DrugPatentWatch Database Preview
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 Jazz Pharms Intl 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. One supplier is listed for this compound. Additional details are available on the ziconotide acetate profile page.
Summary for PRIALT
| International Patents: | 6 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 16 |
| Clinical Trials: | 6 |
| Drug Prices: | Drug price information for PRIALT |
| DailyMed Link: | PRIALT at DailyMed |
Generic Entry Opportunity Date for PRIALT
*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 PRIALT
| Drug Class | N-type Calcium Channel Antagonist |
| Mechanism of Action | N-Calcium Channel Receptor Antagonists |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for PRIALT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | ➤ Sign Up | ➤ Sign Up |
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | ➤ Sign Up | ➤ Sign Up |
| Jazz Pharms Intl | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for PRIALT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,268,774 | Method for reducing pain | ➤ Sign Up |
| 7,268,109 | Method for reducing pain | ➤ Sign Up |
| 8,513,198 | Pharmaceutical formulation for reducing pain | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for PRIALT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1689401 | ➤ Sign Up |
| Japan | 2007507538 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2005032556 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for PRIALT
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0027 | France | ➤ Sign Up | 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 |
| C/GB05/033 | United Kingdom | ➤ Sign Up | 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
