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Minocycline hydrochloride - Generic Drug Details
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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 Sun Pharm Inds Ltd, Cnty Line Pharms, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent, Watson Labs, Watson Labs Teva, Zydus, Lederle, Rempex Pharms, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Zydus Pharms, Epi Hlth, Medicis, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-four NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Minocycline hydrochloride has fifty-nine patent family members in twenty-six countries.
There are fifteen drug master file entries for minocycline hydrochloride. Fifty-four suppliers are listed for this compound. There are seven tentative approvals for this compound.
Summary for minocycline hydrochloride
| International Patents: | 59 |
| US Patents: | 12 |
| Tradenames: | 7 |
| Applicants: | 29 |
| NDAs: | 34 |
| Drug Master File Entries: | 15 |
| Suppliers / Packagers: | 54 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 196 |
| Patent Applications: | 2,888 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for minocycline hydrochloride |
| DailyMed Link: | minocycline hydrochloride at DailyMed |
Pharmacology for minocycline hydrochloride
| Drug Class | Tetracycline-class Drug |
Medical Subject Heading (MeSH) Categories for minocycline hydrochloride
Synonyms for minocycline hydrochloride
| (2E,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione hydrochloride |
| (2Z,4S,4aS,5aR,12aS)-2-[amino(hydroxy)methylidene]-4,7-bis(dimethylamino)-10,11,12a-trihydroxy-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione hydrochloride |
| (4S-(4alpha,4aalpha,5aalpha,12aalpha))-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride |
| (4S,12aS,4aS,5aR)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide Hydrochloride |
| (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide hydrochloride |
| [4S-(4?,4a?,5a?,12a?)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a,tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide |
| [4S-(4|A,4a|A,5a|A,12a|A)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydro-1,11-dioxo-2-naphthacenecarboxamide Hydrochloride |
| [4S-(4|A,4a|A,5a|A,12a|A)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride |
| [4S-(4a,4aa,5aa,12aa)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a,tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide |
| [4S-(4alpha,4aalpha,5aalpha,12aalpha)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxonaphthacene-2-carboxamide monohydrochloride |
| 0020414E5U |
| 10118-90-8 (base) |
| 10118-90-8 (Parent) |
| 1071702-75-4 |
| 11006-27-2 |
| 1236362-29-0 |
| 13614-98-7 |
| 150231-24-6 |
| 2-Naphthacenecarboxamide, 4,7- bis(dimethylamino)-1,4,4a,5,5a,6,11,12a- octahydro-3,10,12,12a-tetrahydroxy-1,11dioxo-, monohydrochloride, [4S-(4alpha,4aalpha,5aalpha,12aalpha)] |
| 2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, monohydrochloride |
| 2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, monohydrochloride, (4S-(4alpha,4aalpha,5aalpha,12aalpha))- |
| 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride |
| 614M987 |
| 7-Dimethylamino-6-demethyl-6-deoxytetracycline, HCl |
| AB1009463 |
| AC-22362 |
| AC1NQY0N |
| AC1NSG07 |
| Acnez |
| AKOS015951312 |
| Arestin |
| Arestin (TN) |
| BC207859 |
| BCP06597 |
| C23H27N3O7.HCl |
| C23H28ClN3O7 |
| CAS-13614-98-7 |
| CCG-40107 |
| CHEBI:50697 |
| CHEMBL1200881 |
| CS-1256 |
| D00850 |
| DSSTox_CID_24545 |
| DSSTox_GSID_44545 |
| DSSTox_RID_80306 |
| DTXSID8044545 |
| Dynacin |
| Dynacin (TN) |
| EINECS 237-099-7 |
| FT-0082736 |
| FT-0601821 |
| FXFM-244 |
| GLMUAFMGXXHGLU-VQAITOIOSA-N |
| HMS1568P12 |
| HY-17412 |
| J10198 |
| KB-274624 |
| Klinomycin |
| KS-00000XT8 |
| Lederderm |
| LS-91518 |
| LS-93852 |
| M2288 |
| MFCD00083669 |
| MINO |
| Minocin |
| Minocin (TN) |
| Minocycline (hydrochloride) |
| Minocycline chloride |
| Minocycline HCl |
| Minocycline hydrochloride (internal use) |
| Minocycline hydrochloride (JP17/USP) |
| Minocycline hydrochloride [USAN:JAN] |
| Minocycline hydrochloride [USP:JAN] |
| Minocycline hydrochloride, 97% |
| Minocycline hydrochloride, Antibiotic for Culture Media Use Only |
| Minocycline hydrochloride, crystalline |
| Minocycline hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Minocycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material |
| Minocycline hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Minocycline, HCl |
| Minocycline, Hydrochloride |
| Minocyclinhydrochlorid |
| Minomax |
| Minomycin |
| Minomycin chloride |
| minomycin hydrochloride |
| MLS002548863 |
| MolPort-003-666-235 |
| MolPort-042-652-589 |
| Mynocine |
| Mynocine hydrochloride |
| NC00460 |
| NCGC00096006-01 |
| NCGC00178854-03 |
| NCGC00255988-01 |
| NSC-757120 |
| NSC757120 |
| Periocline |
| Pharmakon1600-01500414 |
| Prestwick_626 |
| Q-201407 |
| S051 |
| s4226 |
| SC-19210 |
| SCHEMBL2537 |
| SMR001906766 |
| Solodyn |
| Solodyn (TN) |
| SPECTRUM1500414 |
| SR-01000075625 |
| SR-01000075625-1 |
| ST24034766 |
| Tox21_111250 |
| Tox21_111250_1 |
| Tox21_113183 |
| Tox21_301590 |
| Tri-mino |
| Tri-minocycline |
| UNII-0020414E5U |
| Vectrin |
| W-5076 |
| Ximino |
Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for minocycline hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Triax Pharms | MINOCIN | minocycline hydrochloride | CAPSULE;ORAL | 050315-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Sun Pharm Inds Ltd | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-001 | Jul 11, 2012 | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-005 | Jul 23, 2009 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Sandoz | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090422-001 | Aug 13, 2009 | AB | RX | No | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-007 | Aug 27, 2010 | AB | RX | Yes | No | ➤ 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 minocycline hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sun Pharm Inds Ltd | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-001 | Jul 11, 2012 | ➤ Sign Up | ➤ Sign Up |
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-008 | Aug 27, 2010 | ➤ Sign Up | ➤ Sign Up |
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | ➤ Sign Up | ➤ Sign Up |
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-002 | May 8, 2006 | ➤ Sign Up | ➤ Sign Up |
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | ➤ Sign Up | ➤ Sign Up |
| Sun Pharm Inds Ltd | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-005 | Jul 11, 2012 | ➤ Sign Up | ➤ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for minocycline hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 188331 | ➤ Sign Up |
| Australia | 2009201777 | ➤ Sign Up |
| Russian Federation | 2012147527 | ➤ Sign Up |
| Mexico | 347919 | ➤ Sign Up |
| Norway | 20080444 | ➤ Sign Up |
| Japan | 2005521467 | ➤ Sign Up |
| >Country | >Patent Number | >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 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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ISSN: 2162-2639
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Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.