<<

Mar. 2021 API PRODUCT PORTFOLIO

API PRODUCT INDICATION CEP/DMF MICRONIZED

Arformoterol tartrateP polymorph A and D COPD √ US-CN DMF fumarate and COPD √ CEP / US-JP-KR-CN DMF Glycopyrronium bromideP COPD √ CEP / US-CN DMF maleateP Asthma and COPD √ EU/US DMF xinafoateP Asthma and COPD √ CEP / US-CN-KR DMF COPD √ CEP / US-CN DMF trifenatate Asthma and COPD √ EU DMF

API PRODUCT PIPELINE

TECHNICAL VALIDATION PRODUCT INDICATION SAMPLES DMF PACKAGE BATCH

Abediterol Asthma and COPD 2023 2023 COPD √ √ √ Q3 2021 Batefenterol COPD 2023 2024 OlodaterolP COPD √ √ √ Q2 2022 COPD Q2 2021 Q4 2021 COPD √ √ Q2 2021 Q4 2021

CEP = Products with Certificate of Suitability / P = Patent applications/granted patents owned by Neuraxpharm

Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorization. In particular these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, i.e. activities carried out to obtain a Marketing Authorization. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

© INKE. All rights reserved. Mar. 2021

API THERAPEUTIC AREA PRODUCT INDICATION CEP/DMF MICRONIZED

Antiallergics LoratadineP Allergy √ JP DMF Antiarrhythmics DronedaroneP & general arrhythmia DMF tartrateP polymorph A and D COPD US-CN DMF Formoterol fumarate Asthma and COPD √ CEP/US-JP-KR-CN DMF Glycopyrronium bromideP COPD √ CEP/ US-CN DMF Antiasthmatics, COPD and Indacaterol maleateP Asthma and COPD √ EU/US DMF respiratory diseases sodiumP Asthma, allergic & seasonal rhinitis EU-JP DMF Salmeterol xinafoateP Asthma and COPD √ CEP/ US-CN-KR DMF Tiotropium Bromide COPD √ CEP/US-CN DMF Vilanterol Trifenatate Asthma and COPD √ EU DMF Aprepitant Emesis US DMF Granisetron baseP Emesis US DMF Antiemetics Granisetron hydrochlorideP Emesis CEP/ US-JP-KR DMF Ondansetron baseP Emesis √ EU-US DMF Ondansetron hydrochlorideP Emesis √ CEP/US DMF Antifungals FluconazoleP Antifungal CEP/US-KR DMF CarvedilolP Hypertension, angina, heart failure JP DMF Enalapril maleateP Hypertension CEP/KR DMF Antihipertensive Imidapril Hypertension EU DMF Hypertension √ CEP/DMF Eletriptan HBrP Migraine √ JP DMF Antimigrainics Rizatriptan benzoateP Migraine √ EU-US DMF ZolmitriptanP Migraine √ EU-US DMF Asenapine maleateP Schizophrenia and acute mania √ JP DMF OlanzapineP Schizophrenia, psychosis EU-US- DMF Antipsychotics hemifumarate P Schizophrenia, psychosis JP-KR DMF RisperidoneP Schizophrenia, psychosis √ CEP/US-KR DMF Prasugrel baseP Prophylaxis and therapy of thrombosis EU DMF Antithrombotics Rivaroxaban Thrombosis. Stroke DMF Spasmolytic EU DMF

CEP = Products with Certificate of Suitability / P = Patent applications/granted patents owned by Neuraxpharm

Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorization. In particular these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, i.e. activities carried out to obtain a Marketing Authorization. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

© INKE. All rights reserved. Mar. 2021

TECHNICAL VALIDATION THERAPEUTIC AREA PRODUCT INDICATION SAMPLES DMF PACKAGE BATCH

Abediterol Asthma and COPD 2023 2023

Aclidinium bromide COPD √ √ √ Q3 2021

Batefenterol COPD 2023 2024 Antiasthmatics, COPD and respiratory diseases OlodaterolP COPD √ √ √ Q2 2022

Revefenacin COPD Q2 2021 Q4 2021

Umeclidinium bromide COPD √ √ Q2 2021 Q4 2021

Antihipertensive ClevidipineP Hypertension √ √ √ Q2 2021

Benserazide Parkinson’s disease Q2 2021 Q1 2022 Antiparkinson Huntington’s disease chorea and Tetrabenazine √ √ √ √ Tardive dyskinesia pamoate Schizophrenia, psychosis √ √ √ Q4 2021 Antipsychotics Paliperidone Palmitate Schizophrenia, bipolar mania

Tafamidis meglumine Transthyretin amyloidosis √ Q3/Q4 2020 √ Q3 2021 Other disorders Tolvaptan Hyponatremia √ √ Q2 2021 Q1 2022

CEP = Products with Certificate of Suitability P = Patent applications/granted patents owned by Neuraxpharm

Listed products protected by valid patents are developed solely for purposes related to the development, preparation and submission of information to obtain a Marketing Authorisation. In particular, these products are under development for uses related to the activities stated in Art. 10.6 of Directive 2001/83/EC amended by the Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2014, i.e. activities carried out to obtain a Marketing Authorisation. None of the products are offered for sale or supplied to countries in which they could be in conflict with valid patents.

© INKE. All rights reserved.