IP Library Granted Patent US 11,400,101
Granted Patent B2
US 11,400,101 · App. 17/003,584 · Granted Aug 2, 2022

Treatment of allergic rhinitis using a combination of mometasone and olopatadine

Inventors: Neelima Khairatkar-Joshi (Thane, IN); Abhay Kulkarni (Navi Mumbai, IN); Dinesh Pradeep Wale (Maharashtra, IN); Vikram M. Bhosale (Mumbai, IN); Piyush Agarwal (Mumbai, IN); Patrick Keohane (London, GB); Sudeesh K. Tantry (Jamison, PA); Chad Oh (San Francisco, CA)
Assignee: GLENMARK SPECIALTY S.A.
A61K31/58A61K9/0043A61K31/335A61K31/573A61P11/02A61P27/14A61P37/08A61M11/007A61M15/08
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Quick Facts
Patent No.
US 11,400,101
App. No.
17/003,584
Granted
Aug 2, 2022
Kind
B2
Abstract

The present invention relates to a method of treating allergic rhinitis in a subject (e.g., a pediatric human subject) in need thereof comprising nasally administering to the subject an effective amount of a fixed-dose pharmaceutical composition comprising mometasone or its salt and olopatadine or its salt.

Claims (33)

1. A method of treating one or more symptoms associated with allergic rhinitis in a human subject in need thereof comprising nasally administering twice daily, two sprays per nostril of a fixed-dose pharmaceutical composition comprising mometasone furoate and olopatadine hydrochloride, wherein (i) each spray comprises about 25 mcg of mometasone furoate and about 665 mcg olopatadine hydrochloride, and (ii) the administration provides relief from one or more symptoms associated with allergic rhinitis faster than nasal administration of the 50 mcg mometasone furoate or 1330 mcg olopatadine hydrochloride alone.

2. The method of claim 1 , wherein the symptoms are selected from nasal symptoms.

3. The method of claim 2 , wherein the nasal symptoms are selected from nasal congestion, rhinorrhea, itching and sneezing.

4. The method of claim 1 , wherein the human subject is 2 to under 12 years of age.

5. The method of claim 1 , wherein the human subject is 2 to under 6 years of age.

6. The method of claim 1 , wherein the human subject is 6 to under 12 years of age.

7. The method of claim 1 , wherein the allergic rhinitis is selected from seasonal allergic rhinitis, perennial allergic rhinitis, and persistent allergic rhinitis.

8. The method of claim 7 , wherein the allergic rhinitis is seasonal allergic rhinitis.

9. The method of claim 7 , wherein the allergic rhinitis is perennial allergic rhinitis.

10. The method of claim 1 , wherein the administration of the pharmaceutical composition provides relief from one or more symptoms of allergic rhinitis within 15 minutes of administration.

11. The method of claim 1 , wherein the administration of the pharmaceutical composition provides relief from one or more symptoms of allergic rhinitis within 10 minutes of administration.

12. A method of treating a human subject suffering from allergic rhinitis comprising the steps of:

(a) prescribing to a subject a fixed-dose pharmaceutical composition for twice daily nasal administration of two sprays per nostril, wherein

(i) the pharmaceutical composition comprises mometasone furoate and olopatadine hydrochloride, and each spray of the pharmaceutical composition comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride, and

(ii) the prescribing being performed in response to (A) marketing of the pharmaceutical composition as providing (I) faster onset of action for relief of one or more symptoms of allergic rhinitis than nasal administration of 50 mcg mometasone furoate or 1330 mcg olopatadine hydrochloride alone or (II) onset of action for relief of one or more symptoms of allergic rhinitis within 15 minutes of administration, and (B) diagnosis of the subject as suffering from allergic rhinitis; and

(b) administering the prescribed pharmaceutical composition to the human subject.

13. The method of claim 12 , wherein the symptoms are selected from nasal symptoms and non-nasal symptoms.

14. The method of claim 12 , wherein the symptoms are selected from nasal symptoms.

15. The method of claim 14 , wherein the nasal symptoms are selected from nasal congestion, rhinorrhea, itching and sneezing.

16. The method of claim 12 , wherein the allergic rhinitis is seasonal allergic rhinitis.

17. The method of claim 12 , wherein the allergic rhinitis is perennial allergic rhinitis.

18. The method according to claim 12 , wherein the faster onset of action occurs within about 15 minutes.

19. A method of treating a human subject suffering from allergic rhinitis comprising the step of administering to the subject a prescribed pharmaceutical composition for twice daily nasal administration of two sprays per nostril, wherein

the pharmaceutical composition comprises mometasone furoate and olopatadine hydrochloride, and each spray of the pharmaceutical composition comprises about 25 mcg of mometasone furoate and about 665 mcg of olopatadine hydrochloride, and the pharmaceutical composition is administered to the human subject after being prescribed in response to

(a) marketing of the pharmaceutical composition as providing (I) faster onset of action for relief of symptoms of allergic rhinitis than nasal administration of 50 mcg mometasone furoate or 1330 mcg olopatadine hydrochloride alone or (II) onset of action for relief of one or more symptoms of allergic rhinitis within 15 minutes of administration, and

(b) a diagnosis of the human subject as suffering from allergic rhinitis.

20. The method of claim 19 , wherein the symptoms are selected from nasal symptoms.

21. The method of claim 20 , wherein the nasal symptoms are selected from nasal congestion, rhinorrhea, itching and sneezing.

22. The method of claim 19 , wherein the allergic rhinitis is seasonal allergic rhinitis.

23. The method of claim 19 , wherein the allergic rhinitis is perennial allergic rhinitis.

24. The method of claim 1 , wherein the one or more symptoms are selected from non-nasal symptoms.

25. The method of claim 24 , wherein the non-nasal symptoms are ocular symptoms.

26. The method of claim 25 , wherein the ocular symptoms are selected from itching or burning of the eyes, tearing of the eyes, watering of the eyes, and redness of the eyes.

Assignments (1)
CHANGE OF ADDRESS Recorded Oct 26, 2023
From: GLENMARK SPECIALTY S.A.
To: GLENMARK SPECIALTY S.A.
Reel/Frame 065379/0694 →
Priority Claims (1)
IN 3174/MUM/2013 · Oct 4, 2013 · national
Continuity (8)
Continuation 15903597 · Feb 23, 2018
Continuation In Part 15842063 · Dec 14, 2017
Continuation In Part 15716661 · Sep 27, 2017
Continuation In Part 15691500 · Aug 30, 2017
Continuation In Part 15636120 · Jun 28, 2017
Continuation In Part 14682001 · Apr 8, 2015
Continuation In Part 14506122 · Oct 3, 2014
Related Publication 20210077506A1 · Mar 18, 2021