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Generated: June 19, 2019

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SPIRIVA Drug Profile

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When do Spiriva patents expire, and what generic alternatives are available?

Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ninety-one patent family members in fifty-two countries.

The generic ingredient in SPIRIVA is tiotropium bromide. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

Drug patent expirations by year for SPIRIVA
Pharmacology for SPIRIVA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for SPIRIVA
Synonyms for SPIRIVA
(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
(1?,2?,4?,5?,7?)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide hydrate
(1a,2b,4b,5a,7b)-7-[(hydroxydi-2-thienylacety l)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide hydrate
(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
(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
(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--water (1/1)
(1beta,5beta)-3beta-[[Hydroxybis(2-thienyl)acetyl]oxy]-8,8-dimethyl-6beta,7beta-epoxy-8-azoniabicyclo[3.2.1]octane
(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(thiophen-2-yl)acetoxy)-9,9-dimethyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide hydrate
(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
(1r,2r,4s,5s,7s)-7-{[hydroxy(Dithiophen-2-Yl)acetyl]oxy}-9,9-Dimethyl-3-Oxa-9-Azoniatricyclo[3.3.1.0~2,4~]nonane
(1R,2R,4S,5S)-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
[3H]tiotropium
0EB439235F
0HK
136310-93-5
139404-48-1
186691-13-4
2759AH
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)-
3-Oxa-9-azoniatricyclo(3.3.1.02,4)nonane, 7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-, bromide, monohydrate, (1alpha,2beta,4beta,5alpha,7beta)-
3-Oxa-9-azoniatricyclo(3.3.1.02,4)nonane, 7-((hydroxydi-2-thienylacetyl)oxy)-9,9-dimethyl-, bromide, hydrate, (1alpha,2beta,4beta,5alpha,7beta)-
411207-31-3
6beta,7beta-Epoxy-3beta-hydroxy-8-methyl-1alphaH,5alphaH-tropanium bromide, di-2-thienylglycolate
7-((hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane
7-((Hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane bromide
AB01274813-01
AB01274813-02
AB01274813-03
AB01568260_01
AB1004875
AC-1300
ACT04740
ACT04741
AJ-64506
AK-72842
AK161935
AKOS015900631
AKOS015920264
AN-15059
API0006410
AX8018159
BA 679 BR
BA 679BR
BA-679-BR
BC209107
BC220523
BCP02924
BCP02925
BCP0726000293
BDBM50066861
BR-72842
C19H22BrNO4S2
C19H22NO4S2.Br.H2O
CAS-136310-93-5
CHEBI:32230
CHEBI:90959
CHEBI:90960
CHEMBL1900528
CHEMBL3189058
CHEMBL3305968
CHEMBL3545181
CS-0903
CS-2571
CT0199
DB01409
DSSTox_CID_24214
DSSTox_GSID_44214
DSSTox_RID_80122
DT1167
DTXSID2044214
DTXSID5044281
FC1259
FC1260
FT-0080433
G00011-Watson-Int
GTPL367
GTPL8592
HMS2090H20
HY-17360
HY-B0460
KB-61741
KB-61742
KB-81162
KS-1402
L64SXO195N
LERNTVKEWCAPOY-DZZGSBJMSA-N
MolPort-005-935-362
MolPort-008-266-524
MQLXPRBEAHBZTK-SEINRUQRSA-M
Name: Tiotropium bromide hydrate
NCGC00167971-01
s2547
SCHEMBL1405692
SCHEMBL155760
SCHEMBL440873
SCHEMBL4662461
SCHEMBL7607795
SCHEMBL8625
Spiriva Handihaler
Spiriva Respimat
ST24026077
ST24050179
SW219041-1
Tiopropium
Tiotropium
Tiotropium (bromide hydrate)
Tiotropium (Bromide)
TIOTROPIUM BROMIDE
Tiotropium bromide [USAN:INN:BAN]
Tiotropium bromide hydrate
Tiotropium Bromide hydrate (BA679BR)
Tiotropium bromide monohydrate
Tiotropium bromide monohydrate, >=98% (HPLC)
Tiotropium bromide monohydrate, European Pharmacopoeia (EP) Reference Standard
Tiotropium Bromide Monohydrate, Pharmaceutical Secondary Standard; Certified Reference Material
Tiotropium bromide xhydrate
Tiotropium Bromide(Spiriva, BA 679BR)
Tiotropium for system suitability 1, European Pharmacopoeia (EP) Reference Standard
Tiova
Tox21_112598
UNII-0EB439235F
UNII-L64SXO195N
UNII-XX112XZP0J
W-5156
XX112XZP0J
ZINC100008319
ZINC13900863
ZINC145199092

US Patents and Regulatory Information for SPIRIVA

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 021936-001 Sep 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Boehringer Ingelheim SPIRIVA RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-002 Sep 15, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for SPIRIVA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Boehringer Ingelheim SPIRIVA tiotropium bromide POWDER;INHALATION 021395-001 Jan 30, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for SPIRIVA
Drugname Dosage Strength RLD Date
➤ Subscribe Inhalation Powder Capsules 18 mcg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for SPIRIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0418716 0290010-8 Sweden ➤ Sign Up PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
0418716 SPC/GB02/036 United Kingdom ➤ Sign Up 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 C300084 Netherlands ➤ Sign Up PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 300084 Netherlands ➤ Sign Up PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716 05C0039 France ➤ Sign Up 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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