DrugPatentWatch Database Preview
NUEDEXTA Drug Profile
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When do Nuedexta patents expire, and when can generic versions of Nuedexta launch?
This drug has sixty-four patent family members in twenty-one countries.
The generic ingredient in NUEDEXTA is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.
Summary for NUEDEXTA
| International Patents: | 64 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 8 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUEDEXTA |
| DailyMed Link: | NUEDEXTA at DailyMed |
Generic Entry Opportunity Date for NUEDEXTA
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NUEDEXTA
US Patents and Regulatory Information for NUEDEXTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | AB | 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 |
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Expired US Patents for NUEDEXTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ➤ Sign Up | ➤ Sign Up |
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ➤ Sign Up | ➤ Sign Up |
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for NUEDEXTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 20 mg/10 mg | ➤ Subscribe | ➤ Sign Up |
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International Patents for NUEDEXTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| South Korea | 20120089706 | ➤ Sign Up |
| Australia | 2003251971 | ➤ Sign Up |
| Israel | 211593 | ➤ Sign Up |
| Israel | 166166 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for NUEDEXTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013 00059 | Denmark | ➤ Sign Up | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
| 1 | Finland | ➤ Sign Up | |
| 90056-8 | Sweden | ➤ Sign Up | PRODUCT NAME: KOMBINATION AV (A) DEXTROMETORFAN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. DEXTROMETORFAN-HYDROBROMID OCH I SYNNERHET DEXTROMETORFAN- HYDROBROMID MONOHYDRAT OCH (B) KINIDIN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. KINIDINSULFAT OCH I SYNNERHET KINIDINSULFAT DIHYDRAT; REG. NO/DATE: EU/1/13/833 20130626 |
| 323 | Luxembourg | ➤ Sign Up | PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
