Concept of Generics in Pharmaceuticals.


  • Introduction:

    • In the realm of pharmaceuticals, generic drugs play a pivotal role in ensuring accessibility, affordability, and widespread availability of essential medications. Let’s see the fundamental aspects of generics.

  • What Are Generic Drugs?

  • Definition: Generic drugs are equivalent copies of brand-name (innovator) drugs.

  • Bioequivalence: Generic drugs have the same active ingredients, dosage form, strength, route of administration, and intended use as their innovator counterparts.

  • Regulatory Approval: Generic drugs undergo a streamlined approval process based on abbreviated new drug applications (ANDAs).

  • Cost-Effectiveness: Since generic manufacturers don’t invest in extensive research, these drugs are usually more cost-effective.

Key Points of Generic Drugs:

  • Bioequivalence: Generics are bioequivalent to their innovator counterparts, meaning they produce similar therapeutic effects.

  • Quality Assurance: Regulatory agencies ensure that generic drugs meet stringent quality standards.

  • Interchangeability: Generic drugs can often be interchanged with brand-name drugs without compromising safety or efficacy.

  • Patent Expiry: Generic versions become available once the innovator drug’s patent protection expires.

  • Therapeutic Equivalence: Generics are therapeutically equivalent to brand-name drugs.


Innovator Drugs

Generic Drugs


Pioneering, significant R&D

Replication of existing drug

Patent Protection

Exclusive rights (20 years)

No patent protection



More affordable

Approval Process

Extensive clinical trials

Streamlined ANDA process


Remember that genetics contribute to global healthcare by making essential treatments accessible to a broader population.

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