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Last Updated: October 16, 2019

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Doxycycline - Generic Drug Details

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

Doxycycline is the generic ingredient in eighteen branded drugs marketed by Acp Nimble, Alembic Pharms Ltd, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms, Almirall, Galderma Labs Lp, Rachelle, Chartwell Life Sci, Pfizer, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Teva, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Collagenex, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Tolmar, Mayne Pharma, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Apotex Inc, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Vintage Pharms, and Chartwell Pharma, and is included in one hundred and four NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has thirty-five patent family members in twelve countries.

There are twenty-eight drug master file entries for doxycycline. Forty-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for doxycycline

International Patents:	35
US Patents:	16
Tradenames:	18
Applicants:	55
NDAs:	104
Drug Master File Entries:	28
Suppliers / Packagers:	45
Bulk Api Vendors:	42
Clinical Trials:	262
Patent Applications:	2,658
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for doxycycline
Drug Sales Revenues:	Drug sales revenues for doxycycline
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxycycline
DailyMed Link:	doxycycline at DailyMed

See drug prices for doxycycline

Drug Sales Revenue Trends for doxycycline

See drug sales revenues for doxycycline

Recent Clinical Trials for doxycycline

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Sponsor	Phase
Kenya Medical Research Institute	Phase 4
Kenya National AIDS & STI Control Programme	Phase 4
Merck Sharp & Dohme Corp.	Phase 4

See all doxycycline clinical trials

Recent Litigation for doxycycline

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 doxycycline 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 doxycycline litigation

Generic filers with tentative approvals for DOXYCYCLINE

Applicant	Application No.	Strength	Dosage Form
See Pricing	See Pricing	40MG	CAPSULE;ORAL
See Pricing	See Pricing	40MG	CAPSULE; ORAL
See Pricing	See Pricing	40MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for doxycycline

Drug Class	Tetracycline-class Drug

Medical Subject Heading (MeSH) Categories for doxycycline

Anti-Bacterial Agents
Antimalarials

Synonyms for doxycycline

(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 (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
Oracea
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

US Patents and Regulatory Information for doxycycline

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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
Sandoz Inc	DOXYCYCLINE	doxycycline	TABLET;ORAL	065353-002	Nov 27, 2006		DISCN	No	No	See Pricing	See Pricing				See Pricing
Pfizer	VIBRA-TABS	doxycycline hyclate	TABLET;ORAL	050533-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	See Pricing	See Pricing				See Pricing
Zydus Pharms	DOXYCYCLINE HYCLATE	doxycycline hyclate	CAPSULE;ORAL	207774-001	May 31, 2018	AB	RX	No	No	See Pricing	See Pricing				See Pricing
Sun Pharm Industries	DOXYCYCLINE	doxycycline	TABLET;ORAL	065471-002	Apr 17, 2009		DISCN	No	No	See Pricing	See Pricing				See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for doxycycline

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

International Patents for doxycycline

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Country	Patent Number	Estimated Expiration
Canada	2803922	See Pricing
European Patent Office	1712236	See Pricing
Denmark	1615622	See Pricing
Austria	330615	See Pricing
>Country	>Patent Number	>Estimated Expiration

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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.

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