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 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PYLERA |
| What excipients (inactive ingredients) are in PYLERA? | PYLERA excipients list |
| DailyMed Link: | PYLERA at DailyMed |
Recent Clinical Trials for PYLERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Coimbra | N/A |
| Centro Hospitalar e Universitário de Coimbra, E.P.E. | N/A |
| Hospital da Senhora da Oliveira | Early Phase 1 |
Pharmacology for PYLERA
Anatomical Therapeutic Chemical (ATC) Classes for PYLERA
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | See Plans and Pricing | See Plans and Pricing |
| Allergan | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | See Plans and Pricing | See Plans and Pricing |
| >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 |
|---|---|---|---|
| Norway | 329126 | See Plans and Pricing | |
| Argentina | 014126 | USO DE UNA SAL SOLUBLE DE BISMUTO, UN PRIMER ANTIBIOTICO Y UN SEGUNDO ANTIBIOTICO Y UNA FORMA DE DOSIFICACION FARAMACEUTICA | See Plans and Pricing |
| Turkey | 200001761 | See Plans and Pricing | |
| Indonesia | 26340 | See Plans and Pricing | |
| China | 1285741 | See Plans and Pricing | |
| Germany | 3887353 | See Plans and Pricing | |
| China | 1147292 | See Plans and Pricing | |
| >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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