List of Excipients in API hydromorphone hydrochloride
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Excipients in NDA-approved (novel) drugs containing hydromorphone hydrochloride
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | ANHYDROUS LACTOSE | |
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | BUTYLATED HYDROXYTOLUENE | |
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | CELLULOSE ACETATE | |
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | FERRIC OXIDE RED | |
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | FERROSOFERRIC OXIDE | |
| SpecGx LLC | HYDROMORPHONE HYDROCHLORIDE | hydromorphone hydrochloride | 0406-3308 | HYPROMELLOSE 2910 | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing hydromorphone hydrochloride
Detailed excipient profiles for hydromorphone hydrochloride
Excipient focus: ACETONE
hydromorphone hydrochloride drug variants containing ACETONE
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | hydromorphone hydrochloride | 31722-119 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-266 |
| XLCare Pharmaceuticals Inc | hydromorphone hydrochloride | 72865-168 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing ACETONE
Excipient focus: AMMONIO METHACRYLATE COPOLYMER TYPE A
hydromorphone hydrochloride drug variants containing AMMONIO METHACRYLATE COPOLYMER TYPE A
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing AMMONIO METHACRYLATE COPOLYMER TYPE A
Excipient focus: ANHYDROUS LACTOSE
hydromorphone hydrochloride drug variants containing ANHYDROUS LACTOSE
hydromorphone hydrochloride drug variants not containing ANHYDROUS LACTOSE
Excipient focus: BUTYLATED HYDROXYTOLUENE
hydromorphone hydrochloride drug variants containing BUTYLATED HYDROXYTOLUENE
hydromorphone hydrochloride drug variants not containing BUTYLATED HYDROXYTOLUENE
Excipient focus: CELLULOSE ACETATE
hydromorphone hydrochloride drug variants containing CELLULOSE ACETATE
hydromorphone hydrochloride drug variants not containing CELLULOSE ACETATE
Excipient focus: CELLULOSE, MICROCRYSTALLINE
hydromorphone hydrochloride drug variants containing CELLULOSE, MICROCRYSTALLINE
hydromorphone hydrochloride drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: CITRIC ACID MONOHYDRATE
hydromorphone hydrochloride drug variants containing CITRIC ACID MONOHYDRATE
hydromorphone hydrochloride drug variants not containing CITRIC ACID MONOHYDRATE
Excipient focus: D&C RED NO. 30
hydromorphone hydrochloride drug variants containing D&C RED NO. 30
hydromorphone hydrochloride drug variants not containing D&C RED NO. 30
Excipient focus: D&C YELLOW NO. 10
hydromorphone hydrochloride drug variants containing D&C YELLOW NO. 10
hydromorphone hydrochloride drug variants not containing D&C YELLOW NO. 10
Excipient focus: D&C YELLOW NO. 10 ALUMINUM LAKE
hydromorphone hydrochloride drug variants containing D&C YELLOW NO. 10 ALUMINUM LAKE
| Company | Ingredient | NDC |
|---|---|---|
| Trigen Laboratories LLC | hydromorphone hydrochloride | 13811-703 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing D&C YELLOW NO. 10 ALUMINUM LAKE
Excipient focus: EDETATE DISODIUM
hydromorphone hydrochloride drug variants containing EDETATE DISODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | hydromorphone hydrochloride | 0641-6254 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing EDETATE DISODIUM
Excipient focus: ETHYLCELLULOSE
hydromorphone hydrochloride drug variants containing ETHYLCELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing ETHYLCELLULOSE
Excipient focus: FD&C BLUE NO. 1
hydromorphone hydrochloride drug variants containing FD&C BLUE NO. 1
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing FD&C BLUE NO. 1
Excipient focus: FD&C RED NO. 40
hydromorphone hydrochloride drug variants containing FD&C RED NO. 40
| Company | Ingredient | NDC |
|---|---|---|
| ATLANTIC BIOLOGICALS CORP | hydromorphone hydrochloride | 17856-0386 |
| Lohxa | hydromorphone hydrochloride | 70166-250 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing FD&C RED NO. 40
Excipient focus: FD&C YELLOW NO. 6 ALUMINUM LAKE
hydromorphone hydrochloride drug variants containing FD&C YELLOW NO. 6 ALUMINUM LAKE
| Company | Ingredient | NDC |
|---|---|---|
| Trigen Laboratories LLC | hydromorphone hydrochloride | 13811-703 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing FD&C YELLOW NO. 6 ALUMINUM LAKE
Excipient focus: FERRIC OXIDE RED
hydromorphone hydrochloride drug variants containing FERRIC OXIDE RED
hydromorphone hydrochloride drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
hydromorphone hydrochloride drug variants containing FERRIC OXIDE YELLOW
hydromorphone hydrochloride drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: FERROSOFERRIC OXIDE
hydromorphone hydrochloride drug variants containing FERROSOFERRIC OXIDE
hydromorphone hydrochloride drug variants not containing FERROSOFERRIC OXIDE
Excipient focus: GLYCERIN
hydromorphone hydrochloride drug variants containing GLYCERIN
| Company | Ingredient | NDC |
|---|---|---|
| Lannett Company Inc | hydromorphone hydrochloride | 0527-1873 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-001 |
| Purdue Pharma LP | hydromorphone hydrochloride | 59011-451 |
| American Health Packaging | hydromorphone hydrochloride | 60687-566 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing GLYCERIN
Excipient focus: HYDROCHLORIC ACID
hydromorphone hydrochloride drug variants containing HYDROCHLORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Hikma Pharmaceuticals USA Inc | hydromorphone hydrochloride | 0641-6254 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing HYDROCHLORIC ACID
Excipient focus: HYPROMELLOSE
hydromorphone hydrochloride drug variants containing HYPROMELLOSE
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | hydromorphone hydrochloride | 31722-119 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-266 |
| XLCare Pharmaceuticals Inc | hydromorphone hydrochloride | 72865-168 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2208
hydromorphone hydrochloride drug variants containing HYPROMELLOSE 2208
| Company | Ingredient | NDC |
|---|---|---|
| Trigen Laboratories LLC | hydromorphone hydrochloride | 13811-703 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing HYPROMELLOSE 2208
Excipient focus: HYPROMELLOSE 2910
hydromorphone hydrochloride drug variants containing HYPROMELLOSE 2910
hydromorphone hydrochloride drug variants not containing HYPROMELLOSE 2910
Excipient focus: ISOPROPYL ALCOHOL
hydromorphone hydrochloride drug variants containing ISOPROPYL ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | hydromorphone hydrochloride | 31722-119 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-266 |
| XLCare Pharmaceuticals Inc | hydromorphone hydrochloride | 72865-168 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: LACTIC ACID
hydromorphone hydrochloride drug variants containing LACTIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Hospira Inc | hydromorphone hydrochloride | 0409-1283 |
| Hospira Inc | hydromorphone hydrochloride | 0409-2552 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing LACTIC ACID
Excipient focus: LACTOSE
hydromorphone hydrochloride drug variants containing LACTOSE
| Company | Ingredient | NDC |
|---|---|---|
| STAT RX USA LLC | hydromorphone hydrochloride | 16590-774 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing LACTOSE
Excipient focus: LACTOSE MONOHYDRATE
hydromorphone hydrochloride drug variants containing LACTOSE MONOHYDRATE
hydromorphone hydrochloride drug variants not containing LACTOSE MONOHYDRATE
Excipient focus: LACTOSE, ANHYDROUS
hydromorphone hydrochloride drug variants containing LACTOSE, ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| STAT Rx USA LLC | hydromorphone hydrochloride | 16590-942 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing LACTOSE, ANHYDROUS
Excipient focus: MAGNESIUM STEARATE
hydromorphone hydrochloride drug variants containing MAGNESIUM STEARATE
hydromorphone hydrochloride drug variants not containing MAGNESIUM STEARATE
Excipient focus: MANNITOL
hydromorphone hydrochloride drug variants containing MANNITOL
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing MANNITOL
Excipient focus: METHYLPARABEN
hydromorphone hydrochloride drug variants containing METHYLPARABEN
hydromorphone hydrochloride drug variants not containing METHYLPARABEN
Excipient focus: POLYETHYLENE GLYCOL
hydromorphone hydrochloride drug variants containing POLYETHYLENE GLYCOL
hydromorphone hydrochloride drug variants not containing POLYETHYLENE GLYCOL
Excipient focus: POLYETHYLENE GLYCOL 3350
hydromorphone hydrochloride drug variants containing POLYETHYLENE GLYCOL 3350
| Company | Ingredient | NDC |
|---|---|---|
| SpecGx LLC | hydromorphone hydrochloride | 23635-408 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POLYETHYLENE GLYCOL 3350
Excipient focus: POLYETHYLENE GLYCOL 400
hydromorphone hydrochloride drug variants containing POLYETHYLENE GLYCOL 400
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POLYETHYLENE GLYCOL 400
Excipient focus: POLYETHYLENE GLYCOL 7000000
hydromorphone hydrochloride drug variants containing POLYETHYLENE GLYCOL 7000000
| Company | Ingredient | NDC |
|---|---|---|
| Trigen Laboratories LLC | hydromorphone hydrochloride | 13811-703 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POLYETHYLENE GLYCOL 7000000
Excipient focus: POLYETHYLENE GLYCOLS
hydromorphone hydrochloride drug variants containing POLYETHYLENE GLYCOLS
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | hydromorphone hydrochloride | 54868-6387 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POLYETHYLENE GLYCOLS
Excipient focus: POLYETHYLENE OXIDE 200000
hydromorphone hydrochloride drug variants containing POLYETHYLENE OXIDE 200000
hydromorphone hydrochloride drug variants not containing POLYETHYLENE OXIDE 200000
Excipient focus: POLYSORBATE 80
hydromorphone hydrochloride drug variants containing POLYSORBATE 80
| Company | Ingredient | NDC |
|---|---|---|
| Camber Pharmaceuticals Inc | hydromorphone hydrochloride | 31722-119 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-266 |
| XLCare Pharmaceuticals Inc | hydromorphone hydrochloride | 72865-168 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POLYSORBATE 80
Excipient focus: POVIDONE
hydromorphone hydrochloride drug variants containing POVIDONE
hydromorphone hydrochloride drug variants not containing POVIDONE
Excipient focus: POVIDONE K30
hydromorphone hydrochloride drug variants containing POVIDONE K30
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POVIDONE K30
Excipient focus: POVIDONES
hydromorphone hydrochloride drug variants containing POVIDONES
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | hydromorphone hydrochloride | 54868-6387 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing POVIDONES
Excipient focus: PROPYLENE GLYCOL
hydromorphone hydrochloride drug variants containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| ATLANTIC BIOLOGICALS CORP | hydromorphone hydrochloride | 17856-0386 |
| Lohxa | hydromorphone hydrochloride | 70166-250 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing PROPYLENE GLYCOL
Excipient focus: PROPYLPARABEN
hydromorphone hydrochloride drug variants containing PROPYLPARABEN
hydromorphone hydrochloride drug variants not containing PROPYLPARABEN
Excipient focus: RASPBERRY
hydromorphone hydrochloride drug variants containing RASPBERRY
| Company | Ingredient | NDC |
|---|---|---|
| ATLANTIC BIOLOGICALS CORP | hydromorphone hydrochloride | 17856-0386 |
| Lohxa | hydromorphone hydrochloride | 70166-250 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing RASPBERRY
Excipient focus: SACCHARIN SODIUM ANHYDROUS
hydromorphone hydrochloride drug variants containing SACCHARIN SODIUM ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| ATLANTIC BIOLOGICALS CORP | hydromorphone hydrochloride | 17856-0386 |
| Lohxa | hydromorphone hydrochloride | 70166-250 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SACCHARIN SODIUM ANHYDROUS
Excipient focus: SILICON DIOXIDE
hydromorphone hydrochloride drug variants containing SILICON DIOXIDE
hydromorphone hydrochloride drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM CHLORIDE
hydromorphone hydrochloride drug variants containing SODIUM CHLORIDE
hydromorphone hydrochloride drug variants not containing SODIUM CHLORIDE
Excipient focus: SODIUM CITRATE
hydromorphone hydrochloride drug variants containing SODIUM CITRATE
hydromorphone hydrochloride drug variants not containing SODIUM CITRATE
Excipient focus: SODIUM HYDROXIDE
hydromorphone hydrochloride drug variants containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Hospira Inc | hydromorphone hydrochloride | 0409-1283 |
| Hospira Inc | hydromorphone hydrochloride | 0409-2552 |
| Hikma Pharmaceuticals USA Inc | hydromorphone hydrochloride | 0641-6254 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SODIUM HYDROXIDE
Excipient focus: SODIUM LACTATE
hydromorphone hydrochloride drug variants containing SODIUM LACTATE
| Company | Ingredient | NDC |
|---|---|---|
| Hospira Inc | hydromorphone hydrochloride | 0409-1283 |
| Hospira Inc | hydromorphone hydrochloride | 0409-2552 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SODIUM LACTATE
Excipient focus: SODIUM METABISULFITE
hydromorphone hydrochloride drug variants containing SODIUM METABISULFITE
hydromorphone hydrochloride drug variants not containing SODIUM METABISULFITE
Excipient focus: SODIUM STARCH GLYCOLATE TYPE A POTATO
hydromorphone hydrochloride drug variants containing SODIUM STARCH GLYCOLATE TYPE A POTATO
| Company | Ingredient | NDC |
|---|---|---|
| Aurolife Pharma LLC | hydromorphone hydrochloride | 13107-107 |
| Bryant Ranch Prepack | hydromorphone hydrochloride | 71335-0723 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SODIUM STARCH GLYCOLATE TYPE A POTATO
Excipient focus: SORBITOL
hydromorphone hydrochloride drug variants containing SORBITOL
| Company | Ingredient | NDC |
|---|---|---|
| ATLANTIC BIOLOGICALS CORP | hydromorphone hydrochloride | 17856-0386 |
| Lohxa | hydromorphone hydrochloride | 70166-250 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SORBITOL
Excipient focus: STEARIC ACID
hydromorphone hydrochloride drug variants containing STEARIC ACID
hydromorphone hydrochloride drug variants not containing STEARIC ACID
Excipient focus: SUCROSE
hydromorphone hydrochloride drug variants containing SUCROSE
| Company | Ingredient | NDC |
|---|---|---|
| Lannett Company Inc | hydromorphone hydrochloride | 0527-1873 |
| Ascent Pharmaceuticals Inc | hydromorphone hydrochloride | 43602-001 |
| Purdue Pharma LP | hydromorphone hydrochloride | 59011-451 |
| American Health Packaging | hydromorphone hydrochloride | 60687-566 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing SUCROSE
Excipient focus: TALC
hydromorphone hydrochloride drug variants containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing TALC
Excipient focus: TITANIUM DIOXIDE
hydromorphone hydrochloride drug variants containing TITANIUM DIOXIDE
hydromorphone hydrochloride drug variants not containing TITANIUM DIOXIDE
Excipient focus: TRIACETIN
hydromorphone hydrochloride drug variants containing TRIACETIN
hydromorphone hydrochloride drug variants not containing TRIACETIN
Excipient focus: TRIETHYL CITRATE
hydromorphone hydrochloride drug variants containing TRIETHYL CITRATE
| Company | Ingredient | NDC |
|---|---|---|
| Padagis US LLC | hydromorphone hydrochloride | 0574-0293 |
| >Company | >Ingredient | >NDC |
hydromorphone hydrochloride drug variants not containing TRIETHYL CITRATE
Excipient focus: WATER
hydromorphone hydrochloride drug variants containing WATER
hydromorphone hydrochloride drug variants not containing WATER
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LOE / Generic Entry Opportunies 2025 - 2026
NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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