DEXCHLORPHENIRAMINE MALEATE - Generic Drug Details
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What are the generic drug sources for dexchlorpheniramine maleate and what is the scope of freedom to operate?
Dexchlorpheniramine maleate
is the generic ingredient in three branded drugs marketed by Pai Holdings Pharm, Schering, Capellon Pharms Llc, and Ani Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for dexchlorpheniramine maleate. Two suppliers are listed for this compound.
Summary for DEXCHLORPHENIRAMINE MALEATE
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 4 |
NDAs: | 5 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 5 |
Patent Applications: | 2,433 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in DEXCHLORPHENIRAMINE MALEATE? | DEXCHLORPHENIRAMINE MALEATE excipients list |
DailyMed Link: | DEXCHLORPHENIRAMINE MALEATE at DailyMed |
Recent Clinical Trials for DEXCHLORPHENIRAMINE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Mantecorp Industria Quimica e Farmaceutica Ltd. | Phase 3 |
US Patents and Regulatory Information for DEXCHLORPHENIRAMINE MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Schering | POLARAMINE | dexchlorpheniramine maleate | TABLET;ORAL | 086835-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ani Pharms | DEXCHLORPHENIRAMINE MALEATE | dexchlorpheniramine maleate | TABLET;ORAL | 088682-001 | Jan 17, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Schering | POLARAMINE | dexchlorpheniramine maleate | SYRUP;ORAL | 086837-001 | Jul 19, 1982 | 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 |