Generic Drugs

Extracted Attributes

• Bioequivalence Standard

  90% confidence interval of 80-125% for AUC and Cmax

• Average Generic Copay (US)

  6.06 USD

• Price Reduction (1 competitor)

  Approximately 30 percent

• Price Reduction (5+ competitors)

  Approximately 85 percent

• Standard Patent Protection Duration

  20 years

• US Prescription Market Share (2017)

  90 percent

• Active Pharmaceutical Ingredient (API)

  Identical to brand-name counterpart

• Total US Healthcare Savings (2009-2019)

  2.2 trillion USD

Timeline

• Start of a ten-year period during which generic drugs saved the U.S. healthcare system an estimated $2.2 trillion. (Source: FDA)

  2009-01-01

• Generic drugs accounted for 88 percent of the 4.3 billion prescriptions filled in the United States. (Source: Wikipedia)

  2014-12-31

• Generics reached a market share of 90 percent of all U.S. prescriptions, with patients choosing generics 97 percent of the time when available. (Source: AAM Report)

  2017-12-31

• Beginning of the 2019-2020 fiscal year in which India exported $20.0 billion worth of generic drugs globally. (Source: Wikipedia)

  2019-04-01

• The Global Generic Drugs Market was evaluated at approximately $465.96 million. (Source: Web Search Results)

  2021-12-31

• All-In Podcast Episode 150 discusses the eventual market demand for generic versions of GLP-1 obesity medications. (Source: All-In Podcast)

  2023-10-20

Generic drug

A generic drug is a pharmaceutical drug that contains the same chemical substance as a proprietary drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. They are labeled with the name of the manufacturer and a generic non-proprietary name such as the United States Adopted Name (USAN) or International Nonproprietary Name (INN) of the drug. A generic drug must contain the same active ingredients as the original brand-name formulation. The U.S. Food and Drug Administration (FDA) requires generics to be identical to or within an acceptable bioequivalent range of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties. Biopharmaceuticals, such as monoclonal antibodies, differ biologically from small-molecule drugs. Biosimilars have active pharmaceutical ingredients that are almost identical to the original product and are typically regulated under an extended set of rules, but they are not the same as generic drugs as the active ingredients are not the same as those of their reference products. In most cases, generic products become available after the patent protections afforded to the drug's original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection. However, many countries and regions, such as the European Union and the United States, may grant up to five years of additional protection ("patent term restoration") if manufacturers meet specific goals, such as conducting clinical trials for pediatric patients. Manufacturers, wholesalers, insurers, and drugstores can all increase prices at various stages of production and distribution. In 2014, according to an analysis by the Generic Pharmaceutical Association, generic drugs accounted for 88 percent of the 4.3 billion prescriptions filled in the United States. "Branded generics" on the other hand are defined by the FDA and National Health Service as "products that are (a) either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or (b) a molecule copy of an off-patent product with a trade name." Since the company making branded generics can spend little on research and development, it is able to spend on marketing alone, thus earning higher profits and driving costs down. For example, the largest revenues of Ranbaxy, now owned by Sun Pharma, came from branded generics.

Web Search Results

• Generic drug - Wikipedia

  Pharmaceutical equivalent to a brand-name product A generic drug is a pharmaceutical drug that contains the same chemical substance as a proprietary drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is equivalent in performance compared to their performance at the time when they were patented drugs. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging. [...] Before a company can market a generic drug, it needs to file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug" and proving that it can manufacture the drug safely and consistently. For an ANDA to be approved, the FDA requires that the 90% confidence interval of the geometric mean test/reference ratios for the total drug exposure (represented by the area under the curve or AUC) and the maximum plasma concentration (Cmax) should fall within limits of 80–125%. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted [...] India is a leading country in the world's generic drugs market, exporting US$20.0 billion worth of drugs in the 2019–20 (April–March) year. India exports generic drugs to the United States and the European Union. Also according to the market research community the Global Generic Drugs Market was evaluated US$465.96 million in 2021 and is expected to rise with a CAGR of 5.5% from 2022–2028 during the forecast period. In the United Kingdom, generic drug pricing is controlled by the government's reimbursement rate. The price paid by pharmacists and doctors is determined mainly by the number of license holders, the sales value of the original brand, and the ease of manufacture. A typical price decay graph will show a "scalloped" curve, which usually starts at the brand-name price on the day

• Generic Drugs: Questions & Answers - FDA

  Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug. Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This abbreviated pathway is why the application is called an “abbreviated new drug application.” [...] The active ingredient is the same as that of the brand-name drug/innovator drug. + An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating. + Generic drug companies must provide scientific evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence. The generic medicine is the same strength. The medicine is the same type of product (such as a tablet or an injectable). The medicine has the same route of administration (such as oral or topical). It has the same use indications. The inactive ingredients of the medicine are acceptable. [...] FDA takes several actions to ensure safety and quality before and after a new or generic medicine is approved. When a generic drug application is submitted, FDA conducts a thorough examination of the data submitted by the applicant and evaluates information obtained by FDA investigators while inspecting the related testing and manufacturing facilities to ensure that every generic drug is safe, effective, high quality, and substitutable to the brand name drug. FDA staff continually monitors all approved drug products, including generics, to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and high quality.

• 7 FAQs About Generic Drugs | Pfizer

  Careers Investors Medicines Wellness # 7 FAQs About Generic Drugs Share ### 1. What is a generic drug? A generic drug is loosely defined as a “copy” of a brand name drug. The active ingredient or drug content is identical or “bioequivalent,” and works in the body the same way as the brand name drug. Such drugs must show that their active ingredients get to the bloodstream at the same time and to the same extent as the brand name version. [...] Drug products usually have a chemical name, generic name, and brand name. When a drug is first discovered, it is given a chemical name, which describes the atomic or molecular structure of the drug. Generic names are usually more complicated and harder to remember than brand names. Many generic names are a shorthand version of the drug’s chemical name, structure, or formula. The brand name is created by the company and is usually shorter and easier to remember. Caroline Pak, PharmD, is the Medical Editor-in-Chief for Pfizer’s Get Healthy Stay Healthy website. [...] ### 5. Are all brand drugs available in generic form? Not every brand drug has a generic version. Most brand drugs are developed under patent protection for up to 20 years. This means that no one else is allowed to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it. ### 6. How do I know if there is a generic for my brand prescription? To find out if there is a generic equivalent for your brand drug, ask your doctor or pharmacist. You can also check out this site: Always first speak to your doctor or pharmacist to see if a generic drug is right for you. ### 7. Why are the names of brand drugs so different from the names of generic drugs?

• Generic Drug Facts | FDA

  Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. In addition, multiple generic drugs are often approved for the same single product; this creates competition in the marketplace, typically resulting in lower prices. The reduction in upfront research costs means that they are typically sold at substantially lower prices. For example, a single generic competitor can lead to price reductions of 30%, while five generics competing are associated with prices drops of nearly 85%. According to the IMS Health Institute, generic drugs saved the U.S. health care system $2.2 trillion from 2009 to 2019. (#f1)

• [PDF] Generic Drug Access & Savings in the U.S.

  Key Findings or Less 93% of Generic Prescriptions Are Filled at $20 Average Generic Copay: $6.06 8 AAM / Generic Drug Access & Savings Report The amount set by the insurance plans. Average Primary Copay Brands $40.30 Generics $6.06 Key Findings AAM / Generic Drug Access & Savings Report 9 Brand-Name Drugs Represent Only 10 Percent of Prescriptions but 77 Percent of Drug Spending 77% 23% $ GENERICS GENERICS ACCOUNT FOR 9 OUT OF 10 PRESCRIPTIONS FILLED IN THE U.S. In 2017, nine out of every 10 prescriptions in the U.S. were dispensed using generic drugs. When both brand and generic versions of the prescribed medication were available, the generic was chosen 97 percent of the time, resulting in significant patient savings. By any definition, generics represent a health care success story. [...] 2017 Top 10 Generic Drugs Ranked by Savings 18 AAM / Generic Drug Access & Savings Report Arthritis $154,573,232 Autoimmune Diseases $1,027,061,436 Cancer $10,093,397,494 Diabetes $7,757,796,210 Epilepsy $17,290,107,706 Heart Disease $47,617,946,027 Kidney Disease $2,287,158,164 Mental Illness $48,440,025,255 Multiple Sclerosis $28,384,966 Osteoporosis $1,900,712,183 Parkinson's Disease $1,710,286,026 Source: IQVIA. Savings by Patient Condition What’s At Stake PATIENT SAVINGS AAM / Generic Drug Access & Savings Report 19 In 2017, the average state saved $5.2 billion through use of generic prescription drugs. The statewide annual amount saved ranged from $354 million in Alaska to a high of $23.4 billion in California. [...] Genentech 12/1/17 Ogivri™ trastuzumab-dkst Mylan/Biocon Pending Herceptin® Genentech 12/13/17 Ixifi™ infliximab-qbtx Pfizer none planned Remicade® Janssen 5/15/18 Retacrit® epoetin alfa-epbx Pfizer est. 2018 Epogen® Amgen 6/4/18 Fulphila™ pegfilgrastim-jmbd Mylan/Biocon est. 2018 Neulasta® Amgen (As of June 25, 2018) AAM / Generic Drug Access & Savings Report 25 What’s At Stake BIOSIMILARS Biologic Monopolies The 2010 Biologics Price Competition and Innovation Act (BPCIA), which gave FDA authority to establish a regulatory process for approving lower-cost biosimilar versions of pricey brand biologic medicines, gives new drug innovators 12 years of market exclusivity in which to recoup their research and development costs. This is a longer monopoly period than is available in any other