Details for New Drug Application (NDA): 211988
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NDA 211988 describes ZYNRELEF KIT, which is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ZYNRELEF KIT profile page.
The generic ingredient in ZYNRELEF KIT is bupivacaine; meloxicam. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine; meloxicam profile page.
The generic ingredient in ZYNRELEF KIT is bupivacaine; meloxicam. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupivacaine; meloxicam profile page.
Summary for 211988
| Tradename: | ZYNRELEF KIT |
| Applicant: | Heron Theraps Inc |
| Ingredient: | bupivacaine; meloxicam |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211988
Generic Entry Date for 211988*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, EXTENDED RELEASE;PERIARTICULAR |
*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: 211988
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 211988
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988 | NDA | Heron Therapeutics, Inc. | 47426-301 | 47426-301-02 | 1 CARTON in 1 KIT (47426-301-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-301-04) / 14 mL in 1 VIAL, SINGLE-DOSE (47426-301-06) |
| ZYNRELEF KIT | bupivacaine; meloxicam | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | 211988 | NDA | Heron Therapeutics, Inc. | 47426-302 | 47426-302-02 | 1 CARTON in 1 KIT (47426-302-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-302-04) / 10.5 mL in 1 VIAL, SINGLE-DOSE (47426-302-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION, EXTENDED RELEASE;PERIARTICULAR | Strength | 60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML) | ||||
| Approval Date: | May 12, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 12, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Jan 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO EXPAND THE USE IN CERTAIN SOFT TISSUE AND CERTAIN ORTHOPEDIC SURGICAL PROCEDURES AS WELL AS REVISING THE LIMITATIONS OF USE | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 20, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF POSTSURGICAL PAIN PROVIDING ANALGESIA TO A PATIENT FOR UP TO 72 HOURS, FOR EXAMPLE, AFTER BUNIONECTOMY, OPEN INGUINAL HERNIORRHAPHY, OR TOTAL KNEE ARTHROPLASTY VIA SOFT TISSUE OR PERIARTICULAR INSTILLATION | ||||||||
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