Generic Drugs Print E-mail

Generic medicinal product contains the same qualitative and quantitative content as active ingredients, has the same pharmaceutical form as the original formulation and must be bioequivalent to original medical product with respect to acceptable bioavailability studies.

According to "Regulation on the registration of medicinal products for human use" Article 9, generic products get registration via abbreviated applications. If there is a data protection for the original product, the abbreviated application for the generic drug can be done after 6 years from the first registration date of original product in Customs Union Area.

In the first sentence of Article 9 it is indicated that, In the Abbreviated applications, Decree Law. No 551 pertaining to Protection of Patent Rights decisions dated 24/6/1995 is valid.

According to article of Decree Law No 551 pertaining to Protection of Patent Rights which indicates exception of patent rights, drug registration studies not exist in patent rights scope.

According to another description; equivalent drugs are the products which have the same properties with reference drug and these products can be marketed after expire of the reference drug protection time.

Reference drugs protection time is determined by basic patent that related to subject drug. Generic products can be marketed only after expire of the basic drug patent.

Besides base drug patent, Original manufacturers take out various secondary patents for preventing or delaying the generic drug competition. This is a patent strategy for original manufacturers (evergreening). Secondary patents can protect secondary properties of product that include some changes/modifications like as new polymorph, new hydrate, new solvates, new particle size, new intermediate, new formulation, new dosage form.

Generic products that are marketed after expire of base patent should not infringe on secondary patents.

For that reason patent profile studies must begin at the early of project stage and patent studies must execute in coordination together with registration studies.

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