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
| US Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,067 |
| Drug Prices: | Drug price information for XOPENEX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XOPENEX |
| DailyMed Link: | XOPENEX at DailyMed |
Pharmacology for XOPENEX
| Drug Class | beta2-Adrenergic Agonist |
| Mechanism of Action | Adrenergic beta2-Agonists |
Synonyms for XOPENEX
| (-)-Salbutamol hydrochloride |
| (|A1R)-|A1-[[(1,1-Dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol Hydrochloride |
| (r)-(-)-a1-((tert-butylamino)methyl)-4-hydroxy-m-xylene-a,a'-diol hydrochloride |
| (R)-4-(2-(tert-Butylamino)-1-hydroxyethyl)-2-(hydroxymethyl)phenol hydrochloride |
| (R)-Albuterol Hydrochloride |
| (R)-alpha--[[1,1-dimethylethyl}amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride |
| (R)-alpha(sup 1)-((tert-Butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol hydrochloride |
| (R)-Salbutamol ((R)-Albuterol HCl) |
| (R)-Salbutamol hydrochloride |
| 1,3-Benzenedimethanol, alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, hydrochloride, (alpha1R)- |
| 148563-16-0 |
| 293L908 |
| 4-[(1R)-2-(tert-butylamino)-1-hydroxy-ethyl]-2-(hydroxymethyl)phenol hydrochloride |
| 4-[(1R)-2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol hydrochloride |
| 50293-90-8 |
| AC-23919 |
| AC1L3WYA |
| AC1Q3F9A |
| ACM50293908 |
| AK307325 |
| AKOS015961919 |
| alfa1-[[1,1-Dimethylethylamino]methyl]-4-hydroxy-1-(S),3-benzene dimethanol Hydrochlorid |
| AN-41529 |
| BC209011 |
| BG0555 |
| BS-1006 |
| C13H22ClNO3 |
| CCG-39986 |
| CHEMBL1201061 |
| D02281 |
| DTXSID20198296 |
| FT-0621958 |
| Levalbuterol HCl |
| Levalbuterol hydrochloride |
| Levalbuterol hydrochloride (USAN) |
| Levalbuterol hydrochloride [USAN:USP] |
| Levalbuterol hydrochloride [USAN] |
| Levalbuterol hydrochloride, >=98% (HPLC) |
| Levalbuterol hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| Levosalbutamol Hydrochloride |
| LS-175140 |
| MolPort-003-666-750 |
| NSC-759255 |
| NSC759255 |
| OWNWYCOLFIFTLK-YDALLXLXSA-N |
| Pharmakon1600-01505811 |
| R-albuterol hydrochloride |
| R-ALBUTEROLHYDROCHLORIDE |
| S105 |
| SC-47702 |
| SCHEMBL40682 |
| TL8002564 |
| UNII-P12862PDAK component OWNWYCOLFIFTLK-YDALLXLXSA-N |
| UNII-WDQ1526QJM |
| WDQ1526QJM |
| Xopenex (TN) |
| Zopenex |
| Zopenex [common misspelling of Xopenex] |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | AN | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | AN | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | AN | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | AN | RX | Yes | Yes | ➤ 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 XOPENEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-002 | Mar 25, 1999 | ➤ Sign Up | ➤ Sign Up |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-001 | Mar 25, 1999 | ➤ Sign Up | ➤ Sign Up |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-003 | Jan 30, 2002 | ➤ Sign Up | ➤ Sign Up |
| Oak Pharms Inc | XOPENEX | levalbuterol hydrochloride | SOLUTION;INHALATION | 020837-004 | Jul 18, 2003 | ➤ Sign Up | ➤ Sign Up |
| Oak Pharms Inc | 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 |
Paragraph IV (Patent) Challenges for XOPENEX
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Inhalation Aerosol | 0.045 mg/actuation | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Inhalation Solution | 0.0025 | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Inhalation Solution | 0.0103%, 0.021% and 0.042% | ➤ Subscribe | ➤ Sign Up |
