PLIAGLIS Drug Patent Profile
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When do Pliaglis patents expire, and when can generic versions of Pliaglis launch?
Pliaglis is a drug marketed by Taro Pharms 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. Four 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 |
University of Michigan | Phase 4 |
American Association of Endodontists | 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 ⤷ 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 PLIAGLIS
Solid-forming local anesthetic formulations for pain control
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid-forming local anesthetic formulations for pain control
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid-forming topical formulations for pain control
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 PLIAGLIS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Brazil
Patent: 2012017554
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 22220
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2834096
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 23660
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12008168
Estimated Expiration: ⤷ 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.
See the table below for additional patents covering PLIAGLIS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2450366 | ⤷ Try a Trial | |
European Patent Office | 1702597 | ⤷ Try a Trial | |
Spain | 2260936 | ⤷ Try a Trial | |
Spain | 2276697 | ⤷ Try a Trial | |
Canada | 2568598 | ⤷ Try a Trial | |
Australia | 5924199 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 02100386 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |