DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Drug Patent Profile
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Which patents cover Dextromethorphan Hydrobromide And Quinidine Sulfate, and when can generic versions of Dextromethorphan Hydrobromide And Quinidine Sulfate launch?
Dextromethorphan Hydrobromide And Quinidine Sulfate is a drug marketed by Actavis Elizabeth and is included in one NDA.
The generic ingredient in DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE is dextromethorphan hydrobromide; quinidine sulfate. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dextromethorphan hydrobromide; quinidine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dextromethorphan Hydrobromide And Quinidine Sulfate
A generic version of DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE was approved as dextromethorphan hydrobromide; quinidine sulfate by ACTAVIS ELIZABETH on October 10th, 2017.
Summary for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 11 |
| Patent Applications: | 72 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE at DailyMed |
Recent Clinical Trials for DEXTROMETHORPHAN HYDROBROMIDE AND 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 AND QUINIDINE SULFATE clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
US Patents and Regulatory Information for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Elizabeth | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 202934-001 | Oct 10, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for DEXTROMETHORPHAN HYDROBROMIDE AND 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 |
