Law, patents & policy
Patents, competition law, Medicare and Medicaid. 26 articles: 3 data story, 19 explainers, 4 history.
Patents & exclusivity
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.
Generic drug labeling, skinny labels and carve-outs
Why a generic's label must match the brand's, how section viii carve-outs create skinny labels, what the 2011, 2013 and 2026 Supreme Court decisions held, and which changes generics cannot make alone.
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.
Competition & enforcement
What the FTC's study of pharmacy benefit managers found
The FTC ordered the largest PBMs to open their books in 2022. Two interim reports later, here is what staff found about specialty generic markups and pharmacy pay.
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.
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.
Medicare & Medicaid
Generics fill 84.5% of Medicare Part D claims and account for 11.6% of the cost
CMS grand totals for 2013 to 2024 show the generic share of Part D claims rising and the generic share of cost falling, plus a 2024 drop in generic spending that matches a pricing rule change.
Generics fill 86% of Medicaid prescriptions and take 11% of the spending
A GxRadar analysis of CMS State Drug Utilization Data, 2014 to 2025: generic share of Medicaid prescriptions and gross spending, how brands took over the dollars, and what rebates change.
How Medicare drug price negotiation works
Which drugs Medicare has negotiated, the first prices in effect since January 2026, the 2027 and 2028 rounds, and how a generic or biosimilar takes a drug out of the program.
Medicare Part B and Part D drugs compared
Which drugs Medicare covers under Part B and which under Part D, how the ASP-plus-6-percent payment works, what enrollees pay in 2026 and how Part B inflation rebates lower some coinsurance.
How Medicaid pays for generic drugs
Generics are 86 percent of Medicaid prescriptions and 14 percent of its gross drug spending. How the rebate program, the 2015 generic inflation rebate and Federal Upper Limits shape what Medicaid pays.
How Medicare Part D pays for generics
Generics are 90% of Part D prescriptions and about 12.5% of its gross spending. How plan bids, pharmacy contracts and the redesigned benefit decide who pays for a generic fill.
The Inflation Reduction Act and generic drugs
The 2022 law created Medicare price negotiation, a Part D out-of-pocket cap and inflation rebates. Each treats generics differently, and a generic launch is the main way a drug leaves negotiation.
Compounding & importation
Drug importation under section 804
What the 2003 law letting states import prescription drugs from Canada requires, how FDA's 2020 rule set it up, and where the first two state programs stood in late 2026.
How 503A and 503B compounding pharmacies differ
The two federal frameworks for drug compounding, how the 2012 fungal meningitis outbreak led Congress to pass the Drug Quality and Security Act, and how FDA and state boards split oversight.
Drug law history
The 1938 Food, Drug, and Cosmetic Act
A 1937 elixir made with an antifreeze-like solvent killed 107 people, and Congress responded with the law that still governs US drugs. What it required, and why the solvent is still in FDA guidance.
The Durham-Humphrey Amendment of 1951
A 1951 law drew the federal line between prescription and over-the-counter drugs. What it said, how the Rx legend and switch rules changed, and why the line still shapes generics.
The Kefauver-Harris Amendments of 1962
After thalidomide, Congress made drugmakers prove their products work. How the 1962 law changed approval, and how its review of older drugs produced the first abbreviated applications for copies.
The Orphan Drug Act of 1983
A 1983 law gave rare-disease drugs tax credits and seven years of exclusive marketing. FDA counts 6,340 designations in its first 40 years. How it was built, amended, and where generics meet it.
Pricing policy
Most-favored-nation drug pricing, from the 2020 rule to the 2026 models
Tying US drug prices to what other rich countries pay failed in court in 2020 and returned by executive order in 2025. What exists now, its legal status, and why generics are mostly left out.
Pharmaceutical tariffs, and why generics were left out
A 2026 proclamation put tariffs of up to 100% on imported patented drugs and exempted generics for now. The Section 232 rates, the generic definition, and the April 2027 review date.
State generic drug price-gouging laws and the court fights over them
Maryland's 2017 ban on generic price gouging was struck down in 2018. Minnesota's was blocked in 2025. Illinois's is still in force. How each law works, why courts split, and what our price data show.
State prescription drug affordability boards
How state drug affordability boards review prices and set upper payment limits, which states have them, where Colorado's blocked cap and Maryland's first limits stand, and how generics fit in.
What the 2026 federal PBM law changes, and what states did first
Congress wrote its first broad rules for pharmacy benefit managers into a February 2026 spending law. What each section does, when it starts, and how it fits with 50 states' worth of PBM laws.