IP Library Granted Patent US 8,653,135
Granted Patent B1
US 8,653,135 · App. 11/672,075 · Granted Feb 18, 2014

Alternating sympathomimetic therapy for the treatment of respiratory aliments

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 8,653,135
App. No.
11/672,075
Granted
Feb 18, 2014
Kind
B1
Abstract

A combination of dosage units for alleviating respiratory ailments and a method of alleviating respiratory ailments which uses this combination of dosage units. The dosage units comprise one or more first dosage units comprising pseudoephedrine and/or a pharmaceutically acceptable salt thereof and one or more second dosage units comprising phenylephrine and/or a pharmaceutically acceptable salt thereof. This Abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

Claims (45)

1. A combination of oral dosage units for alleviating respiratory ailments, wherein the combination comprises:

(a) one or more first dosage units which comprise at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof; and

(b) one or more second dosage units which comprise at least one of phenylephrine and a pharmaceutically acceptable salt thereof;

and wherein the first and second dosage units are different and separate from each other and at least one of the first and second dosage units at least one of (i) comprises an antihistamine, (ii) is free of an expectorant and (iii) is free of a cough suppressant.

2. The combination of claim 1 , wherein at least one of the first and second dosage units further comprises at least one of an antihistamine, a cough suppressant, an expectorant, an analgesic and an anti-inflammatory agent.

3. The combination of claim 2 , wherein the first and second dosage units each independently comprise at least one of an antihistamine, a cough suppressant, an expectorant, an analgesic and an anti-inflammatory agent.

4. The combination of claim 2 , wherein at least one of the first and second dosage units comprises at least one of an antihistamine and a cough suppressant.

5. The combination of claim 3 , wherein the first and second dosage units each independently comprise at least one of an antihistamine and a cough suppressant.

6. The combination of claim 3 , wherein at least one of the first and second dosage units comprises an antihistamine and the other one of the first and second dosage units comprises a cough suppressant.

7. The combination of claim 2 , wherein at least the first dosage unit comprises an antihistamine.

8. The combination of claim 2 , wherein at least the second dosage unit comprises a cough suppressant.

9. The combination of claim 7 , wherein at least the second dosage unit comprises a cough suppressant.

10. The combination of claim 2 , wherein the first dosage unit further comprises at least one active ingredient selected from chlorpheniramine, promethazine, carbetapentane, diphenhydramine, codeine and pharmaceutically acceptable salts thereof.

11. The combination of claim 2 , wherein the first dosage unit further comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

12. The combination of claim 2 , wherein the second dosage unit further comprises at least one active ingredient selected from chlorpheniramine, dexchlorpheniramine, diphenhydramine, carbinoxamine, hydrocodone, codeine, guaifenesin and pharmaceutically acceptable salts thereof.

13. The combination of claim 2 , wherein the second dosage unit further comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

14. The combination of claim 1 , wherein the first dosage unit comprises from about 50 mg to about 130 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one of pseudoephedrine and any other pharmaceutically acceptable salt thereof.

15. The combination of claim 1 , wherein the second dosage unit comprises from about 40 mg to about 80 mg of phenylephrine hydrochloride or an equivalent amount of at least one of phenylephrine and any other pharmaceutically acceptable salt thereof.

16. The combination of claim 1 , wherein the first dosage unit comprises from about 60 mg to about 120 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one of pseudoephedrine and any other pharmaceutically acceptable salt thereof and the second dosage unit comprises from about 50 mg to about 75 mg of phenylephrine hydrochloride or an equivalent amount of at least one of phenylephrine and any other pharmaceutically acceptable salt thereof.

17. The combination of claim 16 , wherein the first dosage unit further comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

18. The combination of claim 16 , wherein the second dosage unit further comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

19. The combination of claim 16 , wherein both the first dosage unit and the second dosage unit further comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

20. The combination of claim 1 , wherein the first dosage unit and the second dosage unit each independently comprise at least one of a tablet, a capsule, a powder, a solution, a suspension, a gel and a syrup.

21. The combination of claim 20 , wherein the first and second dosage units each comprise a suspension.

22. The combination of claim 20 , wherein the first and second dosage units each comprise a tablet.

23. The combination of claim 1 , wherein at least the second dosage unit comprises a controlled release formulation.

24. The combination of claim 1 , wherein at least one of the first and second dosage units comprises a multilayered tablet.

25. The combination of claim 24 , wherein the first and second dosage units both comprise a multilayered tablet.

26. The combination of claim 24 , wherein the first dosage unit comprises a multilayered tablet comprising at least a first layer which is an immediate release layer and a second layer which is a controlled release layer.

27. The combination of claim 26 , wherein the first layer of the first dosage unit comprises an antihistamine.

28. The combination of claim 24 , wherein the second dosage unit comprises a multilayered tablet comprising at least two different controlled release layers.

29. The combination of claim 28 , wherein at least one of the controlled release layers comprises a cough suppressant.

30. The combination of claim 1 , wherein the combination is a packaged combination comprising the one or more first dosage units contained in at least one first container and the one or more second dosage units contained in at least one second container.

31. The combination of claim 1 , wherein the combination further comprises instructions directing ingestion of the first dosage units prior to periods during which a subject intends to be awake and ingestion of the second dosage units prior to periods during which a subject intends to sleep.

32. A packaged combination of oral dosage units for alleviating respiratory ailments, wherein the combination comprises:

(a) one or more first dosage units which comprise at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof and further comprises an antihistamine; and

(b) one or more second dosage units which comprise at least one of phenylephrine and a pharmaceutically acceptable salt thereof and further comprises a cough suppressant;

and wherein the first and second dosage units are different and separate from each other.

33. The combination of claim 32 , wherein the antihistamine of the one or more first dosage units comprises at least one of diphenhydramine and a pharmaceutically acceptable salt thereof.

34. The combination of claim 32 , wherein the one or more second dosage units further comprise an antihistamine.

35. The combination of claim 32 , wherein the first dosage unit comprises from about 60 mg to about 120 mg of pseudoephedrine hydrochloride or an equivalent amount of at least one of pseudoephedrine and any other pharmaceutically acceptable salt thereof.

36. The combination of claim 35 , wherein the second dosage unit comprises from about 50 mg to about 75 mg of phenylephrine hydrochloride or an equivalent amount of at least one of phenylephrine and any other pharmaceutically acceptable salt thereof.

37. The combination of claim 32 , wherein the first and second dosage units each comprise a tablet.

38. The combination of claim 36 , wherein the first dosage unit comprises a multilayered tablet.

39. The combination of claim 37 , wherein the second dosage unit comprises a multilayered tablet.

Assignments (5)
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST Recorded Jan 3, 2020
From: MIDCAP BUSINESS CREDIT, LLC
To: SOVEREIGN PHARMACEUTICALS, LLC
Reel/Frame 051463/0377 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 2, 2020
From: SOVEREIGN PHARMACEUTICALS, LLC
To: CAPELLON PHARMACEUTICALS, LLC
Reel/Frame 051400/0616 →
SECURITY INTEREST Recorded Jan 3, 2019
From: SOVEREIGN PHARMACEUTICALS, LLC
To: MIDCAP BUSINESS CREDIT LLC
Reel/Frame 047890/0729 →
CHANGE OF NAME Recorded Mar 5, 2010
From: SOVEREIGN PHARMACEUTICALS, LTD.
To: SOVEREIGN PHARMACEUTICALS, LLC
Reel/Frame 024039/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2007
From: DIXIT, SURESH; MENENDEZ, JUAN CARLOS; BROWN, RALPH
To: SOVEREIGN PHARMACEUTICALS, INC.
Reel/Frame 019233/0982 →