`
`CLAIMS
`
`1. A pharmaceutical single-use, unit-dose formulation for intravenous
`administration to a human to reduce the likelihood of cancer chemotherapy-
`induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic
`solution, said solution comprising:
`
`5
`
`palonosetron hydrochloride in an amount of 0.25 mg based on the weight
`of its free base;
`
`from 0.005 mg/mL to 1.0 mg/mL EDTA; and
`
`10
`
`from 10 mg/mL to 80 mg/mL mannitol,
`
`wherein said formulation is stable at 24 months when stored at room
`temperature.
`
`2. The pharmaceutical formulation of claim 1, wherein said EDT A is in
`an amount of0.5 mg/mL.
`
`15
`
`3. The pharmaceutical formulation of claim 1, wherein said mannitol is in
`an amount of 41.5 tng/mL.
`
`4. The pharmaceutical formulation of claim 1, wherein said solution
`further comprises a citrate buffer.
`
`5. The pharmaceutical formulation of claim 4, wherein said citrate buffer
`is at a concentration of 20 millimolar.
`
`20
`
`6. The pharmaceutical formulation of claim 1, wherein said solution is
`buffered at a pH of 5.0 ± 0.5.
`
`7. The pharmaceutical formulation of claim 1, wherein said EDT A is in
`an amount of 0.5 mg/mL, wherein said mannitol is in an amount of 41.5 mg/mL,
`
`5579776vl 18
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`Reddy Exhibit 1050
`
`Exh. 1050
`
`
`
`wherein said solution further comprises a citrate buffer at a concentration of 20
`tnillitnolar, and wherein said solution is buffered at a pH of 5.0 ± 0.5.
`
`8. A pharmaceutical single-use, unit-dose formulation for intravenous
`administration to a human to reduce the likelihood of cancer chemotherapy-
`induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic
`solution, said solution comprising:
`
`5
`
`palonosetron hydrochloride in an amount of 0.25 mg based on the weight
`of its free base;
`
`from 0.005 mg/mL to 1.0 mg/mL EDTA; and
`
`10
`
`from 10 mg/mL to 80 mg/mL mannitol, wherein said formulation is stable
`at 18 months when stored at room temperature.
`
`9. A pharmaceutical single-use, unit-dose formulation for intravenous
`administration to a human to reduce the likelihood of cancer chemotherapy-
`induced nausea and vomiting, comprising a 50 mL sterile isotonic solution
`buffered at a pH of 4.8 ± 0.5 comprising:
`
`15
`
`palonosetron hydrochloride in an amount of 0.75 mg based on the weight
`of its free base;
`
`450.0 mg sodium chloride;
`
`2.5 mgEDTA;
`
`20
`
`18.5 mg sodium citrate; and
`
`7. 8 mg citric acid monohydrate,
`
`wherein said formulation is contained in a polyethylene multilayer film infusion
`bag comprising an isoprene rubber stopper.
`
`5579776vl 19
`
`Exh. 1050
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
