Generic medications: definition, legal regulation, and effectiveness!

Generic is a drug that is sold under an international nonproprietary name or under a patented name, different from the brand name of the drug developer. In fact, generic is an analog of a certain pharmacological drug, but its components and the form of release are not the same.

International legal regulation of generics

In accordance with the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS Agreement), generic drugs are medications, whose active ingredient has expired for patent protection, or patents-protected drugs that are issued under a compulsory license. The terms of patent protection vary from country to country.

With the expiry of the patent or other exclusive rights, legislative restrictions on the sale of the medicinal product are no longer valid, and only then other drugmakers will be able to produce generics (that is, to reproduce the formula of the original drug in their manufacturing facilities) according to international and local rules.

Advantages and disadvantages of generics

One of the main advantages of generics is their low cost (cheap Viagra online produced as generic is not uncommon now), which means that patients and medical organizations can afford them. This is achieved by the absence of expenses on development, clinical trials, licensing payments, etc. But the low cost of generics is also their drawback. It can be the cause of incomplete compliance with the original drug according the pharmacokinetics, the differences in the auxiliary substances in the medication, etc. Low-quality generics can have lower efficiency and are associated with other side effects, than original medication may cause. For instance, generic Viagra online is often counterfeited. Some sellers offer “female Viagra” but this drug isn’t approved to treat sexual dysfunction in females. There is the only drug in this area, which is called flibanserin. But it has different mechanism of action and cannot be called “Viagra”.

Do generics work as well as the original drugs?

The Medical Letter magazine has recently summarized some studies that evaluated the clinical effects of taking genetics, instead of original drug:

  • A systematic review of 47 studies of cardiovascular drugs has not found evidence that the original drugs have advantages in terms of clinical outcomes.
  • A randomized controlled research in which the original antibiotic was compared with a generic drug did not show any difference in clinical effects.
  • The FDA conducted its own assessment of proton pump inhibitors (such as Prilosec & Losec). All 5 generic meds met dissolution standards.
  • Retrospective studies related to antiepileptic drugs have revealed indications of therapeutic non-equivalence. Limitations of these studies (patients switching to drugs from other manufacturers could be something different from those people who did not do this) do not allow to do a final conclusion.