Olopatadine - USA

IPR decision (Sep 17, 2018):

AIA Review	Filing Date	Institution Date	Petitioner	Patent No.	Decision
IPR2018-01020	06/05/2018	--	Cipla Limited	8,791,154	Terminated-Settled
IPR2018-01021	06/05/2018	--	Cipla Limited	9,533,053

On US’154 patent, Argentum & Apotex previously filed IPRs (IPR2016-00544 & IPR2016-01640) which were also terminated by PTAB.

US 8,791,154 (Alcon Research, Ltd; Exp: 05/19/2032) – OB listed

1. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % olopatadine dissolved in the solution; PEG having a molecular weight of 300 to 500; polyvinylpyrrolidone; hydroxypropyl-.gamma.-cyclodextrin; benzalkonium chloride; and water.

4. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % but no greater than 1.0 w/v % olopatadine dissolved in the solution; 2.0 w/v % to 6.0 w/v % PEG having a molecular weight of 300 to 500; 2.0 w/v % to 6.0 w/v % polyvinylpyrrolidone; at least 0.5 w/v % but no greater than 2.0 w/v % cyclodextrin derivative selected from the group consisting of SAE-.beta.-cyclodextrin, HP-.gamma.-cyclodextrin, HP-.beta.-cyclodextrin and combinations thereof; and water.

8. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % but no greater than 1.0 w/v % olopatadine dissolved in the solution; 2.0 w/v % to 6.0 w/v % PEG having a molecular weight of 300 to 500; 2.0 w/v % to 6.0 w/v % polyvinylpyrrolidone; at least 0.5 w/v % but no greater than 2.0 w/v % hydroxypropyl-.gamma.-cyclodextrin; and water.

21. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % but no greater than 1.0 w/v % olopatadine dissolved in the solution; 2.0 w/v % to 6.0 w/v % PEG having a molecular weight of 300 to 500; 2.0 w/v % to 6.0 w/v % polyvinylpyrrolidone; at least 0.5 w/v % but no greater than 2.0 w/v % hydroxypropyl-.gamma.-cyclodextrin; greater than 0.003 w/v % but less than 0.03 w/v % benzalkonium chloride; and water; wherein the pH of the solution is 6.0 to 7.8 and the osmolality of the solution is 200 to 400 mOsm/kg.

US 9,533,053 (Alcon Research, Ltd; Exp: 05/19/2032) – OB listed

1. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800; polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of SAE-.beta.-cyclodextrin, hydroxypropyl-.beta.-cyclodextrin and hydroxypropyl-.gamma.-cyclodextrin; and water.

8. An aqueous ophthalmic solution for treatment of ocular allergic conjunctivitis, the solution comprising: at least 0.67 w/v % olopatadine dissolved in the solution; PEG having a molecular weight of 200 to 800; polyvinylpyrrolidone; a cyclodextrin selected from the group consisting of hydroxybrobyl-.beta.-cyclodextrin and hydroxypropyl-.gamma.-cyclodextrin; benzalkonium chloride; hydroxypropylmethyl cellulose; and water.