Importance of patents and data exclusivity in fixed-dose combination medicinal products

Guideline on clinical development of fixed combination medicinal products

Guideline on Clinical Development of Fixed Combination Medicinal Products

DISCUSSION IN THE EFFICACY WORKING PARTY June – October 1994 TRANSMISSION TO THE CPMP October 1994 TRANSMISSION TO INTERESTED PARTIES October 1994 DEADLINE FOR COMMENTS 15 April 1995 RE-SUBMISSION TO THE EFFICACY WORKING PARTY October 1995 RE-SUBMISSION TO THE CPMP November 1995 RE-SUBMISSION TO THE EFFICACY WORKING PARTY March 1996 RE-SUBMISSION TO THE CPMP March 1996 APPROVAL BY THE CPMP 17 A...

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

INTRODUCTION Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. OBJECTIVES Trends in FDA approved FDC in the period 1980-2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity...

Fixed-dose combination Therapy in Hypertension: Focus on Fixed-dose combination of Amlodipine and Valsartan (exforge®)

Hypertension is the leading cause of disability and cardiovascular mortality world-wide. Approximately one-third of the US adult population and over a billion people world-wide have hypertension. Despite increased awareness of hypertension and availability of many effective antihypertensive agents, only one third of patients achieve their target blood pressure (BP). All expert panels now recomm...

Formulation and Evaluation of Fixed Dose Combination Products of Rifampicin and Isoniazid with Improved Rifampicin Stability

Introduction: One of the main reasons for the development of the resistance in the therapy for Tuberculosis is the mono drug therapy. This may be due to the drug-drug interactions as the therapy includes combination of various drugs leading to poor bioavailability of these drugs. One such reported interaction is between Rifampicin and Isoniazid which leads to poor bioavailability of Rifampicin....