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Last Updated: December 11, 2019

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Tiotropium bromide - Generic Drug Details

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What are the generic drug sources for tiotropium bromide and what is the scope of freedom to operate?

Tiotropium bromide is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tiotropium bromide has five hundred and seventy-three patent family members in fifty-four countries.

There are eight drug master file entries for tiotropium bromide. Two suppliers are listed for this compound.

Recent Clinical Trials for tiotropium bromide

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

SponsorPhase
University Medical Center GroningenPhase 4
Huashan HospitalN/A
Center for Integrated Rehabilitation and Organ Failure HornPhase 4

See all tiotropium bromide clinical trials

Recent Litigation for tiotropium bromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. LUPIN ATLANTIS HOLDINGS SA2018-11-30
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. LUPIN ATLANTIS HOLDINGS SA2018-08-10

See all tiotropium bromide litigation

Pharmacology for tiotropium bromide
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for tiotropium bromide
Synonyms for tiotropium bromide
(1?,2?,4?,5?,7?)-7-[(2-Hydroxy-2,2-di-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide
(1a,2b,4b,5a,7b)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide
(1alpha,2beta,4beta,5alpha,7beta)-7-[(hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.0(2,4)]nonane bromide
(1R,2R,4S,5S,7R)-7-{[2-hydroxy-2,2-bis(thiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0^{2,4}]nonan-9-ium bromide
(1R,2R,4S,5S,7R)-7-{[2-hydroxy-2,2-bis(thiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0?,?]nonan-9-ium bromide
(1R,2R,4S,5S,7S)-7-(2-Hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.0
(1R,2R,4S,5S,7s)-7-(2-Hydroxy-2,2-di(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide
(1R,2R,4S,5S,7s)-7-[2-Hydroxy-2,2-di(2-thienyl)acetoxy]-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium Bromide
136310-93-5
3-Oxa-9-azoniatricyclo(3,3.1.0(2,4))nonane, 7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-, bromide, (1alpha,2beta,4beta,5alpha,7beta)-
7-((Hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane bromide
AB1004875
AC-1300
ACT04740
ACT04741
AK-72842
AKOS015920264
AN-15059
API0006410
AX8018159
BA 679 BR
BA 679BR
BA-679-BR
BC209107
BCP02925
BCP0726000293
BR-72842
C19H22BrNO4S2
CAS-136310-93-5
CHEBI:90959
CHEMBL3189058
CS-0903
DSSTox_CID_24214
DSSTox_GSID_44214
DSSTox_RID_80122
DT1167
DTXSID2044214
FC1260
HMS2090H20
HY-17360
KB-81162
KS-1402
MolPort-005-935-362
NCGC00167971-01
SCHEMBL440873
SCHEMBL7607795
SCHEMBL8625
Spiriva
Spiriva Handihaler
Spiriva Respimat
ST24026077
Tiopropium
Tiotropium
Tiotropium (Bromide)
Tiotropium bromide [USAN:INN:BAN]
Tiotropium Bromide(Spiriva, BA 679BR)
Tiova
Tox21_112598
UNII-XX112XZP0J
W-5156
XX112XZP0J
Paragraph IV (Patent) Challenges for TIOTROPIUM BROMIDE
Tradename Dosage Ingredient NDA Submissiondate
SPIRIVA POWDER;INHALATION tiotropium bromide 021395 2018-05-11

US Patents and Regulatory Information for tiotropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 tiotropium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015   Start Trial   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015   Start Trial   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015   Start Trial   Start Trial
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tiotropium bromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 SPC/GB02/036 United Kingdom   Start Trial PRODUCT NAME: SCOPINE DI-(2-THIENYL)GLYCOLATE IN THE FORM OF THE QUATERNARY SALTS - ESPECIALLY SALTS OF TIOTROPIUM - PREFERRED TIOTROPIUMBROMIDE AND TIOTROPIUMBROMIDE MONOHYDRATE; REGISTERED: NL RVG26191 20011009; UK PL14598/0062 20020514
0418716 300084 Netherlands   Start Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 C300084 Netherlands   Start Trial PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 05C0039 France   Start Trial PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Harvard Business School
Mallinckrodt
Moodys
Merck

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