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ACCUNEB Drug Profile
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When do Accuneb patents expire, and what generic alternatives are available?
Accuneb is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has twelve patent family members in eight countries.
The generic ingredient in ACCUNEB is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Accuneb
A generic version of ACCUNEB was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5th, 1989.
Summary for ACCUNEB
| International Patents: | 12 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 60 |
| Clinical Trials: | 1 |
| Patent Applications: | 3,939 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ACCUNEB |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACCUNEB |
| DailyMed Link: | ACCUNEB at DailyMed |
Recent Clinical Trials for ACCUNEB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Florida | Phase 4 |
Paragraph IV (Patent) Challenges for ACCUNEB
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ACCUNEB | SOLUTION;INHALATION | albuterol sulfate | 020949 | 2005-10-19 |
US Patents and Regulatory Information for ACCUNEB
| 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 | ACCUNEB | albuterol sulfate | SOLUTION;INHALATION | 020949-002 | Apr 30, 2001 | AN | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Mylan Speciality Lp | ACCUNEB | albuterol sulfate | SOLUTION;INHALATION | 020949-001 | Apr 30, 2001 | AN | RX | Yes | Yes | 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 ACCUNEB
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2464660 | Start Trial |
| Japan | 2006513129 | Start Trial |
| Australia | 2002347948 | Start Trial |
| China | 1720036 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
