Published April 5, 2026 · Updated monthly
When Will My Drug Go Generic? Patent Expiry Dates
A drug goes generic when its patent protection and market exclusivity expire, allowing other manufacturers to produce cheaper versions. The "patent cliff" is the date when this protection ends. Generic drugs typically cost 80-85% less than the brand-name version within a year of launch.
How Drug Patents Work
Drug manufacturers get several types of protection that prevent generic competition:
- Utility patents (20 years from filing) — Protect the chemical compound, formulation, or use of the drug. Because patents are filed years before FDA approval, effective patent life is usually 10-14 years after the drug reaches market.
- FDA exclusivity periods — New chemical entities get 5 years, new clinical studies get 3 years, and orphan drugs get 7 years of market exclusivity regardless of patent status.
- Patent extensions — The Hatch-Waxman Act allows up to 5 years of patent term restoration to compensate for time lost during FDA review.
Upcoming Patent Cliffs
| Drug | Condition | Cost/Claim | Patent Status | Annual Spending |
|---|---|---|---|---|
| Januvia | Diabetes | $219 | 2026-07-17 | $2734M |
| Trintellix | Mental Health | $278 | 2026-09-30 | $1067M |
| Entresto | Heart Failure | $379 | 2026-11-11 | $4765M |
| Revlimid | Cancer | $12,786 | 2027-03-15 | $7825M |
| Pomalyst | Cancer | $17,250 | 2027-04-09 | $3312M |
| Trulicity | Diabetes | $473 | 2027-09-18 | $4215M |
| Gilenya | Multiple Sclerosis | $5,738 | 2027-09-22 | $1423M |
| Jakafi | Cancer | $11,432 | 2027-11-16 | $2698M |
| Keytruda | Cancer | $18,176 | 2028-06-28 | $7234M |
| Basaglar | Diabetes | $130 | 2028-12-16 | $845M |
| Repatha | High Cholesterol | $757 | 2029-08-27 | $2589M |
| Vraylar | Mental Health | $383 | 2029-09-17 | $1654M |
| Enbrel | Autoimmune Diseases | $1,726 | 2029-11-02 | $1698M |
| Venclexta | Cancer | $6,784 | 2030-04-11 | $2198M |
| Trelegy Ellipta | Asthma/COPD | $380 | 2030-09-26 | $2876M |
| Harvoni | Hepatitis C | $24,958 | 2030-10-10 | $1198M |
| Dupixent | Autoimmune Diseases | $2,819 | 2031-03-28 | $4398M |
| Breztri Aerosphere | Asthma/COPD | $305 | 2031-07-24 | $756M |
| Ozempic | Diabetes | $685 | 2031-09-20 | $4956M |
| Fasenra | Asthma/COPD | $2,836 | 2031-11-14 | $987M |
| Tagrisso | Cancer | $11,591 | 2032-11-13 | $2156M |
| Biktarvy | HIV | $3,746 | 2033-02-07 | $3821M |
| Rinvoq | Autoimmune Diseases | $3,498 | 2033-08-16 | $2267M |
| Skyrizi | Autoimmune Diseases | $4,475 | 2035-04-23 | $2345M |
| Mounjaro | Diabetes | $673 | 2036-05-13 | $2478M |
What Happens When a Patent Expires
When a drug's last patent expires, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with the FDA. They must prove their generic is bioequivalent to the brand-name drug but do not need to repeat clinical trials. This dramatically reduces development costs, which translates to lower prices.
Typically, the first generic entrant captures significant market share within 6 months. After multiple generics enter, prices drop to 10-20% of the brand-name cost. For biologics, the equivalent process produces "biosimilars" — which are similar but not identical to the original, and typically priced 15-40% lower.
Evergreening: How Manufacturers Delay Generics
Drug companies use several strategies to extend exclusivity beyond the original patent:
- Patent thickets — Filing dozens of secondary patents on formulations, dosing, and delivery methods
- Product hopping — Launching a slightly modified version (extended-release, new combination) before the original patent expires
- Pay-for-delay settlements — Paying generic manufacturers to delay market entry (increasingly scrutinized by the FTC)
- REMS requirements — Using safety programs to restrict generic access to samples needed for bioequivalence testing
Search any drug on DrugPrice to check its patent status, generic availability, and cost comparison. Our Generic Watch page tracks the most impactful upcoming patent expirations.
Frequently Asked Questions
Search your drug name on DrugPrice to see if a generic equivalent is available. You can also check the FDA Orange Book or ask your pharmacist. If a generic exists, your insurance plan likely requires or incentivizes you to use it.
Yes. The FDA requires generics to be bioequivalent to the brand-name drug, meaning they deliver the same active ingredient in the same amount at the same rate. The inactive ingredients (fillers, dyes) may differ, which occasionally affects tolerance but not efficacy.
Some drugs maintain exclusivity through patent extensions, reformulations, or because they are complex biologics that are difficult to replicate. Orphan drugs for rare diseases may also lack generic competition because the small market size does not attract generic manufacturers.
/methodology