BROMPHENIRAMINE MALEATE - Generic Drug Details
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What are the generic drug sources for brompheniramine maleate and what is the scope of freedom to operate?
Brompheniramine maleate
is the generic ingredient in eight branded drugs marketed by Alpharma Us Pharms, Kv Pharm, Pharm Assoc, Usl Pharma, Watson Labs, Wyeth Ayerst, Wyeth Cons, Barr, Ivax Sub Teva Pharms, Newtron Pharms, Nexgen Pharma Inc, Par Pharm, Pioneer Pharms, Upsher Smith Labs, Vitarine, Wockhardt, Wockhardt Bio Ag, Acella, Alkem Labs Ltd, Bionpharma, Chartwell Molecular, Dr Reddys Labs Sa, Padagis Us, Rhodes Pharms, Taro, Wes Pharma Inc, Robins Ah, and Alza, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for brompheniramine maleate.
Summary for BROMPHENIRAMINE MALEATE
| US Patents: | 0 |
| Tradenames: | 8 |
| Applicants: | 28 |
| NDAs: | 33 |
| Drug Master File Entries: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 72 |
| Clinical Trials: | 4 |
| Patent Applications: | 1,997 |
| DailyMed Link: | BROMPHENIRAMINE MALEATE at DailyMed |
Recent Clinical Trials for BROMPHENIRAMINE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ache Laboratorios Farmaceuticos S.A. | Phase 3 |
| Wyeth is now a wholly owned subsidiary of Pfizer | Phase 1 |
Medical Subject Heading (MeSH) Categories for BROMPHENIRAMINE MALEATE
Anatomical Therapeutic Chemical (ATC) Classes for BROMPHENIRAMINE MALEATE
US Patents and Regulatory Information for BROMPHENIRAMINE MALEATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ivax Sub Teva Pharms | BROMPHENIRAMINE MALEATE | brompheniramine maleate | TABLET;ORAL | 084351-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Padagis Us | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 205292-001 | Jul 15, 2014 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Sa | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 207676-001 | Dec 4, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Molecular | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 213125-001 | Apr 17, 2020 | AA | 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 |
