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SPIRIVA Drug Profile
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-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: | 2,691 |
| 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 |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic 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|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
| 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 | |||
| 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 | ➤ 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 |
Paragraph IV (Patent) Challenges for SPIRIVA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Inhalation Powder Capsules | 18 mcg | ➤ Subscribe | ➤ Sign Up |
International Patents for SPIRIVA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Saudi Arabia | 1628 | ➤ Sign Up |
| Costa Rica | 6937 | ➤ Sign Up |
| Croatia | P20020437 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
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 |
| 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 |
| 00084 | Netherlands | ➤ Sign Up | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
