PLIAGLIS Drug Patent Profile
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Which patents cover Pliaglis, and when can generic versions of Pliaglis launch?
Pliaglis is a drug marketed by Taro and is included in one NDA. There are three patents protecting this drug.
This drug has seven patent family members in seven countries.
The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.
DrugPatentWatch® Generic Entry Outlook for Pliaglis
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 14, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for PLIAGLIS
International Patents: | 7 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 10 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PLIAGLIS |
What excipients (inactive ingredients) are in PLIAGLIS? | PLIAGLIS excipients list |
DailyMed Link: | PLIAGLIS at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PLIAGLIS
Generic Entry Date for PLIAGLIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL |
*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 PLIAGLIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cutia Therapeutics(Wuxi)Co.,Ltd | Phase 3 |
American Association of Endodontists | Phase 4 |
University of Michigan | Phase 4 |
Pharmacology for PLIAGLIS
Drug Class | Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic |
Physiological Effect | Local Anesthesia |
Anatomical Therapeutic Chemical (ATC) Classes for PLIAGLIS
US Patents and Regulatory Information for PLIAGLIS
PLIAGLIS is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PLIAGLIS is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 PLIAGLIS
Solid-forming local anesthetic formulations for pain control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid-forming local anesthetic formulations for pain control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid-forming topical formulations for pain control
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Taro | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Taro | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 PLIAGLIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Taro | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Taro | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PLIAGLIS
When does loss-of-exclusivity occur for PLIAGLIS?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 11205730
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012017554
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 22220
Estimated Expiration: ⤷ Sign Up
China
Patent: 2834096
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 23660
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12008168
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PLIAGLIS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2002336585 | ⤷ Sign Up | |
European Patent Office | 1117356 | APPAREIL D'ADMINISTRATION DE FENTANYL ET DE SUFFENTANIL (APPARATUS FOR IMPROVED ADMINISTRATION OF FENTANYL AND SUFENTANIL) | ⤷ Sign Up |
European Patent Office | 1702597 | ⤷ Sign Up | |
Brazil | 112012017554 | formulações de anestésicas locais formadoras de sólido para controle da dor | ⤷ Sign Up |
Australia | 5924199 | ⤷ Sign Up | |
Japan | 2005501014 | ⤷ Sign Up | |
Japan | 2003524508 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |