Tiotropium bromide - Generic Drug Details
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What are the generic sources for tiotropium bromide and what is the scope of freedom to operate?
Tiotropium bromide
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Lupin, and is included in three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Tiotropium bromide has one hundred and seventy-eight patent family members in thirty-seven countries.
There are seven drug master file entries for tiotropium bromide. Three suppliers are listed for this compound.
Summary for tiotropium bromide
International Patents: | 178 |
US Patents: | 9 |
Tradenames: | 3 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 103 |
Clinical Trials: | 115 |
Patent Applications: | 5,499 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for tiotropium bromide |
What excipients (inactive ingredients) are in tiotropium bromide? | tiotropium bromide excipients list |
DailyMed Link: | tiotropium bromide at DailyMed |
Recent Clinical Trials for tiotropium bromide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Guangzhou Institute of Respiratory Disease | N/A |
Boehringer Ingelheim | N/A |
University of Saskatchewan | Phase 4 |
Pharmacology for tiotropium bromide
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for tiotropium bromide
Anatomical Therapeutic Chemical (ATC) Classes for tiotropium bromide
Paragraph IV (Patent) Challenges for TIOTROPIUM BROMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SPIRIVA RESPIMAT | Inhalation Aerosol | tiotropium bromide | 2.5 mcg per actuation | 021936 | 1 | 2023-03-07 |
SPIRIVA | Inhalation Powder Capsules | tiotropium bromide | 18 mcg | 021395 | 1 | 2018-05-11 |
US Patents and Regulatory Information for tiotropium bromide
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 | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-002 | Sep 15, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Boehringer Ingelheim | SPIRIVA | tiotropium bromide | POWDER;INHALATION | 021395-001 | Jan 30, 2004 | AB | 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 tiotropium bromide
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 | 021936-001 | Sep 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | SPIRIVA RESPIMAT | tiotropium bromide | SPRAY, METERED;INHALATION | 021936-001 | Sep 24, 2014 | ⤷ 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 | 021936-001 | Sep 24, 2014 | ⤷ 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 |
International Patents for tiotropium bromide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Malaysia | 153151 | INHALATION KIT COMPRISING INHALABLE POWDER OF TIOTROPIUM | ⤷ Sign Up |
Japan | 2012157733 | ATOMIZER AND METHOD OF ATOMIZING FLUID | ⤷ Sign Up |
European Patent Office | 2254634 | INHALATEUR ET FILTRE POUR UN INHALATEUR (INHALER AND SIEVE FOR AN INHALER) | ⤷ Sign Up |
Japan | 5668024 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2004053362 | ⤷ Sign Up | |
Serbia | 50551 | SREDSTVO ZA DRŽANJE FLUIDNE KOMPONENTE (DEVICE FOR HOLDING A FLUIDIC COMPONENT) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tiotropium bromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0418716 | 05C0039 | France | ⤷ Sign Up | PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009 |
0418716 | C300084 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009 |
0418716 | 0290010-8 | 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 |
0418716 | SPC/GB02/036 | United Kingdom | ⤷ Sign Up | 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 | 300084 | Netherlands | ⤷ Sign Up | 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 |
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