IPRATROPIUM BROMIDE - Generic Drug Details
✉ Email this page to a colleague
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, Mylan Speciality Lp, Nephron, 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. Nineteen 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: | 19 |
Raw Ingredient (Bulk) Api Vendors: | 69 |
Clinical Trials: | 84 |
Patent Applications: | 7,297 |
Formulation / Manufacturing: | see details |
Drug Sales Revenues: | Drug sales revenues for IPRATROPIUM BROMIDE |
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 |
---|---|
Oman Medical Speciality Board | Phase 4 |
Hat Yai Medical Education Center | Phase 3 |
The First Affiliated Hospital of Guangzhou Medical University | N/A |
Pharmacology for IPRATROPIUM BROMIDE
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | ATROVENT | ipratropium bromide | SPRAY, METERED;NASAL | 020393-001 | Oct 20, 1995 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apotex Inc | IPRATROPIUM BROMIDE | ipratropium bromide | SPRAY, METERED;NASAL | 076155-001 | Apr 18, 2003 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ritedose Corp | IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 075693-001 | Jan 26, 2001 | AN | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sun Pharm | IPRATROPIUM BROMIDE | ipratropium bromide | SOLUTION;INHALATION | 207903-001 | Jan 3, 2017 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 IPRATROPIUM BROMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | ATROVENT | ipratropium bromide | SPRAY, METERED;NASAL | 020393-001 | Oct 20, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | ATROVENT | ipratropium bromide | AEROSOL, METERED;INHALATION | 019085-001 | Dec 29, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | ATROVENT HFA | ipratropium bromide | AEROSOL, METERED;INHALATION | 021527-001 | Nov 27, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for IPRATROPIUM BROMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5436430 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2009037085 | ⤷ Try a Trial | |
Spain | 2539285 | ⤷ Try a Trial | |
Germany | 102007045438 | Inhalier-Gerät | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.