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1. 发明授权

US11523984B1 Compositions and methods of administering baclofen 有权
公开(公告)号：US11523984B1
公开(公告)日：2022-12-13
申请号：US17525298
申请日：2021-11-12
申请人： AMNEAL PHARMACEUTICALS LLC
发明人： Leonard O'Mahony , John Devane , Sharon Hamm , David Penake
IPC分类号： A61K31/197 , A61K9/00
摘要： Injectable baclofen formulations and methods that are bioequivalent in terms of plasma baclofen exposure to oral dosage forms but with reduced exposure ratios of baclofen to the M1 metabolite.

2. 发明申请

US20180256562A1 Transdermal Delivery System 审中-公开
公开(公告)号：US20180256562A1
公开(公告)日：2018-09-13
申请号：US15758269
申请日：2016-09-09
申请人： Amneal Pharmaceuticals LLC
发明人： Sameer Sachdeva , Tarun Goswami , Jay Audett
IPC分类号： A61K31/485 , A61K9/00 , A61K9/70 , A61K47/12 , A61K47/14 , A61K47/32 , A61M35/00 , A61F13/02 , A61F13/00
CPC分类号： A61K31/485 , A61F13/00063 , A61F13/0253 , A61F13/0259 , A61F13/0289 , A61F2013/0296 , A61K9/0014 , A61K9/7061 , A61K9/7069 , A61K47/12 , A61K47/14 , A61K47/32 , A61M35/00 , A61M2207/00
摘要： Described is a transdermal device comprising a backing layer; a single layer adhesive matrix comprising buprenorphine or a salt thereof, a pressure sensitive adhesive including a silicone-type adhesive blended with an acrylate-type adhesive, a solubilizer, a permeation enhancer, and a crystallization inhibitor; and a release layer. Also described is a method of relieving pain and a method of preparing a transdermal delivery system.

3. 发明申请

US20170202801A1 Stabilization Of Moisture-Sensitive Drugs 审中-公开
公开(公告)号：US20170202801A1
公开(公告)日：2017-07-20
申请号：US15477479
申请日：2017-04-03
申请人： Amneal Pharmaceuticals LLC
发明人： Marianthi Karakatsani , Anita Kumar , Devjibhai D. Kumbhani , Pallapalayam M. Thangamathesvaran
IPC分类号： A61K31/216 , A61K9/20 , A61K31/4439 , A61K47/36 , A61K31/235 , A61K31/4418
CPC分类号： A61K31/216 , A61K9/1623 , A61K9/20 , A61K9/2018 , A61K9/2095 , A61K9/284 , A61K9/2893 , A61K31/222 , A61K31/235 , A61K31/4418 , A61K31/4439 , A61K47/36
摘要： Described are stability-enhancing formulations of drugs that are sensitive to moisture. The formulations comprise co-granulates containing a moisture-sensitive drug and an excipient selected from fructose, xylitol, maltitol, and mixtures thereof. Also described are methods of producing a pharmaceutical tablet. The method comprises forming a blend of a moisture-sensitive drug and a first excipient selected from fructose, xylitol, maltitol, and mixtures thereof; spraying the blend with water to produce granules; drying and milling the granules; mixing a second excipient with the granules; and compressing into tablets.

4. 发明申请

US20150157839A1 Applicator for Applying a Fluid to a Surface 有权
标题翻译：将流体涂抹在表面上的涂抹器
公开(公告)号：US20150157839A1
公开(公告)日：2015-06-11
申请号：US14100817
申请日：2013-12-09
申请人： Amneal Pharmaceuticals LLC
发明人： Padam Bansal , Hardik Patel , David R. Schiff , Jason Zerweck
IPC分类号： A61M35/00 , A61K9/00 , A61K31/568
CPC分类号： A61M35/003 , A61K9/0014 , A61K31/568
摘要： An applicator for applying a fluid to a surface is provided, the applicator comprising a support comprising an upper outer surface and a lower holding surface; a flexible membrane comprising a central opening, an inner wall comprising a lower end and an upper end, an outer wall at least partially surrounding the upper outer surface of the support, the outer wall comprising a lower end and an upper end, and an upper folded wall connecting the upper ends of the inner wall and outer wall; and a membrane holder for fixedly securing the lower end of the inner wall of the flexible membrane to the upper outer surface of the support; wherein the upper surface of the membrane holder and the inner wall of the flexible membrane define a reservoir for holding a fluid, and wherein the lower end of the outer wall of the flexible membrane is free to move axially relative to the upper outer surface of the support when pressure is applied to the upper folded wall of the flexible membrane. In an embodiment, the applicator has particular utility for applying a topical or transdermal testosterone composition to the skin of a patient in need of testosterone replacement therapy.
摘要翻译：提供了一种用于将流体施加到表面的施加器，所述施加器包括包括上外表面和下保持表面的支撑件; 包括中心开口的柔性膜，包括下端和上端的内壁，至少部分地围绕所述支撑件的上外表面的外壁，所述外壁包括下端和上端，以及上端连接内壁和外壁上端的折叠壁; 以及用于将柔性膜的内壁的下端牢固地固定到支撑体的上外表面的膜保持器; 其中所述膜保持器的上表面和所述柔性膜的内壁限定用于保持流体的储存器，并且其中所述柔性膜的外壁的下端相对于所述柔性膜的所述上外表面自由地轴向移动当压力施加到柔性膜的上折叠壁时的支撑。在一个实施方案中，施用器具有将局部或透皮睾酮组合物施用于需要睾酮替代疗法的患者皮肤的特殊用途。

5. 发明申请

US20180235903A1 Fentanyl Transdermal Delivery System 审中-公开
公开(公告)号：US20180235903A1
公开(公告)日：2018-08-23
申请号：US15557637
申请日：2016-03-11
申请人： Amneal Pharmaceuticals LLC
发明人： Jay Audett , Chee Youb Won
IPC分类号： A61K9/70 , A61K9/00 , A61K31/4468 , A61F13/00 , A61F13/02
CPC分类号： A61K9/7069 , A61F13/00063 , A61F13/0253 , A61K9/0014 , A61K9/7053 , A61K9/7061 , A61K31/4468
摘要： Described is a transdermal device comprising a backing layer; an adhesive matrix comprising fentanyl as an active agent suspended on a plurality of pressure sensitive adhesives along with a cross-linked moisture absorbent comprising cross-linked polyvinylpyrrolidone; and a release layer. Also described is a method of relieving pain, which comprising applying said transdermal device to the skin of a patient in need thereof.

6. 发明申请

US20160194309A1 A Process For The Preparation Of Rivaroxaban 有权
标题翻译：一种制备利伐沙班的方法
公开(公告)号：US20160194309A1
公开(公告)日：2016-07-07
申请号：US14911914
申请日：2014-08-19
申请人： AMNEAL PHARMACEUTICALS LLC
发明人： Agarwal Virendra Kumar , Upadhyay Ashish Rameshchandra , Thumar Nilesh Mansukhlal , Vala Hardevsinh Kanaksinh
IPC分类号： C07D413/14 , C07D413/12 , C07D265/32
CPC分类号： C07D413/14 , C07D265/32 , C07D413/12
摘要： Described is an improved, industrially feasible and environmental friendly process for the preparation of Rivaroxaban. Also described are novel compounds which may be used as intermediates in preparation of Rivaroxaban.
摘要翻译：描述了一种改进的，工业上可行的和环境友好的制备里卡沙班的方法。还描述了可用作制备里卡沙康的中间体的新化合物。

7. 发明申请

US20160030347A1 Stabilization Of Moisture-Sensitive Drugs 有权
标题翻译：水分敏感药物的稳定化
公开(公告)号：US20160030347A1
公开(公告)日：2016-02-04
申请号：US14772999
申请日：2014-03-07
申请人： AMNEAL PHARMACEUTICALS, LLC
发明人： Marianthi Karakatsani , Anita Kumar , Devjibhai D. Kumbhani , Pallapalayam M. Thangamathesvaran
IPC分类号： A61K9/16 , A61K9/20 , A61K9/28 , A61K31/222
CPC分类号： A61K31/216 , A61K9/1623 , A61K9/20 , A61K9/2018 , A61K9/2095 , A61K9/284 , A61K9/2893 , A61K31/222 , A61K31/235 , A61K31/4418 , A61K31/4439 , A61K47/36
摘要： Described are stability-enhancing formulations of drugs that are sensitive to moisture. The formulations comprise co-granulates containing a moisture-sensitive drug and an excipient selected from fructose, xylitol, maltitol, and mixtures thereof. Also described are methods of producing a pharmaceutical tablet. The method comprises forming a blend of a moisture-sensitive drug and a first excipient selected from fructose, xylitol, maltitol, and mixtures thereof; spraying the blend with water to produce granules; drying and milling the granules; mixing a second excipient with the granules; and compressing into tablets.
摘要翻译：描述了对湿度敏感的药物的稳定性增强制剂。制剂包含含有湿敏药物和选自果糖，木糖醇，麦芽糖醇及其混合物的赋形剂的共颗粒剂。还描述了制备药物片剂的方法。该方法包括形成湿敏药物和选自果糖，木糖醇，麦芽糖醇及其混合物的第一赋形剂的共混物; 用水喷洒混合物以产生颗粒; 干燥和研磨颗粒; 将第二赋形剂与颗粒混合; 并压缩成片剂。

8. 发明授权

US09227044B2 Applicator for applying a fluid to a surface 有权
标题翻译：将流体施加到表面的施加器
公开(公告)号：US09227044B2
公开(公告)日：2016-01-05
申请号：US14100817
申请日：2013-12-09
申请人： Amneal Pharmaceuticals LLC
发明人： Padam Bansal , Hardik Patel , David R. Schiff , Jason Zerweck
IPC分类号： A61M35/00 , A61K31/568 , A61K9/00
CPC分类号： A61M35/003 , A61K9/0014 , A61K31/568
摘要： An applicator for applying a fluid to a surface is provided, the applicator comprising a support comprising an upper outer surface and a lower holding surface; a flexible membrane comprising a central opening, an inner wall comprising a lower end and an upper end, an outer wall at least partially surrounding the upper outer surface of the support, the outer wall comprising a lower end and an upper end, and an upper folded wall connecting the upper ends of the inner wall and outer wall; and a membrane holder for fixedly securing the lower end of the inner wall of the flexible membrane to the upper outer surface of the support; wherein the upper surface of the membrane holder and the inner wall of the flexible membrane define a reservoir for holding a fluid, and wherein the lower end of the outer wall of the flexible membrane is free to move axially relative to the upper outer surface of the support when pressure is applied to the upper folded wall of the flexible membrane. In an embodiment, the applicator has particular utility for applying a topical or transdermal testosterone composition to the skin of a patient in need of testosterone replacement therapy.
摘要翻译：提供了一种用于将流体施加到表面的施加器，所述施加器包括包括上外表面和下保持表面的支撑件; 包括中心开口的柔性膜，包括下端和上端的内壁，至少部分地围绕所述支撑件的上外表面的外壁，所述外壁包括下端和上端，以及上端连接内壁和外壁上端的折叠壁; 以及用于将柔性膜的内壁的下端牢固地固定到支撑体的上外表面的膜保持器; 其中所述膜保持器的上表面和所述柔性膜的内壁限定用于保持流体的储存器，并且其中所述柔性膜的外壁的下端相对于所述柔性膜的所述上外表面自由地轴向移动当压力施加到柔性膜的上折叠壁时的支撑。在一个实施方案中，施用器具有将局部或透皮睾酮组合物施用于需要睾酮替代疗法的患者皮肤的特殊用途。

9. 发明授权

US08969623B2 Method for the preparation of cinacalcet and intermediates and impurities thereof 有权
标题翻译：西那卡塞及其中间体及其杂质的制备方法
公开(公告)号：US08969623B2
公开(公告)日：2015-03-03
申请号：US14052116
申请日：2013-10-11
申请人： Amneal Pharmaceuticals, LLC , Megafine Pharma (P) Ltd.
发明人： Vijayavitthal Thippannachar Mathad , Navnath Chintaman Niphade , Gorakshanath Balasaheb Shinde , Sharad Subhash Ippar , Shrikant Prataprao Deshmukh , Raghavendra Kumar Panchangam
IPC分类号： C07C209/00 , C07C209/62 , C07C209/86 , C07C211/08 , C07C249/02 , C07C251/30 , C07C211/30 , C07C251/16 , C07C251/24 , C07C251/06
CPC分类号： C07C209/62 , C07B2200/07 , C07B2200/13 , C07C211/30 , C07C249/02 , C07C251/06 , C07C251/16 , C07C251/24 , C07C251/30
摘要： A method for the preparation of Cinacalcet is disclosed comprising treating (R)-1-naphthyl ethylamine with an aromatic aldehyde to form (1R)-1-(2-naphthyl)-N-(aryl methylene)ethanamine derivative of Formula (IV), which is further treated with 1-(3-halopropyl)-3-(trifluoromethyl)benzene of Formula (V) to obtain an iminium salt of Formula (VI), followed by hydrolysis to obtain Cinacalcet free base.
摘要翻译：公开了制备西那卡塞的方法，其包括用芳族醛处理（R）-1-萘基乙胺以形成式（IV）的（1R）-1-（2-萘基）-N-（芳基亚甲基）乙胺衍生物，其进一步用式（V）的1-（3-卤代丙基）-3-（三氟甲基）苯处理，得到式（VI）的亚铵盐，随后水解得到西那卡塞游离碱。

10. 发明授权

US11491125B1 Baclofen formulations and methods of minimizing patient exposure to metabolite variations 有权
公开(公告)号：US11491125B1
公开(公告)日：2022-11-08
申请号：US17489343
申请日：2021-09-29
申请人： AMNEAL PHARMACEUTICALS LLC
发明人： Leonard O'Mahony , Sharon Hamm , John Devane , David Penake
IPC分类号： A61K31/197
摘要： Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure to baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.

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