IP Library › Granted Patent US 12,472,190
Granted Patent B2
US 12,472,190 · App. 17/347,806 · Granted Nov 18, 2025

Pharmaceutical compositions

Inventors: Geena Malhotra (Maharashtra, IN); Shrinivas Madhukar Purandare (Maharashtra, IN); Amar Lulla (Maharashtra, IN)
Assignee: CIPLA Limited
A61K31/58A61K9/0075A61K9/008A61K31/137A61K31/138A61K31/167A61K31/46A61K31/4704A61K31/4709A61K45/06
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Quick Facts
Patent No.
US 12,472,190
App. No.
17/347,806
Granted
Nov 18, 2025
Kind
B2
Abstract

A pharmaceutical composition for inhalation comprising R (+) budesonide and one or more bronchodilators, and, optionally, one or more pharmaceutically acceptable excipients is described.

Claims (22)

1 . A pharmaceutical composition comprising R (+) budesonide and arformoterol tartrate, and, optionally, one or more pharmaceutically acceptable excipients, formulated for once daily administration; wherein a ratio of the R (+) budesonide to the arformoterol tartrate is about 33:1.

2 . A pharmaceutical composition according to claim 1 , wherein: the R (+) budesonide is provided in an amount ranging from 80 mcg to 640 mcg, and the arformoterol tartrate is provided in an amount ranging from about 2.4 mcg to about 20.4 mcg.

3 . A pharmaceutical composition according to claim 1 , comprising one or more anticholinergics.

4 . A pharmaceutical composition according to claim 1 , comprising one or more anticholinergics selected from tiotropium, ipratropium, oxitropium or combinations thereof.

5 . A pharmaceutical composition according to claim 1 , comprising tiotropium, wherein tiotropium is provided in an amount ranging from 9 mcg to 18 mcg.

6 . A pharmaceutical composition according to claim 1 , comprising oxitropium.

7 . A pharmaceutical composition according to claim 1 , comprising ipratropium.

8 . A pharmaceutical composition according to claim 1 , wherein the R (+) budesonide and the arformoterol tartrate, along with any excipients, are formulated in a single pharmaceutical composition.

9 . A pharmaceutical composition according to claim 4 , wherein the R (+) budesonide, the arformoterol tartrate, and the one or more anticholinergics, along with any excipients, are formulated in a single pharmaceutical composition.

10 . A pharmaceutical composition according to claim 1 , formulated as an inhalation composition.

11 . A pharmaceutical composition according to claim 1 , formulated for use in a metered dose inhaler, and comprising a propellant.

12 . A pharmaceutical composition according claim 1 , comprising an excipient selected from a cosolvent, an antioxidant, a surfactant, a bulking agent and a lubricant.

13 . A pharmaceutical composition according to claim 1 , formulated for use as a dry powder inhalation formulation.

14 . A pharmaceutical composition according to claim 1 , comprising at least one finely divided pharmaceutically acceptable carrier suitable for use in dry powder inhalation formulations.

15 . A combination composition according to claim 14 , wherein said carrier includes a saccharide and/or a sugar alcohol.

16 . A combination composition according to claim 1 , formulated for use as an inhalation solution.

17 . A combination composition according to claim 16 , comprising an excipient selected from a wetting agent, osmotic agent, a pH regulator, a buffering agent and a complexing agent, provided in a pharmaceutically acceptable vehicle.

18 . A pharmaceutical composition according to claim 1 , formulated for inhalation, for use as a nasal spray, for use as nasal drops, for use as an insufflation powder, or for use as a spray patch.

19 . A pharmaceutical composition comprising a fixed dose combination comprising R-(+)-budesonide and arformoterol tartrate, and, optionally, one or more pharmaceutically acceptable excipients, formulated in a metered multi-dose container, wherein the metered multi-dose container contains (quantity/container):

R (+) Budesonide 16 mg; and

arformoterol tartarate 0.48 mg;

wherein the fixed dose combination of the R-(+)-budesonide and arformoterol tartrate is formulated for administration once per day.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 22, 2025
From: MALHOTRA, GEENA; PURANDARE, SHRINIVAS MADHUKAR
To: CIPLA LIMITED
Reel/Frame 072643/0448 →
Priority Claims (3)
IN 2051/MUM/2010 · Jul 16, 2010 · national
IN 3156/MUM/2010 · Nov 18, 2010 · national
IN 3157/MUM/2010 · Nov 18, 2010 · national
Continuity (4)
Division 15645513 · Jul 10, 2017
Division 13962094 · Aug 8, 2013
Continuation 13810656
Related Publication 20210308150A1 · Oct 7, 2021
References Cited (82)
US 7348362B2 · Banerjee et al. · 2008 [cited by applicant]
US 7579335B2 · Biggadike et al. · 2009 [cited by applicant]
US 7892483B2 · Amar et al. · 2011 [cited by applicant]
US 7915451B2 · Rao et al. · 2011 [cited by applicant]
US 8088362B2 · Church et al. · 2012 [cited by applicant]
US 8313732B2 · Davies et al. · 2012 [cited by applicant]
US 8962601B2 · Lulla et al. · 2015 [cited by applicant]
US 9295644B2 · Ekström · 2016 [cited by applicant]
US 9402854B2 · Purandare et al. · 2016 [cited by applicant]
US 9446054B2 · Lulla et al. · 2016 [cited by applicant]
US 10179139B2 · Malhotra et al. · 2019 [cited by applicant]
US 10307432B2 · Malhotra et al. · 2019 [cited by applicant]
US 11077124B2 · Malhotra et al. · 2021 [cited by applicant]
US 20010049396A1 · Ekstrom · 2001 [cited by examiner]
US 20030190289A1 · Lewis et al. · 2003 [cited by applicant]
US 20050042174A1 · Nilsson et al. · 2005 [cited by applicant]
US 20070020190A1 · Razzetti et al. · 2007 [cited by applicant]
US 20070020298A1 · Pipkin et al. · 2007 [cited by applicant]
US 20070020299A1 · Pipkin et al. · 2007 [cited by applicant]
US 20080004247A1 · Lindmark et al. · 2008 [cited by applicant]
US 20090088408A1 · Meade et al. · 2009 [cited by applicant]
US 20090298802A1 · Sequeira et al. · 2009 [cited by applicant]
US 20130074834A1 · Lulla et al. · 2013 [cited by applicant]
AU 2011278096B2 · 2014 [cited by applicant]
CA 2445167 · 2003 [cited by examiner]
CA 2455167A1 · 2003 [cited by applicant]
CN 1753678A · 2006 [cited by applicant]
CN 1984653A · 2007 [cited by applicant]
CN 101249093A · 2008 [cited by applicant]
EP 1452178A · 2004 [cited by applicant]
EP 1553922A · 2005 [cited by applicant]
EP 2011534A · 2009 [cited by applicant]
JP 2002517450A · 2002 [cited by applicant]
JP 2004515454A · 2004 [cited by applicant]
JP 2005502608A · 2005 [cited by applicant]
JP 2005524664A · 2005 [cited by applicant]
JP 2005539046A · 2005 [cited by applicant]
JP 2008534611A · 2008 [cited by applicant]
JP 2010519195A · 2010 [cited by applicant]
WO 9964014A · 1999 [cited by applicant]
WO 0030608A1 · 2000 [cited by applicant]
WO 0053188A1 · 2000 [cited by applicant]
WO 0178737A1 · 2001 [cited by applicant]
WO 0178742A1 · 2001 [cited by applicant]
WO 0185174 · 2001 [cited by applicant]
WO 2003013547A1 · 2003 [cited by applicant]
WO 2003063841A1 · 2003 [cited by applicant]
WO 2003063842A1 · 2003 [cited by applicant]
WO 03074025A1 · 2003 [cited by applicant]
WO 2004028545A1 · 2004 [cited by applicant]
WO 2008102128A2 · 2008 [cited by applicant]
WO 201207729A3 · 2012 [cited by applicant]
King, “Role of arfomoterol in management of COPD” International Journal of Chronic Obstructive Pulmonary Disease, Sep. 2008; 3(3): 385-392. [cited by examiner]
Brovana, last updated on RxList Aug. 24, 2022. [cited by examiner]
Brovana, Prescribing Information, FDA, Feb. 2014. [cited by applicant]
Cazzola et al., “Arformoterol tartrate in the treatment of COPD”, Expert Reviews Ltd., (2010), pp. 155-162. [cited by applicant]
King, “Role of arformoterol in the management of COPD”, International Journal of Chronic Obstructive Pulmonary Disease, (2008), pp. 385-392. [cited by applicant]
Welte, “Optimising treatment for COPD—new strategies for combination therapy”, The International Journal of Clinical Practice, (2009), pp. 1136-1149. [cited by applicant]
Australian Patent Examination Report No. 1, Application No. 2011278096, dated Feb. 26, 2014. [cited by applicant]
Canadian Reasons for Rejection, Application No. 2,805,700, dated Jul. 27, 2021. [cited by applicant]
Chinese 1st Office Action, Application No. 201180039543.9, dated Jan. 21, 2014. [cited by applicant]
Chinese 2nd Office Action, Application No. 201180039543.9, dated Sep. 29, 2014. [cited by applicant]
Chinese Office Action, Application No. 201510665216.4, dated Aug. 1, 2017. [cited by applicant]
Chinese Decision of Rejection, Application No. CN 201180039543.9 dated 2015, English translation, pp. 1-4. [cited by applicant]
European Communication pursuant to Article 94(3) EPC, Application No. 11738260.6, dated Jun. 20, 2017. [cited by applicant]
The extended European Search Report, Application No. 21166612.8, dated Jul. 15, 2021. [cited by applicant]
Japanese Office Action, Application No. JP 2013-520199, dated Jun. 16, 2015. [cited by applicant]
Japanese Final Office Action, Application No. JP 2013-520199, dated May 24, 2016. [cited by applicant]
Japanese Final Office Action, Application No. JP 2016-185143, dated Apr. 3, 2018. [cited by applicant]
Korean Office Action, Application No. 1020137003819, dated Apr. 11, 2017. [cited by applicant]
Korean Decision of Rejection, Application No. KR 10-2013-7003819, dated Mar. 29, 2018. [cited by applicant]
Korean Re-Examination Decision of Rejection, Application No. KR 10-2013-7003819, dated Jul. 9, 2018. [cited by applicant]
Korean Official Action, Application No. KR 10-2018-7022543 dated Jan. 2, 2019. [cited by applicant]
New Zealand Examination Report, Application No. 605920 dated Sep. 4, 2013. [cited by applicant]
New Zealand Examination Report, Application No. 605920 dated Jul. 11, 2014. [cited by applicant]
New Zealand Examination Report, Application No. 605920 dated Nov. 10, 2014. [cited by applicant]
PCT Search Report and Written Opinion, Application No. PCT/GB2011/001077, dated Apr. 18, 2012. [cited by applicant]
Russian Office Action, Application No. 2013106866/15, dated Dec. 5, 2014. [cited by applicant]
Russian Office Action, Application No. 2013106866/15, dated Mar. 5, 2015. [cited by applicant]
Turkey Office Action, Application No. 2013/01662, dated Feb. 19, 2015. [cited by applicant]
Turkey Examination Report, Application No. 2013/01662, dated Jun. 15, 2015. [cited by applicant]
European Communication pursuant to Article 94(3), dated Jan. 29, 2025, Application No. 21166612.8. [cited by applicant]