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SPIRIVA Drug Profile
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See Plans and PricingWhen 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-four 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.
US ANDA Litigation and Generic Entry Outlook for Spiriva
Spiriva was eligible for patent challenges on January 30, 2008.
Annual sales in 2017 were $4.2bn, indicating a strong incentive for generic entry (peak sales were $4.4bn in 2013).
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SPIRIVA
| International Patents: | 294 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 130 |
| Clinical Trials: | 97 |
| Patent Applications: | 2,868 |
| Drug Prices: | Drug price information for SPIRIVA |
| Drug Sales Revenues: | Drug sales revenues for SPIRIVA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPIRIVA |
| DailyMed Link: | SPIRIVA at DailyMed |
Recent Clinical Trials for SPIRIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Orion Corporation, Orion Pharma | N/A |
| Shanghai Zhongshan Hospital | N/A |
| Guangzhou Institute of Respiratory Disease | N/A |
Recent Litigation for SPIRIVA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. LUPIN ATLANTIS HOLDINGS SA | 2018-11-30 |
| BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. v. LUPIN ATLANTIS HOLDINGS SA | 2018-08-10 |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
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 |
Paragraph IV (Patent) Challenges for SPIRIVA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SPIRIVA | POWDER;INHALATION | tiotropium bromide | 021395 | 2018-05-11 |
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 | 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 | 021936-001 | Sep 24, 2014 | RX | Yes | Yes | 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 | Y | Start Trial | |||
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | 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 | 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 | ||||
| >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 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 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | Start Trial | Start Trial |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPIRIVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Peru | 20020424 | Start Trial |
| Hong Kong | 1060567 | Start Trial |
| Montenegro | P46708 | Start Trial |
| Ukraine | 80123 | Start Trial |
| South Africa | 200303149 | Start Trial |
| Argentina | 034166 | Start Trial |
| Uruguay | 27751 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 0290010-8 | Sweden | Start Trial | 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 | 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 | 05C0039 | France | Start Trial | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
