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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Queensland Health
Medtronic
Healthtrust
Merck
Baxter
Deloitte
US Army
Colorcon

Generated: June 21, 2018

DrugPatentWatch Database Preview

ORACEA Drug Profile

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Which patents cover Oracea, and when can generic versions of Oracea launch?

Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in twelve countries.

The generic ingredient in ORACEA is doxycycline. There are twenty-seven drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the doxycycline profile page.
Drug patent expirations by year for ORACEA
Pharmacology for ORACEA
Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug
Medical Subject Heading (MeSH) Categories for ORACEA
Synonyms for ORACEA
(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
(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)-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)-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
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)
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-
334895S862
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-Deoxyoxytetracycline
6-Deoxytetracycline
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)
AC1L1WYQ
AC1NQXW7
AC1NUYS8
Acticlate
AK322076
AKOS015900372
alpha-6-Deoxy-5-hydroxytetracycline
alpha-6-Deoxyoxytetracycline
alpha-6-Deoxyoxytetracycline monohydrate
alpha-6-Tetracycline monohydrate
alpha-Doxycycline
Alti-Doxycycline
Anhydrous doxycycline
API0002491
Apo-Doxy
AS-13499
Atridox
Azudoxat
BCBcMAP01_000024
BMY 28689
BMY-28689
BMY28689
BSPBio_001936
BU 3839T
BU-3839T
C06973
CCG-204498
CHEBI:50845
CHEMBL1433
CHEMBL436921
D07876
D0S0LZ
DB00254
Deoxymykoin
DivK1c_000345
DMSC (*Fosfatex)
Doryx
Dossiciclina
Dossiciclina [DCIT]
DOXCYCLINE ANHYDROUS
Doxiciclina
Doxiciclina [INN-Spanish]
Doxiciclina [Italian]
Doxitard
Doxivetin
DOXY
Doxy-Caps
Doxy-Puren
Doxy-Tabs
Doxycen
Doxychel
Doxychel (TN)
Doxycin
Doxycyclin
doxycycline
Doxycycline (200mg/day) or Placebo
Doxycycline (anhydrous)
Doxycycline (INN)
Doxycycline (internal use)
Doxycycline (TN)
Doxycycline [USAN:INN:BAN]
Doxycycline anhydrous
DOXYCYCLINE CALCIUM
Doxycycline HCl
Doxycycline hyclate
Doxycycline hydrochloride
Doxycycline-Chinoin
Doxycycline, Antibiotic for Culture Media Use Only
Doxycyclinum
Doxycyclinum [INN-Latin]
Doxylin
Doxysol
Doxytec
Doxytetracycline
DTXSID0037653
EINECS 209-271-1
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-187766
LS-93868
MCULE-4368118692
MMV000011
MolPort-002-507-423
MolPort-039-338-208
MolPort-042-652-606
Monodox
Monodox (*monohydrate)
NCGC00161602-01
NCGC00161602-03
NCGC00161602-04
NCGC00161602-05
NCGC00188979-01
NINDS_000345
Novo-Doxylin
NSC633557
Nu-Doxycycline
Oxytetracycline, 6-deoxy-
Periostat
Periostat (TN)
PL000396
PL040705
Ronaxan
RPRXAHFLWOCXQL-AKNGSSGZSA-N
SBI-0050391.P004
SC-15766
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
STOCK1N-34341
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

US Patents and Regulatory Information for ORACEA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for ORACEA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Capsules 40 mg ➤ Subscribe 2008-12-11

Non-Orange Book US Patents for ORACEA

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
7,014,858 Use methods of treating acne and telangiectasia ➤ Sign Up
8,658,189 Methods of treating acne ➤ Sign Up
8,052,983 Methods of treating acne ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Covington
McKinsey
Fish and Richardson
Moodys
Medtronic
Fuji
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.