GENERIC DRUG IN COMBINATION OF AN ALPHA-BLOCKER AND AN ANTICHOLINERGIC FOR THE TREATMENT OF SYMPTOMS OF BENIGN PROSTATE HYPERPLASIA (Q3173737): Difference between revisions
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(Removed claim: summary (P836): This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the ref...) |
(Created claim: summary (P836): This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the refer...) |
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This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English) | |||||||||||||||
| Property / summary: This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English) / rank | |||||||||||||||
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| Property / summary: This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 21:22, 12 October 2021
Project Q3173737 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | GENERIC DRUG IN COMBINATION OF AN ALPHA-BLOCKER AND AN ANTICHOLINERGIC FOR THE TREATMENT OF SYMPTOMS OF BENIGN PROSTATE HYPERPLASIA |
Project Q3173737 in Spain |
Statements
450,404.0 Euro
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900,808.0 Euro
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50.0 percent
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16 November 2018
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31 July 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 plantea el desarrollo de una nueva especialidad farmacéutica genérica de tamsulosina-solifenacina, comprimidos de liberación modificada, a una dosis de 0,4mg de tamsulosina y 6mg de solifenacina, para el tratamiento de los síntomas de llenado y vaciado asociados a la hiperplasia benigna de próstata (HBP)._x000D_ Actualmente no figura registrado ningún genérico de esta combinación en el mercado español y el desarrollo previsto deberá demostrar su bioequivalencia con la especialidad de referencia (Volutsa® / Vesomni® de Astellas Pharma, S.A.)._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 una patente de uso de la combinación de tamsulosina y solifenacina, y por otras 4 patentes de tecnología farmacéutica._x000D_ Se plantea diseñar un plan de desarrollo no infringente, desarrollando una formulación adecuada para una composición farmacéutica de liberación prolongada con polióxidos de etileno, excipientes y aglutinantes distintos a los reivindicados por patente. Las fases del desarrollo de la especialidad del proyecto se van a centrar en la formulación galénica de la nueva especialidad farmacéutica genérica, en la realización de los estudios de bioequivalencia y la preparación de la documentación para registro. NORMON contará con la colaboración de la Fundación de Investigación Biomédica del Hospital Universitario de la Princesa y de Anapharm Europe, S.L. para llevar a cabo los estudios de bioequivalencia y los bioanálisis asociados (Spanish)
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This project raises the development of a new generic pharmaceutical speciality of tamsulosin-solifenacin, modified release tablets, at a dose of 0.4 mg tamsulosin and 6 mg solifenacin, for the treatment of filling and emptying symptoms associated with benign prostate hyperplasia (BPH)._x000D_ Currently no generic of this combination is registered on the Spanish market and the planned development will demonstrate its bioequivalence with the reference specialty (Volutsa®/Vesomni® of Astellas Pharma, S.A.). The phases of the development of the specialty of the project will focus on the galenical formulation of the new generic pharmaceutical specialty, the conduct of bioequivalence studies and the preparation of the documentation for registration. Normon will have the collaboration of the Biomedical Research Foundation of the Hospital Universitario de la Princesa and Anapharm Europe, S.L. to carry out the bioequivalence studies and associated bioanalysis (English)
12 October 2021
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Tres Cantos
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Identifiers
IDI-20190021
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