XOPENEX HFA Drug Patent Profile
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Which patents cover Xopenex Hfa, and when can generic versions of Xopenex Hfa launch?
Xopenex Hfa is a drug marketed by Lupin and is included in one NDA.
The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
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Summary for XOPENEX HFA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 6 |
| Patent Applications: | 50 |
| Drug Prices: | Drug price information for XOPENEX HFA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XOPENEX HFA |
| What excipients (inactive ingredients) are in XOPENEX HFA? | XOPENEX HFA excipients list |
| DailyMed Link: | XOPENEX HFA at DailyMed |
Recent Clinical Trials for XOPENEX HFA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Ascension Genesys Hospital | Phase 4 |
| Fahim Khorfan, MD | Phase 4 |
Pharmacology for XOPENEX HFA
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Paragraph IV (Patent) Challenges for XOPENEX HFA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XOPENEX HFA | Inhalation Aerosol | levalbuterol tartrate | 0.045 mg/actuation | 021730 | 1 | 2012-02-27 |
US Patents and Regulatory Information for XOPENEX HFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | 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 |
Expired US Patents for XOPENEX HFA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XOPENEX HFA
See the table below for patents covering XOPENEX HFA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 4595689 | ⤷ Start Trial | |
| Australia | 631155 | ⤷ Start Trial | |
| Canada | 2004598 | AEROSOLS MEDICINAUX (MEDICINAL AEROSOL FORMULATIONS) | ⤷ Start Trial |
| Canada | 2303601 | ⤷ Start Trial | |
| Germany | 68904300 | ⤷ Start Trial | |
| Germany | 68924540 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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