What are generic drugs?
Generic drugs use the same active ingredients as the original brand name products, and are generally available in the same strengths and dosage forms as the original. A generic drug must be bioequivalent to the original brand name drug and should meet the same quality standards as the innovative drug.
What are innovative drugs?
An innovative drug is often the result of research and development of a new drug chemical. The developer of such a drug will usually produce it or license its production and typically take out a patent to protect it. Having a patent effectively enables the developer to market the drug product on an exclusive basis for a predetermined period once it is approved by the relevant health authority. When an innovator company develops a new drug, the drug is typically known both by its generic name - the name of the active ingredient - and by its brand name, which is the name under which the manufacturer markets the product.
How does a drug innovator protect its product?
When a developer of a new drug chemical believes it has a useful product, it may decide to apply for a patent, which if granted, will typically last for twenty years, depending on the jurisdiction in which its issued. This means that, among other rights, that the drug developer - the originator of the drug - has the sole right to obtain regulatory approval of, manufacture and market the drug, or license others to do so, during the life of the patent. Also, the brand name of an innovative drug is often protected as a trade mark and cannot be used by any other party. Developers often secure additional and ancillary patents after the initial patent is issued, in order to prolong their period of exclusivity.
What happens when the patent on a brand name drug expires?
Once the patent on an innovative drug expires, the drug may be manufactured and sold by other companies under a different brand name, or under its generic name, once regulatory approval is obtained. When the drug is to be sold under its generic name it is referred to as a generic drug. All manufacturing and marketing of the generic drug must be conducted in strict compliance with the guidelines established by the relevant regulatory health authorities in the countries where the drug is to be manufactured and marketed.
Does every brand name drug have a generic counterpart?
No. If a generic version of a drug is not developed by anyone, even after expiration of the patent on an innovative drug, the innovative drug would still remain the only approved product available. Sometimes a generic version is approved and available in a specific country or countries, whilst in other countries the innovative drug remains the only drug on the market. However, with the growing emphasis on generics, it's rare that a generic version or more than one generic version of a drug is not developed around about the time that its innovative counterpart comes "off patent". The reason for not doing so may be, for example, a complex manufacturing process of a drug designed for a limited use, where the cost of developing and selling a generic version of the drug would not be viable.
What are the manufacturing standards for generic drugs?
The manufacturing facilities and processes of all pharmaceutical companies, whether they are makers of innovative or generic drugs, must adhere to strict quality control procedures and standards, and are subject to stringent inspections by regulatory health authorities. The approval process is complex for both innovative and generic manufacturing facilities. Many pharmaceutical companies that make innovative drugs also make drugs sold under generic labels.
What is the quality of generic drugs?
To be considered bioequivalent to its innovative counterpart, a generic drug must not only have the same active pharmaceutical ingredient, but the rate and extent of absorption of its active ingredient into the bloodstream must also be the same or similar, within ranges designated and approved by the relevant regulatory health authority. (Most oral medications must be absorbed into the bloodstream before they can produce the medical results your physician is trying to achieve). If the regulatory authority is satisfied with the tests submitted by the manufacturers for its review, the authority rates the generic drug as bioequivalent to the brand, which means that the generic version is acknowledged as having the same therapeutic effect as the innovative drug.
Does a generic drug look the same as its brand name equivalent?
Sometimes the generic version of a drug may have a different color or shape from its brand name counterpart. These differences have no effect on the medical action of the drug. They are created simply to distinguish the appearance of one drug from another.
Are generic drugs as safe and effective as brand name drugs?
The approval of a generic version of a drug means that it has been tested for bioequivalence, which ensures that the safety and efficacy standards of generic drugs are the same as brand name drugs. The manufacturing process of generic drugs is strictly regulated according to standards which rank with the manufacturing process of original innovative drugs.
Is generic drug production just copying brand name drugs?
Developing and manufacturing generic drugs is a complex process. The generic manufacturer must first show that it uses the same active ingredient in the same quantity as that found in the innovative drug. It must then prove that the generic product demonstrates, in the human body, a rate of absorption of the active ingredient and levels of concentration in the blood similar to those of the innovative drug (bioequivalence).
Why are generic drugs dispensed?
The time required to develop a generic drug is shorter and the costs much lower than that of an innovative medicine. Therefore, generic drug manufacturers can typically afford to sell their generic drugs for a lower price than their innovative counterparts. By passing this cost benefit on to the consumer, the generic drug industry helps make medications accessible to individuals who might otherwise not be able to afford them.
Generic drugs use the same active ingredients as the original brand name products, and are generally available in the same strengths and dosage forms as the original. A generic drug must be bioequivalent to the original brand name drug and should meet the same quality standards as the innovative drug.
What are innovative drugs?
An innovative drug is often the result of research and development of a new drug chemical. The developer of such a drug will usually produce it or license its production and typically take out a patent to protect it. Having a patent effectively enables the developer to market the drug product on an exclusive basis for a predetermined period once it is approved by the relevant health authority. When an innovator company develops a new drug, the drug is typically known both by its generic name - the name of the active ingredient - and by its brand name, which is the name under which the manufacturer markets the product.
How does a drug innovator protect its product?
When a developer of a new drug chemical believes it has a useful product, it may decide to apply for a patent, which if granted, will typically last for twenty years, depending on the jurisdiction in which its issued. This means that, among other rights, that the drug developer - the originator of the drug - has the sole right to obtain regulatory approval of, manufacture and market the drug, or license others to do so, during the life of the patent. Also, the brand name of an innovative drug is often protected as a trade mark and cannot be used by any other party. Developers often secure additional and ancillary patents after the initial patent is issued, in order to prolong their period of exclusivity.
What happens when the patent on a brand name drug expires?
Once the patent on an innovative drug expires, the drug may be manufactured and sold by other companies under a different brand name, or under its generic name, once regulatory approval is obtained. When the drug is to be sold under its generic name it is referred to as a generic drug. All manufacturing and marketing of the generic drug must be conducted in strict compliance with the guidelines established by the relevant regulatory health authorities in the countries where the drug is to be manufactured and marketed.
Does every brand name drug have a generic counterpart?
No. If a generic version of a drug is not developed by anyone, even after expiration of the patent on an innovative drug, the innovative drug would still remain the only approved product available. Sometimes a generic version is approved and available in a specific country or countries, whilst in other countries the innovative drug remains the only drug on the market. However, with the growing emphasis on generics, it's rare that a generic version or more than one generic version of a drug is not developed around about the time that its innovative counterpart comes "off patent". The reason for not doing so may be, for example, a complex manufacturing process of a drug designed for a limited use, where the cost of developing and selling a generic version of the drug would not be viable.
What are the manufacturing standards for generic drugs?
The manufacturing facilities and processes of all pharmaceutical companies, whether they are makers of innovative or generic drugs, must adhere to strict quality control procedures and standards, and are subject to stringent inspections by regulatory health authorities. The approval process is complex for both innovative and generic manufacturing facilities. Many pharmaceutical companies that make innovative drugs also make drugs sold under generic labels.
What is the quality of generic drugs?
To be considered bioequivalent to its innovative counterpart, a generic drug must not only have the same active pharmaceutical ingredient, but the rate and extent of absorption of its active ingredient into the bloodstream must also be the same or similar, within ranges designated and approved by the relevant regulatory health authority. (Most oral medications must be absorbed into the bloodstream before they can produce the medical results your physician is trying to achieve). If the regulatory authority is satisfied with the tests submitted by the manufacturers for its review, the authority rates the generic drug as bioequivalent to the brand, which means that the generic version is acknowledged as having the same therapeutic effect as the innovative drug.
Does a generic drug look the same as its brand name equivalent?
Sometimes the generic version of a drug may have a different color or shape from its brand name counterpart. These differences have no effect on the medical action of the drug. They are created simply to distinguish the appearance of one drug from another.
Are generic drugs as safe and effective as brand name drugs?
The approval of a generic version of a drug means that it has been tested for bioequivalence, which ensures that the safety and efficacy standards of generic drugs are the same as brand name drugs. The manufacturing process of generic drugs is strictly regulated according to standards which rank with the manufacturing process of original innovative drugs.
Is generic drug production just copying brand name drugs?
Developing and manufacturing generic drugs is a complex process. The generic manufacturer must first show that it uses the same active ingredient in the same quantity as that found in the innovative drug. It must then prove that the generic product demonstrates, in the human body, a rate of absorption of the active ingredient and levels of concentration in the blood similar to those of the innovative drug (bioequivalence).
Why are generic drugs dispensed?
The time required to develop a generic drug is shorter and the costs much lower than that of an innovative medicine. Therefore, generic drug manufacturers can typically afford to sell their generic drugs for a lower price than their innovative counterparts. By passing this cost benefit on to the consumer, the generic drug industry helps make medications accessible to individuals who might otherwise not be able to afford them.
