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SPIRIVA Drug Profile
» See Plans and Pricing
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 seventeen patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred 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.
DrugPatentWatch® Generic Entry Outlook for Spiriva
Spiriva was eligible for patent challenges on January 30, 2008.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 11, 2022. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $3.9bn, 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: | 300 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 95 |
| Clinical Trials: | 98 |
| Patent Applications: | 4,241 |
| 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 |
| What excipients (inactive ingredients) are in SPIRIVA? | SPIRIVA excipients list |
| DailyMed Link: | SPIRIVA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for SPIRIVA
Generic Entry Date for SPIRIVA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for SPIRIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nephron Pharmaceuticals Corporation | Phase 2 |
| Rho, Inc. | Phase 2 |
| Orion Corporation, Orion Pharma | N/A |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
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 | 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 | ||||
| >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 |
|---|---|---|
| South Korea | 100823860 | Start Trial |
| Saudi Arabia | 1524 | Start Trial |
| Malaysia | 153151 | Start Trial |
| Portugal | 1487832 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 300084 | Netherlands | Start Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 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 | C300084 | Netherlands | Start Trial | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
