GENERIC REVERSIBLE AND DIRECT COMPETITIVE THROMBIN INHIBITOR FOR THE TREATMENT OF THROMBOEMBOLIC EVENTS (Q3175984): Difference between revisions
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(Removed claim: summary (P836): This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pu...) |
(Created claim: summary (P836): This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pulm...) |
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This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pulmonary embolism, and prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with risk factors). In addition, there are 9 other patents related to synthesis, polymorphic forms or pharmaceutical technology of the manufacturing process._x000D_ It is proposed to design a non-infringing development plan, carrying out a strategy of formulation of multi-layer pellets in hard capsules, with strict control of moisture, particle size and appearance of impurities. (English) | |||||||||||||||
| Property / summary: This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pulmonary embolism, and prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with risk factors). In addition, there are 9 other patents related to synthesis, polymorphic forms or pharmaceutical technology of the manufacturing process._x000D_ It is proposed to design a non-infringing development plan, carrying out a strategy of formulation of multi-layer pellets in hard capsules, with strict control of moisture, particle size and appearance of impurities. (English) / rank | |||||||||||||||
Normal rank | |||||||||||||||
| Property / summary: This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pulmonary embolism, and prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with risk factors). In addition, there are 9 other patents related to synthesis, polymorphic forms or pharmaceutical technology of the manufacturing process._x000D_ It is proposed to design a non-infringing development plan, carrying out a strategy of formulation of multi-layer pellets in hard capsules, with strict control of moisture, particle size and appearance of impurities. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 18:37, 12 October 2021
Project Q3175984 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | GENERIC REVERSIBLE AND DIRECT COMPETITIVE THROMBIN INHIBITOR FOR THE TREATMENT OF THROMBOEMBOLIC EVENTS |
Project Q3175984 in Spain |
Statements
416,254.5 Euro
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832,509.0 Euro
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50.0 percent
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4 June 2018
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28 February 2021
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LABORATORIOS NORMON, S.A.
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40°36'23.69"N, 3°42'23.51"W
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28903
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El presente proyecto pretende dar continuidad a la política de desarrollo de especialidades farmacéuticas genéricas destinadas al tratamiento de patologías con alto impacto socioeconómico, y plantea el desarrollo de una nueva especialidad farmacéutica genérica de dabigatran, cápsulas duras de 75mg, 110mg y 150mg, para la prevención y tratamiento de eventos tromboembólicos en pacientes adultos (tratamiento de la trombosis venosa profunda y de la embolia pulmonar, y prevención de ictus y embolia sistémica en pacientes adultos con fibrilación auricular no valvular con factores de riesgo)._x000D_ Actualmente no figura registrado ningún genérico de dabigatran en el mercado español y el desarrollo previsto deberá demostrar su bioequivalencia con la especialidad de referencia (Pradaxa® de Boehringer Ingelheim International GmbH)._x000D_ El proyecto se enmarca en el desarrollo de medicamentos genéricos como medida de contención del gasto farmacéutico y para su ejecución se plantea el desarrollo de una formulación alternativa a la especialidad de referencia, mediante procedimientos galénicos alternativos y procesos de formulación y fabricación de la forma farmacéutica prevista que permitan respetar los derechos de patentes y propiedad industrial de la especialidad de referencia._x000D_ El medicamento de referencia está protegido por la patente de producto ES2199426 T3 que estará vigente hasta 2023. Además, hay otras 9 patentes relacionadas con la síntesis, las formas polimórficas o la tecnología farmacéutica del proceso de fabricación._x000D_ Se plantea diseñar un plan de desarrollo no infringente, realizando una estrategia de formulación de pellets multicapa en cápsulas duras, con un estricto control de la humedad, del tamaño de partícula y de la aparición de impurezas. (Spanish)
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This project aims to give continuity to the policy of development of generic proprietary medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic medicinal product of dabigatran, hard capsules of 75 mg, 110 mg and 150 mg, for the prevention and treatment of thromboembolic events in adult patients (treatment of deep venous thrombosis and pulmonary embolism and pulmonary embolism, and prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with risk factors). In addition, there are 9 other patents related to synthesis, polymorphic forms or pharmaceutical technology of the manufacturing process._x000D_ It is proposed to design a non-infringing development plan, carrying out a strategy of formulation of multi-layer pellets in hard capsules, with strict control of moisture, particle size and appearance of impurities. (English)
12 October 2021
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Tres Cantos
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Identifiers
IDI-20180835
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