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COMBIVENT Drug Profile
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When do Combivent patents expire, and what generic alternatives are available?
Combivent is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are eight patents protecting this drug.
The generic ingredient in COMBIVENT is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
US ANDA Litigation and Generic Entry Outlook for Combivent
Annual sales in 2018 were $1.0bn, indicating a strong incentive for generic entry.
There is one tentative approval for the generic drug (albuterol sulfate; ipratropium bromide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for COMBIVENT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 21 |
| Patent Applications: | 4,035 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COMBIVENT |
| Drug Sales Revenues: | Drug sales revenues for COMBIVENT |
| DailyMed Link: | COMBIVENT at DailyMed |
Recent Clinical Trials for COMBIVENT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ontario Lung Association | Phase 4 |
| University Medical Center Groningen | Phase 4 |
| Wouter van Geffen | Phase 4 |
US Patents and Regulatory Information for COMBIVENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | COMBIVENT | albuterol sulfate; ipratropium bromide | AEROSOL, METERED;INHALATION | 020291-001 | Oct 24, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747-001 | Oct 7, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 COMBIVENT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | COMBIVENT | albuterol sulfate; ipratropium bromide | AEROSOL, METERED;INHALATION | 020291-001 | Oct 24, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
