SPIRIVA Drug Patent 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 six patents protecting this drug and one Paragraph IV challenge.
This drug has forty-three patent family members in thirty countries.
The generic ingredient in SPIRIVA 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Spiriva
A generic version of SPIRIVA was approved as tiotropium bromide by LUPIN on June 20th, 2023.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for SPIRIVA?
- What are the global sales for SPIRIVA?
- What is Average Wholesale Price for SPIRIVA?
Summary for SPIRIVA
| International Patents: | 43 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 80 |
| Clinical Trials: | 110 |
| Patent Applications: | 3,917 |
| 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 |


Recent Clinical Trials for SPIRIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundacio Privada Mon Clinic Barcelona | PHASE4 |
| GlaxoSmithKline | PHASE4 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | PHASE1 |
Pharmacology for SPIRIVA
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
Paragraph IV (Patent) Challenges for SPIRIVA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SPIRIVA | Inhalation Powder Capsules | tiotropium bromide | 18 mcg | 021395 | 1 | 2018-05-11 |
US Patents and Regulatory Information for SPIRIVA
SPIRIVA is protected by one US patents.
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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPIRIVA
See the table below for patents covering SPIRIVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | E031876 | ⤷ Get Started Free | |
| Uruguay | 26959 | NUEVOS POLVOS PARA INHALACIÓN QUE CONTIENEN TIOTROPIO | ⤷ Get Started Free |
| Serbia | 50495 | POSTUPAK ZA PRIPREMANjE PREPARATA U OBLIKU PRAHA (METHOD FOR PRODUCING POWDERY FORMULATIONS) | ⤷ Get Started Free |
| Mexico | PA04009056 | BROMURO DE TIOTROPIO CRISTALINO MICRONIZADO. (MICRONIZED CRYSTALLINE TIOTROPIUM BROMIDE.) | ⤷ Get Started Free |
| Taiwan | 589313 | ⤷ Get Started Free | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SPIRIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0418716 | 05C0039 | France | ⤷ Get Started Free | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
| 0418716 | C300084 | Netherlands | ⤷ Get Started Free | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
| 0418716 | SPC/GB02/036 | United Kingdom | ⤷ Get Started Free | 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 | 0290010-8 | Sweden | ⤷ Get Started Free | 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 | 300084 | Netherlands | ⤷ Get Started Free | 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 |
Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SPIRIVA
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