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Details for New Drug Application (NDA): 021060
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NDA 021060 describes PRIALT, which is a drug marketed by Tersera Theraps Llc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the PRIALT profile page.
The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ziconotide acetate profile page.
The generic ingredient in PRIALT is ziconotide acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ziconotide acetate profile page.
Summary for 021060
| Tradename: | PRIALT |
| Applicant: | Tersera Theraps Llc |
| Ingredient: | ziconotide acetate |
| Patents: | 3 |
Generic Entry Opportunity Date for 021060
Generic Entry Date for 021060*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRATHECAL |
*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: 021060
| Mechanism of Action | N-Calcium Channel Receptor Antagonists |
Suppliers and Packaging for NDA: 021060
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | Jazz Pharmaceuticals, Inc. | 18860-720 | 18860-720-10 | 1 VIAL, GLASS in 1 CARTON (18860-720-10) > 1 mL in 1 VIAL, GLASS |
| PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060 | NDA | Jazz Pharmaceuticals, Inc. | 18860-722 | 18860-722-10 | 1 VIAL, GLASS in 1 CARTON (18860-722-10) > 5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRATHECAL | Strength | 500MCG/20ML (25MCG/ML) | ||||
| Approval Date: | Dec 28, 2004 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ANALGESIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PAIN | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 1, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ANALGESIA | ||||||||
Expired US Patents for NDA 021060
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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