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PYLERA Drug Profile
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When do Pylera patents expire, and what generic alternatives are available?
Pylera is a drug marketed by Allergan and is included in one NDA.
The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
Summary for PYLERA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PYLERA |
| DailyMed Link: | PYLERA at DailyMed |
Paragraph IV (Patent) Challenges for PYLERA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PYLERA | CAPSULE;ORAL | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | 050786 | 2014-08-12 |
US Patents and Regulatory Information for PYLERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | RX | Yes | Yes | Start Trial | Start Trial | 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 PYLERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | Start Trial | Start Trial |
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | Start Trial | Start Trial |
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PYLERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 8903219 | Start Trial |
| Poland | 341737 | Start Trial |
| Australia | 2413599 | Start Trial |
| European Patent Office | 1037614 | Start Trial |
| Italy | 1296980 | Start Trial |
| Malaysia | 121713 | Start Trial |
| Portugal | 1037614 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
