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DUONEB Drug Profile
» See Plans and Pricing
Which patents cover Duoneb, and when can generic versions of Duoneb launch?
Duoneb is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug.
This drug has fifteen patent family members in eight countries.
The generic ingredient in DUONEB 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 Duoneb
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 DUONEB
| International Patents: | 15 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DUONEB at DailyMed |
Recent Clinical Trials for DUONEB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospitals Cleveland Medical Center | Phase 1 |
| Shin-hwar Wu | N/A |
Paragraph IV (Patent) Challenges for DUONEB
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUONEB | SOLUTION;INHALATION | albuterol sulfate; ipratropium bromide | 020950 |
US Patents and Regulatory Information for DUONEB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950-001 | Mar 21, 2001 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for DUONEB
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2006505486 | Start Trial |
| Australia | 3297402 | Start Trial |
| Japan | 2003221335 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
