GENERIC NON-SEDATING AND LONG-ACTING HISTAMINE ANTAGONIST DRUG FOR THE TREATMENT OF ALLERGIC RHINOCONJUNCTIVITIS AND HIVES. (Q3189865): Difference between revisions

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(‎Changed label, description and/or aliases in en: translated_label)
(‎Removed claim: summary (P836): This project aims to give continuity to the policy on the development of generic medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic specialty of bilastine, 20 mg tablets, for the treatment of allergic rhinoconjunctivitis and hives._x000D_ Currently no generic bilastin is registered on the Spanish market and the planned development must demonstrate its bioe...)
Property / summary
This project aims to give continuity to the policy on the development of generic medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic specialty of bilastine, 20 mg tablets, for the treatment of allergic rhinoconjunctivitis and hives._x000D_ Currently no generic bilastin is registered on the Spanish market and the planned development must demonstrate its bioequivalence with the reference specialty (available in 3 presentations: Bilaxten®, Ibis® and Obalix®)._x000D_ The project is part of the development of generic medicines as a measure of containment of pharmaceutical expenditure and for their implementation the development of an alternative formulation to the reference speciality, through alternative gallnic procedures and processes of formulation and manufacture of the pharmaceutical form envisaged to allow respect for the patent rights and industrial property of the reference speciality._x000D_ The reference medicinal product is protected by the product patent ES 2124167 T3 that will be in force until 2021. In addition, there is another patent for polymorphism that protects a crystalline polymorph (form I) with certain melting point properties._x000D_ Consequently, it is proposed to design a non-infringing development plan, developing an appropriate formulation with a polymorph other than that protected by patent, which is sufficiently robust and stable and does not experience transition problems. A production process is proposed through direct compression._x000D_ 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. (English)
 
Property / summary: This project aims to give continuity to the policy on the development of generic medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic specialty of bilastine, 20 mg tablets, for the treatment of allergic rhinoconjunctivitis and hives._x000D_ Currently no generic bilastin is registered on the Spanish market and the planned development must demonstrate its bioequivalence with the reference specialty (available in 3 presentations: Bilaxten®, Ibis® and Obalix®)._x000D_ The project is part of the development of generic medicines as a measure of containment of pharmaceutical expenditure and for their implementation the development of an alternative formulation to the reference speciality, through alternative gallnic procedures and processes of formulation and manufacture of the pharmaceutical form envisaged to allow respect for the patent rights and industrial property of the reference speciality._x000D_ The reference medicinal product is protected by the product patent ES 2124167 T3 that will be in force until 2021. In addition, there is another patent for polymorphism that protects a crystalline polymorph (form I) with certain melting point properties._x000D_ Consequently, it is proposed to design a non-infringing development plan, developing an appropriate formulation with a polymorph other than that protected by patent, which is sufficiently robust and stable and does not experience transition problems. A production process is proposed through direct compression._x000D_ 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. (English) / rank
Normal rank
 
Property / summary: This project aims to give continuity to the policy on the development of generic medicinal products intended for the treatment of pathologies with high socio-economic impact, and proposes the development of a new generic specialty of bilastine, 20 mg tablets, for the treatment of allergic rhinoconjunctivitis and hives._x000D_ Currently no generic bilastin is registered on the Spanish market and the planned development must demonstrate its bioequivalence with the reference specialty (available in 3 presentations: Bilaxten®, Ibis® and Obalix®)._x000D_ The project is part of the development of generic medicines as a measure of containment of pharmaceutical expenditure and for their implementation the development of an alternative formulation to the reference speciality, through alternative gallnic procedures and processes of formulation and manufacture of the pharmaceutical form envisaged to allow respect for the patent rights and industrial property of the reference speciality._x000D_ The reference medicinal product is protected by the product patent ES 2124167 T3 that will be in force until 2021. In addition, there is another patent for polymorphism that protects a crystalline polymorph (form I) with certain melting point properties._x000D_ Consequently, it is proposed to design a non-infringing development plan, developing an appropriate formulation with a polymorph other than that protected by patent, which is sufficiently robust and stable and does not experience transition problems. A production process is proposed through direct compression._x000D_ 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. (English) / qualifier
point in time: 13 October 2021
Timestamp+2021-10-13T00:00:00Z
Timezone+00:00
CalendarGregorian
Precision1 day
Before0
After0
 

Revision as of 23:22, 12 October 2021

Project Q3189865 in Spain
Language Label Description Also known as
English
GENERIC NON-SEDATING AND LONG-ACTING HISTAMINE ANTAGONIST DRUG FOR THE TREATMENT OF ALLERGIC RHINOCONJUNCTIVITIS AND HIVES.
Project Q3189865 in Spain

    Statements

    contained in NUTS
    Madrid
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    country
    Spain
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    EU contribution
    173,828.5 Euro
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    budget
    347,657.0 Euro
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    co-financing rate
    50.0 percent
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    start time
    3 August 2018
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    end time
    31 December 2020
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    beneficiary name (string)
    LABORATORIOS NORMON, S.A.
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    beneficiary
    Q3158582
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    coordinate location

    40°36'23.69"N, 3°42'23.51"W
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    postal code
    28903
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    summary
    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 bilastina, comprimidos de 20mg, para el tratamiento de la rinoconjuntivitis alérgica y la urticaria._x000D_ Actualmente no figura registrado ningún genérico de bilastina en el mercado español y el desarrollo previsto deberá demostrar su bioequivalencia con la especialidad de referencia (disponible en 3 presentaciones: Bilaxten®, Ibis® y Obalix®)._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 ES 2124167 T3 que estará vigente hasta 2021. Además, hay otra patente de polimorfismo que protege un polimorfo cristalino (forma I) con unas determinadas propiedades de punto de fusión._x000D_ En consecuencia, se plantea diseñar un plan de desarrollo no infringente, desarrollando una formulación adecuada con un polimorfo distinto al protegido por patente, que sea lo suficientemente robusto y estable y que no experimente problemas de transición. Se plantea un proceso productivo mediante compresión directa._x000D_ 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. (Spanish)
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    location (string)
    Tres Cantos
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    Identifiers

    Spanish Kohesio ID
    IDI-20181229
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