{"id":56587,"date":"2023-01-20T10:00:12","date_gmt":"2023-01-20T15:00:12","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=56587"},"modified":"2023-01-17T16:56:17","modified_gmt":"2023-01-17T21:56:17","slug":"authorized-generics","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/authorized-generics\/","title":{"rendered":"What are authorized generics?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Chances are, you\u2019ve taken a generic or authorized generic medication, and for good reason\u2014according to the U.S. Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">An estimated <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/buying-using-medicine-safely\/generic-drugs\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">90%<\/span><\/a><span style=\"font-weight: 400;\"> of prescriptions filled in the United States are for <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6025009\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">commonly prescribed generic drugs<\/span><\/a><span style=\"font-weight: 400;\">. Examples include <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/lisinopril\"><span style=\"font-weight: 400;\">lisinopril<\/span><\/a><span style=\"font-weight: 400;\"> for <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/blood-pressure-treatment-and-medications\"><span style=\"font-weight: 400;\">high blood pressure<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/levothyroxine-sodium\"><span style=\"font-weight: 400;\">levothyroxine<\/span><\/a><span style=\"font-weight: 400;\"> for <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/hypothyroidism-treatment-and-medications\"><span style=\"font-weight: 400;\">hypothyroidism<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/atorvastatin-calcium\"><span style=\"font-weight: 400;\">atorvastatin<\/span><\/a><span style=\"font-weight: 400;\"> for <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/high-cholesterol-treatment-and-medications\"><span style=\"font-weight: 400;\">high cholesterol<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/www.singlecare.com\/conditions\/type-2-diabetes-treatment-and-medications\"><span style=\"font-weight: 400;\">Type 2 diabetes<\/span><\/a><span style=\"font-weight: 400;\"> medications like <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/metformin-hcl\"><span style=\"font-weight: 400;\">metformin<\/span><\/a><span style=\"font-weight: 400;\">, and others.\u00a0<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/most-prescribed-drugs-2022\/\"><b>Top 50 most prescribed drugs of 2022<\/b><\/a> <b>| <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/are-generic-drugs-as-good-as-brand-name-medicines\/\"><b>Brand-name vs. generic drugs<\/b><\/a><\/p>\n<p><span style=\"font-weight: 400;\">But, what\u2019s the difference between a regular generic and an authorized generic? Here\u2019s everything you need to know.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What are authorized generics?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Authorized generic drugs and generic drugs have similarities, but there are a few key differences. Here, we explain the differences.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Generic drugs<\/span><\/h3>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/frequently-asked-questions-popular-topics\/generic-drugs-questions-answers\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Generic drugs<\/span><\/a><span style=\"font-weight: 400;\"> have the same active ingredients as their brand-name counterparts and must follow the same quality and manufacturing standards. Generic drugs must also be identical to brand-name drugs in the following ways:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dosage form<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Route of administration<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Safety<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Effectiveness<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Strength<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Labeling<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">While generic medications must have the same active ingredient as the brand-name, they may have some inactive ingredients not found in the original medication. They are also manufactured by companies other than the company that originally produced the brand-name drug.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Generic drugs must seek approval from the FDA via a form called an Abbreviated New Drug Application (ANDA) to ensure that they are <\/span><a href=\"https:\/\/www.fda.gov\/animal-veterinary\/abbreviated-new-animal-drug-applications\/bioequivalence\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">bioequivalent<\/span><\/a><span style=\"font-weight: 400;\"> to the brand-name med, or \u201cequal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.\u201d That means it reaches the same area of the body at the same interval of time and at the same amount as the brand-name. Evidence of the generic drug\u2019s safety is not required if bioequivalence can be proved.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Generic drugs are less expensive than their brand-name version, and are just as safe and effective, says <\/span><a href=\"https:\/\/www.drsuzannesoliman.com\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Suzanne Soliman<\/span><\/a><span style=\"font-weight: 400;\">, Pharm.D., a board-certified pharmacist, chief academic officer of the Accreditation Council for Medical Affairs, and founder of <\/span><a href=\"https:\/\/www.pharmacistmomsgroup.com\/aboutus\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Pharmacist Moms Group<\/span><\/a>. <span style=\"font-weight: 400;\">They are able to be sold at a lower price because the manufacturers do not have the same development and marketing costs as the original company who developed the medication, explains Dr. Soliman.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Authorized generics<\/span><\/h3>\n<p><a href=\"https:\/\/www.fda.gov\/drugs\/abbreviated-new-drug-application-anda\/fda-list-authorized-generic-drugs\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Authorized generics<\/span><\/a><span style=\"font-weight: 400;\"> are similar to generic drugs, but with an important difference\u2014they are identical to brand-name drugs. Still, they are marketed without using the brand name, and might be a different color or have distinct markings compared with the brand name. In some cases, the authorized generic has the exact same appearance as the brand. They can be produced by the original manufacturer, or another company approved by the brand. Like generic drugs, an authorized generic is often less expensive than the brand-name version of the drug, says Dr. Soliman.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Because authorized generics are deemed to be the therapeutic equivalent of the brand name, no ANDA form is required, but the manufacturer holding the New Drug Application (NDA) for the original drug must give the FDA notice when marketing an authorized generic. The authorized generic can be marketed at the same time as the brand-name.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">The value of authorized generics\u00a0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Since they are identical to the brand-name drug that they are copying, authorized generics provide a lower-cost alternative for consumers, says Dr. Soliman. What\u2019s more, they help increase competition in the market, she adds. \u201cThey are often introduced after the patent on the brand-name drug has expired, which allows other manufacturers to produce generic versions of the drug,\u201d Dr. Soliman explains. \u201cAuthorized generics can help increase access to affordable medications for patients and may also help reduce overall healthcare costs.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Authorized generics are typically manufactured and sold by either the brand-name company or a company authorized to make the medication, says <\/span><a href=\"https:\/\/www.mytoolboxgenomics.com\/about-us\/erika-gray\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Erika Gray<\/span><\/a><span style=\"font-weight: 400;\">,<\/span><span style=\"font-weight: 400;\"> Pharm.D., chief medical officer and co-founder of <\/span><a href=\"https:\/\/www.toolboxgenomics.com\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Toolbox Genomics<\/span><\/a><span style=\"font-weight: 400;\">, a DNA and epigenetic testing company. When a drug\u2019s patent expires, other manufacturers are able to create generic medications, which greatly reduces the brand company\u2019s profits. By creating an authorized generic to market at a reduced price, the brand company maintains a share in the medication\u2019s revenue.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The concept of authorized generics was first introduced in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which created the Medicare Part D prescription drug benefit, with the goal being increased competition and lower prices for Medicare recipients, says Dr. Gray<\/span><span style=\"font-weight: 400;\">. <\/span><span style=\"font-weight: 400;\">Currently, there are nearly <\/span><a href=\"https:\/\/www.fda.gov\/media\/77725\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">1,200 authorized generics<\/span><\/a><span style=\"font-weight: 400;\">. <\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How to switch to an authorized generic prescription<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">You can start an authorized generic medication by asking your healthcare provider to write the prescription for the authorized generic medication name, says Dr. Gray. If you need help determining the name (or particular manufacturer) of the authorized generic, ask your pharmacist.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">SingleCare can help you save on authorized generics (and other prescriptions). Just follow these three easy steps:\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Download our<\/span> <a href=\"https:\/\/singlecare.onelink.me\/OxIQ\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">iOS<\/span><\/a> <span style=\"font-weight: 400;\">or<\/span> <a href=\"https:\/\/singlecare.onelink.me\/OxIQ\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Android<\/span><\/a> <span style=\"font-weight: 400;\">app or go to our<\/span> <a href=\"https:\/\/www.singlecare.com\/browse-prescriptions\"><span style=\"font-weight: 400;\">website<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Search for your medication, making sure to adjust for quantity, dosage, and zip code.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Choose the participating pharmacy closest to you and either print, text, or email yourself a free drug coupon.\u00a0<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">When you go to the pharmacy, show your pharmacist the coupon. It\u2019s that simple!\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Chances are, you\u2019ve taken a generic or authorized generic medication, and for good reason\u2014according to the U.S. Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs.\u00a0 An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs. Examples include lisinopril for high blood pressure, levothyroxine for [&hellip;]<\/p>\n","protected":false},"author":135,"featured_media":56292,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[15103,3418],"coauthors":[20608],"class_list":["post-56587","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","tag-drug-pricing","tag-generic-drugs","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>What are authorized generics?<\/title>\n<meta name=\"description\" content=\"Authorized generics are approved brand-name drugs that are marketed without the brand name on the label. 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