What this means
DOXEPIN HYDROCHLORIDE is the active ingredient in DOXEPIN HYDROCHLORIDE / SINEQUAN / ZONALON and 1 others (marketed by NEW RIVER PHARMACEUTICALS INC and 3 others). Available as capsule;oral, concentrate;oral, and 2 other dosage forms. First approved 1981 — 44 years on market. Currently protected by 16 patents. The earliest market opportunity is 2027-05-17 (in 10 months). This drug has FDA Competitive Generic Therapy designation — first-to-file generic earns 180-day exclusivity, FDA expedites approval. 163+ ANDAs already filed — saturated market, thin margins expected. Bottom line: saturated — high competition will compress margins.
Designated 2022-04-19. First CGT approval: Edenbridge Pharmaceuticals, LLC, ANDA 213796, approved 2022-04-19
| Patent | Type | Expiry | Verdict |
|---|---|---|---|
| US 9486437 ↗US 9486437 | U-620 | 2027-05-17 | — |
| US 9861607 ↗US 9861607 | U-620 | 2027-05-17 | — |
| US 10238620 ↗US 10238620 | U-620 | 2027-05-17 | — |
| US 12083090 ↗US 12083090 | U-620 | 2027-05-17 | — |
| US 10653662 ↗US 10653662 | U-620 | 2027-05-17 | — |
| US 9572814 ↗US 9572814 | U-620 | 2027-07-19 | — |
| US 10653660 ↗US 10653660 | U-620 | 2027-07-19 | — |
| US 11110074 ↗US 11110074 | U-620 | 2027-07-19 | — |
| US 7915307 ↗US 7915307 | U-620 | 2027-08-23 | — |
| US 11234954 ↗US 11234954 | U-620 | 2028-01-17 | — |
| US 10548871 ↗US 10548871 | U-620 | 2028-04-10 | — |
| US 11096920 ↗US 11096920 | U-620 | 2028-04-10 | — |
| US 9907780 ↗US 9907780 | Product | 2028-04-10 | — |
| US 9107898 ↗US 9107898 | U-620 | 2028-04-30 | — |
| US 9532971 ↗US 9532971 | Product | 2029-05-31 | — |
| US 8513299 ↗US 8513299 | U-620 | 2030-09-06 | — |
EQ 10MG BASE · CAPSULE;ORAL · approved 1981-12-31 · NEW RIVER PHARMACEUTICALS INC
EQ 25MG BASE · CAPSULE;ORAL · approved 1981-12-31 · NEW RIVER PHARMACEUTICALS INC
EQ 50MG BASE · CAPSULE;ORAL · approved 1981-12-31 · NEW RIVER PHARMACEUTICALS INC
EQ 75MG BASE · CAPSULE;ORAL · approved 1981-12-31 · NEW RIVER PHARMACEUTICALS INC
EQ 100MG BASE · CAPSULE;ORAL · approved 1981-12-31 · NEW RIVER PHARMACEUTICALS INC
EQ 150MG BASE · CAPSULE;ORAL · approved 1987-04-12 · NEW RIVER PHARMACEUTICALS INC
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE;ORAL · approved 1981-12-31 · PFIZER LABORATORIES DIV PFIZER INC
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE;ORAL · approved 1981-12-31 · PFIZER LABORATORIES DIV PFIZER INC
EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE;ORAL · approved 1981-12-31 · PFIZER LABORATORIES DIV PFIZER INC
EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE;ORAL · approved 1981-12-31 · PFIZER LABORATORIES DIV PFIZER INC
EQ 150MG BASE · approved 2022-04-18
EQ 10MG BASE · approved 2020-07-27
EQ 25MG BASE · approved 2020-07-27
EQ 50MG BASE · approved 2020-07-27
EQ 75MG BASE · approved 2020-07-27
EQ 100MG BASE · approved 2020-07-27
EQ 10MG BASE · approved 2019-09-12
EQ 25MG BASE · approved 2019-09-12
EQ 50MG BASE · approved 2019-09-12
EQ 75MG BASE · approved 2019-09-12