Details for New Drug Application (NDA): 022399
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NDA 022399 describes HORIZANT, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the HORIZANT profile page.
The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gabapentin enacarbil profile page.
The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gabapentin enacarbil profile page.
Summary for 022399
| Tradename: | HORIZANT |
| Applicant: | Azurity |
| Ingredient: | gabapentin enacarbil |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022399
Generic Entry Date for 022399*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022399
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 022399
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0101 | 53451-0101-1 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-1) |
| HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399 | NDA | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 53451-0101 | 53451-0101-9 | 5 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0101-9) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 600MG | ||||
| Approval Date: | Apr 6, 2011 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 6, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 10, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 11, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS | ||||||||
Expired US Patents for NDA 022399
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-002 | Dec 13, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| Azurity | HORIZANT | gabapentin enacarbil | TABLET, EXTENDED RELEASE;ORAL | 022399-001 | Apr 6, 2011 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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