PRIALT Drug Patent 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. One supplier is 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: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 31 |
Clinical Trials: | 6 |
Patent Applications: | 1,219 |
Drug Prices: | Drug price information for PRIALT |
What excipients (inactive ingredients) are in PRIALT? | PRIALT excipients list |
DailyMed Link: | PRIALT at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
Pharmacology for PRIALT
Drug Class | N-type Calcium Channel Antagonist |
Mechanism of Action | N-Calcium Channel Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for PRIALT
US Patents and Regulatory Information for PRIALT
PRIALT is protected by five US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PRIALT is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting PRIALT
Method for administering omega-conopeptide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ANALGESIA
Method for administering omega-conopeptide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Method for administering omega-conopeptide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: ANALGESIA
Method for administering omega-conopeptide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PAIN
Method for administering .omega.-conopeptide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SEVERE CHRONIC PAIN VIA INTRATHECAL INFUSION OF ZICONOTIDE IN PATIENTS ALSO RECEIVING MORPHINE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-003 | Dec 28, 2004 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-004 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-001 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Tersera | PRIALT | ziconotide acetate | INJECTABLE;INTRATHECAL | 021060-002 | Dec 28, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRIALT
See the table below for patents covering PRIALT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9313128 | ⤷ Try a Trial | |
Germany | 69637021 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005032556 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9701351 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRIALT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0835126 | SPC019/2005 | Ireland | ⤷ Try a Trial | SPC019/2005: 20060407, EXPIRES: 20200220 |
0835126 | CA 2005 00033 | Denmark | ⤷ Try a Trial | |
0835126 | 289 | Finland | ⤷ Try a Trial | |
0835126 | SPC/GB05/033 | United Kingdom | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |