throbber
111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008772306Bl
`
`(12) United States Patent
`Eller
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,772,306 Bl
`*Jul. 8,2014
`
`(54) METHOD OF ADMINISTRATION OF
`GAMMA HYDROXYBUTYRATE WITH
`MONOCARBOXYLATE TRANSPORTERS
`
`(71) Applicant: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`(72)
`
`Inventor: Mark Eller, Redwood City, CA (US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.c. 154(b) by 0 days.
`
`This patent is subject to a tenninal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/872,997
`
`(22)
`
`Filed:
`
`Apr. 29, 2013
`
`Related U.S. Application Data
`
`(63)
`
`(60)
`
`Continuation of application No. 13/837,714, filed on
`Mar. 15,2013.
`
`Provisional application No. 611771,557, filed on Mar.
`1,2013, provisional application No. 611777,873, filed
`on Mar. 12,2013.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K 31/505
`A61K 31/33
`A61K 31/55
`(52) U.S. Cl.
`USPC ....................... 5141275; 5141183; 514/214.03
`(58) Field of Classification Search
`USPC ..................................... 514/275,183,214.03
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,325,361 A
`3,385,886 A
`4,155,929 A
`4,393,236 A
`5,380,937 A
`5,758,095 A
`5,833,599 A
`5,845,255 A
`6,014,631 A
`6,067,524 A
`6,112,182 A
`6,204,245 Bl
`6,317,719 Bl
`6,356,873 Bl
`6,482,431 B2
`
`611967 Meunier
`511968 Nicholson et al.
`511979 Chignac et aI.
`711983 Klosa
`111995 Koehler et aI.
`511998 Albaum et al.
`1111998 Schrier et al.
`1211998 Mayaud
`112000 Teagarden et aI.
`5/2000 Byerly et al.
`8/2000 Akers et al.
`3/2001 Siegel et al.
`1112001 Schrier et al.
`3/2002 Teagarden et aI.
`1112002 Smith
`
`6,780,889 B2
`7,015,200 B2
`7,072,840 Bl
`7,262,219 B2
`7,572,605 B2
`7,668,730 B2
`7,765,106 B2
`7,765,107 B2
`7,797,171 B2
`7,851,506 B2
`7,895,059 B2
`8,263,650 B2
`8,324,275 B2
`2003/0171270 Al *
`2006/0018933 Al
`2008/0293698 Al *
`200910137565 Al
`201010112056 Al
`201010160299 Al
`201110237664 Al *
`201210076865 Al
`
`812004 Cook et aI.
`3/2006 Mamelak et al.
`7/2006 Mayaud
`8/2007 Cook et aI.
`8/2009 Mamelak et al.
`212010 Reardan et al.
`7/2010 Reardan et al.
`7/2010 Reardan et al.
`912010 Reardan et al.
`1212010 Cook et aI.
`212011 Reardan et al.
`912012 Cook et aI.
`1212012 Cook et aI.
`912003 Civelli et al.
`112006 Vaya et al.
`1112008 Johnson ........................ 514/220
`5/2009 Frucht
`512010 Rourke et al.
`6/2010 Baker, Jr. et aI.
`912011 Dalton et al.
`................. 514/522
`3/2012 Allphin et al.
`
`................... 514112
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`GB
`GB
`GB
`WO
`WO
`WO
`WO
`WO
`
`237309
`922029
`980279
`1 522450
`WO 2006/053186
`WO 20101053691
`WO 20111119839
`WO 20111139271
`WO 20121037457
`
`5/1985
`3/1963
`111965
`8/1978
`5/2006
`5/2010
`912011
`1112011
`3/2012
`
`OTHER PUBLICATIONS
`
`Arena et aI., "Absorption of Sodium y-Hydroxybutyrate and Its
`Prodrug y-Butyrolactone: Relationship between In Vitro Transport
`and In Vivo Absorption," J Pharmaceutical Sciences, 69(3): 356-
`358, 1980.
`Auler et aI., "Diclofenac Plasma Protein Binding: PK-PD Modelling
`in Cardiac Patients Submitted to Cardiopulmonary Bypass," Braz. J
`Med. Bio. Res., 30: 369-374, 1997.
`
`(Continued)
`
`Primary Examiner - Shirley V Gembeh
`Jones Day
`(74) Attorney, Agent, or Firm -
`
`(57)
`ABSTRACT
`One embodiment of the present invention is to improve the
`safety and efficacy of the administration of GHB or a salt
`thereof to a patient. It has been discovered that the concomi(cid:173)
`tant administration of an MCT inhibitor, such as diclofenac,
`valproate, or ibuprofen, will affect GHB administration. For
`example, it has been discovered that diclofenac lowers the
`effect of GHB in the body, thereby potentially causing an
`unsafe condition. Furthermore, it has been discovered that
`val pro ate increases the effect of GHB on the body, thereby
`potentially causing an unsafe condition.
`
`34 Claims, 10 Drawing Sheets
`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 1 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 2 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 3 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 4 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 5 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 6 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 7 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 8 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 9 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 10 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 11 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 12 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 13 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 14 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 15 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 16 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 17 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 18 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 19 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 20 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 21 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 22 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 23 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 24 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 25 of 26
`
`

`
`PAR1001
`IPR of U.S. Patent No. 8,772,306
`Page 26 of 26

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket