File Name: list of brand name drugs and their generic equivalents .zip
Buying more generic prescription drugs instead of their brand-name equivalents and purchasing brand-name drugs with discounts can significantly reduce overall prescription drug expenditures.
Dramatic growth in the use of generic drugs has generated substantial savings for American consumers. We begin by briefly reviewing trends in generic drug use, the legislative origin of generic drugs in the United States, and the pathways by which generic drugs can reduce healthcare costs.
Next, we examine the literature on generic drug pricing and the associated healthcare savings. We group information on barriers to generic drug use in three broad areas: state laws on generic substitution; factors related to availability of generics; and consumer and prescriber perceptions and behavior.
Overall, we found that current levels of generic drug use are fairly high. There is potential for increased savings from generic drug use both through increased availability of generic drugs and through increased substitution, particularly therapeutic substitution as discussed below. The rate of generic prescribing for all prescriptions reached almost 75 percent in , up from 57 percent in Generic drugs cost much less than their branded counterpart, so the high rate of generic prescribing resulted in billions of dollars of savings for the U.
Maintaining or improving the generic prescribing rate is an important tool in efforts to control health care costs. Innovative branded drugs seeking Food and Drug Administration FDA approval are required to submit to FDA a new drug application that includes clinical trial data that establishes the safety and efficacy of the new drug. Manufacturers of innovative branded drugs expend considerable time and resources in research and development and the approval of new drugs.
Some estimates indicate that bringing a new drug to market costs more than a billion dollars and takes years 2. Generic drugs are therapeutically equivalent to a branded drug. Generic drugs are required to have the same active ingredient and the same strength, dosage form, and route of administration as the brand name or reference product. Most generic drugs do not need to contain the same inactive ingredients as the brand product.
In addition, a generic drug must be bioequivalent to the brand drug, that is there must be no significant difference between the generic and brand product in the rate or the extent to which the active ingredient is delivered to the patient.
There can be some variability between brand name and generic drugs, but FDA puts limits on how much variability is acceptable. Drugs approved by FDA as therapeutically equivalent can be substituted with the expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product.
The Drug Price Competition and Patent Term Restoration Act of frequently referred to as the Hatch-Waxman Act amended the Federal Food, Drug, and Cosmetic Act to create an abbreviated pathway for approval of new drugs that are therapeutically equivalent to a branded drug.
In addition to the patents that protect new inventions, Hatch-Waxman granted periods of exclusivity to manufacturers that had new drugs approved by FDA. If the branded drug is still in the period of exclusivity or protected under patent, generic versions of the branded drug can not be brought to market. Once the drug is approved by the FDA and the branded drug is no longer protected by patent or exclusivity, the generic can be brought to market.
Because they can reverse-engineer an innovator drug, and need not repeat safety and effectiveness studies, generic manufacturers can bypass the time and costs to develop a new drug and bring a drug to market with a much smaller investment. The Hatch-Waxman Act also offered incentives for generic manufacturers to challenge the patents of innovator drugs by offering a day period of exclusivity for the first generic applicant to challenge the validity of a patent.
The Act also allows exemptions from patent infringement for pre-application activities by generic drug sponsors. Most experts agree that the Hatch-Waxman Act greatly increased the availability of generic drugs in the U. Prior to the Act, 35 percent of top selling innovator drugs no longer under patent had generic equivalents.
By the late s, almost all had generic equivalents 3. Generic drugs can reduce healthcare costs through multiple pathways. These include generic substitution of drugs, substitution of drugs in the same therapeutic class, and reduction in the average branded prices paid by consumers due to generic substitution. The largest cost savings come from generic substitution of drugs by substituting the less expensive generic drug for the therapeutically equivalent branded drug.
FDA publishes a list of drug products that are therapeutically equivalent in its publication Approved Drug Products with Therapeutic Equivalence Evaluations ; however, generic substitution is not regulated by FDA. It can be done by the prescriber or the pharmacist, according to state laws and regulations. Because the generic drug is therapeutically equivalent to the branded drug, this substitution is straightforward.
Generic substitution rates, the rate at which generic drugs are dispensed in the U. However, restrictions on the ability of pharmacists to carry out generic substitution vary by state. Additional savings can result from therapeutic substitution. Therapeutic substitution is switching to a generic from a branded drug in the same therapeutic class. For example, a prescriber may switch a patient from the branded lipid-lowering statin, Lipitor which as yet has no generic equivalent to simvastatin, the generic equivalent of the branded lipid-lowering statin, Zocor.
This substitution has to be done by the prescriber; a pharmacist can not substitute between drugs that are not therapeutically equivalent.
Formularies 5 , prior approval 6 , prescriber incentives 7 , and step therapy 8 create incentives for prescribers to substitute less expensive generics for branded drugs with the same indication. FDA does not regulate therapeutic substitution. Historically, there has been little evidence of significant savings from this type of substitution, but there is recent evidence that it is becoming a more important source of savings.
For example, after introduction of generic simvastatin therapeutically equivalent to Zocor , a study of Medicaid drug expenditures found that prescriptions of Lipitor declined from 43 percent of total statin use before the introduction of generic simvastatin to 31 percent a year after the introduction of generic simvastatin 9. Another possible pathway for savings is a reduction in average branded prices paid by consumers resulting from generic substitution.
A study by Rizzo and Zeckhauser found that a higher share of generic prescriptions result in lower average brand drug prices. The theory is that consumers are more likely to substitute generics for higher cost branded drugs and conversely less likely to substitute generics for lower cost branded drugs.
This selective substitution would then effectively lower the average cost of branded drugs by leading brand name manufacturers to choose lower initial prices. This study found that a 10 percent increase in the generic substitution rate is associated with a Generic drug manufacturers face much lower costs to enter the market than manufacturers of branded drugs.
While estimates of the cost to bring a new branded drug to market are in excess of a billion dollars, the research and development costs for a new generic drug are only 1 to 2 million dollars The relatively low costs to entry for generic drugs lead to increased competition, which drive prices for generic drugs down dramatically.
The number of generic entrants appears to affect the price difference between branded and generic drugs. FDA analyzed the effect of generic drug entry on average prices for generics as a percentage of the price of the branded drug.
They found that the first entrant has a relatively small effect on price, but subsequent entrants dramatically reduce the average relative price. Figure 1 below shows the average relative price for generics relative to branded drugs by number of generic entrants in the market This analysis measures price as the price paid by the pharmacy, not the consumer. Pharmacies typically have higher markups for new generic drugs than branded drugs and older generic drugs Also, the FDA analysis does not account for the fact that the most profitable markets attract the most generic competitors.
As a result, the FDA analysis may overestimate the size of the price decrease for early generic entrants. Figure 1: Average relative price of generic to brand by number of generic competitors Generic Competition and Drug Prices. Although 65 percent of prescriptions were filled by generic drugs, those prescriptions accounted for only 25 percent of total drug costs.
A number of studies have estimated the potential savings from increasing the rate at which generics are dispensed.
This estimate was likely an underestimate for , as it did not include prescriptions for children and did not account for missing data in MEPS Another study from Fisher and Avorn estimated spending by Medicaid for drugs for 48 states and the District of Columbia. They found considerable state-level variation in potential savings ranging from 3. However, the authors did not explore reasons for the variability between states.
Across the 20 reference drugs the substitution rate ranged from 44 percent to 99 percent with an average generic substitution rate of 87 percent. This study found that most of the potential savings were concentrated in newly available generic substitutes due to a time lag in prescriber and pharmacist adoption of substitution with the newly available generic These studies consider the cost savings from achieving a percent generic substitution rate.
This is probably not a realistic or desirable goal. Generic drugs and their branded counterparts may differ in inactive ingredients, such as flavors, colors or binders and for some patients these differences can be important. For example, a patient with an allergy to a certain dye may be limited to using the branded drug or another generic that does not use that dye.
Studies of savings from Medicaid are uncertain due to rebates Medicaid receives from manufacturers. By law, Medicaid receives a larger rebate for branded than for generic drugs. These rebates are based on the average manufacturer price, which is proprietary, so researchers can not calculate the actual rebate. The difference in generic and branded drug price may be small in the first six months after introduction of the generic, when the first generic has exclusivity from other generic manufacturers.
Therefore, in some cases generic drugs can be more expensive for Medicaid than branded drugs due to the larger rebate for branded drugs.
Further increases in savings are achievable from increasing therapeutic substitution. Barriers to the use of generic drugs can occur at a number of points, including state laws on generic substitution; factors related to availability of generics; and consumer and prescriber perceptions and behavior. State laws regulate the practice of pharmacy.
As a result, there is variation in requirements for when pharmacists can or must dispense generics among states. Some states require a pharmacist to substitute a therapeutically equivalent generic for a brand name drug, unless the physician specifies that a generic must not be substituted.
Other states take a more permissive approach and allow, but do not require, pharmacists to substitute a generic drug, as long as the prescriber does not specify brand only. Some states impose an additional limitation that the pharmacist must get consent from the patient before substituting a generic. All states also allow the physician to specify that the brand name must be prescribed, although with different levels of effort from the physician.
Appendix A provides state laws governing generic substitution by pharmacies. A recent study of the effect of state generic substitution laws on drug spending under Medicaid found that state generic substitution laws can have a significant impact on drug spending. The study looked at spending by state on Zocor, generic simvastatin, and Lipitor in the first six quarters after the introduction of generic simvastatin.
The study found a significant impact of patient consent laws on generic substitution. States that require patient consent had higher average prescription costs for Zocor and generic simvastatin combined than states that did not require patient consent. Similarly, six months after patent expiration, 98 percent of simvastatin prescriptions were written for generic simvastatin in states that did not require patient consent, while less than one third of prescriptions were filled by generic simvastatin in states that did require patient consent.
The study did not find consistent differences in generic prescription rates between states that permitted pharmacists to prescribe generic alternative versus states that required pharmacists to prescribe a generic alternative Pharmacists have a financial incentive to prescribe generics, as the mark up received by pharmacies is largest for new generics. The study also looked at the impact of state laws and Medicaid policies, like prior authorization, on prescriptions for Lipitor, another statin in the same therapeutic class, but not therapeutically equivalent to simvastatin.
Lipitor use declined from 43 percent of statin use before the introduction of generic simvastatin to 36 percent six quarters after the introduction of generic simvastatin. In states that required prior authorization for the prescription of Lipitor, Lipitor use was 31 percent lower than in states that did not. Other state generic substitution laws did not affect the levels of Lipitor use.
These findings for statin use in Medicaid may not be generalizable.
Dramatic growth in the use of generic drugs has generated substantial savings for American consumers. We begin by briefly reviewing trends in generic drug use, the legislative origin of generic drugs in the United States, and the pathways by which generic drugs can reduce healthcare costs. Next, we examine the literature on generic drug pricing and the associated healthcare savings. We group information on barriers to generic drug use in three broad areas: state laws on generic substitution; factors related to availability of generics; and consumer and prescriber perceptions and behavior. Overall, we found that current levels of generic drug use are fairly high. There is potential for increased savings from generic drug use both through increased availability of generic drugs and through increased substitution, particularly therapeutic substitution as discussed below.
Generic Name, Brand Name. alendronate tablet, Fosamax. acyclovir capsule, Zovirax. acyclovir tablet, Zovirax. albuterol inhalation solution, Albuterol Inhalation.
Can now be purchased on Amazon. Here are the links: Paperback eBook. Brand name prescription medications are expensive.
Once a new drug is approved, the pharmaceutical company receives an exclusive right to market that drug for a guaranteed minimum of 5 to 7 years. Most new drugs are also protected by patents that last 20 years from the first discovery of the molecule before its clinical testing. Altogether, new drugs receive about 12 to 14 years of market exclusivity. Market exclusivity periods allow companies to get a return on their investment into development of that drug and to make a profit. When the market exclusivity period is over, other companies can apply for approval of their versions of the product containing the same active ingredient. The active ingredient is the chemical substance that carries the effect of the medication.
Hover over each icon below for an explanation of their meaning. Scroll down to find all drugs and dosages that can offer savings or information by clicking on the drug name then click on the icon. If doing a drug search, scroll down to see your drug search results. Programs created by pharmaceutical companies to provide free or discounted medicines to people who are unable to afford them.
Understanding the differences between generic and brand name medications can help injured workers understand their workers' compensation prescriptions a bit better.
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