Details for New Drug Application (NDA): 215431
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NDA 215431 describes SYMBRAVO, which is a drug marketed by Axsome and is included in one NDA. It is available from one supplier. There are seventy-five patents protecting this drug. Additional details are available on the SYMBRAVO profile page.
The generic ingredient in SYMBRAVO is meloxicam; rizatriptan benzoate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meloxicam; rizatriptan benzoate profile page.
The generic ingredient in SYMBRAVO is meloxicam; rizatriptan benzoate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meloxicam; rizatriptan benzoate profile page.
Summary for 215431
| Tradename: | SYMBRAVO |
| Applicant: | Axsome |
| Ingredient: | meloxicam; rizatriptan benzoate |
| Patents: | 75 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215431
Generic Entry Date for 215431*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
TABLET;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: 215431
Suppliers and Packaging for NDA: 215431
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431 | NDA | Axsome Therapeutics, Inc. | 81968-020 | 81968-020-02 | 1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE |
| SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431 | NDA | Axsome Therapeutics, Inc. | 81968-020 | 81968-020-03 | 1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG;EQ 10MG BASE | ||||
| Approval Date: | Jan 30, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 11, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCING TMAX OF ORALLY ADMINISTERED MELOXICAM | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 11, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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