[의약품]Noven Pharmaceuticals, Inc. 대 Actavis Laboratories UT, Inc. 간의 의약품 관련 특허 분쟁
발생일자 2015.03.20
사건번호 1:15-cv-00249
법원국가 UNITED STATES OF AMERICA
관할법원명 D.C.Delaware(지방법원)
침해권리 특허
원고명 Noven Pharmaceuticals, Inc. ( 미국 / 외국기업 )
피고명 Actavis Laboratories UT, Inc. ( 미국 / 외국기업 )
소송유형 침해금지
분쟁내용
[Noven Pharmaceuticals, Inc. v. Actavis Laboratories UT, Inc.] 사건번호 1:15-cv-00249에 따르면 원고 Noven Pharmaceuticals, Inc.는 피고 Actavis Laboratories UT, Inc.을 상대로 특허 US8231906을 침해하였다는 이유로 미국 델라웨어 지방법원에 소를 제기하였다.
분쟁결과 분쟁중
산업분류 화학∙바이오 > 의약품
계쟁제품 Generic Estradiol Transdermal System, USP "TwiceWeekly" in 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day dosage strengths of the product
지재권번호/명칭 US8231906 Transdermal estrogen device and delivery
Transdermal estrogen device and delivery
Abstract
Described are transdermal drug delivery systems for the transdermal administration of estrogen, comprising a polymer matrix and estrogen. Methods of making and using such systems also are described.
Claims
What is claimed is:
1. A monolithic transdermal drug delivery system for estradiol, comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area.
2. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble polyvinylpyrrolidone (PVP).
3. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises about 2-25% by weight acrylic adhesive, about 45-70% by weight silicone adhesive, about 2-25% by weight soluble PVP, and about 5-15% penetration enhancer, all based on the total dry weight of the polymer matrix.
4. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol.
5. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises dipropylene glycol.
6. The transdermal drug delivery system of claim 3, wherein the penetration enhancer comprises oleyl alcohol and dipropylene glycol.
7. The transdermal drug delivery system of claim 3, wherein the acrylic adhesive and silicone adhesive are present in a ratio of from about 1:2 to about 1:6, based on the total weight of the acrylic and silicone adhesives.
8. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver a therapeutically effective amount of estradiol over a period of time selected from the group consisting of at least 1 day, at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days and at least 7 days.
9. The transdermal drug delivery system of claim 1, wherein the polymer matrix comprises an amount of estradiol effective to deliver an amount of estradiol selected from the group consisting of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day.
10. A monolithic transdermal drug delivery system for estradiol comprising a single polymer matrix layer comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, and the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2 and is effective to deliver an amount of estradiol per day of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day, respectively.
11. A method for administering estradiol, con to the skin or mucosa of a subject in need thereof a monolithic transdermal drug delivery system comprising a single polymer matrix layer defining an active surface area and comprising a polymer matrix comprising estradiol as the only drug, wherein the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2, includes greater than 0.156 mg/cm.sup.2 estradiol, and achieves an estradiol flux that is greater than 0.01 mg/cm.sup.2/day, based on the active surface area.
12. The method of claim 11, wherein the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2 and is effective to deliver an amount of estradiol per day of about 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day, respectively.
13. A method of making a monolithic transdermal drug delivery system for administering estradiol, comprising forming a polymer matrix comprising estradiol as the only drug and a polymer blend comprising an acrylic adhesive, a silicone adhesive, and soluble PVP, and applying the polymer matrix to a support layer to form a single polymer matrix layer such that the polymer matrix layer has a coat weight selected from the group consisting of 12.5 mg/cm.sup.2 and 15 mg/cm.sup.2 and includes greater than 0.156 mg/cm.sup.2 estradiol.
14. The method of claim 13, wherein the system has an active surface area that is about 60% of a size selected from the group consisting of 2.5, 3.75, 5.0, 7.5 and 10.0 cm.sup.2.
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