[의약품]CEPHALON, Inc. 대 Fresenius Kabi USA, LLC 간의 의약품 관련 특허 분쟁
발생일자 2015.06.24
사건번호 1:15-cv-00536
법원국가 UNITED STATES OF AMERICA
관할법원명 D.C.Delaware(지방법원)
침해권리 특허
원고명 CEPHALON, Inc. ( 미국 / 외국기업 )
피고명 Fresenius Kabi USA, LLC ( 미국 / 외국기업 )
소송유형 침해금지
분쟁내용
[CEPHALON, Inc. v. Fresenius Kabi USA, LLC] 사건번호 1:15-cv-00536에 따르면 원고 CEPHALON, Inc.는 피고 Fresenius Kabi USA, LLC을(를) 상대로 특허 US8344006을(를) 침해하였다는 이유로 미국 델라웨어 지방법원에 소를 제기하였다.
분쟁결과 분쟁중
산업분류 화학∙바이오 > 의약품
계쟁제품
Bendamustine hydrochloride injection for intravenous infusion, generic versions of TREANDAⓇ
지재권번호/명칭
US8344006 Liquid formulations of bendamustine
Liquid formulations of bendamustine
Abstract
Stable liquid formulations of bendamustine, and pharmaceutically acceptable salts thereof, and polar aprotic solvents, are described.
Claims
What is claimed is:
1. A stable, non-aqueous liquid, pharmaceutical formulation comprising from about 5 mg/ml to about 120 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof, solubilized in about 66% (v/v) of dimethylacetamide and about 34% (v/v) of propylene glycol, wherein said formulation, following dilution with a pharmaceutically acceptable diluent, is suitable for injection into a patient without lyophilization.
2. The formulation of claim 1, comprising about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof.
3. The formulation of claim 1, wherein the bendamustine is bendamustine hydrochloride.
4. The formulation of claim 1, further comprising at least one pharmaceutically acceptable excipient or diluent.
5. The formulation of claim 1, further comprising an antioxidant, a surfactant, a lipid, a filler, an organic acid, a hydrophilic polymer, a complexing agent, a preservative, or a combination thereof.
6. A method of treating chronic lymphocytic leukemia or non-Hodgkin's lymphoma comprising providing a liquid, pharmaceutical formulation of claim 1; diluting the liquid pharmaceutical formulation with a pharmaceutically acceptable injectable diluent to form an injectable pharmaceutical preparation; administering the injectable pharmaceutical preparation to a patient in need of treatment thereof.
7. The method of claim 6, wherein the liquid pharmaceutical formulation comprises about 100 mg/mL of bendamustine, or a pharmaceutically acceptable salt thereof.
8. The method of claim 6, wherein the pharmaceutically acceptable injectable diluent is 0.9% sodium chloride.
9. The formulation of claim 2, comprising 90 mg/mL of bendamustine hydrochloride.
10. The method of claim 7, comprising 90 mg/mL of bendamustine hydrochloride.
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