An originator medicinal product is an innovative medicine introduced to the market for the first time with a new active substance. It has undergone a full programme of preclinical and clinical studies confirming its quality, efficacy and safety, and is protected by a patent for a specified period. Once the patent protection expires, other pharmaceutical companies may manufacture generic medicines - equivalent versions of the originator product containing the same active substance.

Main characteristics of originator medicinal products:

• Innovation:
  The originator medicine is developed from the ground up and contains a new active substance that has not previously been synthesised.
• Proven efficacy and safety:
  The medicine has successfully completed all required stages of research, including preclinical studies and clinical trials, confirming its quality, safety and therapeutic efficacy.
• Patent protection:
  The originator medicine is protected by a patent, granting the developer exclusive rights to manufacture and market it for a specified period.
• Higher cost:
  Due to the significant investment required for research and development, originator medicines are generally more expensive than their generic equivalents.

A generic medicine is a version of an originator medicinal product that becomes available after the original product's patent protection has expired.

• Equivalent composition:
  A generic medicine contains the same active substance as the originator product and is supplied in the same pharmaceutical dosage form.
• Proven bioequivalence:
  Generic medicines must undergo studies confirming that they are bioequivalent to the originator product and produce the same therapeutic effect.
• Lower price:
  Because generic manufacturers do not bear the full cost of developing a new medicine, they can usually offer their products at a lower price.