DrugPatentWatch Database Preview
PRIALT Drug Profile
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Which patents cover Prialt, and when can generic versions of Prialt launch?
Prialt is a drug marketed by Tersera 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.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 20 |
| Clinical Trials: | 6 |
| Patent Applications: | 1,779 |
| Drug Prices: | Drug price information for PRIALT |
| What excipients (inactive ingredients) are in PRIALT? | PRIALT excipients list |
| DailyMed Link: | PRIALT at DailyMed |
DrugPatentWatch® Estimated 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 |
ATC Classes for PRIALT
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 | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | DISCN | No | No | Get Started Free | Get Started Free | Get Started Free | ||||
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | Get Started Free | Get Started Free | Get Started Free | ||||
| >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 | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | Get Started Free | Get Started Free |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | Get Started Free | Get Started Free |
| Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | Get Started Free | Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRIALT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H09104634 | Get Started Free |
| European Patent Office | 0835126 | Get Started Free |
| Denmark | 1336409 | Get Started Free |
| >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 | Get Started Free | 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 | SPC019/2005 | Ireland | Get Started Free | SPC019/2005: 20060407, EXPIRES: 20200220 |
| 0835126 | CA 2005 00033 | Denmark | Get Started Free | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
