Details for New Drug Application (NDA): 201923
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NDA 201923 describes ILUVIEN, which is a drug marketed by Alimera Sciences Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ILUVIEN profile page.
The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in ILUVIEN is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 201923
| Tradename: | ILUVIEN |
| Applicant: | Alimera Sciences Inc |
| Ingredient: | fluocinolone acetonide |
| Patents: | 2 |
Pharmacology for NDA: 201923
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 201923
Suppliers and Packaging for NDA: 201923
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923 | NDA | ANI Pharmaceuticals, Inc. | 68611-190 | 68611-190-02 | 1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | IMPLANT;INTRAVITREAL | Strength | 0.19MG | ||||
| Approval Date: | Sep 26, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 8,871,241 | Patent Expiration: | Aug 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,849,027 | Patent Expiration: | Nov 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | THE TREATMENT OF DIABETIC MACULAR EDEMA (DME) IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH A COURSE OF CORTICOSTEROIDS AND DID HAVE A CLINICALLY SIGNIFICANT RISE IN INTRAOCULAR PRESSURE | ||||||||
| Patent: | 9,849,027 | Patent Expiration: | Nov 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE | ||||||||
Expired US Patents for NDA 201923
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | 6,217,895 | ⤷ Get Started Free |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | 8,252,307 | ⤷ Get Started Free |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | 6,375,972 | ⤷ Get Started Free |
| Alimera Sciences Inc | ILUVIEN | fluocinolone acetonide | IMPLANT;INTRAVITREAL | 201923-001 | Sep 26, 2014 | 6,548,078 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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