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Last Updated: October 31, 2020

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Claims for Patent: 9,907,801

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Summary for Patent: 9,907,801
Title:Combination of brimonidine and timolol for topical ophthalmic use
Abstract: Disclosed are pharmaceutical compositions comprising brimonidine and timolol for topical ophthalmic delivery and a method of treatment comprising administering said composition when indicated for glaucoma and associated conditions such as elevated intraocular pressure in the eyes of humans.
Inventor(s): Chang; Chin-Ming (Tustin, CA), Beck; Gary J. (Fullerton, CA), Pratt; Cynthia C. (Mission Viejo, CA), Batoosingh; Amy L. (Mission Viejo, CA)
Assignee: ALLERGAN SALES, LLC (Irvine, CA)
Application Number:15/802,179
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,907,801
Patent Claims: 1. A method of treating a patient with glaucoma or ocular hypertension comprising topically administering twice daily to an affected eye of the patient a single composition comprising 0.2% w/v brimonidine tartrate and 0.68% w/v timolol maleate as the sole active agents, wherein said method reduces the incidence of one or more adverse events, as compared to the administration of 0.2% w/v brimonidine tartrate monotherapy three times per day, wherein the adverse event is selected from the group consisting of conjunctival hyperemia, oral dryness, eye pruritus, allergic conjunctivitis, foreign body sensation, conjunctival folliculosis, and somnolence.

2. The method of claim 1, wherein the composition further comprises about 0.005% w/v benzalkonium chloride, about 0.43% w/v sodium phosphate monobasic monohydrate, about 2.15% w/v sodium phosphate dibasic heptahydrate, sodium hydroxide, hydrochloric acid, and water.

3. The method of claim 1, wherein the adverse event is conjunctival hyperemia.

4. The method of claim 1, wherein the adverse event is oral dryness.

5. The method of claim 1, wherein the adverse event is eye pruritus.

6. The method of claim 1, wherein the adverse event is allergic conjunctivitis.

7. The method of claim 1, wherein the adverse event is foreign body sensation.

8. The method of claim 1, wherein the adverse event is conjunctival folliculosis.

9. The method of claim 1, wherein the adverse event is somnolence.

10. The method of claim 2, wherein the adverse event is conjunctival hyperemia.

11. The method of claim 2, wherein the adverse event is oral dryness.

12. The method of claim 2, wherein the adverse event is eye pruritus.

13. The method of claim 2, wherein the adverse event is allergic conjunctivitis.

14. The method of claim 2, wherein the adverse event is foreign body sensation.

15. The method of claim 2, wherein the adverse event is conjunctival folliculosis.

16. The method of claim 2, wherein the adverse event is somnolence.

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