Branded generic is a generic drug, which is manufactured by either original manufacturer after patent expiry of the brand, or is manufactured by a generic manufacturer. Branded generic has to go through abbreviated new drug application (ANDA) process before it can be marketed. Branded generic are cheaper than their branded counterparts but can be costlier than generic versions of the drug. Branded generic is defined as a product that is a novel dosage form of a branded off-patent medicine, and is manufactured by a different manufacturer than originator, or a molecule copy of an off-patent product with a trade name. Branded generics can also be different salts of an FDA-approved brand name drug.
It is easy to confuse branded generics with authorized generics, but they are not the same. Branded generics go through the same FDA approval process as other generics after branded drug patents expire. Authorized generics, however, are created by makers of branded drugs, under the same NDA (New Drug Approval) authorization as the original branded drug, and they may be sold before drug patents expire.
Market Dynamics
Rising ANDA approvals is a major factor which is supporting the market growth. According to an article published by Delhi Pharmaceutical Sciences & Research University on March 7 2023, a total of 742 Abbreviated New Drug Application (ANDA) approvals were granted during the calendar year 2022, registering a growth of 17% over last year. Additionally, 136 Tentative Approvals were also granted, again a similar growth over 2021 numbers (117) as seen for final ANDA approvals. Indian players contributed a large proportion of the incremental number of approvals this year with 88 more approvals than last year. Additionally, demand for generic medications is in surge owing to the affordable prices of branded generics.
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