Case: 1:16-cv-00651 Document #: 178 Filed: 12/19/18 Page 1 of 5 PageID #:6162
` AO 120 (Rev. 08/10)
`
`TO:
`
`Mail Stop 8
`Director of the U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`REPORT ON THE
`FILING OR DETERMINATION OF AN
`ACTION REGARDING A PATENT OR
`TRADEMARK
`
`In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § 1116 you are hereby advised that a court action has been
`filed in the U.S. District Court
`on the following
`G Trademarks or G Patents. ( G the patent action involves 35 U.S.C. § 292.):
`DOCKET NO.
`DATE FILED
`U.S. DISTRICT COURT
`
`PLAINTIFF
`
`DEFENDANT
`
`PATENT OR
`TRADEMARK NO.
`
`DATE OF PATENT
`OR TRADEMARK
`
`HOLDER OF PATENT OR TRADEMARK
`
` 1
`
` 2
`
` 3
`
` 4
`
` 5
`
`DATE INCLUDED
`
`PATENT OR
`TRADEMARK NO.
`
`In the above—entitled case, the following patent(s)/ trademark(s) have been included:
`INCLUDED BY
`
`G Amendment
`DATE OF PATENT
`OR TRADEMARK
`
`G Other Pleading
`G Cross Bill
`G Answer
`HOLDER OF PATENT OR TRADEMARK
`
` 1
`
` 2
`
` 3
`
` 4
`
` 5
`
`In the above—entitled case, the following decision has been rendered or judgement issued:
`DECISION/JUDGEMENT
`
`CLERK
`
`(BY) DEPUTY CLERK
`
`DATE
`
`Copy 1—Upon initiation of action, mail this copy to Director Copy 3—Upon termination of action, mail this copy to Director
`Copy 2—Upon filing document adding patent(s), mail this copy to Director Copy 4—Case file copy
`
`

`

`Case: 1:16-cv-00651 Document #: 178 Filed: 12/19/18 Page 2 of 5 PageID #:6163
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US008242158B 1
`
`c12) United States Patent
`Roychowdhury et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,242,158 Bl
`Aug. 14, 2012
`
`(54) DEXMEDETOMIDINE PREMIX
`FORMULATION
`
`(75)
`
`Inventors: Priyanka Roychowdhury, San Rafael,
`CA (US); Robert A. Cedergren,
`Libertyville, IL (US)
`
`(73) Assignee: Hospira, Inc., Lake Forest, IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 13/343,672
`
`(22) Filed:
`
`Jan.4,2012
`
`(51)
`
`Int. Cl.
`A61K 311164
`(2006.01)
`(52) U.S. Cl. ........................................ 514/396; 514/816
`(58) Field of Classification Search ........................ None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`5,344,840 A
`9/1994 Maze et al.
`6,716,867 Bl
`412004 Aantaa et al.
`2010/0197694 Al
`8/2010 Horn
`2011/0152271 Al
`6/2011 Horn
`2011/0230534 Al
`912011 Miyawaki et al.
`
`FOREIGN PATENT DOCUMENTS
`WO WO 2010/031819
`3/2010
`
`OTHER PUBLICATIONS
`
`Precedex™
`Labeling:
`Draft
`HCL
`"Dexmedetomidine
`Dexmedetomidine Hydrochloride Injection," FDA approved label,
`dated Dec. 17, 1999, and available online Jul. 26, 2001, pp. 1-13.
`Downloaded from < http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038_Precedex_prntlbl.pdf> on Jan. 4, 2012.
`FDA Memorandum from Cynthia G. McCormick, M.D., Director,
`Divison on Anesthetics, Critical Care and Addiction Drug Products,
`dated Nov. 30, 1999, in connection with the Medical Reviews of the
`Precedes ( dexmedetomidine hydrochloride injection) Application
`No. 21-038 submitted to the FDA by Abbott Laboratories on Dec. 18,
`1998, and available on the FDA website Jul. 26, 2001. Downloaded
`on Mar. 7, 2012 from< http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038 Precedex.cfm>.
`
`James D Anderson
`Primary Examiner -
`Assistant Examiner - Gregg Polansky
`(74) Attorney, Agent, or Firm - Baker Botts LLP
`
`(57)
`
`ABSTRACT
`
`The presently disclosed subject matter relates to pharmaceu(cid:173)
`tical compositions comprising dexmedetomidine or a phar(cid:173)
`maceutically acceptable salt thereof wherein the composition
`is formulated as a liquid for parenteral administration to a
`subject, and wherein the composition is disposed within a
`sealed container as a premixture. The pharmaceutical com(cid:173)
`positions can be used, for example, in perioperative care of a
`patient or for sedation.
`
`4 Claims, No Drawings
`
`

`

`Case: 1:16-cv-00651 Document #: 178 Filed: 12/19/18 Page 3 of 5 PageID #:6164
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US008338470Bl
`
`c12) United States Patent
`Roychowdhury et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,338,470 Bl
`*Dec. 25, 2012
`
`(54) DEXMEDETOMIDINE PREMIX
`FORMULATION
`
`(75)
`
`Inventors: Priyanka Roychowdhury, San Rafael,
`CA (US); Robert A. Cedergren,
`Libertyville, IL (US)
`
`(73) Assignee: Hospira, Inc., Lake Forest, IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/541,524
`
`(22) Filed:
`
`Jul. 3, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 13/343,672, filed on
`Jan. 4, 2012, now Pat. No. 8,242,158.
`
`(51)
`
`Int. Cl.
`A61K 311164
`(2006.01)
`(52) U.S. Cl. ........................................ 514/396; 514/816
`(58) Field of Classification Search ........................ None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`5,344,840 A
`9/1994 Maze et al.
`5,716,988 A *
`211998 Ibrahim et al.
`6,716,867 Bl
`412004 Aantaa et al.
`6,806,291 Bl*
`10/2004 Sunkel et al.
`2010/0094219 Al
`412010 Kriesel et al.
`2010/0197694 Al
`8/2010 Horn
`2010/0305160 Al
`12/2010 Brummett
`2010/0326868 Al
`12/2010 McClain et al.
`2011/0152271 Al
`6/2011 Horn
`2011/0230534 Al
`912011 Miyawaki et al.
`2011/0269666 Al
`1112011 Quintin
`
`FOREIGN PATENT DOCUMENTS
`WO WO 2010/031819
`3/2010
`
`OTHER PUBLICATIONS
`
`Precedex® Package Insert, Document EN-2680, Hospira, Inc., Sep.
`2010, downloaded on Aug. 10, 2012 from "www.precedex.com/wp(cid:173)
`content/uploads/2010/ 11/Precedex_Pl.pdf', pp. 1-24. *
`Xylocaine® Package Insert, AstraZeneca LP, 2001 and 2007, down(cid:173)
`loaded on Aug. 10, 2012 from "www.pdr3d.com/print.php?c~4818",
`pp. 1-30.*
`Venn et al., British Journal of Anaesthesia, 2002, vol. 88(5), pp.
`669-675.*
`Unger et al., Biomaterials, vol. 22, 2001, pp. 2031-2037.*
`U.S. Appl. No. 13/343,672, filed Jan. 4, 2012.
`
`U.S. Appl. No. 13/343,672, Apr. 18, 2012 Notice of Allowance.
`U.S. Appl. No. 13/343,672, Apr. 18, 2012 Examiner Initiated Inter(cid:173)
`view Summary.
`U.S. Appl. No. 13/343,672, Mar. 13, 2012 Response to Office Action
`and Statement of the Substance of the Interview.
`U.S. Appl. No. 13/343,672, Mar. 6, 2012 Applicant Initiated Inter(cid:173)
`view Summary.
`U.S. Appl. No. 13/343,672, Feb. 13, 2012 Non-Final Rejection.
`U.S. Appl. No. 13/343,672, Jan. 31, 2012 Decision on Petition to
`Make Special for New Application Under 37 C.F.R. § 1.102 & M.P.
`E.P. § 708.02.
`FDA Memorandum from Cynthia G. McCoirnick, M.D., Director,
`Division of Anesthetics, Critical Care and Addiction Drug Products,
`dated Nov. 30, 1999, in connection with the Medical Reviews of the
`Precedex (dexmedetomidine hydrochloride injection) Application
`No. 21-038 submitted to the FDA by Abbott Laboratories on Dec. 18,
`1998, and available on the FDA website Jul. 26, 2001. Downloaded
`on Mar. 7, 2012 from <http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038 Precedex.cfm>.
`Precedex™
`Labeling:
`"Dexmedetomidine
`HCL
`Draft
`Dexmedetomidine Hydrochloride Injection," FDA approved label,
`dated Dec. 17, 1999, and available online Jul. 26, 2001, pp. 1-13.
`Downloaded
`from <http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038_Precedex_prntlbl.pdf> on Jan. 4, 2012.
`Short, "Use of dexmedetomidine for primary sedation in a general
`intensive care unit." Critical Care Nurse (online), Epub Oct. 29, 2009
`[Retrieved on Aug. 13, 2012], vol. 30, No. 1, pp. 29-38, Feb. 2010,
`Retrieved from the internet: <URL:http://ccn.aacnjournals.org/con(cid:173)
`tent/30/ 1/29>.
`International Search Report and Written Opinion in International
`Application No. PCT/US2012/042940, mailed Aug. 24, 2012.
`in Pharmaceutical Primary Packaging for
`Petersen, "Trends
`Injectables-Solutions for New Challenges," Drug Development and
`Delivery, Issue Date: Sep. 2012, Posted on: Sep. 5, 2012. Down(cid:173)
`loaded on Sep. 14, 2012 from< http://http://www.drug-dev.com/
`ME2/dirmod.
`asp?sid~4306B 1 E9C3CC4 E07 A4 D64E23 FBDB23 2C
`&nm~ Back+ Issues&type~ Publishing
`&mod~ Publications%3 A %3 AArticle
`&mid~8F3A 702742l841978F18BE895F87F79 l&tieF4
`&id~C2347A2CEAE1422DAA7E592E47648D77 >.
`* cited by examiner
`
`Jeffrey S. Lundgren
`Primary Examiner -
`Assistant Examiner - Gregg Polansky
`(74) Attorney, Agent, or Firm - Baker Botts LLP
`
`ABSTRACT
`(57)
`The presently disclosed subject matter relates to pharmaceu(cid:173)
`tical compositions comprising dexmedetomidine or a phar(cid:173)
`maceutically acceptable salt thereof wherein the composition
`is formulated as a liquid for parenteral administration to a
`subject, and wherein the composition is disposed within a
`sealed container as a premixture. The pharmaceutical com(cid:173)
`positions can be used, for example, in perioperative care of a
`patient or for sedation.
`
`7 Claims, No Drawings
`
`

`

`Case: 1:16-cv-00651 Document #: 178 Filed: 12/19/18 Page 4 of 5 PageID #:6165
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US008455527B 1
`
`c12) United States Patent
`Roychowdhury et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,455,527 Bl
`*Jun. 4, 2013
`
`(54) METHODS OF TREATMENT USING A
`DEXMEDETOMIDINE PREMIX
`FORMULATION
`
`(71) Applicant: Hospira, Inc., Lake Forest, IL (US)
`
`(72)
`
`Inventors: Priyanka Roychowdhury, Foster City,
`CA (US); Robert A. Cedergren,
`Libertyville, IL (US)
`
`(73) Assignee: Hospira, Inc., Lake Forest, IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/678,148
`
`(22) Filed:
`
`Nov. 15, 2012
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 13/541,524, filed on
`Jul. 3, 2012, now Pat. No. 8,338,470, which is a
`continuation of application No. 13/343,672, filed on
`Jan. 4, 2012, now Pat. No. 8,242,158.
`
`U.S. Appl. No. 13/343,672, Jan. 31, 2012 Decision on Petition to
`Make Special for New Application Under 37 C.F.R. § 1.102 & M.P.
`E.P. § 708.02.
`U.S. Appl. No. 13/541,524, Oct. 22, 2012 Notice of Allowance.
`U.S. Appl. No.13/541,524, Sep.17, 2012 Response to Office Action.
`U.S. Appl. No. 13/541,524, Aug. 17, 2012 Non-Final Rejection.
`U.S. Appl. No. 13/541,524, Jul. 30, 2012 Decision on Petition to
`Make Special for New Application Under 37 C.F.R. § 1.102 & M.P.
`E.P. § 708.02.
`FDA Memorandum from Cynthia G. McCormick, M.D., Director,
`Division of Anesthetics, Critical Care and Addiction Drug Products,
`dated Nov. 30, 1999, in connection with the Medical Reviews of the
`Precedex (dexmedetomidine hydrochloride injection) Application
`No. 21-038 submitted to the FDA by Abbott Laboratories on Dec. 18,
`1998, and available on the FDA website Jul. 26, 2001. Downloaded
`on Mar. 7, 2012 from <http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038 Precedex.cfm>.
`Petersen, "Trends
`in Pharmaceutical Primary Packaging for
`Injectables-Solutions for New Challenges," Drug Development and
`Delivery, Issue Date: Sep. 2012, Posted on Sep. 5, 2012. Downloaded
`on Sep. 14, 2012 from < http:// http://www.drug-dev.com/ME2/
`dirmod.asp?sid~4306BlE9C3CC4E07 A4D64E23FBDB232C&
`nm~ Back+ Issues&type~ Publishing&mod~ Publications%3 A %3A
`Article&mid~8F3A7027421841978Fl8BE895F87F79l&tieF4&
`id~C2347A2CEAE1422DAA7E592E47648D77 >.
`Short, "Use of dexmedetomidine for primary sedation in a general
`intensive care unit." Critical Care Nurse (online), Epub Oct. 29, 2009
`[Retrieved on Aug. 13, 2012], vol. 30, No. 1, pp. 29-38, Feb. 2010,
`Retrieved from the internet: <URL:http://ccn.aacnjournals.org/con(cid:173)
`tent/30/ 1/29>.
`International Search Report and Written Opinion in International
`Application No. PCT/US2012/042940, mailed Aug. 24, 2012.
`Unger et al., "Adsorption of xenobiotics to plastic tubing incorpo(cid:173)
`rated into dynamic in vitro systems used in pharmacological
`research-limits and progress." Biomaterials, vol. 22, 2001, pp. 2031-
`2037.
`Precedex® Package Insert, Document EN-2680, Hospira, Inc., Sep.
`2010, downloaded on Aug. 10, 2012 from <URL:http://www.
`precedex.corn/wp-content/uploads/2010/ 11/Precedex_PI.pdf>, pp.
`1-24.
`X ylocaine® Package Insert, AstraZeneca LP, 2001 and 2007, down(cid:173)
`loaded on Aug. 10, 2012 from <URL:http://www.pdr3d.com/print.
`php?c~4818>, pp. 1-30.
`Venn et al., "Pharmacokinetics of dexmedetomidine infusions for
`sedation of postoperative patients requiring intensive care." British
`Journal of Anaesthesia, 2002, vol. 88(5), pp. 669-675.
`Precedex™
`"Dexmedetomidine
`HCL
`Draft
`Labeling:
`Dexmedetomidine Hydrochloride Injection," FDA approved label,
`dated Dec. 17, 1999, and available online Jul. 26, 2001, pp. 1-13,
`Downloaded
`from <http://www.aceessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038_Precedex_prntlbl.pdf> on Jan. 4, 2012.
`
`Jeffrey S. Lundgren
`Primary Examiner -
`Assistant Examiner - Gregg Polansky
`(74) Attorney, Agent, or Firm - Baker Botts, L.L.P.
`
`ABSTRACT
`(57)
`The presently disclosed subject matter relates to pharmaceu(cid:173)
`tical compositions comprising dexmedetomidine or a phar(cid:173)
`maceutically acceptable salt thereof wherein the composition
`is formulated as a liquid for parenteral administration to a
`subject, and wherein the composition is disposed within a
`sealed container as a premixture. The pharmaceutical com(cid:173)
`positions can be used, for example, in perioperative care of a
`patient or for sedation.
`
`15 Claims, No Drawings
`
`(2006.01)
`
`(51)
`
`(52)
`
`Int. Cl.
`A61K 311164
`U.S. Cl.
`USPC ........................................... 514/396; 514/816
`(58) Field of Classification Search
`None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`4,910,214 A
`3/ 1990 Karjalainen et al.
`5,344,840 A
`9/1994 Maze et al.
`5,716,988 A
`211998 Ibrahim et al.
`6,716,867 Bl
`412004 Aantaa et al.
`6,806,291 Bl
`10/2004 Sunkel et al.
`2010/0094219 Al
`412010 Kriesel et al.
`2010/0197694 Al
`8/2010 Horn
`2010/0305160 Al
`12/2010 Brummett
`2010/0326868 Al
`12/2010 McClain et al.
`2011/0152271 Al
`6/2011 Horn
`2011/0230534 Al
`912011 Miyawaki et al.
`2011/0269666 Al
`1112011 Quintin
`
`FOREIGN PATENT DOCUMENTS
`WO WO 2010/031819
`3/2010
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 13/343,672, filed Jan. 4, 2012.
`U.S. Appl. No. 13/541,524, filed Jul. 3, 2012.
`U.S. Appl. No. 13/343,672, Apr. 18, 2012 Notice of Allowance.
`U.S. Appl. No. 13/343,672, Apr. 18, 2012 Examiner Initiated Inter(cid:173)
`view Summary.
`U.S. Appl. No. 13/343,672, Mar. 13, 2012 Response to Office Action
`and Statement of the Substance of the Interview.
`U.S. Appl. No. 13/343,672, Mar. 6, 2012 Applicant Initiated Inter(cid:173)
`view Summary.
`U.S. Appl. No. 13/343,672, Feb. 13, 2012 Non-Final Rejection.
`
`

`

`Case: 1:16-cv-00651 Document #: 178 Filed: 12/19/18 Page 5 of 5 PageID #:6166
`I lllll llllllll Ill lllll lllll lllll lllll lllll 111111111111111111111111111111111
`US008648106B2
`
`c12) United States Patent
`Roychowdhury et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,648,106 B2
`*Feb.11,2014
`
`(54) DEXMEDETOMIDINE PREMIX
`FORMULATION
`
`(71) Applicant: Hospira, Inc., Lake Forest, IL (US)
`
`(72)
`
`Inventors: Priyanka Roychowdhury, Foster City,
`CA (US); Robert A. Cedergren,
`Libertyville, IL (US)
`
`(73) Assignee: Hospira, Inc., Lake Forest, IL (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/867,861
`
`(22) Filed:
`
`Apr. 22, 2013
`
`(65)
`
`Prior Publication Data
`
`US 2013/0237576 Al
`
`Sep. 12, 2013
`
`(63)
`
`(51)
`
`(52)
`
`(58)
`
`(56)
`
`Related U.S. Application Data
`
`Continuation of application No. 13/678,260, filed on
`Nov. 15, 2012, now Pat. No. 8,436,033, which is a
`continuation of application No. 13/541,524, filed on
`Jul. 3, 2012, now Pat. No. 8,338,470, which is a
`continuation of application No. 13/343,672, filed on
`Jan. 4, 2012, now Pat. No. 8,242,158.
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K 311164
`C07D 233156
`U.S. Cl.
`USPC ......................... 514/396; 514/816; 548/346.1
`Field of Classification Search
`None
`See application file for complete search history.
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,910,214 A
`5,344,840 A
`5,716,988 A
`6,716,867 Bl
`6,806,291 Bl
`8,242,158 Bl
`8,338,470 Bl
`8,436,033 Bl
`8,455,527 Bl
`2010/0094219 Al
`2010/0197694 Al
`2010/0305160 Al
`2010/0326868 Al
`2011/0152271 Al
`2011/0230534 Al
`2011/0269666 Al
`
`3/ 1990 Karjalainen et al.
`9/1994 Maze et al.
`211998 Ibrahim et al.
`412004 Aantaa et al.
`10/2004 Sunkel et al.
`8/2012 Roychowdhury et al.
`12/2012 Roychowdhury et al.
`512013 Roychowdhury et al.
`612013 Roychowdhury et al.
`412010 Kriesel et al.
`8/2010 Horn
`12/2010 Brummett
`12/2010 McClain et al.
`6/2011 Horn
`912011 Miyawaki et al.
`1112011 Quintin
`
`FOREIGN PATENT DOCUMENTS
`
`OTHER PUBLICATIONS
`U.S. Appl. No. 13/343,672, filed Jan. 4, 2012.
`U.S. Appl. No. 13/541,524, filed Jul. 3, 2012.
`U.S. Appl. No. 13/678,148, filed Nov. 15, 2012.
`U.S. Appl. No. 13/678,260, filed Nov. 15, 2012.
`U.S. Appl. No. 13/343,672, Jul. 18, 2012 Issue Fee payment.
`U.S. Appl. No. 13/343,672, Apr. 18, 2012 Notice of Allowance.
`U.S. Appl. No. 13/343,672, Mar. 13, 2012 Response to Non-Final
`Office Action (Accelerated Exam).
`U.S. Appl. No. 13/343,672, Feb. 13, 2012 Non-Final Office Action.
`U.S. Appl. No. 13/541,524, Nov. 20, 2012 Issue Fee payment.
`U.S. Appl. No. 13/541,524, Oct. 22, 2012 Notice of Allowance.
`U.S. Appl. No. 13/541,524, Sep. 17, 2012 Response to Non-Final
`Office Action and Terminal Disclaimer filed.
`U.S. Appl. No. 13/541,524, Aug. 17, 2012 Non-Final Office Action.
`U.S. Appl. No. 13/678, 148, May 9, 2013 Issue Fee payment.
`U.S. Appl. No. 13/678,148, Jan. 11, 2013 Notice of Allowance.
`U.S. Appl. No. 13/678260, Apr. 8, 2013 Issue Fee payment.
`U.S. Appl. No. 13/678,260, Jan. 8, 2013 Notice of Allowance
`"Dexmedetomidine
`HCL
`Draft
`Labeling:
`Precedex™
`Dexmedetomidine Hydrochloride Injection," FDA approved label,
`dated Dec. 17, 1999, and available online Jul. 26, 2001, pp. 1-13.
`Downloaded
`from <http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038 _Precedex_prntlbl.pdf> on Jan. 4, 2012.
`FDA Memorandum from Cynthia G. McCormick, M.D., Director,
`Division of Anesthetics, Critical Care and Addiction Drug Products,
`dated Nov. 30, 1999, in connection with the Medical Reviews of the
`Precedex (dexmedetomidine hydrochloride injection) Application
`No. 21-038 submitted to the FDA by Abbott Laboratories on Dec. 18,
`1998, and available on the FDA website Jul. 26, 2001. Downloaded
`on Mar. 7, 2012 from <http://www.accessdata.fda.gov/drugsatfda_
`docs/nda/99/21-038 Precedex.dfm>.
`Petersen, "Trends
`in Pharmaceutical Primary Packaging for
`Injectables-Solutions for New Challenges," Drug Development and
`Delivery, Issue Date: Sep. 2012, Posted on: Sep. 5, 2012. Down(cid:173)
`loaded on Sep. 14, 2012 from< http://www.drug-dev.com/ME2/
`dirmod.asp?mod~Publications%3A %3AArticle
`&mid~8F3A 702742l841978F18BE895F87F87F79 l&tier~
`&id~C2347A2CEAE1422DAA7E592E47648D77 >.
`Precedex® Package Insert, Document EN-2680, Hospira, Inc., Sep.
`2010, downloaded on Aug. 10, 2012 from <URL:http://www.
`precedex.corn/wp-content/uploads/2010/ 11/Precedex_PI.pdf>, pp.
`1-24.
`
`(Continued)
`
`Primary Examiner - Savitha Rao
`Assistant Examiner - Gregg Polansky
`(74) Attorney, Agent, or Firm - Baker Botts LLP
`
`(57)
`
`ABSTRACT
`
`The presently disclosed subject matter relates to pharmaceu(cid:173)
`tical compositions comprising dexmedetomidine or a phar(cid:173)
`maceutically acceptable salt thereof wherein the composition
`is formulated as a liquid for parenteral administration to a
`subject, and wherein the composition is disposed within a
`sealed container as a premixture. The pharmaceutical com(cid:173)
`positions can be used, for example, in perioperative care of a
`patient or for sedation.
`
`WO WO 2010/031819
`
`3/2010
`
`9 Claims, No Drawings
`
`