List of Excipients in API ISOTRETINOIN
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Excipients in NDA-approved (novel) drugs containing ISOTRETINOIN
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | FERRIC OXIDE YELLOW | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | GELATIN | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | PEG-32 HYDROGENATED PALM GLYCERIDES | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | POTASSIUM HYDROXIDE | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | PROPYL GALLATE | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | PROPYLENE GLYCOL | |
| Sun Pharmaceutical Industries Inc | ABSORICA | isotretinoin | 10631-115 | SHELLAC | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing ISOTRETINOIN
Detailed excipient profiles for ISOTRETINOIN
Excipient focus: .ALPHA.-TOCOPHEROL
ISOTRETINOIN drug variants containing .ALPHA.-TOCOPHEROL
ISOTRETINOIN drug variants not containing .ALPHA.-TOCOPHEROL
Excipient focus: .ALPHA.-TOCOPHEROL, DL-
ISOTRETINOIN drug variants containing .ALPHA.-TOCOPHEROL, DL-
| Company | Ingredient | NDC |
|---|---|---|
| Upsher-Smith Laboratories LLC | isotretinoin | 0832-8301 |
| Akorn Operating Company LLC | isotretinoin | 61748-301 |
| Mayne Pharma | isotretinoin | 68308-781 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing .ALPHA.-TOCOPHEROL, DL-
Excipient focus: ALCOHOL
ISOTRETINOIN drug variants containing ALCOHOL
ISOTRETINOIN drug variants not containing ALCOHOL
Excipient focus: ALPHA-TOCOPHEROL
ISOTRETINOIN drug variants containing ALPHA-TOCOPHEROL
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | isotretinoin | 0555-1054 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing ALPHA-TOCOPHEROL
Excipient focus: AMMONIA
ISOTRETINOIN drug variants containing AMMONIA
ISOTRETINOIN drug variants not containing AMMONIA
Excipient focus: BUTYL ALCOHOL
ISOTRETINOIN drug variants containing BUTYL ALCOHOL
ISOTRETINOIN drug variants not containing BUTYL ALCOHOL
Excipient focus: BUTYLATED HYDROXYANISOLE
ISOTRETINOIN drug variants containing BUTYLATED HYDROXYANISOLE
ISOTRETINOIN drug variants not containing BUTYLATED HYDROXYANISOLE
Excipient focus: CORN OIL
ISOTRETINOIN drug variants containing CORN OIL
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | isotretinoin | 0378-6611 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing CORN OIL
Excipient focus: COTTONSEED OIL
ISOTRETINOIN drug variants containing COTTONSEED OIL
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6307 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing COTTONSEED OIL
Excipient focus: D&C RED NO. 27
ISOTRETINOIN drug variants containing D&C RED NO. 27
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing D&C RED NO. 27
Excipient focus: D&C RED NO. 30
ISOTRETINOIN drug variants containing D&C RED NO. 30
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing D&C RED NO. 30
Excipient focus: D&C RED NO. 7
ISOTRETINOIN drug variants containing D&C RED NO. 7
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | isotretinoin | 0555-1054 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing D&C RED NO. 7
Excipient focus: D&C YELLOW NO. 10
ISOTRETINOIN drug variants containing D&C YELLOW NO. 10
| Company | Ingredient | NDC |
|---|---|---|
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing D&C YELLOW NO. 10
Excipient focus: DEHYDRATED ALCOHOL
ISOTRETINOIN drug variants containing DEHYDRATED ALCOHOL
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing DEHYDRATED ALCOHOL
Excipient focus: DIMETHICONE
ISOTRETINOIN drug variants containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6307 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing DIMETHICONE
Excipient focus: EDETATE DISODIUM
ISOTRETINOIN drug variants containing EDETATE DISODIUM
ISOTRETINOIN drug variants not containing EDETATE DISODIUM
Excipient focus: FD&C BLUE NO. 1
ISOTRETINOIN drug variants containing FD&C BLUE NO. 1
| Company | Ingredient | NDC |
|---|---|---|
| Actavis Pharma Inc | isotretinoin | 0591-2433 |
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing FD&C BLUE NO. 1
Excipient focus: FD&C BLUE NO. 2
ISOTRETINOIN drug variants containing FD&C BLUE NO. 2
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing FD&C BLUE NO. 2
Excipient focus: FD&C RED NO. 40
ISOTRETINOIN drug variants containing FD&C RED NO. 40
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing FD&C RED NO. 40
Excipient focus: FD&C YELLOW NO. 6
ISOTRETINOIN drug variants containing FD&C YELLOW NO. 6
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | isotretinoin | 0555-1054 |
| Physicians Total Care Inc | isotretinoin | 54868-6366 |
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing FD&C YELLOW NO. 6
Excipient focus: FERRIC OXIDE RED
ISOTRETINOIN drug variants containing FERRIC OXIDE RED
ISOTRETINOIN drug variants not containing FERRIC OXIDE RED
Excipient focus: FERRIC OXIDE YELLOW
ISOTRETINOIN drug variants containing FERRIC OXIDE YELLOW
ISOTRETINOIN drug variants not containing FERRIC OXIDE YELLOW
Excipient focus: FERROSOFERRIC OXIDE
ISOTRETINOIN drug variants containing FERROSOFERRIC OXIDE
ISOTRETINOIN drug variants not containing FERROSOFERRIC OXIDE
Excipient focus: GELATIN
ISOTRETINOIN drug variants containing GELATIN
ISOTRETINOIN drug variants not containing GELATIN
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-5039 |
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| >Company | >Ingredient | >NDC |
Excipient focus: GLYCERIN
ISOTRETINOIN drug variants containing GLYCERIN
ISOTRETINOIN drug variants not containing GLYCERIN
Excipient focus: HYDROGENATED SOYBEAN OIL
ISOTRETINOIN drug variants containing HYDROGENATED SOYBEAN OIL
ISOTRETINOIN drug variants not containing HYDROGENATED SOYBEAN OIL
Excipient focus: ISOPROPYL ALCOHOL
ISOTRETINOIN drug variants containing ISOPROPYL ALCOHOL
ISOTRETINOIN drug variants not containing ISOPROPYL ALCOHOL
Excipient focus: MEDIUM-CHAIN TRIGLYCERIDES
ISOTRETINOIN drug variants containing MEDIUM-CHAIN TRIGLYCERIDES
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing MEDIUM-CHAIN TRIGLYCERIDES
Excipient focus: METHYLPARABEN
ISOTRETINOIN drug variants containing METHYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing METHYLPARABEN
Excipient focus: PEG-32 HYDROGENATED PALM GLYCERIDES
ISOTRETINOIN drug variants containing PEG-32 HYDROGENATED PALM GLYCERIDES
| Company | Ingredient | NDC |
|---|---|---|
| Actavis Pharma Inc | isotretinoin | 0591-2433 |
| Sun Pharmaceutical Industries Inc | isotretinoin | 10631-115 |
| Sun Pharmaceutical Industries Inc | isotretinoin | 57664-020 |
| Zydus Pharmaceuticals USA Inc | isotretinoin | 70710-1574 |
| Zydus Lifesciences Limited | isotretinoin | 70771-1662 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing PEG-32 HYDROGENATED PALM GLYCERIDES
Excipient focus: POLYETHYLENE GLYCOL 400
ISOTRETINOIN drug variants containing POLYETHYLENE GLYCOL 400
| Company | Ingredient | NDC |
|---|---|---|
| Zydus Pharmaceuticals USA Inc | isotretinoin | 70710-1022 |
| Zydus Lifesciences Limited | isotretinoin | 70771-1557 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing POLYETHYLENE GLYCOL 400
Excipient focus: POLYSORBATE 80
ISOTRETINOIN drug variants containing POLYSORBATE 80
| Company | Ingredient | NDC |
|---|---|---|
| Teva Pharmaceuticals USA Inc | isotretinoin | 0555-1054 |
| Physicians Total Care Inc | isotretinoin | 54868-6307 |
| Aurobindo Pharma Limited | isotretinoin | 59651-631 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing POLYSORBATE 80
Excipient focus: POLYVINYL ACETATE PHTHALATE
ISOTRETINOIN drug variants containing POLYVINYL ACETATE PHTHALATE
| Company | Ingredient | NDC |
|---|---|---|
| Zydus Pharmaceuticals USA Inc | isotretinoin | 70710-1022 |
| Zydus Lifesciences Limited | isotretinoin | 70771-1557 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing POLYVINYL ACETATE PHTHALATE
Excipient focus: POTASSIUM HYDROXIDE
ISOTRETINOIN drug variants containing POTASSIUM HYDROXIDE
ISOTRETINOIN drug variants not containing POTASSIUM HYDROXIDE
Excipient focus: PROPYL GALLATE
ISOTRETINOIN drug variants containing PROPYL GALLATE
ISOTRETINOIN drug variants not containing PROPYL GALLATE
Excipient focus: PROPYLENE GLYCOL
ISOTRETINOIN drug variants containing PROPYLENE GLYCOL
ISOTRETINOIN drug variants not containing PROPYLENE GLYCOL
Excipient focus: PROPYLPARABEN
ISOTRETINOIN drug variants containing PROPYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| Physicians Total Care Inc | isotretinoin | 54868-6425 |
| Dr Reddy's Laboratories Limited | isotretinoin | 55111-135 |
| BluePoint Laboratories | isotretinoin | 68001-652 |
| JG Pharma Inc | isotretinoin | 72143-231 |
| JG Pharma Inc | isotretinoin | 72143-251 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing PROPYLPARABEN
Excipient focus: SHELLAC
ISOTRETINOIN drug variants containing SHELLAC
ISOTRETINOIN drug variants not containing SHELLAC
Excipient focus: SORBITAN MONOOLEATE
ISOTRETINOIN drug variants containing SORBITAN MONOOLEATE
ISOTRETINOIN drug variants not containing SORBITAN MONOOLEATE
Excipient focus: SORBITOL
ISOTRETINOIN drug variants containing SORBITOL
ISOTRETINOIN drug variants not containing SORBITOL
Excipient focus: SOYBEAN OIL
ISOTRETINOIN drug variants containing SOYBEAN OIL
ISOTRETINOIN drug variants not containing SOYBEAN OIL
| Company | Ingredient | NDC |
|---|---|---|
| >Company | >Ingredient | >NDC |
Excipient focus: STEAROYL POLYOXYL-32 GLYCERIDES
ISOTRETINOIN drug variants containing STEAROYL POLYOXYL-32 GLYCERIDES
| Company | Ingredient | NDC |
|---|---|---|
| Aurobindo Pharma Limited | isotretinoin | 59651-631 |
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing STEAROYL POLYOXYL-32 GLYCERIDES
Excipient focus: TITANIUM DIOXIDE
ISOTRETINOIN drug variants containing TITANIUM DIOXIDE
ISOTRETINOIN drug variants not containing TITANIUM DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| Mylan Pharmaceuticals Inc | isotretinoin | 0378-6611 |
| Physicians Total Care Inc | isotretinoin | 54868-5039 |
| >Company | >Ingredient | >NDC |
Excipient focus: WATER
ISOTRETINOIN drug variants containing WATER
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals NY LLC | isotretinoin | 69238-1254 |
| Zydus Pharmaceuticals USA Inc | isotretinoin | 70710-1022 |
| Zydus Pharmaceuticals USA Inc | isotretinoin | 70710-1574 |
| Zydus Lifesciences Limited | isotretinoin | 70771-1557 |
| Zydus Lifesciences Limited | isotretinoin | 70771-1662 |
| >Company | >Ingredient | >NDC |
ISOTRETINOIN drug variants not containing WATER
Excipient focus: WHITE WAX
ISOTRETINOIN drug variants containing WHITE WAX
ISOTRETINOIN drug variants not containing WHITE WAX
Excipient focus: YELLOW WAX
ISOTRETINOIN drug variants containing YELLOW WAX
ISOTRETINOIN drug variants not containing YELLOW WAX
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LOE / Generic Entry Opportunies 2025 - 2026
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ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
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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