DrugPatentWatch Database Preview
XOPENEX Drug Profile
Which 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.
Summary for XOPENEX
Recent Clinical Trials for XOPENEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henry Ford Health System | Phase 4 |
| Genesys Regional Medical Center | Phase 4 |
| Fahim Khorfan, MD | 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)-(-)-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-hydroxy-ethyl]-2-(hydroxymethyl)phenol |
| 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 |
| AC1L3WY7 |
| ACM34391043 |
| AJ-08305 |
| AKOS005552518 |
| alpha-1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol |
| AN-14841 |
| API0003155 |
| 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 |
| I14-48286 |
| J-019582 |
| Jsp006235 |
| 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)-(-)- |
| MolPort-006-830-342 |
| NCGC00015955-01 |
| NCGC00015955-02 |
| NCGC00015955-03 |
| NCGC00016736-01 |
| NCGC00024698-01 |
| NDAUXUAQIAJITI-LBPRGKRZSA-N |
| R-Albuterol |
| R-Salbutamol |
| Salbutamol;4-(2-tert-Butylamino-1-hydroxy-ethyl)-2-hydroxymethyl-phenol |
| SB19749 |
| SBI-0206903.P001 |
| SC-47248 |
| SCHEMBL4003 |
| STK618645 |
| Tocris-0634 |
| UNII-EDN2NBH5SS |
| UNII-QF8SVZ843E component NDAUXUAQIAJITI-LBPRGKRZSA-N |
| ZINC7601 |
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 | |||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | AN | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sunovion | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730-001 | Mar 11, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 | 020837-003 | Jan 30, 2002 | 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 | 020837-002 | Mar 25, 1999 | Start Trial | Start Trial |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | Start Trial | Start Trial |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for XOPENEX
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Inhalation Aerosol | 0.045 mg/actuation | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Inhalation Solution | 0.0025 | ➤ Subscribe | Start Trial |
| ➤ Subscribe | Inhalation Solution | 0.0103%, 0.021% and 0.042% | ➤ Subscribe | Start Trial |
