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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 freedom to operate?

Doxycycline hyclate is the generic ingredient in fifteen branded drugs marketed by Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Aqua Pharms, Teva, Actavis Labs Fl Inc, Alembic Pharms Ltd, 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, Zydus Pharms Usa Inc, Collagenex, Pfizer, Fresenius Kabi Usa, Rachelle, Mylan Labs Ltd, West-ward Pharms Int, 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 Co Inc, Larken Labs, Lupin Ltd, Mayne Pharma Inc, Novel Labs Inc, Vintage Pharms, Chartwell Pharma, and Galderma Labs Lp, and is included in seventy-three 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-eight suppliers are listed for this compound.

Summary for doxycycline hyclate

International Patents:	2
US Patents:	5
Tradenames:	15
Applicants:	49
NDAs:	73
Drug Master File Entries:	27
Suppliers / Packagers:	98
Bulk Api Vendors:	120
Clinical Trials:	7
Patent Applications:	3,129
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for doxycycline hyclate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxycycline hyclate
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West-ward Pharms Int	DOXYCYCLINE HYCLATE	doxycycline hyclate	INJECTABLE;INJECTION	062992-002	Feb 16, 1989		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Impax Labs Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090505-002	Dec 28, 2010		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Aqua Pharms Llc	ACTICLATE	doxycycline hyclate	TABLET;ORAL	205931-001	Jul 25, 2014	AB	RX	Yes	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Mylan	DOXYCYCLINE HYCLATE	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	090431-001	Dec 28, 2010	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Zydus Pharms Usa Inc	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	207774-001	May 31, 2018	AB	RX	No	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

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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.