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Generated: December 16, 2018

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SPIRIVA Drug Profile

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Which patents cover Spiriva, and when can generic versions of Spiriva launch?

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

This drug has three hundred and thirty patent family members in fifty-nine 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.

Summary for SPIRIVA
International Patents:330
US Patents:10
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 121
Clinical Trials: 93
Patent Applications: 2,652
Drug Prices: Drug price information for SPIRIVA
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for SPIRIVA
DailyMed Link:SPIRIVA at DailyMed
Drug patent expirations by year for SPIRIVA
Pharmacology for SPIRIVA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for SPIRIVA
Bronchodilator Agents
Cholinergic Antagonists
Parasympatholytics
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|A,2|A,4|A,5|A,7|A)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatri-cyclo[3.3.1.02.4]nonane bromide; (1a,2,4,5a,7)-7-[(2-Hydroxy-2,2-di-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]n
(1a,2,4,5a,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,2A,4A,5A,7A)-7-[(Hydroxydi-2-thienylacetyl)oxy]-9,9-dimethyl-3-oxa-9-azoniatri-cyclo[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
(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
(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(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
186691-13-4
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
7-((Hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane bromide
7-{[hydroxy(dithiophen-2-yl)acetyl]oxy}-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide
AB01274813-01
AB01274813-02
AB01274813-03
AB1004875
AC-1300
ACT04740
ACT04741
AJ-64506
AK-72842
AKOS015920264
AN-15059
API0006410
AX8018159
BA 679 BR
BA 679BR
BA-679 BR
BA-679-BR
BC209107
BCP0726000293
BDBM50066861
BR-72842
C19H22BrNO4S2
CAS-136310-93-5
CHEBI:90959
CHEBI:90960
CHEMBL1900528
CHEMBL3189058
CHEMBL3305968
CS-0903
D00VAD
D0P1WA
D0Z7AB
DB01409
DSSTox_CID_24214
DSSTox_GSID_44214
DSSTox_RID_80122
DT1167
DTXSID2044214
DTXSID5044281
FC1260
GTPL367
GTPL8592
HMS2090H20
HY-17360
KB-61741
KB-81162
KS-1402
LERNTVKEWCAPOY-DZZGSBJMSA-N
MFCD00867027
MolPort-005-935-362
NCGC00167971-01
Olodaterol/tiotropium bromide
respimat
SCHEMBL440873
SCHEMBL4662461
SCHEMBL7607795
SCHEMBL8625
Spiriva (TN)
Spiriva Handihaler
Spiriva Respimat
ST24026077
Tiopropium
Tiotropium
Tiotropium (Bromide)
TIOTROPIUM BROMIDE
Tiotropium bromide [USAN:INN:BAN]
Tiotropium bromide [USAN:INN]
Tiotropium bromide monohydrate
Tiotropium Bromide(Spiriva, BA 679BR)
Tiotropiumbromide
Tiova
Tox21_112598
UNII-0EB439235F
UNII-XX112XZP0J
W-5156
XX112XZP0J
ZINC100008319
ZINC13900863
ZINC145199092

US Patents and Regulatory Information for SPIRIVA

Glossary
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 RESPIMAT tiotropium bromide SPRAY, METERED;INHALATION 021936-001 Sep 24, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0084 Netherlands ➤ Sign Up PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
C0039 France ➤ Sign Up PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
00084 Netherlands ➤ Sign Up PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
C/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
90010-8 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Citi
McKinsey
US Department of Justice
US Army
Deloitte
Daiichi Sankyo
UBS
Cipla

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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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