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Triamcinolone acetonide - Generic Drug Details

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

Triamcinolone acetonide is the generic ingredient in twenty-five branded drugs marketed by Abbvie, Sanofi Aventis Us, Astellas, Ivax Pharms, Delcor Asset Corp, Teva, Solvay, Actavis Mid Atlantic, Alkem Labs Ltd, Alpharma Us Pharms, Ambix, Fougera Pharms, G And W Labs, Glenmark Pharms Ltd, Lannett Co Inc, Lupin Atlantis, Macleods Pharms Ltd, Morton Grove, Mylan Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Taro, Taro Pharm Inds Ltd, Teligent Pharma Inc, Topiderm, Crown Labs, Savage Labs, Flexion Theraps Inc, Apothecon, Amneal Pharms Co, Parnell, Sandoz Inc, Watson Labs, Allergan, Novartis Pharms Corp, Akorn, G And W Labs Inc, Wockhardt Bio Ag, Glenmark Pharms, Cmp Pharma Inc, Lyne, Perrigo Israel, Sun Pharm Inds Inc, Perrigo Uk Finco, and Riconpharma Llc, and is included in one hundred and twenty-four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Triamcinolone acetonide has sixty patent family members in twenty-four countries.

There are fifty-one drug master file entries for triamcinolone acetonide. Eighty-seven suppliers are listed for this compound.

Summary for triamcinolone acetonide

International Patents:	60
US Patents:	5
Tradenames:	25
Applicants:	46
NDAs:	124
Drug Master File Entries:	51
Suppliers / Packagers:	87
Bulk Api Vendors:	62
Clinical Trials:	272
Patent Applications:	6,575
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for triamcinolone acetonide
DailyMed Link:	triamcinolone acetonide at DailyMed

Pharmacology for triamcinolone acetonide

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for triamcinolone acetonide

Anti-Inflammatory Agents

Glucocorticoids

Immunosuppressive Agents

Synonyms for triamcinolone acetonide

(11beta,16alpha)-9-Fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione

(1S,2S,4R,8S,9S,11S,12R,13S)-12-FLUORO-11-HYDROXY-8-(2-HYDROXYACETYL)-6,6,9,13-TETRAMETHYL-5,7-DIOXAPENTACYCLO[10.8.0.0(2),?.0?,?.0(1)(3),(1)?]ICOSA-14,17-DIEN-16-ONE

(4aS,4bR,5S,6aS,6bR,9aR)-4b-fluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one

(4aS,4bR,5S,6aS,6bS,9aR,10aS,10bS)-4b-fluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one

(4aS,4bR,5S,6aS,6bS,9aR,10aS,10bS)-4b-fluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one

(6aS,6bR,7S,8aS,8bS,11aR,12aS,12bS)-6b-fluoro-7-hydroxy-8b-(2-hydroxyacetyl)-6a,8a,10,10-tetramethyl-1,2,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-4H-naphtho[2',1':4,5]indeno[

056T834

1,2-d][1,3]dioxol-4-one

13586-95-3

138265-06-2

1TA

5-19-06-00568 (Beilstein Handbook Reference)

76-25-5

8054-16-8

9-alpha-Fluoro-11-beta,21-dihydroxy-16-alpha-isopropylidenedioxy-1,4-pregnadiene,3,20-dione

9-alpha-Fluoro-11-beta,21-dihydroxy-16-alpha,17-alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione

9-alpha-Fluoro-16-alpha-17-alpha-isopropyledenedioxyprednisolone

9-alpha-Fluoro-16-alpha-17-alpha-isopropylidenedioxy-delta-1-hydrocortisone

9-alpha-Fluoro-16-alpha-hydroxyprednisolone 16-alpha,17-alpha-acetonide

9-alpha-Fluoro-16-hydroxyprednisolone acetonide

9-Fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone

9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione-16,17-acetonide

9?-Fluoro-11?,21-dihydroxy-16?,17?-isopropylidenedioxypregna-1,4-diene-3,20-dione

9.alpha.-Fluoro-11.beta.,4-pregnadiene,3,20-dione

9.alpha.-Fluoro-16-hydroxyprednisolone acetonide

9.alpha.-Fluoro-16.alpha.-17.alpha.-isopropyledenedioxyprednisolone

9.alpha.-Fluoro-16.alpha.-17.alpha.-isopropylidenedioxy-.delta.-1-hydrocortisone

9.alpha.-Fluoro-16.alpha.-hydroxyprednisolone 16.alpha.,17.alpha.-acetonide

9|A-Fluoro-11|A,21-dihydroxy-16|A,17-isopropylidenedioxy-1,4-pregnadiene-3,20-dione

911437-91-7

9A-FLUORO-11B,16A,17A,21-TETRAHYDROXY-1,4-PREGNADIENE-3,20-DIONE 16,17-ACETONIDE

9alpha-Fluoro-11beta,21-dihydroxy-16alpha,17-isopropylidenedioxy-1,4-pregnadiene,3,20-dione

9alpha-fluoro-11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione

9alpha-Fluoro-16-hydroxyprednisolone acetonide

9alpha-Fluoro-16alpha-17alpha-isopropyledenedioxyprednisolone

9alpha-fluoro-16alpha-17alpha-isopropylidenedioxy-Delta-1-hydrocortisone

9alpha-Fluoro-16alpha-hydroxyprednisolone 16alpha,17alpha-acetonide

AB00383012_12

AB00383012-11

AB1010917

AC-18909

AC1L1MJ3

AC1Q2CRE

Acetospan

ACN-043361

Adcortyl A

AKOS015894871

AllerNaze

alpha-Fluoro-11beta,16alpha,17,21-tetra-hydroxypregna-1,4-diene-3,20-dione

AN-15131

aristicort

Aristocort A

Aristocort acetonide

Aristoderm

Aristogel

Asmacort [Common Misspelling of Azmacort]

Azmacort

Bio-0665

BRD-K53790871-001-08-6

BRN 0060069

C-22292

C08183

CAS-76-25-5

CCRIS 5231

CHEBI:71418

CHEMBL1504

Cinonide

Coupe-A

CS-2871

D00983

DSSTox_CID_1371

DSSTox_GSID_21371

DSSTox_RID_76115

DTXSID6021371

EINECS 200-948-7

F446C597KA

Flutone

fx-006

FX006

GTPL2867

HMS2232F22

HMS3259A20

HY-B0636

J10453

Kenacort A

Kenacort-A

Kenalog

Kenalog 40

Kenalog in Orabase

Kenalog-H

Kenalone

KS-5330

LS-1692

MFCD00056834

MLS000028538

MLS001148264

MLS002207192

MLS002638825

MolPort-002-529-154

Mytrex

Nasacort Allergy 24 Hour

Nasacort AQ

Nasacort HFA

NC00591

NCGC00023193-04

NCGC00023193-05

NCGC00023193-06

NCGC00256560-01

NCGC00259344-01

NSC 21916

NSC-21916

NSC21916

Omcilon A

Opera_ID_232

Panolog Ointment (Veterinary)

PL000384

Pregna-1,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11.beta.,16.alpha.)-

Pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone

Pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-,cyclic 16,17-acetal with acetone

Pregna-1,20-dione, 9-fluoro-11.beta.,21-dihydroxy-16.alpha.,17-(isopropylidenedioxy)-

Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone

Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-

Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone

Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,16alpha,17,21-tetrahydroxy-, cyclic 16,17-acetal with acetone (8CI)

Q-201855

Rineton

S1628

SCHEMBL4689

SMR000058335

Solodelf

ST24050240

ST51052694

TAC-3

Tox21_110885

Tox21_110885_1

Tox21_201795

Tox21_303014

Tramacin

Tri-Nasal

Triacet

Triaceton

Triam-Injekt

Triamcincolone acetonide

Triamcinolone (acetonide)

Triamcinolone 16,17-acetonide

Triamcinolone acetonide (JP17/USP)

TRIAMCINOLONE ACETONIDE (SEE ALSO TRIAMCINOLONE (124-94-7))

Triamcinolone acetonide [JAN]

Triamcinolone acetonide [USP:INN:BAN:JAN]

Triamcinolone acetonide for system suitability, European Pharmacopoeia (EP) Reference Standard

Triamcinolone Acetonide in Absorbase

Triamcinolone acetonide, analytical standard

Triamcinolone acetonide, European Pharmacopoeia (EP) Reference Standard

Triamcinolone Acetonide, pharmaceutical secondary standard; traceable to USP, PhEur

Triamcinolone acetonide, United States Pharmacopeia (USP) Reference Standard

triamcinoloneacetonide

Triamonide 40

Triamsinolone acetonide

Triatex

Tricinolon

Tricort-40

Trivaris

Trymex

UNII-F446C597KA

Vetalog

Vetalog (Veterinary)

Volon A

Volon A 40

VZ33964

WLN: T F5 E5 B666 GO IO RV AHTTTT&J A1 BF CQ E1 FV1Q H1 H1

YNDXUCZADRHECN-JNQJZLCISA-N

Zilretta

ZINC3875481

US Patents and Regulatory Information for triamcinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	040386-001	Jun 5, 2001		DISCN	No	No
Flexion Theraps Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845-001	Oct 6, 2017		RX	Yes	Yes			Y
Flexion Theraps Inc	ZILRETTA	triamcinolone acetonide	FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR	208845-001	Oct 6, 2017		RX	Yes	Yes
G And W Labs	TRIAMCINOLONE ACETONIDE	triamcinolone acetonide	OINTMENT;TOPICAL	089796-001	Dec 23, 1988	AT	RX	No	No

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Expired US Patents for triamcinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Delcor Asset Corp	KENALOG-H	triamcinolone acetonide	CREAM;TOPICAL	086240-001	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013
Sanofi Aventis Us	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	SPRAY, METERED;NASAL	020468-002	Oct 11, 2013
Abbvie	AZMACORT	triamcinolone acetonide	AEROSOL, METERED;INHALATION	018117-001	Apr 23, 1982

Non-Orange Book US Patents for triamcinolone acetonide

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
9,555,047	Corticosteroids for the treatment of joint pain

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International Patents for triamcinolone acetonide

Country	Document Number	Estimated Expiration
European Patent Office	2600836
Japan	2013535489
Taiwan	I548412
World Intellectual Property Organization (WIPO)	2013019280