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Generic Drug

A generic drug is created to be identical to an already marketed brand-name drug in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help demonstrate bioequivalence, which means that a generic drug works the same way and provides the same clinical advantage as the brand-name drug. In other words, you can get a generic drug as an equivalent substitute for its brand-name counterpart. To submit your article or draft, send us an email at

Does each Brand Name Drug have a Generic Drug?

Not at the start. New drugs are developed under patent defense, and most drug patents protect for 20 years following filing with the FDA. However, researching and bringing the brand name drug to market can take many years. As the patent expires, other pharmaceutical companies seek FDA approval to sell the drug’s generic version.

A generic drug can be “provisionally approved” by the FDA before the patent on the brand name product expires. Various companies may manufacture and sell generic versions of the branded product. However, several drugs may never have a generic because manufacturers may find these products unprofitable or too difficult to manufacture.

Generic Drug
A complete list of products will appear, including generic and brand names and the manufacturer’s name.

If the “TE” (therapeutic equivalence) code starts with the alphabet “A”, then this product is therapeutically equivalent to its reference medicine (RLD), which is the brand name medicine.

For example, several ibuprofen products are considered therapeutically equivalent to Motrin (the RLD).

Since there is a lag between the approval of generic products and their appearance in the “Orange Book”, you should also check the most recent monthly generic approvals from the FDA first.

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