Understand the generic drug market
Reading paths through the articles, plus a glossary of the terms the industry uses.
Start here: how generics reach the shelf
How a generic drug gets approved
Every US generic goes through an Abbreviated New Drug Application. What goes into one, how FDA reviews it, the GDUFA III deadlines, and why a finished review can still end in a tentative approval.
The Hatch-Waxman Act explained
The 1984 law traded a fast generic pathway for extra patent life and new exclusivity for brands. How each side of the deal works, how the caps are calculated, and what Congress has changed since.
Bioequivalence and the 80-125 rule
The 80 to 125 percent range is a statistical test on blood levels. It does not let a generic hold 20 percent less drug. How the test works, what FDA's May 2026 guidance says, and what 2,070 studies showed.
The Orange Book explained
FDA's Orange Book lists every approved drug, the patents and exclusivities that delay generics, and which copies FDA rates as substitutable. How each section works, and what changed in 2021.
What a generic must share with its brand, and what can differ
FDA fixes a generic's active ingredient, strength, form, route and absorption. Fillers, dyes, shape and price can vary. How the rules work, and how to look up one product's ingredients on DailyMed.
Follow the money
What NADAC measures, and what it leaves out
NADAC is the federal estimate of what retail pharmacies pay for a drug. Who publishes it, how the invoice survey works, how Medicaid uses it, and why it is not the price a patient pays.
WAC, AWP, NADAC, MAC, FUL and ASP compared
Six price benchmarks run through US drug payment, and none is what a patient pays. Who sets each one, what goes into it, where it is used, and how far apart they can sit for the same pill.
How pharmacies get paid for a prescription
Ingredient cost plus a dispensing fee is the starting formula. MAC lists, Part D price concessions and spread pricing shape what a pharmacy keeps, as federal rules and government reports document.
Why generic prices fall as competitors enter
One generic maker cuts the brand price by about 39 percent; six or more cut it by over 95 percent. FDA's 2019 study, GAO data and GxRadar's NADAC files show how steep the curve is and why.
The generic price spikes of 2013 to 2015
Generic prices fell overall in the early 2010s, yet 315 established generics at least doubled in price. What GAO and HHS investigators found, what CMS price data show, and what Congress changed.
Why medicines run short
Why drug shortages happen
New US drug shortages fell from 251 in 2011 to four in 2025, yet old ones linger for years. FDA's 2019 root-cause analysis and later HHS research explain why cheap generic drugs run short and stay short.
How FDA tracks drug shortages
What counts as a shortage under federal law, how manufacturers must warn FDA under section 506C, what the CARES Act added in 2020, and what FDA's shortage database showed on Oct. 30, 2026.
Why sterile injectables dominate shortage lists
Injections made up 49 of the 69 drugs on FDA's current shortage list in October 2026, and their shortages ran longer. Sterile manufacturing, few producers and thin margins explain why, according to FDA and HHS.
The 2023 cancer drug shortage, from one plant to most US cancer centers
How the shutdown of one plant left most large US cancer centers short of cisplatin and carboplatin in 2023, what surveys and studies measured, how FDA refilled supply, and why carboplatin is still listed in 2026.
The federal push to make more medicine in the US, and where generics fit
Executive orders since 2020, a new API stockpile, an FDA review pilot and 2026 tariffs on patented drugs, with dates. Generic drugs and their ingredients remain exempt from the tariffs as of late 2026.
Quality and recalls
How drug recalls work
Who starts a drug recall, how FDA sorts recalls into Class I, II and III, how far down the supply chain a recall reaches, and what 18,076 enforcement records since 2012 show.
How to read an FDA recall notice
A field-by-field reading of a real October 2026 Enforcement Report entry, what the recall classes and statuses mean, and how to check whether your own medicine comes from a recalled lot.
CGMP and the rules behind drug manufacturing quality
What current good manufacturing practice requires under 21 CFR parts 210 and 211, how FDA inspectors check it, why data integrity matters, and what quality failures look like in FDA and openFDA recall data.
How a carcinogen in blood pressure pills changed generic drug testing
Since 2018, nitrosamine impurities have produced nearly 500 federal recall records, pushed ranitidine off the US market and led FDA to set daily intake limits for impurities formed from the drug itself.
FDA inspections, Form 483s and warning letters
FDA ran 1,248 drug quality inspections in fiscal 2025 and judged 18 percent of them unacceptable. How plants are chosen, what a Form 483 is and is not, and how warning letters and import alerts follow.
Data stories from GxRadar's own analysis
The GxRadar generic price index
We priced a fixed basket of 43 common generics every month since January 2014. By October 2026 the index stood at 47.4, down about 53 percent. How it works, and where it can mislead.
What pharmacies paid for atorvastatin, 2013 to 2026
Federal survey data show the pharmacy cost of a generic 20 mg atorvastatin tablet fell from 18.3 cents in November 2013 to 2.8 cents in October 2026. The year-by-year record, and the FDA approvals behind it.
Doxycycline's 2013 price spike and the decade-long fall that followed
In late 2013 pharmacies paid $3.36 for one generic doxycycline capsule. By October 2026 they paid 11 cents. What federal records say about the spike, and how slowly the price came back down.
The generics that cost pharmacies more than they did in 2014
Most generics in GxRadar's 47-drug basket got cheaper. Seven cost pharmacies more than in January 2014, led by furosemide at 2.8 times its 2014 price. What federal cost and shortage data show, drug by drug.
Drug recalls by the numbers
GxRadar counted all 18,076 FDA drug recall records from mid-2012 to October 2026 by year, class, event and reason. A handful of giant recall events explain most of the swings.
The longest-running drug shortages
Six drugs on FDA's current shortage list have been there for more than 10 years. GxRadar ranked all 69 current listings by first-posted date and looked at what they have in common.
At the pharmacy counter
How to ask for the cash price at the pharmacy
Two 2018 federal laws let pharmacists tell you when paying without insurance costs less. What the laws say, what pharmacies pay for common generics, and the questions that get you both prices.
Tiered formularies explained
How plans sort drugs into cost tiers, why most generics land on the cheapest one, the federal rules for Medicare Part D tiers in 2026, and how a tiering exception request works.
How to check if your medicine was recalled
Where FDA publishes every drug recall it monitors, how to match a notice to your own bottle by NDC and lot number, and the questions that get a pharmacist to a quick answer.
What to ask when your medicine is in shortage
How FDA publishes shortage information, what the agency can and cannot do about it, and the questions that help a pharmacist and prescriber work out the next fill.
How to dispose of unused medicines
The order of options FDA recommends, from DEA take-back sites and mail-back envelopes to the short flush list and household trash, and what each one accepts.
How to look up a drug on DailyMed
DailyMed is the National Library of Medicine's free archive of drug labels as companies submit them to FDA. How to search it by name or NDC, find inactive ingredients and imprints, and tell the leaflets apart.
Patents, exclusivity and the law
Paragraph IV certifications and the patent fights behind early generics
Every generic application must take a position on each patent the brand has listed with FDA. The rules behind the 20-day notice, the 45-day window to sue, the 30-month stay, and how these cases end.
180-day exclusivity for first generic filers
The first company to challenge a brand's patents with a generic application can win 180 days without later challengers. Who qualifies, what starts the clock, six ways to forfeit, and an August 2026 court ruling.
Pay-for-delay settlements and what the FTC counts
How reverse-payment patent settlements work, what a 2013 Supreme Court decision changed, and what 18 years of FTC settlement filings show about the deals companies still make.
Patent thickets, evergreening and the Orange Book
How secondary patents pile up around brand drugs, which ones FDA lets companies list, what the October 2026 patent data show, and what regulators and courts did about improper listings.
Citizen petitions and generic drug approval
Since 2007, a law has limited how citizen petitions can hold up generic approvals. FDA's reports to Congress show few delays, a steep drop in filings, and a steady complaint about the staff time involved.
How the CREATES Act got generic makers access to brand samples
Generic makers need brand samples to test against. Safety programs called REMS let some brands refuse. How the 2019 CREATES Act changed that, and what FDA, the FTC and GAO have reported.