An original medicinal product is an innovative drug first introduced to the market with a new active ingredient that has undergone a full cycle of preclinical and clinical trials confirming its quality, efficacy and safety, and is protected by a patent for a specified period. After the patent protection expires, other pharmaceutical companies can produce generics – similar copies of the original drug with the same active ingredient.

Key characteristics of original drugs:

• Innovation:
  The original drug is developed from scratch and contains a new, previously unsynthesised active ingredient.
• Proven efficacy and safety:
  The drug has undergone all the necessary stages of research (preclinical and clinical trials) confirming its quality, safety and efficacy for treatment.
• Patent protection:
  The original drug is protected by a patent, which gives the developer company exclusive rights to manufacture and sell it for a specified period.
• High cost:
  Due to research and development costs, original drugs are usually more expensive than their analogues.

Generic (or reproduced drug) is a copy of the original drug that appears on the market after the expiry of the patent protection period.

• Similar composition:
  Generic drugs contain the same active ingredient as the original drug in the same dosage form.
• Proven bioequivalence:
  Generics must also undergo studies proving their bioequivalence (identical action) to the original drug.
• Lower price:
  Since generic manufacturers do not incur the costs of developing a new drug, they can offer their products at a lower price.