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Last Updated: June 4, 2020

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DOXYCYCLINE Drug Profile


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

Doxycycline is a drug 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, Chartwell Life Sci, Mylan Labs Ltd, West-ward Pharms Int, Heritage Pharms Inc, Lannett Co Inc, Mylan, Sun Pharm Industries, Pliva, Medicis, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Amneal Pharms, Changzhou Pharm, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Warner Chilcott, Zhejiang Yongtai, Actavis Elizabeth, Prinston Inc, Amneal Pharms Co, Apotex, Cadila, Caribe Holdings, Emcure Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Larken Labs, Novel Labs Inc, Oaklock Llc, and Vintage Pharms. and is included in eighty-eight NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Doxycycline

A generic version of DOXYCYCLINE was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.

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Drug patent expirations by year for DOXYCYCLINE
Drug Prices for DOXYCYCLINE

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Drug Sales Revenue Trends for DOXYCYCLINE

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Recent Clinical Trials for DOXYCYCLINE

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

SponsorPhase
St. Francis Hospital, New YorkPhase 4
University Hospital of GuadeloupePhase 4
Centre Hospitalier Universitaire de la RéunionPhase 4

See all DOXYCYCLINE clinical trials

Recent Litigation for DOXYCYCLINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories, L.P. v. Amneal Pharmaceuticals, LLC2019-03-01
Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited2016-10-27
Galderma Laboratories L.P. v. Amneal Pharmaceuticals LLC2016-03-31

See all DOXYCYCLINE litigation

PTAB Litigation
PetitionerDate
2015-08-20
2013-06-20

See all DOXYCYCLINE litigation

Pharmacology for DOXYCYCLINE
Medical Subject Heading (MeSH) Categories for DOXYCYCLINE
Synonyms for DOXYCYCLINE
(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)-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
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
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-
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)-
24390-14-5
334895S862
4-(Dimethylamino)-1,5,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-3,4,4a,5,5a,6,12,12a-octahydrotetracene-2-carboximidic acid
4-Epioxytetracycline, 6-deoxy-
5-Hydroxy-alpha-6-deoxytetracycline
564-25-0
564D250
6-alpha-Deoxy-5-oxytetracycline
6-Deoxyoxytetracycline
6-Deoxytetracycline
6alpha-Deoxy-5-oxytetracycline
7164-70-7
94088-85-4
AB00053465_04
AB00053465_05
AB00053465-03
AB08 (*Fosfatex)
AKOS015900372
alpha-6-Deoxy-5-hydroxytetracycline
alpha-6-Deoxyoxytetracycline
alpha-Doxycycline
Anhydrous doxycycline
API0002491
AS-13499
Azudoxat
BCBcMAP01_000024
BMY 28689
BMY-28689
BMY28689
BSPBio_001936
BU 3839T
BU-3839T
C06973
CCG-204498
CHEBI:50845
CHEMBL1433
CHEMBL436921
CS-0009105
D07876
DB00254
Deoxymykoin
DivK1c_000345
DMSC (*Fosfatex)
Dossiciclina
Dossiciclina [DCIT]
DOXCYCLINE ANHYDROUS
Doxiciclina
Doxiciclina [INN-Spanish]
Doxiciclina [Italian]
Doxitard
Doxivetin
DOXY
Doxy-Caps
Doxy-Puren
Doxy-Tabs
Doxycen
Doxychel
Doxychel (TN)
Doxycyclin
Doxycycline (200mg/day) or Placebo
Doxycycline (anhydrous)
Doxycycline (hyclate)
Doxycycline (INN)
Doxycycline (internal use)
Doxycycline (TN)
Doxycycline [USAN:INN:BAN]
Doxycycline anhydrous
DOXYCYCLINE CALCIUM
Doxycycline hyclate
Doxycycline-Chinoin
Doxycycline, Antibiotic for Culture Media Use Only
Doxycyclinum
Doxycyclinum [INN-Latin]
Doxysol
Doxytetracycline
DTXSID0037653
DTXSID80992212
EINECS 209-271-1
FT-0603476
GS-3065
GS-3065 (*monohydrate)
GTPL6464
HMS2090E06
HSDB 3071
HY-N0565
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
Monodox
Monodox (*monohydrate)
NCGC00161602-01
NCGC00161602-03
NCGC00161602-04
NCGC00161602-05
NCGC00188979-01
NINDS_000345
NSC633557
Oracea
Oxytetracycline, 6-deoxy-
Q422442
Ronaxan
RPRXAHFLWOCXQL-AKNGSSGZSA-N
s5159
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 DOXYCYCLINE
Tradename Dosage Ingredient NDA Submissiondate
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-12
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-11

US Patents and Regulatory Information for DOXYCYCLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 211012-001 Sep 24, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm DOXYCYCLINE HYCLATE doxycycline hyclate CAPSULE;ORAL 062469-001 Oct 31, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc DOXYCYCLINE doxycycline TABLET;ORAL 065285-001 Dec 8, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DOXYCYCLINE doxycycline hyclate INJECTABLE;INJECTION 062569-001 Mar 9, 1988 AP RX No Yes   Start Trial   Start Trial   Start Trial
Warner Chilcott DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 062593-001 Aug 28, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma Inc DOXYCYCLINE HYCLATE doxycycline hyclate TABLET;ORAL 208765-001 Jun 14, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Merck
Mallinckrodt
Dow
Boehringer Ingelheim

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 verification 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.