발생일자 2014.12.24 

사건번호 3:14-cv-08030 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.NewJersey(지방법원) 

침해권리 특허 

원고명 Astrazeneca AB/ Aktiebolaget Hassle/ Astrazeneca LP/ Zeneca, Inc. ( 스웨덴 / 외국기업 )  

피고명 Andrx Labs, LLC/ Actavis, Inc./ Andrx Corporation ( 미국 / 외국기업 )  

소송유형 침해금지 

[Astrazeneca AB et al v. Andrx Labs, LLC et al] 사건번호 3:14-cv-08030에 따르면 원고 Astrazeneca AB/ Aktiebolaget Hassle/ Astrazeneca LP/ Zeneca, Inc.는 피고 Andrx Labs, LLC/ Actavis, Inc./ Andrx Corporation을 상대로 특허 US6369085, US7411070을 침해하였다는 이유로 미국 뉴저지 지방법원에 소를 제기하였다. 

분쟁결과 분쟁중 

산업분류 화학∙바이오 > 유기화학기술 

계쟁제품

Esomeprazole Magnesium Delayed-Release Capsules, in a 20 mg dosage form generic version of NEXIUM 24HR 

지재권번호/명칭

US6369085   Form of S-omeprazole 

 US7411070   Form of S-omeprazole 

The present invention relates to a novel form of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1H-ben zimidazole, i.e. S-omeprazole. More specifically, it relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate. The present invention also relates to processes for preparing such a form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. Furthermore, the present invention also relates to new intermediates used in the process. 

What is claimed is: 

1. The magnesium salt of S-omeprazole trihydrate, wherein the compound is characterized by the following major peaks in its X-ray diffractogram: 

2. The magnesium salt of S-omeprazole trihydrate according to claim 1, wherein the compound is in a highly crystalline form. 

3. The magnesium salt of S-omeprazole trihydrate according to claim 1, wherein the compound is in a stable form. 

4. A process for the preparation of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 which comprises treating a magnesium salt of S-omeprazole any other form with water. 

5. A process for the preparation of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 which comprises the following steps: 

a) mixing a potassium salt of S-omeprazole with an organic solvent; 

b) converting the potassium salt of S-omeprazole into a corresponding magnesium salt of S-omeprazole by treating the potassium salt with a magnesium source; 

c) precipitating the magnesium salt of S-omeprazole by addition of a non-solvent; 

d) isolating the obtained magnesium salt of S-omeprazole; 

e) treating the obtained magnesium salt of S-omeprazole with water, and 

f) isolating and drying the obtained magnesium salt of S-omeprazole trihydrate. 

6. The process according to claim 5, wherein the organic solvent of step a) is methanol. 

7. The process according to claim 5, wherein the non-solvent of step c) is acetone. 

8. The process according to claim 5 wherein steps a) to e) are replaced by the following single step: converting the potassium salt of S-omeprazole into a corresponding magnesium salt of S-omeprazole by treating the potassium salt with a magnesium source in water. 

9. The process according to claim 5, wherein the magnesium source is magnesium sulfate. 

10. The process according to claim 8, wherein the magnesium source is magnesium sulfate. 

11. A pharmaceutical composition comprising the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3 as active ingredient and a pharmaceutically acceptable carrier. 

12. A method of treating a gastric acid related condition which method comprises administering to a subject suffering from said condition a therapeutically effective amount of the magnesium salt of S-omeprazole trihydrate according to any of claims 1, 2 or 3.