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PLIAGLIS Drug Profile
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Which patents cover Pliaglis, and what generic alternatives are available?
Pliaglis is a drug marketed by Taro Pharms and is included in one NDA. There is one patent protecting this drug.
This drug has seventeen patent family members in eleven 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.
US ANDA Litigation and Generic Entry Outlook for Pliaglis
Pliaglis was eligible for patent challenges on December 31st, 1968.
Summary for PLIAGLIS
| International Patents: | 17 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Clinical Trials: | 9 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PLIAGLIS |
| DailyMed Link: | PLIAGLIS at DailyMed |
Recent Clinical Trials for PLIAGLIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| American Association of Endodontists | Phase 4 |
| University of Michigan | 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 | |||
| >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 | 2003510259 | Start Trial |
| Japan | 2007126462 | Start Trial |
| Japan | 2012246315 | Start Trial |
| Canada | 2386017 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
