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PLIAGLIS Drug Profile
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» See Plans and PricingWhen 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 two patents protecting this drug.
This drug has twenty-three patent family members in twelve countries.
The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Five 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
Indicators of Generic Entry
Summary for PLIAGLIS
| International Patents: | 23 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 4 |
| 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 | |||
| 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 |
|---|---|---|
| European Patent Office | 1244401 | Start Trial |
| Australia | 7719800 | Start Trial |
| Japan | H11510075 | Start Trial |
| Canada | 2345494 | Start Trial |
| Australia | 2002336585 | Start Trial |
| European Patent Office | 1401408 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
