LEVALBUTEROL HYDROCHLORIDE Drug Patent Profile
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Which patents cover Levalbuterol Hydrochloride, and what generic alternatives are available?
Levalbuterol Hydrochloride is a drug marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mylan Speciality Lp, Ritedose Corp, Sun Pharm, Teva Parenteral, and Teva Pharms Usa. and is included in ten NDAs.
The generic ingredient in LEVALBUTEROL HYDROCHLORIDE is levalbuterol hydrochloride. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the levalbuterol hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levalbuterol Hydrochloride
A generic version of LEVALBUTEROL HYDROCHLORIDE was approved as levalbuterol hydrochloride by IMPAX LABS INC on April 9th, 2008.
Summary for LEVALBUTEROL HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 11 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Clinical Trials: | 33 |
| Patent Applications: | 949 |
| 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 |
| National Heart, Lung, and Blood Institute (NHLBI) | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 078171-002 | Dec 13, 2013 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 207820-001 | Nov 5, 2018 | AN | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | LEVALBUTEROL HYDROCHLORIDE | levalbuterol hydrochloride | SOLUTION;INHALATION | 090297-003 | Apr 26, 2013 | 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 |
