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Generated: June 27, 2017
What are the generic sources for minocycline hydrochloride and what is the scope of minocycline hydrochloride freedom to operate?
Minocycline hydrochloride is the generic ingredient in seven branded drugs marketed by Impax Labs, Medicis, Zydus Worldwide, Mylan Pharms Inc, Triax Pharms, Sun Pharm Inds, Sun Pharm Inds Ltd, Sandoz, Impax Labs Inc, Lupin Ltd, Par Pharm, Dr Reddys Labs Ltd, Lederle, Rempex Pharms Inc, Precision Dermat, Alkem Labs Ltd, Torrent Pharma Inc, Aurobindo Pharma Ltd, Watson Labs, Cnty Line Pharms, Sun Pharm Inds Inc, Aurobindo Pharma, Watson Labs Teva, Orapharma, Barr Labs Inc, and Sidmak Labs India, and is included in thirty-three NDAs. There are fourteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 14 |
| Applicants: | 26 |
| NDAs: | 33 |
| Drug Master File Entries: see list | 13 |
| Suppliers / Packagers: see list | 48 |
| Bulk Api Vendors: see list | 45 |
| Clinical Trials: see list | 2,402 |
| Patent Applications: see list | 2,387 |
| Therapeutic Class: | Dental and Oral Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | minocycline hydrochloride at DailyMed |
| Ingredient-type | Tetracyclines |
| Drug Class | Tetracycline-class Drug |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | EQ 45MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ► Subscribe | ► Subscribe | EQ 135MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| ► Subscribe | ► Subscribe | EQ 115MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Impax Labs | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 065005-003 | Apr 18, 2001 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sidmak Labs India | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204394-005 | Dec 30, 2015 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lupin Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091424-004 | Nov 30, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds Ltd | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-005 | Jul 11, 2012 | RX | No | No | 7,544,373 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Cnty Line Pharms | DYNACIN | minocycline hydrochloride | CAPSULE;ORAL | 063067-002 | Sep 15, 1999 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2003223384 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2011252919 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101208097 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2263596 | ► Subscribe | |||||||||||||||||||||||||||
| Singapore | 185513 | ► 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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