Claims for Patent: 9,463,138

Summary for Patent: 9,463,138

Title:	Packaging system
Abstract:	A packaging system includes a vial with a rim about an upper open end, and a neck between a lower closed end and the rim. The vial contains a pharmaceutical product. A valve is disposed over the open end, and a crimp ring is disposed over the valve with an opening defining an access port. A detachable cap is disposed over the access port. A single tubular label is disposed about the vial, and extends only from a first edge aligned with the closed end to a second edge at the cap. The label has first and second sections separated by a single circumferential perforated boundary aligned with the neck. The first section is backed with an adhesive and attached to the outer vial surface, and extends between the closed end and the boundary. The second section extends at least between the boundary and the cap.
Inventor(s):	McClain; Kimberly A. (Salem, NJ), Baklycki; Michael (Bensalem, PA), McDevitt; Thomas D. (Richboro, PA)
Assignee:	BAXTER INTERNATIONAL INC. (Deerfield, IL) BAXTER HEALTHCARE SA (Glattpark (Opfikon), CH)
Application Number:	12/871,101
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,463,138
Patent Claims:	1. A packaging system comprising: a glass vial including a wall defining a lower closed end and an upper open end, the wall having an outer surface, an inner surface defining a receptacle, a flange-like rim disposed about the open end, and a neck of reduced diameter between the closed end and the rim below the rim; a pharmaceutical product disposed in the receptacle, the product selected from the group of pharmaceutical products consisting of adrenergic agontists, adrenergic antagonists, anesthetic agents, antiarrhythmics, antithrombotic agents, chemotherapeutic agents, hypoglycemics, inotropic medications, sedation agents, opiates, neuromuscular blocking agents, and radiocontrast agents; a valve disposed over the open end and a crimp ring with a first upper end disposed over a portion of the valve and having an opening to define an access port, and a second lower end disposed over a portion of the flange-like rim; a detachable cap disposed over the access port, the cap terminating in a downturned edge about the circumference of the cap; and a single tubular label disposed about the perimeter of the vial, the tubular label extending only from a first lower edge aligned with the closed end of the vial to a second upper edge at the cap, the label having a first lower section and a second upper section separated by a single circumferential perforated boundary aligned with the neck of the vial below the rim, the first section of the label backed at least in part with an adhesive, attached at least in part to the outer surface of the vial and extending between the closed end of the vial and the perforated boundary, and the second section extending at least between the perforated boundary and the cap. 2. The system according to claim 1, the vial comprising a longitudinal axis, and wherein in a first state, the first and second sections of the label are joined at the perforated boundary, in a second state, the first section of the label is separated from the second section of the of the label with a motion normal to the axis of the vial as the label is broken along the perforated boundary about the axis of the vial, and in a third state, the cap is removed by engaging the downturned edge upward. 3. The system according to claim 1, wherein the pharmaceutical product is selected from the group of pharmaceutical products consisting of epinephrine, phenylephine, norepinephrine, propranolol, metoprolol, labetalol, propofol, ketmine, lidocaine, amiodarone, warfarin, heparin, fondaparinux, argatroban, lepirudin, biavalirudin, alteplase, eptifibatide, docetaxel, insulin, exenatide, pramlintide, digoxin, milrinone, midazolam, morphine, codeine, papaverine, succinylcholine, rocuronium, vecuronium, ioxaglic acid, diatrizoic acid, colchicine, epoprostenol, methotrexate, oxycotin, nitroprusside, and promethazine. 4. The system according to claim 1, wherein the pharmaceutical product is selected from the group of pharmaceutical products consisting of heparin and midazolam. 5. The packaging system of claim 1, wherein the crimp ring is of a color that contrasts with the first section of the label. 6. The packaging system of claim 1, wherein the cap has a top surface and comprises a warning message defined on the top surface. 7. The system according to claim 1, wherein the label partially covers the perimeter of the vial. 8. The system according to claim 1, wherein the label fully covers the perimeter of the vial. 9. The system according to claim 1, wherein the second section of the label is attached at least in part to the cap. 10. The system according to claim 9, wherein the label is attached to the downturned edge of the cap. 11. The system according to claim 10, wherein the second edge of the label is aligned with a top surface of the cap.

Details for Patent 9,463,138

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172	11/13/1987		2027-06-13
Genentech, Inc.	CATHFLO ACTIVASE	alteplase	For Injection	103172	09/04/2001		2027-06-13