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Benztropine mesylate - Generic Drug Details
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What are the generic sources for benztropine mesylate and what is the scope of freedom to operate?
Benztropine mesylate
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Navinta Llc, Akorn, Aspen Global Inc, Chartwell Rx, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading Pharma Llc, Oxford Pharms, Pliva, Quantum Pharmics, Upsher Smith Labs, Usl Pharma, Vintage, and Merck, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.There are seven drug master file entries for benztropine mesylate. Twenty-one suppliers are listed for this compound.
Summary for benztropine mesylate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 18 |
NDAs: | 28 |
Drug Master File Entries: | 7 |
Suppliers / Packagers: | 21 |
Bulk Api Vendors: | 95 |
Clinical Trials: | 1 |
Patent Applications: | 1,661 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for benztropine mesylate |
Drug Sales Revenues: | Drug sales revenues for benztropine mesylate |
DailyMed Link: | benztropine mesylate at DailyMed |
Recent Clinical Trials for benztropine mesylate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Boehringer Ingelheim | Phase 2 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
Pharmacology for benztropine mesylate
Drug Class | Anticholinergic Antihistamine |
Mechanism of Action | Cholinergic Antagonists Histamine Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for benztropine mesylate
US Patents and Regulatory Information for benztropine mesylate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upsher Smith Labs | BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 040103-001 | Dec 12, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Leading Pharma Llc | BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 090168-003 | Nov 28, 2012 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Navinta Llc | BENZTROPINE MESYLATE | benztropine mesylate | INJECTABLE;INJECTION | 091525-001 | Feb 5, 2013 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Upsher Smith Labs | BENZTROPINE MESYLATE | benztropine mesylate | TABLET;ORAL | 040103-002 | Dec 12, 1996 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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