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DOXYCYCLINE HYCLATE Drug Profile
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» See Plans and PricingWhich patents cover Doxycycline Hyclate, and when can generic versions of Doxycycline Hyclate launch?
Doxycycline Hyclate is a drug marketed by Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Changzhou Pharm, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Warner Chilcott, Watson Labs, Zydus Pharms, West-ward Pharms Int, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Lannett Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, and Vintage Pharms. and is included in fifty-nine NDAs.
The generic ingredient in DOXYCYCLINE HYCLATE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
US ANDA Litigation and Generic Entry Outlook for Doxycycline Hyclate
A generic version of DOXYCYCLINE HYCLATE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.
Summary for DOXYCYCLINE HYCLATE
See drug prices for DOXYCYCLINE HYCLATE
Recent Clinical Trials for DOXYCYCLINE HYCLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Royal Alexandra Hospital | Phase 2 |
| University of Alberta | Phase 2 |
| PolyPid Ltd. | Phase 1/Phase 2 |
Recent Litigation for DOXYCYCLINE HYCLATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Mayne Pharma International Pty Ltd. v. Actavis Elizabeth LLC | 2017-11-09 |
| WARNER CHILCOTT LABORATORIES IRELAND LIMITED v. MYLAN PHARMACEUTICALS INC. | 2009-05-01 |
| WARNER CHILCOTT LABORATORIES IRELAND LIMITED v. IMPAX LABORATORIES, INC. | 2009-03-18 |
Pharmacology for DOXYCYCLINE HYCLATE
| Drug Class | Tetracycline-class Drug |
Synonyms for DOXYCYCLINE HYCLATE
| (1S,4aS,11R,11aR,12S,12aR)-3-carbamoyl-2,4a,5,7,12-pentahydroxy-N,N,11-trimethyl-4,6-dioxo-1,4,4a,6,11,11a,12,12a-octahydrotetracen-1-aminium chloride--ethanol--water (2/1/1) |
| (4S,4aR,5S,5aR,6R,12aR)-4-(dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)- 3,5,10,12,12a-pentahydroxy- 6-methyl- 1,11-dioxo- 1,4,4a,5,5a,6,11,12a-octahydrotetracene- 2-carboxamide hydrochloride hemiethanolate hemihydrate |
| (4s,4ar,5s,5ar,6r,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide - ethanol (2:1) dihydrochloride hydrate |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide compound with ethanol (2:1) dihydrochloride hydrate |
| (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide--ethanol--hydrogen chloride--water (2/1/2/1) |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide |
| (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide;ethanol;hydrate;dihydrochloride |
| 100929-47-3 |
| 10592-13-9 |
| 10592-13-9 (. HCl) |
| 1368-EP2269978A2 |
| 1368-EP2269985A2 |
| 1368-EP2269991A2 |
| 1368-EP2284150A2 |
| 1368-EP2284151A2 |
| 1368-EP2284152A2 |
| 1368-EP2284153A2 |
| 1368-EP2284155A2 |
| 1368-EP2284156A2 |
| 1368-EP2284164A2 |
| 1368-EP2287140A2 |
| 1368-EP2287148A2 |
| 1368-EP2287150A2 |
| 1368-EP2289871A1 |
| 1368-EP2295402A2 |
| 1368-EP2295419A2 |
| 1368-EP2298732A1 |
| 1368-EP2301534A1 |
| 1368-EP2301912A2 |
| 1368-EP2301913A1 |
| 1368-EP2301914A1 |
| 1368-EP2301916A2 |
| 1368-EP2305637A2 |
| 1368-EP2305640A2 |
| 1368-EP2308863A1 |
| 1368-EP2311451A1 |
| 1368-EP2311796A1 |
| 1368-EP2311797A1 |
| 1368-EP2311798A1 |
| 1368-EP2311799A1 |
| 1368-EP2316450A1 |
| 19XTS3T51U |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))- |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S,4aR,5S,5aR,6R,12aS) |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S,4aR,5S,5aR,6R,12aS)- |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, hydrochloride, (4S,4aR,5S,5aR,6R,12aS)-, compd. with ethanol, hydrate (2:2:1:1) |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S-(4alpha,4aalpha,5alpha,5aalpha,6alpha,12aalpha))- |
| 2-Naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S,4aR,5S,5aR,6R,12aS)- |
| 2-Naphthacenecarboxamide, 4-alpha-S-(dimethylamino)-1,4,4a-alpha-5,5a-alpha,6,11,12a-octahydro-3,5-alpha,10,12,12a-alpha-pentahydroxy-6-alpha-methyl-1,11-dioxo- |
| 2-Naphthacenecarboxamide, 4-dimethylamino-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, hydrochloride |
| 2-Naphthacenecarboxamide, 4beta-(dimeethylamino)-1,4,4abeta,5,5abeta,6,11,12a-octahydro-3,5beta,10,12,12abeta-pentahydroxy-6beta-methyl-1,11-dioxo-, monohydrochloride, compd. with ethyl alcohol (2:1), monohydrate |
| 2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, (4S,4aR,5S,5aR,6R,12aS)- |
| 2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride,(4S,4aR,5S,5aR,6R,12aS)- |
| 2-Naphthacenecarboxamide,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, (4S,4aR,5S,5aR,6R,12aS)-, compd. with ethanol (2:1), monohydrate (9CI) (CA INDEX NAME) |
| 2387AH |
| 24390-14-5 |
| 2C22H24N2O8.C2H6O.2ClH.H2O |
| 2C22H24N2O8.C2H6O.H2O |
| 334895S862 |
| 390D145 |
| 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate |
| 4-(Dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-3,4,4a,5,5a,6,12,12a-octahydrotetracene-2-carboximidic acid |
| 4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide - ethanol (2:1) dihydrochloride hydrate |
| 4-Epioxytetracycline, 6-deoxy- |
| 4182Z6T2ET |
| 5-Hydroxy-alpha-6-deoxytetracycline |
| 564-25-0 |
| 564D250 |
| 6-alpha-Deoxy-5-oxytetracycline |
| 6-Deoxy-5-hydroxytetracycline hydrochloride hemihydrate |
| 6-Deoxyoxytetracycline |
| 6-Deoxytetracycline |
| 6-Desoxy-5-hydroxytetracycline hydrochloride hemihydrate hemiethanolate |
| 6alpha-Deoxy-5-oxytetracycline |
| 7164-70-7 |
| 94088-85-4 |
| AB00053465_04 |
| AB00053465_05 |
| AB00053465-03 |
| AB08 (*Fosfatex) |
| AC-12044 |
| AC-6017 |
| Acticlate |
| Acticlate CAP |
| AKOS015900372 |
| AKOS015924649 |
| AKOS025310153 |
| AKOS025402170 |
| alpha-6-Deoxy-5-hydroxytetracycline |
| alpha-6-Deoxyoxytetracycline |
| alpha-Doxycycline |
| Anhydrous doxycycline |
| API0002491 |
| API0002492 |
| AS-13499 |
| Atridox |
| Azudoxat |
| BCBcMAP01_000024 |
| BDBM50248132 |
| Biocamycin |
| bis((4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide) ethanol hydrate dihydrochloride |
| BMY 28689 |
| BMY-28689 |
| BMY28689 |
| BSPBio_001936 |
| BU 3839T |
| BU-3839T |
| C-0055 |
| C06973 |
| C22H24N2O8.HCl.0.5H2O.0.5C2H6O |
| C22H25ClN2O8 |
| CAS-10592-13-9 |
| CCG-204498 |
| CCG-38949 |
| CHEBI:34730 |
| CHEBI:50845 |
| CHEBI:652992 |
| CHEMBL1200567 |
| CHEMBL1256723 |
| CHEMBL1433 |
| CHEMBL3989740 |
| CHEMBL436921 |
| controlled-release doxycycline hy-clate |
| CS-0009105 |
| CS-2632 |
| D 9891 |
| D02129 |
| D07876 |
| D07877 |
| D4116 |
| DB00254 |
| Dentista |
| Deoxy-5-hydroxytetracycline hydrochloride |
| Deoxymykoin |
| Deoxyoxytetracycline hydrochloride |
| DivK1c_000345 |
| DMSC (*Fosfatex) |
| Doryx |
| Doryx (TN) |
| Doryx Mpc |
| Dossiciclina |
| Dossiciclina [DCIT] |
| DOXCYCLINE ANHYDROUS |
| Doxiciclina |
| Doxiciclina [INN-Spanish] |
| Doxiciclina [Italian] |
| Doxigalumicina |
| Doxitard |
| Doxivetin |
| Doxteric |
| DOXY |
| Doxy 100 |
| DOXY 200 |
| Doxy-Caps |
| Doxy-II |
| Doxy-Lemmon |
| Doxy-Puren |
| Doxy-tablinen |
| Doxy-Tabs |
| Doxycen |
| Doxychel |
| Doxychel (TN) |
| Doxychel Hyclate |
| Doxycyclin |
| doxycycline |
| Doxycycline (200mg/day) or Placebo |
| Doxycycline (anhydrous) |
| Doxycycline (hyclate) |
| Doxycycline (hydrochloride) |
| Doxycycline (INN) |
| Doxycycline (internal use) |
| Doxycycline (TN) |
| Doxycycline [USAN:INN:BAN] |
| Doxycycline anhydrous |
| DOXYCYCLINE CALCIUM |
| Doxycycline HCl |
| Doxycycline Hyclate (100 mg) |
| Doxycycline hyclate (internal use) |
| Doxycycline hyclate (USP) |
| Doxycycline hyclate [USAN:USP] |
| doxycycline hyclate 20 mg twice daily |
| doxycycline hyclate hydrochloride |
| Doxycycline hydrochloride |
| Doxycycline Hydrochloride [JAN] |
| Doxycycline hydrochloride hemiethanolate hemihydrate |
| Doxycycline hydrochloride hydrate |
| Doxycycline hydrochloride hydrate (JP17) |
| DOXYCYCLINE HYLATE |
| Doxycycline-Chinoin |
| doxycycline-hyclate |
| Doxycycline, Antibiotic for Culture Media Use Only |
| Doxycycline, HCl |
| Doxycycline, Hyclate |
| Doxycyclinum |
| Doxycyclinum [INN-Latin] |
| Doxylin |
| Doxyprex |
| Doxysol |
| Doxytetracycline |
| DS-9077 |
| DSSTox_CID_25405 |
| DSSTox_GSID_45405 |
| DSSTox_RID_80856 |
| DTXSID0037653 |
| DTXSID1045405 |
| DTXSID4041020 |
| DTXSID80992212 |
| Ecodox |
| EINECS 209-271-1 |
| EINECS 234-198-7 |
| Ethanol, compd. with (4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride (1:2), monohydrate |
| EU-0100405 |
| FT-0603476 |
| GS-3065 |
| GS-3065 (*monohydrate) |
| GTPL6464 |
| HMS1920I20 |
| HMS2090E06 |
| HSDB 3071 |
| HY-N0565 |
| HY-N0565A |
| Hyclate |
| I015 |
| I455 |
| IDI1_000345 |
| Idocyklin |
| Investin |
| J-000264 |
| J10246 |
| JBIWCJUYHHGXTC-AKNGSSGZSA-N |
| Jenacyclin |
| JRNIHERUNQWMMW-WBYAVNBMSA-N |
| KBio1_000345 |
| KBio2_001287 |
| KBio2_003855 |
| KBio2_006423 |
| KBio3_001156 |
| KBioGR_001133 |
| KBioSS_001287 |
| KS-5254 |
| Liomycin |
| Liviatin |
| LMPK07000001 |
| Lopac0_000405 |
| LP00405 |
| LS-174052 |
| LS-187766 |
| LS-93868 |
| MCULE-4368118692 |
| MCULE-8555113623 |
| Mespafin |
| MFCD07357237 |
| Midoxin |
| MMV000011 |
| Monodoks |
| Monodox |
| Monodox (*monohydrate) |
| NCGC00016693-01 |
| NCGC00161602-01 |
| NCGC00161602-03 |
| NCGC00161602-04 |
| NCGC00161602-05 |
| NCGC00161602-06 |
| NCGC00188979-01 |
| NCGC00261090-01 |
| NINDS_000345 |
| Nivocilin |
| Novadox |
| NPV78C39GQ |
| NSC-633557 |
| NSC-741421 |
| NSC-756751 |
| NSC633557 |
| NSC741421 |
| NSC756751 |
| Oracea |
| Oxytetracycline, 6-deoxy- |
| Periostat |
| Periostat (TN) |
| Pharmakon1600-01500266 |
| Q27105187 |
| Q27116248 |
| Q27284983 |
| Q422442 |
| RETENS |
| Ronaxan |
| Roximycin |
| RPRXAHFLWOCXQL-AKNGSSGZSA-N |
| RUYHIJHUVHIMIR-CVHRZJFOSA-N |
| s5159 |
| Samecin |
| SBI-0050391.P004 |
| SC-15766 |
| SCHEMBL1176275 |
| SCHEMBL17826665 |
| SCHEMBL19270298 |
| SCHEMBL40834 |
| SCHEMBL40930 |
| SCHEMBL66828 |
| SGKRLCUYIXIAHR-AKNGSSGZSA-N |
| SMP1_000107 |
| Spanor |
| SPBio_000246 |
| Spectrum_000807 |
| SPECTRUM1500266 |
| Spectrum2_000143 |
| Spectrum3_000408 |
| Spectrum4_000527 |
| Spectrum5_000947 |
| SR-01000075844 |
| SR-01000075844-1 |
| SR-01000075844-7 |
| SR-01000075844-8 |
| Supracyclin |
| SW219440-1 |
| SW219440-2 |
| Tanamicin |
| Tecacin |
| Tetraclean |
| Tetradox |
| Tox21_110566 |
| Tox21_110566_1 |
| Tox21_500405 |
| UNII-19XTS3T51U |
| UNII-334895S862 |
| UNII-4182Z6T2ET |
| UNII-NPV78C39GQ |
| UPCMLD-DP021 |
| UPCMLD-DP021:001 |
| Vibra-tabs |
| Vibra-tabs (TN) |
| Vibradox |
| Vibramycin |
| Vibramycin (*monohydrate) |
| Vibramycin (TN) |
| Vibramycin hyclate |
| Vibramycin hydrochloride |
| Vibramycin Novum |
| Vibramycin, Hyclate |
| Vibramycine |
| Vibravenos |
| Vivox |
| Vivox (*Hyclate) |
| W-105517 |
| WC 2031 |
| WC2031 |
| Z2791720087 |
| Zenavod |
| ZINC100056779 |
| ZINC100302137 |
| ZINC100611210 |
| ZINC109562088 |
| ZINC16052277 |
Paragraph IV (Patent) Challenges for DOXYCYCLINE HYCLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2017-09-28 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-11-05 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2015-07-01 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2014-05-19 |
| DORYX | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2008-12-19 |
| DORYX MPC | TABLET, DELAYED RELEASE;ORAL | doxycycline hyclate | 050795 | 2008-12-19 |
US Patents and Regulatory Information for DOXYCYCLINE HYCLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 209243-002 | Apr 15, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Watson Labs | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 061717-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Ranbaxy | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062479-002 | Dec 23, 1983 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lupin Ltd | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 208818-001 | Sep 27, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Elizabeth | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090134-002 | Dec 14, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET, DELAYED RELEASE;ORAL | 090431-002 | Dec 28, 2010 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| West-ward Pharms Int | DOXYCYCLINE HYCLATE | doxycycline hyclate | INJECTABLE;INJECTION | 062992-001 | Feb 16, 1989 | DISCN | 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 |
