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DOXYCYCLINE Drug Profile
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» See Plans and PricingWhen do Doxycycline patents expire, and when can generic versions of Doxycycline launch?
Doxycycline is a drug marketed by Acp Nimble, Alembic Pharms Ltd, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Oaklock Llc, and Vintage Pharms. and is included in eighty-eight NDAs.
The generic ingredient in DOXYCYCLINE is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four 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
A generic version of DOXYCYCLINE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.
Summary for DOXYCYCLINE
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Recent Clinical Trials for DOXYCYCLINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Francis Hospital, New York | Phase 4 |
| University Hospital of Guadeloupe | Phase 4 |
| Centre Hospitalier Universitaire de la Réunion | Phase 4 |
Recent Litigation for DOXYCYCLINE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories, L.P. v. Amneal Pharmaceuticals, LLC | 2019-03-01 |
| Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited | 2016-10-27 |
| Galderma Laboratories L.P. v. Amneal Pharmaceuticals LLC | 2016-03-31 |
See all DOXYCYCLINE litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2015-08-20 | |
| 2013-06-20 |
Pharmacology for DOXYCYCLINE
| Drug Class | Tetracycline-class Drug |
Medical Subject Heading (MeSH) Categories for DOXYCYCLINE
Synonyms for DOXYCYCLINE
| (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)-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-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide |
| 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 |
| 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-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-, (4S,4aR,5S,5aR,6R,12aS)- |
| 24390-14-5 |
| 334895S862 |
| 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-Epioxytetracycline, 6-deoxy- |
| 5-Hydroxy-alpha-6-deoxytetracycline |
| 564-25-0 |
| 564D250 |
| 6-alpha-Deoxy-5-oxytetracycline |
| 6-Deoxyoxytetracycline |
| 6-Deoxytetracycline |
| 6alpha-Deoxy-5-oxytetracycline |
| 7164-70-7 |
| 94088-85-4 |
| AB00053465_04 |
| AB00053465_05 |
| AB00053465-03 |
| AB08 (*Fosfatex) |
| AKOS015900372 |
| alpha-6-Deoxy-5-hydroxytetracycline |
| alpha-6-Deoxyoxytetracycline |
| alpha-Doxycycline |
| Anhydrous doxycycline |
| API0002491 |
| AS-13499 |
| Azudoxat |
| BCBcMAP01_000024 |
| BMY 28689 |
| BMY-28689 |
| BMY28689 |
| BSPBio_001936 |
| BU 3839T |
| BU-3839T |
| C06973 |
| CCG-204498 |
| CHEBI:50845 |
| CHEMBL1433 |
| CHEMBL436921 |
| CS-0009105 |
| D07876 |
| DB00254 |
| Deoxymykoin |
| DivK1c_000345 |
| DMSC (*Fosfatex) |
| Dossiciclina |
| Dossiciclina [DCIT] |
| DOXCYCLINE ANHYDROUS |
| Doxiciclina |
| Doxiciclina [INN-Spanish] |
| Doxiciclina [Italian] |
| Doxitard |
| Doxivetin |
| DOXY |
| Doxy-Caps |
| Doxy-Puren |
| Doxy-Tabs |
| Doxycen |
| Doxychel |
| Doxychel (TN) |
| Doxycyclin |
| Doxycycline (200mg/day) or Placebo |
| Doxycycline (anhydrous) |
| Doxycycline (hyclate) |
| Doxycycline (INN) |
| Doxycycline (internal use) |
| Doxycycline (TN) |
| Doxycycline [USAN:INN:BAN] |
| Doxycycline anhydrous |
| DOXYCYCLINE CALCIUM |
| Doxycycline hyclate |
| Doxycycline-Chinoin |
| Doxycycline, Antibiotic for Culture Media Use Only |
| Doxycyclinum |
| Doxycyclinum [INN-Latin] |
| Doxysol |
| Doxytetracycline |
| DTXSID0037653 |
| DTXSID80992212 |
| EINECS 209-271-1 |
| FT-0603476 |
| GS-3065 |
| GS-3065 (*monohydrate) |
| GTPL6464 |
| HMS2090E06 |
| HSDB 3071 |
| HY-N0565 |
| I455 |
| IDI1_000345 |
| Investin |
| JBIWCJUYHHGXTC-AKNGSSGZSA-N |
| Jenacyclin |
| KBio1_000345 |
| KBio2_001287 |
| KBio2_003855 |
| KBio2_006423 |
| KBio3_001156 |
| KBioGR_001133 |
| KBioSS_001287 |
| Liviatin |
| LMPK07000001 |
| Lopac0_000405 |
| LS-187766 |
| LS-93868 |
| MCULE-4368118692 |
| MMV000011 |
| Monodox |
| Monodox (*monohydrate) |
| NCGC00161602-01 |
| NCGC00161602-03 |
| NCGC00161602-04 |
| NCGC00161602-05 |
| NCGC00188979-01 |
| NINDS_000345 |
| NSC633557 |
| Oracea |
| Oxytetracycline, 6-deoxy- |
| Q422442 |
| Ronaxan |
| RPRXAHFLWOCXQL-AKNGSSGZSA-N |
| s5159 |
| SBI-0050391.P004 |
| SC-15766 |
| SCHEMBL1176275 |
| SCHEMBL17826665 |
| SCHEMBL19270298 |
| SCHEMBL40930 |
| SCHEMBL66828 |
| SGKRLCUYIXIAHR-AKNGSSGZSA-N |
| SMP1_000107 |
| Spanor |
| SPBio_000246 |
| Spectrum_000807 |
| Spectrum2_000143 |
| Spectrum3_000408 |
| Spectrum4_000527 |
| Spectrum5_000947 |
| SR-01000075844 |
| SR-01000075844-7 |
| Supracyclin |
| UNII-334895S862 |
| UPCMLD-DP021 |
| UPCMLD-DP021:001 |
| Vibra-tabs |
| Vibramycin |
| Vibramycin (*monohydrate) |
| Vibramycin Novum |
| Vibramycine |
| Vibravenos |
| Vivox (*Hyclate) |
| W-105517 |
| Zenavod |
| ZINC100056779 |
| ZINC100302137 |
| ZINC100611210 |
| ZINC109562088 |
| ZINC16052277 |
Paragraph IV (Patent) Challenges for DOXYCYCLINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-12 |
| ORACEA | CAPSULE;ORAL | doxycycline | 050805 | 2008-12-11 |
US Patents and Regulatory Information for DOXYCYCLINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 211012-001 | Sep 24, 2018 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Superpharm | DOXYCYCLINE HYCLATE | doxycycline hyclate | CAPSULE;ORAL | 062469-001 | Oct 31, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Lannett Co Inc | DOXYCYCLINE | doxycycline | TABLET;ORAL | 065285-001 | Dec 8, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| West-ward Pharms Int | DOXYCYCLINE | doxycycline hyclate | INJECTABLE;INJECTION | 062569-001 | Mar 9, 1988 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Warner Chilcott | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 062593-001 | Aug 28, 1985 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mayne Pharma Inc | DOXYCYCLINE HYCLATE | doxycycline hyclate | TABLET;ORAL | 208765-001 | Jun 14, 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 |
