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Patent cliff

A brand-name drug is shielded from generic competition by patents and FDA exclusivity periods. When the last of those expires, generics can enter — and the price usually falls hard. Below is every brand in the FDA Orange Book whose last listed protection runs out soon, sorted by date.

ⓘ How this was built
Data sources
  • FDA Orange Book (products, patents, exclusivity)
Method

For each brand: the latest patent or exclusivity expiration listed in the Orange Book. Expiry does not guarantee generic entry (settlements, pediatric extensions, and unlisted patents move dates). The 'if generics enter' column applies the measured erosion median from the section below to the brand's current NADAC price — an analog across ~200 recent molecules, not a forecast for any single drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

99
brands lose their last protection in the next 12 months
466
lose it within 5 years
1,380
brands with protection still on the clock

What actually happens to the price

“The price falls” is easy to say. Here is the measured version: across drugs that went from a single manufacturer to two or more since 2019, the typical price fell to 72% of what it was about 23 years later. In every window measured, roughly 7 in 10 of the drugs were cheaper than they had been before competition arrived.

How to read the chart: each row is a window of time aftercompetition began, and the bar shows the typical drug's price then, as a percentage of its own price before competition. A row reading “1–6 mo · 93%” means that in the first six months the typical drug still cost 93% of its old price — the fall starts slowly, then compounds down the chart as more competitors arrive.

ⓘ How this was built
Data sources
  • FDA NDC Directory — marketing start/end dates (when each company was actively selling)
  • NADAC pharmacy acquisition prices, monthly 2013–present (data.medicaid.gov)
Method

An event study. For each molecule we find the month it first went from one active marketer to two or more, index its NADAC price to its own average over the six months before that, and track it forward. Medians pool 74+ molecules per window. The event comes from observed marketing dates rather than Orange Book generic-approval dates on purpose: the Orange Book lists only currently marketed products, so a drug generic since the 1990s whose old ANDAs were delisted looks brand new — anchoring on it produced a median change of +0.0%, indistinguishable from noise.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Time since competition began
Typical price vs before competition (100% = unchanged)
Drugs measured · share cheaper
16 mo
93%
n=98 · 73% fell
712 mo
91%
n=94 · 70% fell
1318 mo
79%
n=82 · 73% fell
1924 mo
79%
n=77 · 74% fell
2530 mo
72%
n=74 · 76% fell

Bars show the median price as a share of the pre-competition price, so shorter is cheaper. Each window rests on 7498 molecules — enough to show the shape, not enough to predict any single drug. Only drugs sold through retail pharmacy appear at all, since that is what NADAC prices.

Steepest declines in the sample
  • efavirenz, emtricitabine and tenofovir disoproxil fumarate95% cheaper
  • amlodipine and valsartan89% cheaper
  • pioglitazone and metformin hydrochloride88% cheaper
  • adapalene and benzoyl peroxide81% cheaper
  • aspirin and dipyridamole78% cheaper
  • levonorgestrel/ethinyl estradiol and ethinyl estradiol71% cheaper
  • brimonidine tartrate and timolol maleate70% cheaper
  • alosetron hydrochloride62% cheaper

Brands losing their last listed protection

Each row is one Orange Book application; the date is the latest expiration across all its listed patents and exclusivity periods. “Patents only” shows the classic cliff — brands whose final protection is a listed patent; “all protections” adds brands whose last shield is a regulatory exclusivity period FDA granted at approval (new chemical entity, orphan drug, new clinical study, or a pediatric add-on).

brands whose final protection is a listed patent
Sep 22, 20261 moSensipar
Cinacalcet Hydrochloride · Tablet
Amgen6 patents~$18.61/EA in ~2–3 yr
Sep 28, 20261 moSprycel
Dasatinib · Tablet
Bristol Myers Squibb12 patents · 12 exclusivities~$18.86/EA in ~2–3 yr
Oct 2, 20261 moVeregen
Sinecatechins · Ointment
Ani Pharms1 patents~$37.11/GM in ~2–3 yr
Oct 4, 20261 moAricept
Donepezil Hydrochloride · Tablet
Eisai Inc1 patents~$10.36/EA in ~2–3 yr
Oct 6, 20261 moSaphris
Asenapine Maleate · Tablet
Abbvie12 patents~$15.26/EA in ~2–3 yr
Oct 11, 20261 moJuvisync
Simvastatin; Sitagliptin Phosphate · Tablet
Merck Sharp Dohme12 patents
Oct 12, 20261 moAndrogel
Testosterone · Gel, Metered
Besins Hlthcare24 patents~$0.3398/GM in ~2–3 yr
Oct 23, 20262 moAdasuve
Loxapine · Powder
Nova Pneuma1 patents
Oct 26, 20262 moSynribo
Omacetaxine Mepesuccinate · Powder
Teva Pharms Intl1 patents
Nov 22, 20263 moSumavel Dosepro
Sumatriptan Succinate · Injectable
Endo Operations2 patents
Nov 28, 20263 moNaropin
Ropivacaine Hydrochloride · Solution
Fresenius Kabi Usa2 patents
Dec 2, 20263 moClindesse
Clindamycin Phosphate · Cream
Padagis Us1 patents~$19.18/GM in ~2–3 yr
Dec 7, 20263 moProtonix
Pantoprazole Sodium · For Suspension, Delayed Release
Wyeth Pharms2 patents~$10.15/EA in ~2–3 yr
Dec 12, 20263 moCorlanor
Ivabradine · Solution
Amgen Inc4 patents · 2 exclusivities~$6.97/dosage unit in ~2–3 yr
Dec 14, 20263 moSignifor
Pasireotide Diaspartate · Solution
Recordati Rare3 patents~$235.69/dosage unit in ~2–3 yr
Dec 19, 20264 moVyndaqel
Tafamidis Meglumine · Capsule
Foldrx Pharms2 patents · 1 exclusivities~$130.50/dosage unit in ~2–3 yr
Jan 1, 20274 moVibativ
Telavancin Hydrochloride · Powder
Apotex2 patents~$24.16/dosage unit in ~2–3 yr
Jan 19, 20275 moStriverdi Respimat
Olodaterol Hydrochloride · Spray, Metered
Boehringer Ingelheim1 patents~$47.51/GM in ~2–3 yr
Jan 29, 20275 moKynamro
Mipomersen Sodium · Solution
Kastle Theraps Llc1 patents
Jan 31, 20275 moNevanac
Nepafenac · Suspension/Drops
Harrow Eye1 patents~$75.40/ML in ~2–3 yr
Feb 1, 20275 moOvide
Malathion · Lotion
Taro2 patents
Feb 2, 20275 moLexiscan
Regadenoson · Solution
Astellas2 patents
Feb 14, 20275 moAltabax
Retapamulin · Ointment
Almirall1 patents~$16.33/dosage unit in ~2–3 yr
Feb 24, 20276 moColazal
Balsalazide Disodium · Capsule
Valeant Pharms Intl4 patents~$4.53/dosage unit in ~2–3 yr
Feb 28, 20276 moAdvil Allergy Sinus
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride · Tablet
Haleon Us Holdings1 patents

Showing 25 of 326 brands losing their last listed protection in the next ~6 years.

How to read it: the “protection clears” date is when nothing on file blocks a generic — not a guarantee one launches that day. A generic maker can also enter earlier by challenging a patent (a Paragraph IV filing) or if the brand delists one.

Source: FDA Orange Book patent and exclusivity listings (canonical.patents_exclusivity joined to Orange Book products). Educational only — not legal or investment advice.