applicant]
Aulton's Pharmaceutics, The Design and Manufacture of Medicines, Third Edition, Course Disperse Systems, pp. 90-91 and 386-388 (2007). [cited by applicant]
Belikov : O a pm a [General Chemistry: Pharmaceutical Chemistry], Part 1. Moscow, Russia, pp. 43-45—with English machine translation (1993). [cited by applicant]
Blakenship et al., “Aripiprazole for irritability associated with autistic disorder in children and adolescents aged 6-17 years”, [cited by applicant]
Chang et al., “Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist”, [cited by applicant]
Chueshov, “[Industrial technology of medicaments],” vol. 1. page 24 (2002)—with English machine translation. [cited by applicant]
Cocoman et al., “Intramuscular injections: a review of best practice for mental health nurses”, [cited by applicant]
Dai et al., “Parallel screening approach to identify solubility-enhancing formulations for improved bioavailability pf a poorly water-soluble compound using milligram quantities of material”, [cited by applicant]
FDA approves new injectable drug to treat schizophrenia, (Oct. 6, 2015) FDA news release. [cited by applicant]
Handbook of Pharmaceutical Excipients, Fifth Edition, Edited by Rowe et al. Extract for Sorbitan Esters, pp. 473-476 (2006). [cited by applicant]
Handbook of Pharmaceutical Excipients, Sixth Edition, Edited by Rowe et al. Extract for Sorbitan Esters, pp. 675-678 (2009). [cited by applicant]
Hard et al., “Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model”, [cited by applicant]
International Preliminary Report on Patentability corresponding to International Patent Application No. PCT/ US2012/029625, dated Sep. 24, 2013. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/IB2013/002995, mailed Jun. 18, 2014, 10 pages. [cited by applicant]
International Search Report corresponding to International Patent Application No. PCT/US2012/029625, dated Aug. 28, 2012. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2013/030916, dated Aug. 27, 2013, 18 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2013/030933, dated Jun. 26, 2013, 14 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2013/030945, dated Jun. 27, 2013, 17 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2013/060677, mailed Feb. 20, 2014, 6 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/US2015/021448, dated Jun. 19, 2015, 12 pages. [cited by applicant]
Lieberman et al.: Eds. Pharmaceutical Dosage Forms: Disperse Systems, Second Edition, vol. 2, pp. 18-22, 285-301 (1997). [cited by applicant]
Mackenzie, “Non-Equilibrium Freezing Behaviour of Aqueous Systems [and Discussion]”, [cited by applicant]
Marszall et al. “The effect of glycols on the hydrophile-lipophile balance and the micelle formation of nonionic surfactants”, [cited by applicant]
Notice of Opposition against corresponding EP Patent No. 2685979 dated May 24, 2017. [cited by applicant]
Park et al., “Preparation and evaluation of flurbiprofen-loaded microemulsion for parenteral delivery”, [cited by applicant]
Pearson Education, Inc. (1995) “Medication Administration Techniques: Injections”, [Last Accessed Oct. 30, 2015]. [cited by applicant]
Pharmaceutics: The Science of Dosage Form Design, Drug Delivery Systems, (1988) Edited by Aulton, Chapter 23: Suspensions and Emulsions, pp. 334-359. [cited by applicant]
Pharmaceutics: The Science of Dosage Form Design, Drug Delivery Systems, (1988) Edited by Aulton, pp. 272-274 and 278. [cited by applicant]
Porras et al., “Studies of formation of W/O nano-emulsions”, [cited by applicant]
Response from the Opposition Division in corresponding EP Patent No. 2685979 dated Mar. 16, 2018. [cited by applicant]
Shinde et al., “Microemulsions and Nanoemulsions for Targeted Drug Delivery to the Brain”, [cited by applicant]
Shintani et al., “A new method to determine the irritation of drugs after intramuscular injection in rabbits”, [cited by applicant]
Strickley et al., “Solubilizing Excipients in Oral and Injectable Formulations”, [cited by applicant]
Tang et al., “Design of freeze-drying processes for pharmaceuticals: practical advice”, [cited by applicant]
The Pharmaceutical Codex, Twelfth Edition, Edited by W. Lund. Suspensions, pp. 72-87 (1994). [cited by applicant]
The HLB System: a time-saving guide to emulsifier selection, Chapter 5, ICI Americas Inc. Wilmington, DE (1984). [cited by applicant]
Workman, “Safe injection techniques”, [cited by applicant]
World Health Organization, “Annex 9: Guide to good storage practices for pharmaceuticals”, [cited by applicant]
Written submission in preparation to/during Oral Proceedings from the Opponent in corresponding EP Patent No. 2685979 dated Sep. 14, 2018. [cited by applicant]