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PRIALT Drug Profile
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When do Prialt patents expire, and when can generic versions of Prialt launch?
Prialt is a drug marketed by Tersera Theraps Llc and is included in one NDA. There are three patents protecting this drug.
This drug has six patent family members in four countries.
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.
US ANDA Litigation and Generic Entry Outlook for Prialt
Prialt was eligible for patent challenges on December 28, 2008.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 1, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for PRIALT
| International Patents: | 6 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 20 |
| Clinical Trials: | 6 |
| Drug Prices: | Drug price information for PRIALT |
| DailyMed Link: | PRIALT at DailyMed |
Generic Entry Opportunity Date for PRIALT
Generic Entry Date for PRIALT*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for PRIALT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Albany Medical College | Phase 4 |
| Aaron Boster | Phase 4 |
| Jazz Pharmaceuticals | N/A |
Pharmacology for PRIALT
| Drug Class | N-type Calcium Channel Antagonist |
| Mechanism of Action | N-Calcium Channel Receptor Antagonists |
Synonyms for PRIALT
| 08CON001 |
| 107452-89-1 |
| 148979-96-8 |
| 148979-97-9 |
| 150770-63-1 |
| AKOS015994641 |
| CHEBI:135912 |
| CHEMBL2103752 |
| Conotoxin MVIIA |
| Conotoxin MVIIA_Smartox |
| CTX MVIIA |
| DRG-0250 |
| GTPL2536 |
| HS-2032 |
| HSDB 7609 |
| MFCD00145036 |
| MolPort-009-194-186 |
| Omega conotoxin MVIIA |
| omega-Conopeptide MVIIA (Conus) |
| omega-Conotoxin M VIIA |
| omega-Conotoxin M VIIA (reduced), cyclic (1-16),(8-20),(15-25)-tris(disulfide) |
| omega-conotoxin MVIIA |
| omega-Conotoxin MVIIA, >=95% (HPLC) |
| omega-Conotoxin mviia, conus magus |
| SNX-111 |
| Y-100004 |
| Ziconotide |
| Ziconotide [USAN:INN] |
US Patents and Regulatory Information for PRIALT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for PRIALT
| 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 | 021060-002 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | Start Trial | Start Trial |
| Tersera Theraps Llc | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRIALT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1689401 | Start Trial |
| Canada | 2540895 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005032556 | Start Trial |
| Japan | 2007507538 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PRIALT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0835126 | SPC/GB05/033 | United Kingdom | Start Trial | PRODUCT NAME: ZICONOTIDE, OPTIONALLY IN THE FORM OF A SALT WITH A PHARMACEUTICALLY ACCEPTABLE ACID, INCLUDING ZICONOTIDE ACETATE; REGISTRATION NO/DATE: EU/1/04/302/001 - 003 20050224 |
| 0835126 | 05C0027 | France | Start Trial | PRODUCT NAME: ZICONOTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/302/001 DU 20050221; REGISTRATION NO/DATE AT EEC: EU/1/04/302/001-003 DU 20050221 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
