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PLIAGLIS Drug Profile
» See Plans and Pricing
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 six patent family members in six 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: | 6 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 9 |
| 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 Generic Entry Opportunity 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 |
|---|---|
| University of Michigan | Phase 4 |
| American Association of Endodontists | Phase 4 |
| Galderma Laboratories, L.P. | Phase 4 |
Pharmacology for PLIAGLIS
| Drug Class | Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic |
| Physiological Effect | Local Anesthesia |
US Patents and Regulatory Information for PLIAGLIS
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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 | Start Trial | Start Trial |
| Taro Pharms | PLIAGLIS | lidocaine; tetracaine | CREAM;TOPICAL | 021717-001 | Jun 29, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PLIAGLIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2008501019 | Start Trial |
| Canada | 2822220 | Start Trial |
| Japan | 2005511120 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
