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NUEDEXTA Drug Profile
» See Plans and Pricing
When do Nuedexta patents expire, and when can generic versions of Nuedexta launch?
Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-two 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.
US ANDA Litigation and Generic Entry Outlook for Nuedexta
There have been eight 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 NUEDEXTA
| International Patents: | 72 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 10 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NUEDEXTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUEDEXTA |
| DailyMed Link: | NUEDEXTA at DailyMed |
Paragraph IV (Patent) Challenges for NUEDEXTA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| NUEDEXTA | CAPSULE;ORAL | dextromethorphan hydrobromide; quinidine sulfate | 021879 | 2011-03-07 |
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 | Start Trial | Start Trial | Start Trial | |||
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | AB | 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 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 | Start Trial | Start Trial |
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | Start Trial | Start Trial |
| Avanir Pharms | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NUEDEXTA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2008201775 | Start Trial |
| European Patent Office | 3459547 | Start Trial |
| South Korea | 20130043217 | Start Trial |
| European Patent Office | 3281630 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for NUEDEXTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1539166 | 2013C/064 | Belgium | Start Trial | PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626 |
| 1539166 | C300626 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
| 1539166 | 132013902215214 | Italy | Start Trial | PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626 |
| 1539166 | C20130030 00105 | Estonia | Start Trial | PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
