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
- FDA Orange Book (products, patents, exclusivity)
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.
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 2–3 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
- FDA NDC Directory — marketing start/end dates (when each company was actively selling)
- NADAC pharmacy acquisition prices, monthly 2013–present (data.medicaid.gov)
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.
Bars show the median price as a share of the pre-competition price, so shorter is cheaper. Each window rests on 74–98 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.
- 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).
| Sep 22, 20261 mo | Sensipar Cinacalcet Hydrochloride · Tablet | Amgen | 6 patents | ~$18.61/EA in ~2–3 yr |
| Sep 28, 20261 mo | Sprycel Dasatinib · Tablet | Bristol Myers Squibb | 12 patents · 12 exclusivities | ~$18.86/EA in ~2–3 yr |
| Oct 2, 20261 mo | Veregen Sinecatechins · Ointment | Ani Pharms | 1 patents | ~$37.11/GM in ~2–3 yr |
| Oct 4, 20261 mo | Aricept Donepezil Hydrochloride · Tablet | Eisai Inc | 1 patents | ~$10.36/EA in ~2–3 yr |
| Oct 6, 20261 mo | Saphris Asenapine Maleate · Tablet | Abbvie | 12 patents | ~$15.26/EA in ~2–3 yr |
| Oct 11, 20261 mo | Juvisync Simvastatin; Sitagliptin Phosphate · Tablet | Merck Sharp Dohme | 12 patents | — |
| Oct 12, 20261 mo | Androgel Testosterone · Gel, Metered | Besins Hlthcare | 24 patents | ~$0.3398/GM in ~2–3 yr |
| Oct 23, 20262 mo | Adasuve Loxapine · Powder | Nova Pneuma | 1 patents | — |
| Oct 26, 20262 mo | Synribo Omacetaxine Mepesuccinate · Powder | Teva Pharms Intl | 1 patents | — |
| Nov 22, 20263 mo | Sumavel Dosepro Sumatriptan Succinate · Injectable | Endo Operations | 2 patents | — |
| Nov 28, 20263 mo | Naropin Ropivacaine Hydrochloride · Solution | Fresenius Kabi Usa | 2 patents | — |
| Dec 2, 20263 mo | Clindesse Clindamycin Phosphate · Cream | Padagis Us | 1 patents | ~$19.18/GM in ~2–3 yr |
| Dec 7, 20263 mo | Protonix Pantoprazole Sodium · For Suspension, Delayed Release | Wyeth Pharms | 2 patents | ~$10.15/EA in ~2–3 yr |
| Dec 12, 20263 mo | Corlanor Ivabradine · Solution | Amgen Inc | 4 patents · 2 exclusivities | ~$6.97/dosage unit in ~2–3 yr |
| Dec 14, 20263 mo | Signifor Pasireotide Diaspartate · Solution | Recordati Rare | 3 patents | ~$235.69/dosage unit in ~2–3 yr |
| Dec 19, 20264 mo | Vyndaqel Tafamidis Meglumine · Capsule | Foldrx Pharms | 2 patents · 1 exclusivities | ~$130.50/dosage unit in ~2–3 yr |
| Jan 1, 20274 mo | Vibativ Telavancin Hydrochloride · Powder | Apotex | 2 patents | ~$24.16/dosage unit in ~2–3 yr |
| Jan 19, 20275 mo | Striverdi Respimat Olodaterol Hydrochloride · Spray, Metered | Boehringer Ingelheim | 1 patents | ~$47.51/GM in ~2–3 yr |
| Jan 29, 20275 mo | Kynamro Mipomersen Sodium · Solution | Kastle Theraps Llc | 1 patents | — |
| Jan 31, 20275 mo | Nevanac Nepafenac · Suspension/Drops | Harrow Eye | 1 patents | ~$75.40/ML in ~2–3 yr |
| Feb 1, 20275 mo | Ovide Malathion · Lotion | Taro | 2 patents | — |
| Feb 2, 20275 mo | Lexiscan Regadenoson · Solution | Astellas | 2 patents | — |
| Feb 14, 20275 mo | Altabax Retapamulin · Ointment | Almirall | 1 patents | ~$16.33/dosage unit in ~2–3 yr |
| Feb 24, 20276 mo | Colazal Balsalazide Disodium · Capsule | Valeant Pharms Intl | 4 patents | ~$4.53/dosage unit in ~2–3 yr |
| Feb 28, 20276 mo | Advil Allergy Sinus Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride · Tablet | Haleon Us Holdings | 1 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.