IPRATROPIUM BROMIDE - Generic Drug Details
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What are the generic sources for ipratropium bromide and what is the scope of freedom to operate?
Ipratropium bromide
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-eight NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Ipratropium bromide has ten patent family members in nine countries.
There are eight drug master file entries for ipratropium bromide. Eighteen suppliers are listed for this compound.
Summary for IPRATROPIUM BROMIDE
International Patents: | 10 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 17 |
NDAs: | 28 |
Drug Master File Entries: | 8 |
Finished Product Suppliers / Packagers: | 18 |
Raw Ingredient (Bulk) Api Vendors: | 69 |
Clinical Trials: | 85 |
Patent Applications: | 7,141 |
What excipients (inactive ingredients) are in IPRATROPIUM BROMIDE? | IPRATROPIUM BROMIDE excipients list |
DailyMed Link: | IPRATROPIUM BROMIDE at DailyMed |
Recent Clinical Trials for IPRATROPIUM BROMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Wake Forest University Health Sciences | Phase 2 |
University of Utah | Phase 2 |
Oregon Health and Science University | Phase 2 |
Pharmacology for IPRATROPIUM BROMIDE
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for IPRATROPIUM BROMIDE
Anatomical Therapeutic Chemical (ATC) Classes for IPRATROPIUM BROMIDE
Paragraph IV (Patent) Challenges for IPRATROPIUM BROMIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ATROVENT HFA | Inhalation Aerosol | ipratropium bromide | 0.21 mg/Inh | 021527 | 1 | 2023-12-29 |
US Patents and Regulatory Information for IPRATROPIUM BROMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Pharms Usa | IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075313-001 | Feb 7, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Zennova | IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075507-001 | Jan 19, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aurobindo Pharma Usa | IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 075552-001 | Mar 31, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Nephron | IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075562-001 | Sep 27, 2001 | AN | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 IPRATROPIUM BROMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | ATROVENT | ipratropium bromide | AEROSOL, METERED;INHALATION | 019085-001 | Dec 29, 1986 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | ATROVENT | ipratropium bromide | SPRAY, METERED;NASAL | 020393-001 | Oct 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | ATROVENT | ipratropium bromide | SPRAY, METERED;NASAL | 020394-001 | Oct 20, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IPRATROPIUM BROMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E025069 | ⤷ Sign Up | |
Japan | 5436430 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2009037085 | ⤷ Sign Up | |
Spain | 2539285 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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