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Minocycline hydrochloride - Generic Drug Details
What are the generic sources for minocycline hydrochloride and what is the scope of freedom to operate?
Minocycline hydrochloride
is the generic ingredient in seven branded drugs marketed by Sun Pharm Inds Inc, Cnty Line Pharms, Bausch, Triax Pharms, Aurobindo Pharma, Impax Labs, 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 Labs Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Sun Pharm Inds Ltd, Zydus Pharms, Epi Hlth, Medicis, Dr Reddys Labs Ltd, Par Pharm, and Sun Pharm Industries, and is included in thirty-five 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. Forty-nine suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for minocycline hydrochloride
| International Patents: | 59 |
| US Patents: | 12 |
| Tradenames: | 7 |
| Applicants: | 30 |
| NDAs: | 35 |
| Drug Master File Entries: | 15 |
| Suppliers / Packagers: | 49 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 202 |
| Patent Applications: | 2,930 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for minocycline hydrochloride |
| DailyMed Link: | minocycline hydrochloride at DailyMed |
Recent Clinical Trials for minocycline hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Riyadh Elm University | N/A |
| Dow University of Health Sciences | Phase 1/Phase 2 |
| Sun Yat-sen University | Phase 2 |
Recent Litigation for minocycline hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Apotex Inc. v. Wyeth LLC | 2015-07-29 |
| Medicis Pharmaceutical Corporation v. Alkem Laboratories Ltd. | 2012-12-05 |
| Medicis Pharmaceutical Corporation v. Zydus Pharmaceuticals USA Inc. | 2012-06-04 |
Generic filers with tentative approvals for MINOCYCLINE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 105MG BASE | Tablet, Extended Release; Oral |
| Start Trial | Start Trial | EQ 80MG BASE | Tablet, Extended Release; Oral |
| Start Trial | Start Trial | EQ 55MG BASE | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
Paragraph IV (Patent) Challenges for MINOCYCLINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SOLODYN | TABLET, EXTENDED RELEASE;ORAL | minocycline hydrochloride | 050808 | 2010-12-13 |
| SOLODYN | TABLET, EXTENDED RELEASE;ORAL | minocycline hydrochloride | 050808 | 2010-12-02 |
| SOLODYN | TABLET, EXTENDED RELEASE;ORAL | minocycline hydrochloride | 050808 | 2010-10-27 |
| SOLODYN | TABLET, EXTENDED RELEASE;ORAL | minocycline hydrochloride | 050808 | 2009-11-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 204453-002 | Sep 28, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm Inds Inc | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | CAPSULE;ORAL | 090867-001 | May 13, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Zydus Pharms | MINOCYCLINE HYDROCHLORIDE | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203553-001 | Nov 16, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-008 | Aug 27, 2010 | Start Trial | Start Trial |
| Sun Pharm Inds Inc | XIMINO | minocycline hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 201922-001 | Jul 11, 2012 | Start Trial | Start Trial |
| Medicis | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for minocycline hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 185513 | Start Trial |
| South Africa | 201208466 | Start Trial |
| European Patent Office | 1489988 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.