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Last Updated: October 22, 2019

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DORYX Drug Profile

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When do Doryx patents expire, and when can generic versions of Doryx launch?

Doryx is a drug marketed by Mayne Pharma Intl, Warner Chilcott, and Mayne Pharma. and is included in three NDAs. There are five patents protecting this drug and seven Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in DORYX is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

Drug patent expirations by year for DORYX
Drug Prices for DORYX

See drug prices for DORYX

Drug Sales Revenue Trends for DORYX

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Recent Litigation for DORYX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Mayne Pharma International Pty Ltd. v. Actavis Elizabeth LLC2017-11-09
WARNER CHILCOTT LABORATORIES IRELAND LIMITED v. MYLAN PHARMACEUTICALS INC.2009-05-01
WARNER CHILCOTT LABORATORIES IRELAND LIMITED v. IMPAX LABORATORIES, INC.2009-03-18

See all DORYX litigation

Pharmacology for DORYX
Synonyms for DORYX
(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-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; ethanol; hydrate; dihydrochloride
(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)-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
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-, (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-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, 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
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-Epioxytetracycline, 6-deoxy-
41411-66-9 (6-epimer, mono-hydrochloride)
5-Hydroxy-alpha-6-deoxytetracycline
5-Hydroxy-alpha-6-deoxytetracycline monohydrate
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
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-6017
AC1L1WYQ
AC1NQXW7
AC1NQZPV
AC1NUYS5
AC1NUYS8
Acticlate
Acticlate CAP
AK175707
AKOS015900372
AKOS025402170
alpha-6-Deoxy-5-hydroxytetracycline
alpha-6-Deoxyoxytetracycline
alpha-6-Deoxyoxytetracycline monohydrate
alpha-6-Tetracycline monohydrate
alpha-Doxycycline
Alti-Doxycycline
AN-18097
Anhydrous doxycycline
API0002491
Apo-Doxy
AS-13499
Atridox
Azudoxat
BCBcMAP01_000024
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
C06973
CCG-204498
CHEBI:50845
CHEMBL1433
CHEMBL3989740
CHEMBL436921
D02129
D07876
D4116
DB00254
Dentista
Deoxymykoin
DivK1c_000345
DMSC (*Fosfatex)
Doryx (TN)
Doryx Mpc
Dossiciclina
Dossiciclina [DCIT]
DOXCYCLINE ANHYDROUS
Doxiciclina
Doxiciclina [INN-Spanish]
Doxiciclina [Italian]
Doxitard
Doxivetin
Doxteric
DOXY
Doxy 100
DOXY 200
Doxy-Caps
Doxy-Lemmon
Doxy-Puren
Doxy-Tabs
Doxycen
Doxychel
Doxychel (TN)
Doxychel Hyclate
Doxycin
Doxycyclin
doxycycline
Doxycycline (200mg/day) or Placebo
Doxycycline (anhydrous)
Doxycycline (hyclate)
Doxycycline (INN)
Doxycycline (internal use)
Doxycycline (TN)
Doxycycline [USAN:INN:BAN]
DOXYCYCLINE CALCIUM
Doxycycline hyclate
Doxycycline Hyclate (100 mg)
Doxycycline hyclate (internal use)
Doxycycline hyclate (USP)
Doxycycline hyclate [USAN:USP]
doxycycline hyclate 20 mg twice daily
Doxycycline hydrochloride hemiethanolate hemihydrate
Doxycycline hydrochloride hydrate (JP17)
DOXYCYCLINE HYLATE
Doxycycline-Chinoin
Doxycycline, Antibiotic for Culture Media Use Only
Doxycyclinum
Doxycyclinum [INN-Latin]
Doxylin
Doxyprex
Doxysol
Doxytec
Doxytetracycline
DS-9077
DTXSID0037653
DTXSID4041020
EINECS 209-271-1
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
FT-0603476
GS-3065
GS-3065 (*monohydrate)
GTPL6464
HMS2090E06
HSDB 3071
Hydramycin
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-174052
LS-187766
LS-93868
MCULE-4368118692
MFCD07357237
MMV000011
MolPort-002-507-423
MolPort-005-932-536
MolPort-039-338-208
Monodoks
Monodox
Monodox (*monohydrate)
NCGC00161602-01
NCGC00161602-03
NCGC00161602-04
NCGC00161602-05
NCGC00188979-01
NINDS_000345
Novo-Doxylin
NPV78C39GQ
NSC-741421
NSC633557
NSC741421
Nu-Doxycycline
Oracea
Oxytetracycline, 6-deoxy-
Periostat
Periostat (TN)
Ronaxan
Roximycin
RPRXAHFLWOCXQL-AKNGSSGZSA-N
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
SW219440-1
SW219440-2
Tetraclean
UNII-19XTS3T51U
UNII-334895S862
UNII-NPV78C39GQ
UPCMLD-DP021
UPCMLD-DP021:001
Vibra-tabs
Vibra-tabs (TN)
Vibramycin
Vibramycin (*monohydrate)
Vibramycin hyclate
Vibramycin Novum
Vibramycine
Vibravenos
Vivox
Vivox (*Hyclate)
W-105517
WC 2031
Z2791720087
Zenavod
ZINC100056779
ZINC100302137
ZINC100611210
ZINC109562088
ZINC16052277

US Patents and Regulatory Information for DORYX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma Intl DORYX doxycycline hyclate CAPSULE, DELAYED RELEASE;ORAL 050582-002 Aug 13, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-001 May 6, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-006 Dec 19, 2014 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-003 Jun 20, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for DORYX
Drugname Dosage Strength RLD Date
➤ Subscribe Delayed-release Tablets 60 mg and 120 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 50 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 80 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 75 mg and 100 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 150 mg ➤ Subscribe   Start Trial
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe   Start Trial

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