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XOPENEX Drug Profile
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» See Plans and PricingWhich patents cover Xopenex, and what generic alternatives are available?
Xopenex is a drug marketed by Oak Pharms Inc and Sunovion and is included in two NDAs. There are three patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in XOPENEX is levalbuterol tartrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
US ANDA Litigation and Generic Entry Outlook for Xopenex
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for XOPENEX
Recent Clinical Trials for XOPENEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Fahim Khorfan, MD | Phase 4 |
| Genesys Regional Medical Center | Phase 4 |
Recent Litigation for XOPENEX
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Sepracor Inc. v. Barr Laboratories Inc. | 2007-07-12 |
| Sepracor Inc. v. Dey LP | 2006-09-27 |
| Sunovion Pharmaceuticals v. Dey Pharma | 2006-02-22 |
Pharmacology for XOPENEX
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for XOPENEX
| (-)-Albuterol |
| (-)-alpha(sup 1)-(((1,1-Dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzenedimethanol |
| (-)-Salbutamol |
| (R) - Albuterol |
| (r)-(-)-salbutamol |
| (R)-4-(2-(tert-butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol |
| (R)-albuterol |
| (R)-alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol |
| (R)-alpha1-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol |
| (R)-salbutamol |
| 1,3-Benzenedimethanol, alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (-)- |
| 1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, (alpha1R)- |
| 34391-04-3 |
| 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol |
| 4-[(1R)-2-(tert-butylamino)-1-oxidanyl-ethyl]-2-(hydroxymethyl)phenol |
| 68H |
| A822211 |
| AC-1542 |
| ACM34391043 |
| AKOS005552518 |
| Albuterol (r)-form |
| alpha-1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol |
| API0003155 |
| ASF-1096 |
| BBL010806 |
| BCP28425 |
| BDBM50361247 |
| BIDD:GT0508 |
| BRD-K34469523-003-01-4 |
| C-23839 |
| C11770 |
| CAS-18559-94-9 |
| CHEBI:8746 |
| CHEMBL1002 |
| D08124 |
| DB13139 |
| DTXSID80187964 |
| EDN2NBH5SS |
| F2173-0564 |
| FT-0770967 |
| GTPL9816 |
| J-019582 |
| Levalbuterol |
| Levolin |
| Levosalbutamol |
| Levosalbutamol (INN) |
| Levosalbutamol (Levalbuterol) |
| Levosalbutamol [INN] |
| Lopac-S-5013 |
| Lopac-S-8260 |
| LS-187796 |
| LS-29860 |
| m-Xylene-alpha,alpha'-diol, alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-, (R)-(-)- |
| NCGC00015955-01 |
| NCGC00015955-02 |
| NCGC00015955-03 |
| NCGC00016736-01 |
| NCGC00024698-01 |
| NDAUXUAQIAJITI-LBPRGKRZSA-N |
| Q408709 |
| R-Albuterol |
| R-Salbutamol |
| SB19749 |
| SBI-0206903.P001 |
| SC-47248 |
| SCHEMBL4003 |
| STK618645 |
| Tocris-0634 |
| UNII-EDN2NBH5SS |
| UNII-QF8SVZ843E component NDAUXUAQIAJITI-LBPRGKRZSA-N |
| ZINC7601 |
Paragraph IV (Patent) Challenges for XOPENEX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XOPENEX | SOLUTION;INHALATION | levalbuterol hydrochloride | 020837 | 2006-05-23 |
| XOPENEX | SOLUTION;INHALATION | levalbuterol hydrochloride | 020837 | 2005-06-20 |
US Patents and Regulatory Information for XOPENEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | AN | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | AN | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | 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 |
Expired US Patents for XOPENEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | Start Trial | Start Trial |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | Start Trial | Start Trial |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for XOPENEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9109596 | Start Trial |
| Hong Kong | 161896 | Start Trial |
| Brazil | 9205466 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
