Atropine - Generic Drug Details
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What are the generic sources for atropine and what is the scope of freedom to operate?
Atropine
is the generic ingredient in twenty-two branded drugs marketed by MMT, Abbvie, Rafa Labs Ltd, Us Army, Akorn, Amneal, Apotex Inc, Bausch And Lomb Inc, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, Hikma, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mayne Pharma Inc, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, Halsey, Mylan Institutional, and Wyeth Ayerst, and is included in sixty-seven NDAs. Additional information is available in the individual branded drug profile pages.There are twenty-three drug master file entries for atropine. One supplier is listed for this compound.
Summary for atropine
US Patents: | 0 |
Tradenames: | 22 |
Applicants: | 54 |
NDAs: | 67 |
Drug Master File Entries: | 23 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 56 |
Clinical Trials: | 389 |
Patent Applications: | 5,355 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for atropine |
What excipients (inactive ingredients) are in atropine? | atropine excipients list |
DailyMed Link: | atropine at DailyMed |
Recent Clinical Trials for atropine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
National Institute of Cardiovascular Diseases, Karachi | Phase 4 |
Erasmus Medical Center | Phase 3 |
Pharmacology for atropine
Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for atropine
US Patents and Regulatory Information for atropine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Am Regent | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 216120-001 | May 26, 2022 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mmt | DUODOTE | atropine; pralidoxime chloride | INJECTABLE;INTRAMUSCULAR | 021983-001 | Sep 28, 2006 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Accord Hlthcare | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | 213424-001 | Mar 19, 2021 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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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