LEVALBUTEROL HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for levalbuterol hydrochloride and what is the scope of freedom to operate?
Levalbuterol hydrochloride
is the generic ingredient in two branded drugs marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Hikma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for levalbuterol hydrochloride. Eleven suppliers are listed for this compound.
Summary for LEVALBUTEROL HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 10 |
NDAs: | 11 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 50 |
Clinical Trials: | 33 |
Patent Applications: | 1,504 |
What excipients (inactive ingredients) are in LEVALBUTEROL HYDROCHLORIDE? | LEVALBUTEROL HYDROCHLORIDE excipients list |
DailyMed Link: | LEVALBUTEROL HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LEVALBUTEROL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Aleppo | Phase 4 |
Children's Hospital Los Angeles | N/A |
University of Illinois at Chicago | N/A |
Pharmacology for LEVALBUTEROL HYDROCHLORIDE
Drug Class | beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for LEVALBUTEROL HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XOPENEX | Inhalation Solution | levalbuterol hydrochloride | 0.25% | 020837 | 1 | 2006-05-23 |
XOPENEX | Inhalation Solution | levalbuterol hydrochloride | 0.0103%, 0.021% and 0.042% | 020837 | 1 | 2005-06-20 |
US Patents and Regulatory Information for LEVALBUTEROL HYDROCHLORIDE
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 | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 078309-001 | Mar 20, 2009 | AN | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ritedose Corp | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 203653-003 | Mar 22, 2016 | 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 LEVALBUTEROL HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Hikma | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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