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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 eleven 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-eight drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

Summary for ORACEA

International Patents:	35
US Patents:	11
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	42
Clinical Trials:	7
Patent Applications:	1,710
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ORACEA
Drug Sales Revenues:	Drug sales revenues for ORACEA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORACEA
DailyMed Link:	ORACEA at DailyMed

See drug prices for ORACEA

See drug sales revenues for ORACEA

Recent Clinical Trials for ORACEA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Derm Research, PLLC	Phase 4
Galderma	Phase 4
Paul Yates, MD, PhD	Phase 2/Phase 3

See all ORACEA clinical trials

Recent Litigation for ORACEA

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 ORACEA litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy’s Laboratories, Ltd.	2015-08-20
Amneal Pharamceuticals, LLC	2013-06-20
Amneal Pharmaceuticals, LLC	2013-06-20

See all ORACEA litigation

Pharmacology for ORACEA

Drug Class

Tetracycline-class Drug

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-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-

24390-14-5

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

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

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 (hyclate)

Doxycycline (INN)

Doxycycline (internal use)

Doxycycline (TN)

Doxycycline [USAN:INN:BAN]

DOXYCYCLINE CALCIUM

Doxycycline hyclate

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

Monodox

Monodox (*monohydrate)

NCGC00161602-01

NCGC00161602-03

NCGC00161602-04

NCGC00161602-05

NCGC00188979-01

NINDS_000345

Novo-Doxylin

NSC633557

Nu-Doxycycline

Oxytetracycline, 6-deoxy-

Periostat

Ronaxan

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

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 ORACEA

Tradename	Dosage	Ingredient	NDA	Submissiondate
ORACEA	CAPSULE;ORAL	doxycycline	050805	2008-12-11

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
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006		RX	Yes	Yes			Y
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006		RX	Yes	Yes
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006		RX	Yes	Yes			Y

Expired US Patents for ORACEA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006

International Patents for ORACEA

Country	Patent Number	Estimated Expiration
Denmark	1383508
Canada	2803922
Canada	2894736
Canada	2440472