A medicine is a substance used for the diagnosis, prevention, treatment, or relief of disease. Medicines are broadly classified into branded and generic forms, where branded medicines are innovator products marketed under a trade name, and generic medicines are equivalent versions introduced after patent expiry with the same safety and efficacy.
Branded medicine
A branded medicine, also known as an innovator drug, is a medicinal product marketed under a proprietary trade name by the patent holding company and is protected by intellectual property rights for a defined period.
Generic medicine
generic drug product is defined as one that is pharmaceutical product manufactured after patent expiry that is interchangeable with the innovator which is equivalent and bioequivalent to an innovator drug product.
Process of Development of Branded Medicines
Drug Discovery
↓
Pre-clinical Studies
(Lab & Animal testing)
↓
Clinical Trials
(Phase I → II → III)
↓
Patent Application
(20 years protection)
↓
Regulatory Approval
(CDSCO / FDA / EMA)
↓
Large-scale Manufacturing
↓
Brand Name Marketing
↓
BRANDED MEDICINE
Development and Approval Process of Branded Medicines
Patent Expiry of Branded Drug
↓
Formulation Development
(Same active ingredient)
↓
Bioequivalence Studies
(Compare with brand)
↓
Regulatory Approval
(CDSCO / FDA)
↓
GMP Manufacturing
↓
Generic / Branded Generic Marketing
↓
GENERIC MEDICINE
Branded medicines are preferred for patients in critical or unstable conditions, such as those in emergency care or ICU, patients taking narrow therapeutic index drugs, and those requiring biologics or special dosage forms, where strict dose accuracy and consistent drug levels are essential.
Generic medicines are appropriate for stable patients with common illnesses or long term conditions, especially elderly or cost sensitive patients, as they provide the same therapeutic benefit with better affordability and adherence.
MBH/AB