PYLERA Drug Patent Profile
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When do Pylera patents expire, and what generic alternatives are available?
Pylera is a drug marketed by Labs Juvise 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. Four suppliers are listed for this compound. Additional details are available on the bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride profile page.
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Summary for PYLERA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 7 |
| Drug Prices: | Drug price information for PYLERA |
| What excipients (inactive ingredients) are in PYLERA? | PYLERA excipients list |
| DailyMed Link: | PYLERA at DailyMed |
Paragraph IV (Patent) Challenges for PYLERA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PYLERA | Capsules | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | 140 mg/125 mg/ 125 mg | 050786 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | AB | 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 |
|---|---|---|---|---|---|---|---|
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Labs Juvise | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PYLERA
See the table below for patents covering PYLERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 2315408 | DOUBLE CAPSULE POUR ADMINISTRER DES PRINCIPES ACTIFS SELON UNE POLYTHERAPIE (A DOUBLE CAPSULE FOR THE ADMINISTRATION OF ACTIVE PRINCIPLESIN MULTIPLE THERAPIES) | ⤷ Sign Up |
| Australia | 2413599 | ⤷ Sign Up | |
| Japan | H03503404 | ⤷ Sign Up | |
| Italy | 1296980 | CAPSULA DOPPIA COME FORMA FARMACEUTICA PER LA SOMMINISTRAZIONE DI PRINCIPI ATTIVI IN TERAPIE MULTIPLE | ⤷ Sign Up |
| Czech Republic | 299181 | Farmaceutická dávková forma obsahující rozpustné soli bismutu, první antibiotikum a druhé antibiotikum (Pharmaceutical dosage form containing bismuth soluble salts, a first antibiotic, and a second antibiotic) | ⤷ Sign Up |
| Spain | 2212391 | ⤷ Sign Up | |
| Germany | 3887353 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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