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 Hetero Labs Ltd Iii and is included in two NDAs.
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.
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Summary for DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 11 |
| Patent Applications: | 57 |
| 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
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| 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 | |||
| >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 |
