DrugPatentWatch Database Preview
PYLERA Drug Profile
When do Pylera patents expire, and what generic alternatives are available?
Pylera is a drug marketed by Allergan Sales Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in PYLERA is bismuth subcitrate potassium; metronidazole; tetracycline. There are twenty-one 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 profile page.
Summary for PYLERA
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PYLERA |
| DailyMed Link: | PYLERA at DailyMed |
Generic Entry Opportunity Date for PYLERA
*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.
Pharmacology for PYLERA
| Ingredient-type | Bismuth Nitroimidazoles Tetracyclines |
| Drug Class | Bismuth Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial |
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 Sales Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| 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 Sales Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ➤ Sign Up | ➤ Sign Up |
| Allergan Sales Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for PYLERA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 140 mg/125 mg/ 125 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for PYLERA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Portugal | 1037614 | ➤ Sign Up |
| China | 1147292 | ➤ Sign Up |
| Italy | MI972788 | ➤ Sign Up |
| Spain | 2212391 | ➤ Sign Up |
| Australia | 2413599 | ➤ Sign Up |
| Peru | 05122000 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
