When can a brand name drug become a generic?

Answer 1

Generic medications and brand name drugs are considered to be therapeutically equivalent - menaing that they are the same dosage form, have the same active ingredient in it and have passed rigorous in vivo (in the body) tests to assure that they act the same way in the body. However, that being said, some medications, specifically ones where mental issues come into play, like anti-scizophrenic drugs, the patient can effect the outcome. There are many instances of patients such as these decompensating or otherwise suffering adverse effects when switching from the brand to generic or vice versa. It doesn't mean that one is less effective, it just means that the patient perceives it to be different. There have been studies that when the brand and generic look exactly the same, this doesn't happen.

The other time that brand and generic are not "identical" is in drugs that have a narrow therapeutic range, or requiring titrating or monitoring to assure that the correct dose is given. An example of this is thyroid medications. Most doctors prefer not to switch their patients, becasue of the increased monitoring. Not to say the brand is better - but just that there might have to be minor tweaks in the dosage.

As for over the counter drugs - any drug that requires FDA approval prior to marketing that is OTC - like Claritin and its generics, require the same rigorous approval process that prescription drugs require. Other OTC medications, like aspirin, are considered "Monograph", which means that they don't need prior approval for selling it - all you need is an approved manufacturing facility. They are required to test to certain standards, but there is no requirement to test in human subjects.

Brand name drugs enjoy patent protection - only after the patent is expired or the generic company files a claim that they don't infringe on the patent or the patent is unenforcable and that claim is properly adjudicated, can the generic company launch their product.

At this point, any brand name drug can become generic, once the aforementioned patent issues are dealt with. The prior answere about synthroid is incorrect. There are synthroid generics. One class or drugs that has not yet gone generics is biologics, although many generic companies are working on them.

Answer 2

Generic drug versions may be introduced once the patent for the brand-name drug expires. The patent protection for a brand-name drug is usually 20 years from the date of submission of the patent.

Not all brand-name drugs have a generic counterpart. Drug companies can introduce generic versions only after they’ve been thoroughly tested by the manufacturer and approved by the U.S. Food and Drug Administration.
A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

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Answer 3

A generic drug is exactly the same as a brand name drug and which is allowed to be produced after the brand name drug's patent has expired. It is also called a "generic equivalent”. A generic drug may be defined as a drug that is not sold under a brand name; for example, carbamazepine can be obtained as a generic drug or as Tegretol or Carbatrol, its brand names. A generic drug may have the same active ingredient, but not necessarily the same inactive ingredients. The term generic is commonly used to identify a non-brand drug that is sold at a lower cost and generally requires a lower co-payment amount by the member selecting the generic drug.
Hope this helps
Matador 89

Answer 4

After its patent expires - and patent expirations vary by drug. The average is between 1-3 years.

When a brand's patent expires, the company wanting to make the generic form has to complete an Abbreviated New Drug Application for the FDA. Once the FDA approves, they add the drug to their Orange Book (Approved Drugs List) and production can begin.

Answer 5

A generic drug and a brand name drug are the same...its like saying you have a T shirt and an Adidas T shirt. One has a maker brand, the other does not, the non branded item is the same chemically and often very much cheaper.

Answer 6

Both are same. In brand name marketing, marketing expances like sample articles and other offers providing to the doctors and chemists, are included in total MRP of the product, so the rate of that product goes high. At other hand, generic drugs directly sold by chemist over the counter, so they dont need any doctor's prescription, so there will not be any expances for the manufcturing company so overall price of that product will be the lower then the brand product.

the main dis advantage is that, he generic drugs are not lab tasted so there will not be any satisfaction guarantee.

Answer 7

Most medications can become generic at any time. The only major exception is Synthroid (brand name thyroid medication). Once you start taking Synthroid you cannot switch to the generic version (levothyroxine) and vise-versa. Otherwise all generic and brand name drugs have the same effect on the body.