Definition of Generic Medicine:

A generic medicine is a medicine that has the same active ingredient, strength, dosage form, and route of administration as a brand-name medicine that has already been approved by the regulatory authorities. A generic medicine is equivalent to the brand-name medicine in terms of safety, effectiveness, quality, and performance. A generic medicine can be marketed after the patent or other exclusivity rights of the brand-name medicine expire. In conclusion, Generic medicines offer a cost-effective alternative to original medications while maintaining quality and effectiveness. However, the drug’s name, appearance (such as color or form), and packaging may differ from those of the reference medicine. A generic medicine can be identified either by its internationally approved non-proprietary scientific name (INN) or by its own brand name.

A doctor is holding two medicines in his hands.

Q&A:

What Defines a Generic Medicine?

A generic medicine is essentially identical to an authorized medication (the ‘reference medicine’). It shares the same active ingredient, and treats the same conditions, but may differ in name, appearance, or packaging.

Does generic medicine work the same as brand-name medicine?

Yes, in terms of quality, safety, and efficacy, generic medications are the same as brand-name medications. Generic medications have the same active component as brand-name medications and have the same therapy effect. They can only be sold if they fulfill the same quality criteria as the brand-name equivalent. The main distinction between generic and brand-name medications is pricing, as They are often less expensive than brand-name medications. This is due to the fact that generic manufacturers are not required to engage in research and development or marketing of the product. on the other hand, generic drugs may differ from brand-name medicines in terms of form, size, color, packaging, or inactive substances. These distinctions have no bearing on the medicine’s performance or safety.

Why Are Generic Medicines Considered Equal to Original Medications?

Generic medicines contain the same active ingredient as the original, undergoing rigorous approval processes. They must be “bioequivalent,” meaning they work in the body in the same way.

What Does “Bioequivalence” Mean?

Bioequivalence ensures that generic medicines and original products have the same rate and extent of the active substance’s availability in the body when given in the same dose.

How Does the EU Ensure the Quality, Safety, and Efficacy of Medicines?

In the EU, all medicines undergo stringent assessments by authorities to ensure high standards of safety, quality, and effectiveness. These tests apply to both generic and original medicines.

Are There Safety Measures for Generic Medicines?

Yes, manufacturing plants for generic medicines follow Good Manufacturing Practice (GMP) standards. Manufacturers also monitor their products for adverse reactions, just like with original medications.

What Benefits Do Generic Medicines Offer to Patients and Healthcare Budgets?

Generic medicines not only provide patients with quality and safety but also substantial cost savings, often between 20-90%. These savings can be reinvested in healthcare for expensive treatments.

In Which Areas Are Generic Medicines Commonly Used?

Generic medicines are widely used for various conditions, including:

      • Cancer

      • Asthma

      • Parkinson’s disease

      • Diabetes

      • Depression

      • High cholesterol

      • High blood pressure

      • Allergies

      • Alzheimer disease

      • Osteoporosis

      • Viral Infection

      • Bacterial infection

      • Migraine

      • HIV/AIDS

      • Inflammation

      • Skin disease

      • Contraceptives

    And many more ensuring quality care at lower costs.

    How Long Does Patent Protection Last for Medications in the EU?

    Patent protection in the EU typically spans 20 years, with the possibility of extension through Supplementary Protection Certificates (SPCs). Generics become available after the patent expires.

    Can a Medicinal Product Be Covered by Multiple Patents?

    Yes, pharmaceutical products can have numerous patents, including those for new uses or formulations, which can extend market protection.

    What Is “Data Exclusivity”?

    Data exclusivity compensates manufacturers when there’s insufficient patent protection in certain countries. During this period, generic manufacturers are not permitted to seek market authorization.

    How Quickly Can Patients Access Generic Medicines After Patent Expiry?

    The registration of a generic medicine typically takes 1 to 2 years, but various factors can lead to extended delays, such as pricing and reimbursement procedures.

    Do Generic Medicines Makers Use Data from Original Products?

    No, generic medicine applications involve independent research and development, meeting EU requirements and confirming bioequivalence. Safety and efficacy are cross-referenced with data from the original product.

    Why generic medicines are cheaper than brand-name medicines?

    Generic medicines are cheaper than brand-name medicines because they do not have to bear the costs of research, development, testing, and marketing that the original drug companies had to pay. Generic medicines use the same active ingredients and have the same effects as the brand-name medicines, but they can be produced and sold after the patent or exclusivity rights of the original drug expire. This allows more competition and lower prices for the consumers. According to the FDA, generic drugs may cost 80–85% less than their brand-name equivalents.

    References

    1. Generic Drugs: Questions & Answers [FDA]

    2. Generic vs. brand-name medicines [healthdirect]

    3. Discussing Brand Versus Generic Medications [US Pharmacist]

    4. Generic drug [Wikipedia]