A generic drug (pl. generic drugs, short: generics) is a drug which is produced and distributed without patent protection. A generic must contain the same active ingredients as the original formulation. In most cases, it is considered bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are assumed to be identical in dose, strength, route of administration, safety, efficacy, and intended use. In most cases, generic products are not available until the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. Drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

A drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. The name of the active ingredient is established by a government or international body, and is typically the U.S. Adopted Name, British Approved Name, or International Nonproprietary Name. Generic drugs must contain the same active ingredients that their brand name counterparts do and are tested to assure that they are therapeutically equivalent, but they may contain different inactive ingredients from those found in the brand name medications.

There are generic versions of both over-the-counter and prescription medications, but not all drugs have generic equivalents. Generic drugs can only be produced when a patent on a brand name drug expires or when a patent has never existed. They are generally cheaper than the equivalent brand name drug because of much lower marketing and development costs. Because a generic competitor can hurt a brand name manufacturer’s profits, drug companies have used legal action and regulatory delays to slow the introduction of generics, or have paid generic manufacturers to postpone the production and marketing of generics. The Medicare overhaul legislation passed in 2003 contained sections designed to speed the introduction of generic drugs by making it easier to challenge weak or invalid drug patents.

When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it. Generic drugs can be legally produced for drugs where: 1) the patent has expired, 2) the generic company certifies the brand company’s patents are either invalid, unenforceable or will not be infringed, 3) for drugs which have never held patents, or 4) in countries where a patent(s) is/are not in force.[citation needed] The expiration of a patent removes the monopoly of the patent holder on drug sales licensing. Patent lifetime differs from country to country, and typically there is no way to renew a patent after it expires. A new version of the drug with significant changes to the compound could be patented, but this requires new clinical trials and does not prevent the generic versions of the original drug.

This allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell that drug. Since the drug has already been tested and approved, the cost of simply manufacturing the drug will be a fraction of the original cost of testing and developing that particular drug.

The principal reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies also incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. For example Thailand is going to import millions of pills of the generic version of Plavix, a blood-thinning treatment to prevent heart attacks, at a cost of 3 US cents per pill from India, the leading manufacturer of generic drugs.

Generic manufacturers do not incur the cost of drug discovery, and instead are able to reverse-engineer known drug compounds to allow them to manufacture bioequivalent versions. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company. In most countries, generic manufacturers must only prove that their preparation is bioequivalent to the existing drug in order to gain regulatory approval. It has been estimated that the average cost to brand-name drug companies of discovering and testing a new innovative drug (with a new chemical entity) may be as much as $800 million.

Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name drug company, including media advertising, presentations by drug representatives, and distribution of free samples. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded name).

Prior to the expiration of a drug patent, a brand name company enjoys a period of “market exclusivity” or monopoly, in which the company is able to set the price of the drug at the level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development. The advantage of generic drugs to consumers comes in the introduction of competition, which prevents any single company from dictating the overall market price of the drug. With multiple firms, the profit-maximizing price generally reflects the ongoing cost of producing the drug, which is usually much lower than the monopoly price.

For as long as there has been baldness, it seems, there have been efforts to cure it: oils and creams, toupees and transplants, not to mention what hair stylists gingerly term ”the comb-over.” But as much as some men may have wanted one, there has never been a baldness pill — until now.

The Food and Drug Administration announced today that it had given Merck & Company, the maker of crucial treatments for heart disease, osteoporosis and AIDS, permission to sell a tiny tan octagonal tablet that, experiments show, either promoted the growth of hair or at least stopped hair loss in 83 percent of men who took it.

There are, however, some drawbacks: The pill, which will be marketed as a prescription medicine under the brand name Propecia, can cause birth defects and so is not approved for women. It is useful only for the genetic condition known as male pattern baldness. It must be taken once a day, every day, for the rest of a bald man’s life. And it carries a slight risk of impotence, lasting as long as it is taken.

”This is not a panacea,” said Dr. E. William Frank, a dermatologist at Beth Israel Deaconess Medical Center in Boston who has been following the progress of the drug during testing. ”It’s not going to grow hair on the pate of every man who takes it. But the clinical studies which have been done so far are promising.”

Critics say the idea of a prescription drug for baldness is frivolous, and complain that no long-term studies have been conducted on the drug.

”It is a cosmetic issue,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, an advocacy organization in Washington. ”What is the risk that we are trading off for a cosmetic benefit?”

And John T. Capps 3d, founder of Bald-Headed Men of America, a support group for bald men, said no right-thinking bald man would even consider a pill.

”We believe that skin is in,” Mr. Capps said.

Under this process, the generic manufacturer uses the safety and efficacy data supplied by the brand company, and must only prove to the FDA that its generic product is equivalent to the branded product. The FDA does not require the generic company to conduct separate and complete clinical studies for safety and efficacy because the brand drug has been used safely for many years.

In order to receive FDA approval, a generic must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, same amount of drug absorbed over the same time, and same clinical effect as the brand product.

The FDA also requires that a generic company’s manufacturing methods conform to current good manufacturing practices (cGMP), as defined in the U.S. Code of Federal Regulations. The company must follow the cGMPs in all phases of the manufacturing process, and continually monitor compliance and measure quality control.

Once all FDA requirements are met, a generic drug is given approval and typically dispensed under the chemical name of the active ingredient, although generic manufacturers may also choose to market specific generic drugs under a unique trade-name. Occasionally generics may be a slightly different size, shape or color than their brand counterpart, but these cosmetic differences have no impact on the safety or effectiveness of a generic prescription drug.

For nearly two decades, America’s generic pharmaceutical industry has been developing, manufacturing and marketing bioequivalent generic versions of brand prescription drugs. These generic products have been used by millions of American consumers, and offer the same safety and effectiveness as their brand counterparts.

In order to be deemed therapeutically equivalent to brand products, generic drugs must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, and same amount of drug absorbed over the same time as the equivalent brand product. Generics are also required to meet the same stringent government standards for strength, purity and potency as the brand version.

The Food and Drug Administration (FDA) has repeatedly affirmed that the generic approval process is as rigorous and thorough as the process by which brand drugs are approved. When a generic drug receives FDA approval, research and clinical experience indicates that the generic drug is not only bioequivalent but also clinically equal to and as safe and effective as the brand name drug it is a copy of.

In order to market a generic equivalent to a brand pharmaceutical company’s drug product (once the market exclusivity on the innovator’s product has expired), a generic pharmaceutical company uses the Abbreviated New Drug Application (ANDA) process of the FDA.

On 19 th August, 2003 , The Food and Drug Administration (FDA) approved Levitra ( (Vardenafil Hydrochloride ), an oral medication to treat erectile dysfunction (ED, or impotence) in men. This is the second oral product approved for this condition.

Levitra is different than currently approved product for ED like Viagra because it works faster and also stays in the body longer.

Manufacturer:
Levitra is manufactured by Bayer and GlaxoSmithKline.

Mode of Action :
Levitra acts by relaxing muscles in the penis and blood vessels, allowing increased blood flow into the penis, which produces an erection.

What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Are generic drugs as safe as brand-name drugs?

Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Emboldened by favorable court rulings and the need to gain an early foothold in the market, generic drug developers are increasingly challenging lucrative drug patents.

In many cases those challenges have been coming in the form of at-risk launches, where a generic version of a patented drug is sold before the patent expires.

Heavyweights including Teva Pharmaceutical Industries Ltd., Barr Pharmaceuticals Inc. and Mylan Pharmaceuticals Inc. have been growing bolder when it comes to this strategy, as the risk-reward equation seems to have shifted to their favor.

“I think they’ve just gotten a lot smarter as an industry,” said WR Hambrecht analyst Andrew S. Forman. “Generics have the sympathy, pricing advantage and generally have facts on their side; there’s been settlements, but no losses.”

Often, he said, pharmaceutical companies will try to gain patent extensions to stave off generic competition. With more insurers and Medicare pushing members to generic options because of the price difference, the market seems to have swayed. Generic drug developers now claim more than two-thirds of all prescriptions, up from less than half 10 years ago.

The most recent salvo came from Teva, the largest generic drug developer in the world. The Israel-based company had challenged Wyeth’s patent on the blockbuster heartburn drug Protonix. That patent isn’t due to expire for three more years, but in December, Teva launched its generic version over the course of several days, before ceasing shipments as part of a deal.

Protonix sales reached $1.9 billion in 2007. Drugstore.com currently lists generic Protonix at a 7.7 percent discount to the branded version. A similar discount currently exists for Lotrel, a blood pressure drug made by Novartis, for which Teva enjoys market exclusivity with a generic.

Other disputes involve Forest Laboratories Inc. and generic drug developers Teva and Barr over the Alzheimer’s disease treatment Namenda. Endo Pharmaceuticals Holdings Inc. and Penwest Pharmaceuticals Co. are suing Impax Laboratories over plans to make a version of the pain reliever Opana ER.

Several pharmaceuticals companies, including Forest and Wyeth, declined comment on the ongoing patent challenges.

“There are just more Paragraph IV (patent dispute) challengers than years ago,” said Mike Dzwonczyk, a patent attorney at Sughrue Mion PLLC. “The likelihood of sharing market space is much higher now than it ever used to be.”

While generic companies run the risk of paying triple-damages if they conduct an at-risk launch and then lose the patent dispute, several recent court cases have gone in favor of generics, he said. It has become harder for pharma to prove a company willfully infringed a patent, for example, lessening the risk of triple damages.

Also, the downside risk to losing a case has become smaller for large companies like Teva, which can often offset any future losses with big sales gains early on.