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SPIRIVA RESPIMAT Drug Profile
When do Spiriva Respimat patents expire, and what generic alternatives are available?
This drug has three hundred and twenty-one patent family members in fifty-one countries.
The generic ingredient in SPIRIVA RESPIMAT is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.
Summary for SPIRIVA RESPIMAT
| International Patents: | 321 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 195 |
| Patent Applications: | 2,593 |
| Drug Prices: | see details |
| DailyMed Link: | SPIRIVA RESPIMAT at DailyMed |
Pharmacology for SPIRIVA RESPIMAT
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for SPIRIVA RESPIMAT
Synonyms for SPIRIVA RESPIMAT
| (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,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 |
| BCP0726000293 |
| BR-72842 |
| C19H22BrNO4S2 |
| CAS-136310-93-5 |
| CHEBI:90959 |
| CHEMBL3189058 |
| CS-0903 |
| D0Z7AB |
| DSSTox_CID_24214 |
| DSSTox_GSID_44214 |
| DSSTox_RID_80122 |
| DT1167 |
| DTXSID2044214 |
| FC1260 |
| HMS2090H20 |
| HY-17360 |
| KB-81162 |
| KS-1402 |
| MFCD00867027 |
| MolPort-005-935-362 |
| NCGC00167971-01 |
| Olodaterol/tiotropium bromide |
| SCHEMBL440873 |
| SCHEMBL7607795 |
| SCHEMBL8625 |
| Spiriva |
| Spiriva Handihaler |
| ST24026077 |
| Tiopropium |
| Tiotropium (Bromide) |
| TIOTROPIUM BROMIDE |
| Tiotropium bromide [USAN:INN:BAN] |
| Tiotropium bromide monohydrate |
| Tiotropium Bromide(Spiriva, BA 679BR) |
| Tiotropiumbromide |
| Tiova |
| Tox21_112598 |
| UNII-XX112XZP0J |
| W-5156 |
| XX112XZP0J |
US Patents and Regulatory Information for SPIRIVA RESPIMAT
| 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 | Y | ➤ Sign Up | |||
| 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 | 021936-002 | Sep 15, 2015 | RX | Yes | No | ➤ 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 RESPIMAT
| 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 | ➤ Sign Up | ➤ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ➤ Sign Up | ➤ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ➤ Sign Up | ➤ Sign Up |
| Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for SPIRIVA RESPIMAT
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,503,440 | Process for making a container with a pressure equalization opening and containers produced accordingly | ➤ Sign Up |
| 7,451,884 | Container provided with a pressure equalization opening | ➤ Sign Up |
| 7,645,383 | Microstructured filter | ➤ Sign Up |
| 5,610,163 | Esters of thienyl carboxylic acids and amino alcohols and their quaternization products | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for SPIRIVA RESPIMAT
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Ecuador | SP056234 | ➤ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004024340 | ➤ Sign Up |
| Croatia | P20100698 | ➤ Sign Up |
| Slovakia | 286702 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA RESPIMAT
| 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 |
| 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
