Orange Book product · Brand (NDA)
HEPZATO
MELPHALAN HYDROCHLORIDE
At a glance
Aug 14, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 14, 2023
2 yr 11 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 14, 2026
in 2 mo
Exclusivity ends · ODE-438
Orphan-drug exclusivity (7 years)
Aug 14, 2030
in 4 yr 3 mo
Patent 10098997 expires
Listed drug product patent expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 10369264 expires
Listed drug product patent expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 10569004 expires
Listed method-of-use patent (U-3680) expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 10569004 expires
Listed method-of-use patent (U-3683) expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 11241522 expires
Listed drug product patent expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 11633528 expires
Listed method-of-use patent (U-3675) expiration.
Nov 07, 2032
in 6 yr 6 mo
Patent 11083831 expires
Listed drug product patent expiration.
Dec 30, 2032
in 6 yr 8 mo
Patent 11833286 expires
Listed drug product patent expiration.
Dec 30, 2032
in 6 yr 8 mo
Patent 10195334 expires
Listed drug product patent expiration.
Jan 16, 2033
in 6 yr 8 mo
Patent 9314561 expires
Listed drug product patent expiration.
Feb 07, 2034
in 7 yr 9 mo
Patent 9707331 expires
Listed drug product patent expiration.
Sep 17, 2034
in 8 yr 4 mo
Pharmaceutical detail
Active ingredient
MELPHALAN HYDROCHLORIDE
Strength
EQ 50MG BASE/VIAL
Dosage form
POWDER
Route
INTRA-ARTERIAL
TE code
Not listed
Application
NDA 201848
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2023IVRABrand (NDA)
NDA 217110 · APOTEX
- 2016EVOMELABrand (NDA)
NDA 207155 · ACROTECH BIOPHARMA
- 1992ALKERANBrand (NDA)
NDA 020207 · APOTEX
- 2024MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 206523 · AVET LIFESCIENCES
- 2024MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 215024 · HETERO LABS
- 2021MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 212960 · MEITHEAL
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209197 · BPI LABS
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209323 · ACTAVIS LLC
- 2020MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 210947 · INGENUS PHARMS LLC
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 211463 · ARTHUR GRP
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 209826 · GLAND
- 2019MELPHALAN HYDROCHLORIDEGeneric (ANDA)
ANDA 204817 · ALMAJECT
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Aug 14, 2026
in 2 mo
- ODE-438Orphan-drug exclusivity (7 years)
Aug 14, 2030
in 4 yr 3 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10098997 | Nov 07, 2032 | in 6 yr 6 mo | Product |
| 10369264 | Nov 07, 2032 | in 6 yr 6 mo | Product |
| 10569004 | Nov 07, 2032 | in 6 yr 6 mo | U-3680 |
| 10569004 | Nov 07, 2032 | in 6 yr 6 mo | U-3683 |
| 11241522 | Nov 07, 2032 | in 6 yr 6 mo | Product |
| 11633528 | Nov 07, 2032 | in 6 yr 6 mo | U-3675 |
| 11083831 | Dec 30, 2032 | in 6 yr 8 mo | Product |
| 11833286 | Dec 30, 2032 | in 6 yr 8 mo | Product |
| 10195334 | Jan 16, 2033 | in 6 yr 8 mo | Product |
| 9314561 | Feb 07, 2034 | in 7 yr 9 mo | Product |
| 9707331 | Sep 17, 2034 | in 8 yr 4 mo | Product |
