Dextromethorphan hydrobromide; quinidine sulfate - Generic Drug Details
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What are the generic drug sources for dextromethorphan hydrobromide; quinidine sulfate and what is the scope of freedom to operate?
Dextromethorphan hydrobromide; quinidine sulfate
is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Hetero Labs Ltd Iii, and Avanir Pharms, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Dextromethorphan hydrobromide; quinidine sulfate has seventy-five patent family members in twenty-one countries.
Two suppliers are listed for this compound.
Summary for dextromethorphan hydrobromide; quinidine sulfate
International Patents: | 75 |
US Patents: | 1 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 11 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dextromethorphan hydrobromide; quinidine sulfate |
DailyMed Link: | dextromethorphan hydrobromide; quinidine sulfate at DailyMed |
Recent Clinical Trials for dextromethorphan hydrobromide; quinidine sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Avanir Pharmaceuticals | Phase 4 |
Avanir Pharmaceuticals | Phase 2 |
Avanir Pharmaceuticals | Phase 1 |
See all dextromethorphan hydrobromide; quinidine sulfate clinical trials
Pharmacology for dextromethorphan hydrobromide; quinidine sulfate
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NUEDEXTA | Capsules | dextromethorphan hydrobromide; quinidine sulfate | 20 mg/10 mg | 021879 | 1 | 2011-03-07 |
US Patents and Regulatory Information for dextromethorphan hydrobromide; quinidine sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd Iii | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 218426-001 | Aug 28, 2024 | AB | RX | No | No | ⤷ 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 | |||
Actavis Elizabeth | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 202934-001 | Oct 10, 2017 | AB | RX | No | No | ⤷ 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 dextromethorphan hydrobromide; quinidine sulfate
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 |
EU/EMA Drug Approvals for dextromethorphan hydrobromide; quinidine sulfate
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Jenson Pharmaceutical Services Limited | Nuedexta | dextromethorphan hydrobromide, quinidine sulfate | EMEA/H/C/002560 Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults. Efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis. |
Withdrawn | no | no | no | 2013-06-24 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for dextromethorphan hydrobromide; quinidine sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovenia | 1980252 | ⤷ Sign Up | |
Poland | 374026 | Kompozycje farmaceutyczne zawierające dekstrometorfan i chinidynę do leczenia zaburzeń neurologicznych (PHARMACEUTICAL COMPOSITIONS COMPRISING DEXTROMETHORPHAN AND QUINIDINE FOR THE TREATMENT OF NEUROLOGICAL DISORDERS) | ⤷ Sign Up |
Australia | 2015203262 | Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders D2 | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for dextromethorphan hydrobromide; quinidine sulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1539166 | 451 | Finland | ⤷ Sign Up | |
1539166 | C20130030 00105 | Estonia | ⤷ Sign Up | PRODUCT NAME: DEKSTROMETORFAAN / KINIDIIN;REG NO/DATE: K(2013)4096 (LOPLIK) 26.06.2013 |
1539166 | SPC/GB13/070 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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