[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-402499-105":59,"doc-detail-402499-en":131},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":124,"head_meta":126,"extra_data":128,"updated_unix":130},105,"en","hiv-prep-generics-frequently-asked-questions-faqs","HIV PrEP Generics - Frequently Asked Questions (FAQs)","","The document explains current HIV pre-exposure prophylaxis (PrEP) options as the market changes, focusing on the introduction of generic formulations. It outlines FDA-approved PrEP medicines (TDF/FTC and TAF/FTC), key eligibility limitations for TAF/FTC, and the FDA’s designation of long-acting injectable cabotegravir. It also details when generic TDF/FTC became available in the US, identifies multiple FDA-approved generic manufacturers, and describes bioequivalence, drug switching, and how competition and FDA exclusivity can affect pricing and PrEP access.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/hiv-prep-generics-frequently-asked-questions-faqs/402499/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/hiv-prep-generics-frequently-asked-questions-faqs/402499.png","ImageObject",300,407,{"name":92,"@type":93},"Alex Sinclair","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-27",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"Which medications are FDA-approved for PrEP, and what are their key limitations?","Question",{"text":113,"@type":114},"FDA has approved TDF/FTC (Truvada and now generic TDF/FTC) and TAF/FTC (Descovy). TAF/FTC is limited and indicated only for gay, bisexual, and other men who have sex with men, as well as transgender women.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"When did generic TDF/FTC become available in the US, and which manufacturers were approved?",{"text":118,"@type":114},"Teva began selling generic TDF/FTC in the US on October 2, 2020. By October 21, 2020, FDA approvals included Amneal Pharmaceuticals, Aurobindo Pharma, and Zydus Pharmaceuticals in addition to Teva.",{"name":120,"@type":111,"acceptedAnswer":121},"What does AB bioequivalence mean for generic PrEP drugs?",{"text":122,"@type":114},"AB bioequivalence indicates that pharmacies can switch patients from the brand-name drug to the generic therapeutic equivalent. It supports comparable safety and efficacy, while allowing differences in size, color, flavor, and inactive ingredients.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},402499,1790621376,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":24,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},1099523882182,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","The HIV pre-exposure prophylaxis (PrEP) landscape is rapidly changing. With the introduction of new drugs approved for PrEP and generic options becoming available, many changes are underway or on the horizon. This FAQ provides current information on the introduction of PrEP generics, potential coverage changes related to the changing PrEP drug market, and the impact on PrEP access.  \n WHAT DRUGS ARE AVAILABLE FOR PrEP?  \n The US Food and Drug Administration (FDA) has approved two medications for PrEP:  \n• Tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) was approved for PrEP by FDA in 2012. Brand name: Truvada® by Gilead Sciences. Generic TDF/FTC is now available from Teva Pharmaceuticals USA.  \n• Tenofoviralafenamide and emtricitabine (TAF/FTC) was approved for PrEP by FDA in October 2019. Brand name: Descovy® by Gilead Sciences. TAF/FTC was approved with limitations and is indicated only for gay, bisexual, and other men who have sex with men as well as transgender women.  \nOn November 17, 2020 FDA designated long-acting, injectable cabotegravir for PrEP as a break-through therapy, expediting consideration for approval. A final FDA approval decision is expected by May 2021. Cabotegravir is manufactured by ViiV Healthcare.  \n WHEN WILL GENERIC TD F/FTC BECOME AVAILABLE IN THE US?  \n On October 2, 2020, Teva Pharmaceuticals USA began selling generic TDF/FTC in the US. The early availability of a single generic formulation ofTDF/FTC stems from a lawsuit settlement five years earlier. Through that lawsuit, Gilead granted Teva exclusive rights to commercialize its version ofTDF/FTC one year before key patents protecting Truvada’s monopoly expire.  \nIn addition to Teva, three other generic manufacturers have received FDA approval to market TDF/FTC as of October 21, 2020: Amneal Pharmaceuticals, Aurobindo Pharma, and Zydus Pharmaceuticals. Gilead and Teva’s confidential settlement may mean only one generic product is available in the US for at least six months. Upto-date information on generics approved for commercialization in the US is available on the FDA Orange Book. The four manufacturers listed above have an “AB” bioequivalence rating for their TDF/FTC  \nPrEP GENERICS ENTERING THE US. MARKET: FREQUENTLY ASKED QUESTIONS (FAQS)  \nproducts. AB bioequivalence indicates that pharmacies can switch competitor entered the market, pharmacy acquisition prices per  \npatients from the brand-name drug to the generic therapeutic equivalent. bottle (30 tablets) were approximately $912 for the generic version and $1,230 for brand-name Epzicom. By June 2017, with multiple  \nInformation on the safety and therapeutic equivalence of generic drugs, competitors, the average price of ABC/3TC was $206 a bottle. As  \nincluding information about the approval process and  patient education of late November 2020, the average price for generic ABC/3TC is  \nresources, is available on the FDA website. approximately $65/bottle, with about six competitors.  \nGENERIC DRUG BIOEQUIVALENCE  \n HOW MUCH DOES GENERIC TD F/FTC   \nCOST? Generic drugs are comparable to the FDA-approved brand-name drug indosage form,  \nstrength, route of administration, quality, performance characteristics, and intended use.  \n As of October 14, 2020, the wholesale acquisition cost These similarities help to demonstrate bioequivalence, meaning a generic medicine price per pill of Teva’s generic TDF/FTC is $48.51, which works in the same way and provides comparable safety and efficacy as its brand-name is approximately 21 percent lower than the brand-name version. Generic drugs may have a different size, color, flavor, and inactive ingredients;  \nversion. NASTAD does not anticipate that Teva’sTDF/FTC’s however, the active pharmaceutical ingredient (API) must be the same. list price will go down during its exclusivity period. The  \nmost significant price decreases typically come about Due to the FDA’s exclusivity periods and various patents on brand-name medications, once multipl","cbCaitjTmqMfd4jZ","https://ap.wps.com/l/cbCaitjTmqMfd4jZ","pdf",1273081,"English","# What drugs are available for PrEP?\n## TDF/FTC and TAF/FTC approvals\n## Long-acting injectable cabotegravir\n# When will generic TDF/FTC become available in the US?\n## Teva launch and additional FDA-approved generics\n# Generic drug bioequivalence\n## AB rating and pharmacy switching\n# How much does generic TDF/FTC cost?\n## Wholesale acquisition cost and pricing dynamics\n# Does competition drive prices down?","[{\"question\":\"Which medications are FDA-approved for PrEP, and what are their key limitations?\",\"answer\":\"FDA has approved TDF/FTC (Truvada and now generic TDF/FTC) and TAF/FTC (Descovy). TAF/FTC is limited and indicated only for gay, bisexual, and other men who have sex with men, as well as transgender women.\"},{\"question\":\"When did generic TDF/FTC become available in the US, and which manufacturers were approved?\",\"answer\":\"Teva began selling generic TDF/FTC in the US on October 2, 2020. By October 21, 2020, FDA approvals included Amneal Pharmaceuticals, Aurobindo Pharma, and Zydus Pharmaceuticals in addition to Teva.\"},{\"question\":\"What does AB bioequivalence mean for generic PrEP drugs?\",\"answer\":\"AB bioequivalence indicates that pharmacies can switch patients from the brand-name drug to the generic therapeutic equivalent. It supports comparable safety and efficacy, while allowing differences in size, color, flavor, and inactive ingredients.\"}]","HIV PrEP Generics - Frequently Asked Questions (FAQs) | PDF",1790531136,13]