Details for New Drug Application (NDA): 212690
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NDA 212690 describes XYWAV, which is a drug marketed by Jazz and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the XYWAV profile page.
The generic ingredient in XYWAV is calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate profile page.
The generic ingredient in XYWAV is calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate profile page.
Summary for 212690
| Tradename: | XYWAV |
| Applicant: | Jazz |
| Ingredient: | calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212690
Generic Entry Date for 212690*:
Constraining patent/regulatory exclusivity:
THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS Dosage:
SOLUTION;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: 212690
Suppliers and Packaging for NDA: 212690
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XYWAV | calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate | SOLUTION;ORAL | 212690 | NDA | Jazz Pharmaceuticals, Inc. | 68727-150 | 68727-150-01 | 180 mL in 1 BOTTLE, PLASTIC (68727-150-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | ||||
| Approval Date: | Jul 21, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS | ||||||||
| Regulatory Exclusivity Expiration: | Jan 21, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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