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. One supplier is 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: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 5 |
| Patent Applications: | 2,433 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for DEXCHLORPHENIRAMINE MALEATE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pai Holdings Pharm | DEXCHLORPHENIRAMINE MALEATE | dexchlorpheniramine maleate | SYRUP;ORAL | 088251-001 | Mar 23, 1984 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | POLARAMINE | dexchlorpheniramine maleate | TABLET;ORAL | 086835-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Capellon Pharms Llc | POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520-001 | Jul 16, 2018 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ani Pharms | DEXCHLORPHENIRAMINE MALEATE | dexchlorpheniramine maleate | TABLET;ORAL | 088682-001 | Jan 17, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | POLARAMINE | dexchlorpheniramine maleate | SYRUP;ORAL | 086837-001 | Jul 19, 1982 | DISCN | 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 |
