Loss-of-Exclusivity Exposure
Which drug patent and exclusivity expiries actually matter — ranked by the Medicare Part D spending behind them, not by date.
$209.3bn of Medicare Part D spending sits on drugs whose listed protection lapses in the next 24 months
Apixaban alone accounts for 15.4% of it — $32.2bn, with its earliest listed date 2026-11-21.
The top five carry 46.5% of the total. This is exposure, not forecast savings.
Of the 25 drugs ranked, 1 already have a marketed generic.
$154.7bn of this spending is on drugs with no marketed generic today.
$2.5bn is on drugs where competition has already arrived — the listed date is not the start of competition for those.
Ranked by Part D spending (2024, gross of rebates)
| # | Drug | Part D spending | Earliest listed date | Generic today? | Applications |
|---|---|---|---|---|---|
| 1 |
Apixaban
ELIQUIS, ELIQUIS SPRINKLE |
$32.2bn | 2026-11-21 | Approved, not marketed | 4 approved |
| 2 |
Semaglutide
OZEMPIC, RYBELSUS |
$24.2bn | 2027-02-27 | Brand only | 0 approved |
| 3 |
Empagliflozin
JARDIANCE |
$18.5bn | 2026-09-21 | Brand only | 0 approved |
| 4 |
Tirzepatide
Mounjaro, ZEPBOUND |
$12.3bn | 2026-11-08 | Brand only | 0 approved |
| 5 |
Lenalidomide
Revlimid |
$10.1bn | 2027-04-27 | Approved, not marketed | 110 approved |
| 6 |
Enzalutamide
Xtandi |
$5.8bn | 2026-11-17 | Brand only | 0 approved |
| 7 |
Sitagliptin
JANUVIA, ZITUVIO |
$4.9bn | 2026-11-24 | Approved, not marketed | 9 approved |
| 8 |
Tafamidis
Vyndamax |
$4.7bn | 2026-12-19 | Brand only | 0 approved |
| 9 |
Ibrutinib
Imbruvica |
$3.5bn | 2026-12-28 | Brand only | 0 approved |
| 10 |
Ruxolitinib
JAKAFI, OPZELURA |
$3.4bn | 2026-11-24 | Brand only | 0 approved |
| 11 |
Palbociclib
Ibrance |
$3.3bn | 2027-03-05 | Brand only | 0 approved |
| 12 |
Pomalidomide
Pomalyst |
$3.3bn | 2027-05-14 | Approved, not marketed | 20 approved |
| 13 |
Linaclotide
Linzess |
$3.1bn | 2027-02-28 | Brand only | 0 approved |
| 14 |
Valbenazine
INGREZZA, INGREZZA Sprinkle |
$3.0bn | 2027-11-08 | Approved, not marketed | 2 approved |
| 15 |
Zanubrutinib
BRUKINSA |
$2.9bn | 2026-11-14 | Brand only | 0 approved |
| 16 |
Acalabrutinib
CALQUENCE |
$2.9bn | 2026-11-21 | Brand only | 0 approved |
| 17 |
Osimertinib
TAGRISSO |
$2.7bn | 2027-02-16 | Brand only | 0 approved |
| 18 |
Cyclosporine
CEQUA, Gengraf |
$2.5bn | 2027-11-03 | Generic already marketed | 28 approved |
| 19 |
Upadacitinib
Rinvoq |
$2.4bn | 2027-04-26 | Brand only | 0 approved |
| 20 |
Apalutamide
ERLEADA |
$2.3bn | 2027-03-27 | Approved, not marketed | 1 approved |
| 21 |
Tiotropium
Spiriva |
$2.0bn | 2026-10-10 | Approved, not marketed | 1 approved |
| 22 |
Darolutamide
NUBEQA |
$1.9bn | 2028-06-03 | Brand only | 0 approved |
| 23 |
Macitentan
OPSUMIT |
$1.9bn | 2026-12-03 | Approved, not marketed | 5 approved |
| 24 |
Rifaximin
XIFAXAN |
$1.8bn | 2027-09-02 | Brand only | 0 approved |
| 25 |
Apremilast
Otezla |
$1.7bn | 2027-01-19 | Approved, not marketed | 15 approved |
Showing the top 25 of 434 drugs with a listed event in this window.
How to read this
- This is EXPOSURE, not forecast savings. It is the Medicare Part D spending recorded against drugs whose listed protection lapses in the window. Whether anything is actually saved depends on a generic launching, at what price, and how fast it takes share — none of which is in this data.
- The spending figures are GROSS, before manufacturer rebates. CMS publishes Part D spending before rebates are applied, so the net cost to the programme is lower — materially lower on heavily-rebated brands — and these figures should not be read as net.
- This ranks Orange Book drugs only: small molecules approved under an NDA or ANDA. Biologics are licensed under BLAs, appear in the FDA Purple Book, and are among the largest Part D line items. They are absent from this ranking, so it is not a complete picture of drug spending.
- An expiry date is not a launch date, and a Paragraph IV settlement can let a generic arrive earlier than the date shown. Those agreements are private and are not in this data.
- A drug that already has a marketed generic appears here too, because a listed protection is still lapsing — but its spending is already open to competition. The market-status column separates the two.
- Spending is CMS Part D data for 2024. CMS publishes it annually in arrears, so it describes that year rather than today.
FDA Orange Book listings and CMS Medicare Part D Spending by Drug — informational, not legal, investment or medical advice, and not a forecast of generic entry or savings.
Data: FDA Orange Book patent/exclusivity listings and CMS Medicare Part D Spending by Drug — Orange Book snapshot ingested 2026-09-13 · CMS Part D spending for 2024 · source
Machine access — this tool is available as structured data for AI assistants and agents:
GET https://rxfinder.ai/tools/loe-exposure/data.json?window=…&limit=…
