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: | 2,119 |
Formulation / Manufacturing: | see details |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rhodes Pharms | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 202955-001 | Nov 5, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bionpharma | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 203997-001 | Sep 30, 2020 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Nexgen Pharma Inc | BROMPHENIRAMINE MALEATE | brompheniramine maleate | TABLET;ORAL | 086187-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Wyeth Ayerst | DIMETANE-TEN | brompheniramine maleate | INJECTABLE;INJECTION | 011418-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Par Pharm | BROMPHENIRAMINE MALEATE | brompheniramine maleate | TABLET;ORAL | 087009-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Alpharma Us Pharms | BROMANATE DM | brompheniramine maleate; dextromethorphan hydrobromide; pseudoephedrine hydrochloride | SYRUP;ORAL | 088722-001 | Mar 7, 1985 | DISCN | 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 |