ATROPINE SULFATE - Generic Drug Details
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What are the generic drug sources for atropine sulfate and what is the scope of patent protection?
Atropine sulfate
is the generic ingredient in seventeen branded drugs marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, 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, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, 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, Norvium Bioscience, Abbvie, and Wyeth Ayerst, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for atropine sulfate. Twenty-three suppliers are listed for this compound.
Summary for ATROPINE SULFATE
US Patents: | 0 |
Tradenames: | 17 |
Applicants: | 55 |
NDAs: | 66 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 138 |
Clinical Trials: | 50 |
Patent Applications: | 6,413 |
What excipients (inactive ingredients) are in ATROPINE SULFATE? | ATROPINE SULFATE excipients list |
DailyMed Link: | ATROPINE SULFATE at DailyMed |
Recent Clinical Trials for ATROPINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited | Phase 1 |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
Shandong University of Traditional Chinese Medicine | N/A |
Pharmacology for ATROPINE SULFATE
Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE SULFATE
US Patents and Regulatory Information for ATROPINE SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Md Pharm | DI-ATRO | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085266-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Norvium Bioscience | ENLON-PLUS | atropine sulfate; edrophonium chloride | INJECTABLE;INJECTION | 019677-001 | Nov 6, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Strides Pharma | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 040357-001 | May 2, 2000 | 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 |
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