Baxter Healthcare Corporation/ Baxter Healthcare SA/ Baxter International, Inc 대 Sagent Pharmaceuticals, Inc. 간의 의약품 관련 특허 분쟁
발생일자 2015.03.11
사건번호 1:15-cv-02076
법원국가 UNITED STATES OF AMERICA
관할법원명 D.C.N.D.Illinois(지방법원)
침해권리 특허
원고명 Baxter Healthcare Corporation/ Baxter Healthcare SA/ Baxter International, Inc ( 미국 / 외국기업 )
피고명 Sagent Pharmaceuticals, Inc. ( 미국 / 외국기업 )
소송유형 침해금지
분쟁내용
[Baxter Healthcare Corporation et al v. Sagent Pharmaceuticals, Inc.] 사건번호 1:15-cv-02076에 따르면 원고 Baxter Healthcare Corporation/ Baxter Healthcare SA/ Baxter International, Inc는 피고 Sagent Pharmaceuticals, Inc.을 상대로 특허 US6310094|US6528540을 침해하였다는 이유로 미국 일리노이 북부 지방법원에 소를 제기하였다.
분쟁결과 분쟁중
산업분류 화학∙바이오 > 의약품
계쟁제품
Esmolol Hydrochloride in Sodium Chloride Solution dosages of 10 mg/mL 250 mL and 20 mg/mL 100 mL infusion bags, generic version of BREVIBLOC
지재권번호/명칭
US6310094 Ready-to-use esmolol solution
US6528540 Esmolol formulation
Ready-to-use esmolol solution
Abstract
A ready-to-use injectable, aqueous pharmaceutical composition for the treatment of cardiac conditions, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy] phenylpropionate hydrochloride (esmolol hydrochloride), a buffering agent and an osmotic-adjusting agent, as well as a method for its manufacture in a container, is disclosed.
Claims
We claim:
1. An injectable, aqueous pharmaceutical composition for the treatment of cardiac conditions, having a pH between 3.5 and 6.5 and comprising
a. 0.1-100 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy] phenylpropionate hydrochloride (esmolol hydrochloride),
b. 0.1-5.0 mg/ml buffering agent, and
c. 1-100 mg/ml osmotic-adjusting agent.
2. The composition of claim 1 wherein the buffering agent comprises at least one of acetate, glutamate, citrate, tartrate, benzoate, lactate, gluconate, phosphate and glycine.
3. The composition of claim 1 wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.
4. A method for preparing a sterile, injectable aqueous pharmaceutical composition for the treatment of cardiac conditions, comprising forming an aqueous composition having a pH between 3.5 and 6.5 comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy] phenylpropionate hydrochloride (esmolol hydrochloride), a buffering agent, and an osmotic-adjusting agent in a sealed container, and autoclaving for a period of time sufficient to render the composition sterile.
5. The method of claim 4 wherein the composition comprises 0.1-100 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy] phenylpropionate hydrochloride (esmolol hydrochloride), 0.1-5.0 mg/ml buffering agent, and 1-100 mg/ml osmotic-adjusting agent.
6. The method of claim 4 wherein the composition is autoclaved at a temperature ranging from 115 to 130.degree. C. for a period of time ranging from 5 to 40 minutes.
7. The method of claim 4 wherein the container is a flexible polymeric container free from polyvinyl chloride.
8. The method of claim 4 further comprising providing the container with a moisture barrier.
9. The method of claim 8 wherein the moisture barrier is an aluminum overpouch.
Esmolol formulation
Abstract
An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, comprising methyl-3-[4-(2-hydroxy-3-isopropylamino)propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), a buffering agent and an osmotic-adjusting agent, as well as a method for its manufacture, are disclosed.
Claims
What is claimed is:
1. An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, having a pH between 3.5 and 6.5 comprising: a. 0.1-500 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (esmolol hydrochloride); b. 0.01-2 M buffering agent; and c. 1-500 mg/ml osmotic-adjusting agent.
2. The pharmaceutical composition of claim 1, wherein the pH is between 4.5 and 5.5.
3. The pharmaceutical composition of claim 1, wherein the buffering agent comprises at least one of acetate, glutamate, citrate, tartrate, benzoate, lactate, gluconate, phosphate and glycine.
4. The pharmaceutical composition of claim 1, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.
5. The pharmaceutical composition of claim 3, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.
6. The pharmaceutical composition of claim 1 comprising: a. 0.1-100 mg/ml esmolol hydrochloride; b. 0.01-0.5 M buffering agent; and c. 1-100 mg/ml osmotic-adjusting agent.
7. The pharmaceutical product of claim 1 comprising: a. 100-500 mg/ml esmolol hydrochloride; b. 0.5-2 M buffering agent; and c. 50-500 mg/ml osmotic-adjusting agent.
8. The pharmaceutical composition of claim 1, wherein the composition is provided in a heat sterilized container.
9. The pharmaceutical composition of claim 8, wherein the container is a vial, ampul, bag, bottle or syringe.
10. The pharmaceutical composition of claim 9, wherein the container is from 1-500 ml in volume.
11. The pharmaceutical composition of claim 4, having a pH of about 5 and comprising about 100-250 mg/ml of esmolol hydrochloride and 0.5-2 M buffering agent and 50-500 mg/ml osmotic-adjusting agent.
12. An aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, having a pH of about 5.0 and comprising about 1-20 mg/ml esmolol hydrochloride, 0.02-0.1 M buffering agent and 1-100 mg/ml osmotic-adjusting agent, wherein the osmotic-adjusting agent comprises at least one of sodium chloride, dextrose, sodium bicarbonate, calcium chloride, potassium chloride, sodium lactate, Ringer's solution and lactated Ringer's solution.
13. A method for preparing an aqueous, sterile pharmaceutical composition suitable for parenteral administration for the treatment of cardiac conditions, comprising forming an aqueous composition having a pH between 3.5 and 6.5 comprising 0.1-500 mg/ml methyl-3-[4-(2-hydroxy-3-isopropylamino) propoxy]phenylpropionate hydrochloride (esmolol hydrochloride), 0.01-2 M buffering agent, and 1-500 mg/ml osmotic-adjusting agent in a sealed container and autoclaving for a period of time sufficient to render the composition sterile.
14. The method of claim 13, wherein the composition has a pH between 4.5 and 5.5.
15. The method of claim 13, wherein autoclaving is carried out a temperature ranging from 115.degree. C. to 130.degree. C. for a period of time ranging from 5 to 40 minutes.
16. The method of claim 14, wherein autoclaving is carried out a temperature ranging from 115.degree. C. to 130.degree. C. for a period of time ranging from 5 to 40 minutes.
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