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Generated: August 21, 2017
What is the patent landscape for Pylera, and what generic Pylera alternatives are available?
Pylera is a drug marketed by Forest Labs Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Clinical Trials: see list | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | PYLERA at DailyMed |
| Ingredient-type | Nitroimidazoles Tetracyclines Bismuth |
| Drug Class | Nitroimidazole Antimicrobial Tetracycline-class Antimicrobial Bismuth |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Forest Labs Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Forest Labs Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Forest Labs Llc | PYLERA | bismuth subcitrate potassium; metronidazole; tetracycline | CAPSULE;ORAL | 050786-001 | Sep 28, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride | Capsules | 140 mg/125 mg/ 125 mg | Pylera | 8/12/2014 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indonesia | 26340 | ► Subscribe | |||||||||||||||||||||||||||
| Turkey | 200001761 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1037614 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 743090 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20003159 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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