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DOXYCYCLINE HYCLATE - Generic Drug Details

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What are the generic drug sources for doxycycline hyclate and what is the scope of doxycycline hyclate patent protection?

Doxycycline hyclate is the generic ingredient in fourteen branded drugs marketed by Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Aqua Pharms, Teva, Actavis Labs Fl Inc, Amneal Pharms, Chartwell Life Sci, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Mylan, Par Pharm, Pvt Form, Ranbaxy, Sun Pharm Industries, Superpharm, Watson Labs, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Mylan Labs Ltd, West-ward Pharms Int, Zydus Pharms Usa Inc, Tolmar, Mayne Pharma, Actavis Elizabeth, Heritage Pharms Inc, Impax Labs Inc, Mylan Pharms Inc, Prinston Inc, Aqua Pharms Llc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Lannett, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Vintage Pharms, and Galderma Labs Lp, and is included in seventy-one NDAs. There are five patents protecting this compound and seven Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxycycline hyclate has two patent family members in two countries.

There are twenty-seven drug master file entries for doxycycline hyclate. Ninety-five suppliers are listed for this compound.

Summary for DOXYCYCLINE HYCLATE

International Patents:	2
US Patents:	5
Tradenames:	14
Applicants:	47
NDAs:	71
Drug Master File Entries:	27
Suppliers / Packagers:	95
Bulk Api Vendors:	108
Clinical Trials:	219
Patent Applications:	3,083
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	DOXYCYCLINE HYCLATE at DailyMed

Pharmacology for DOXYCYCLINE HYCLATE

Ingredient-type	Tetracyclines
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)

(2E,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione

(2E,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; ethanol; hydrate; dihydrochloride

(2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; ethanol; hydrate; dihydrochloride

(2Z,4S,4AR,5S,5AR,6R,12AS)-2-[AMINO(HYDROXY)METHYLIDENE]-4-(DIMETHYLAMINO)-5,10,11,12A-TETRAHYDROXY-6-METHYL-1,2,3,4,4A,5,5A,6,12,12A-DECAHYDROTETRACENE-1,3,12-TRIONE

(2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione

(2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione hydrochloride

(2Z,4S,4aR,5S,5aR,6R,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione; ethanol; hydrate; dihydrochloride

(2Z,4S,4aR,5S,5aR,6R)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione

(2Z)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione

(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)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-5,10,11,12a-tetrahydroxy-6-methyl-4a,5,5a,6-tetrahydro-4H-tetracene-1,3,12-trione

(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-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)

10597-92-9

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

17086-28-1 (mono-hydrate)

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-, monohydrochloride, (4S,4aR,5S,5aR,6R,12aS)-, compd. with ethanol (2:1), mono

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-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, monohydrochloride, compd. with ethanol (2:1), monohydrate, (4S-(4alpha,4aalpha,5alpha,5aalpha,6alpha,

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,4,4a,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)-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-

41411-66-9 (6-epimer, mono-hydrochloride)

4182Z6T2ET

5-Hydroxy-alpha-6-deoxytetracycline

5-Hydroxy-alpha-6-deoxytetracycline monohydrate

53108-42-2

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

61281-03-6

62149-53-5

69935-17-7 (mono-hydrochloride, di-hydrate)

6alpha-Deoxy-5-oxytetracycline

7164-70-7

7264-10-0

94088-85-4 (calcium salt (1:2))

AB00053465_04

AB00053465_05

AB00053465-03

AB08 (*Fosfatex)

AC-12044

AC-6017

AC1L1WYQ

AC1NQXW7

AC1NQZPV

AC1NTTH2

AC1NUYS5

AC1NUYS8

Acticlate

Acticlate CAP

AK321970

AK322076

AKOS015900372

AKOS015924649

AKOS025310153

AKOS025402170

alpha-6-Deoxy-5-hydroxytetracycline

alpha-6-Deoxyoxytetracycline

alpha-6-Deoxyoxytetracycline monohydrate

alpha-6-Tetracycline monohydrate

alpha-Doxycycline

Alti-Doxycycline

Ambap100929-47-3

AN-18097

Anhydrous doxycycline

API0002491

API0002492

Apo-Doxy

AS-13499

Atridox

Azudoxat

BCBcMAP01_000024

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

CHEMBL436921

CS-2632

D 9891

D02129

D07876

D07877

D0S0LZ

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

Doxycin

Doxycyclin

doxycycline

Doxycycline (200mg/day) or Placebo

Doxycycline (anhydrous)

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 hydrochloride

Doxycycline Hydrochloride [JAN]

Doxycycline hydrochloride hemiethanolate hemihydrate

Doxycycline hydrochloride hydrate (JP17)

DOXYCYCLINE HYLATE

Doxycycline-Chinoin

Doxycycline, Antibiotic for Culture Media Use Only

Doxycycline, Hyclate

Doxycycline, hydrochloride, hemiethanolate, hemihydrate;

Doxycyclinum

Doxycyclinum [INN-Latin]

Doxylin

Doxyprex

Doxysol

Doxytec

Doxytetracycline

DSSTox_CID_25405

DSSTox_GSID_45405

DSSTox_RID_80856

DTXSID0037653

DTXSID1045405

DTXSID4041020

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-N0565A

Hydramycin

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

MolPort-002-507-423

MolPort-003-666-171

MolPort-005-932-536

MolPort-023-220-303

MolPort-039-338-208

MolPort-042-652-606

Monodoks

Monodox

Monodox (*monohydrate)

NCGC00016693-01

NCGC00161602-01

NCGC00161602-03

NCGC00161602-04

NCGC00161602-05

NCGC00161602-06

NCGC00188979-01

NCGC00261090-01

NINDS_000345

Nivocilin

Novadox

Novo-Doxylin

NPV78C39GQ

NSC-633557

NSC-741421

NSC-756751

NSC633557

NSC741421

NSC756751

Nu-Doxycycline

Oracea

Oxytetracycline, 6-deoxy-

Periostat

Periostat (TN)

Pharmakon1600-01500266

PL000396

PL040705

RETENS

Ronaxan

Roximycin

RPRXAHFLWOCXQL-AKNGSSGZSA-N

RUYHIJHUVHIMIR-CVHRZJFOSA-N

Samecin

SBI-0050391.P004

SC-15766

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-01000075844-7

STOCK1N-34341

Supracyclin

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

Z2791720087

Zenavod

ZINC100056779

ZINC100302137

ZINC100611210

ZINC109562088

ZINC16052277

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
Ranbaxy	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	062479-001	Dec 23, 1983		DISCN	No	No
Teva	DOXY-LEMMON	doxycycline hyclate	TABLET;ORAL	062581-001	Mar 15, 1985		DISCN	No	No
Mayne Pharma	DORYX MPC	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-007	May 20, 2016		DISCN	Yes	No			Y
Mayne Pharma Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET;ORAL	208765-002	Jun 14, 2017	AB	RX	No	No

Non-Orange Book US Patents for DOXYCYCLINE HYCLATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
2,016,151,395

International Patents for DOXYCYCLINE HYCLATE

Country	Document Number	Estimated Expiration
Australia	2005299253
World Intellectual Property Organization (WIPO)	2006045152