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Last Updated: November 22, 2024

ATROPINE - Generic Drug Details


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What are the generic drug sources for atropine and what is the scope of patent protection?

Atropine is the generic ingredient in twenty-two branded drugs marketed by MMT, Abbvie, Rafa Labs Ltd, 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, and Wyeth Ayerst, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine. Two suppliers are listed for this compound.

Summary for ATROPINE
Drug Prices for ATROPINE

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Recent Clinical Trials for ATROPINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Southern California College of Optometry at Marshall B. Ketchum UniversityPhase 1
Ohio State UniversityPhase 1
Indiana UniversityPhase 1

See all ATROPINE clinical trials

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
Us Army ATNAA atropine; pralidoxime chloride INJECTABLE;INTRAMUSCULAR 021175-001 Jan 17, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019678-001 Nov 6, 1991 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mankind Pharma ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 218148-001 Jan 8, 2024 AT1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ascot DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087934-001 Jul 19, 1983 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Medpointe Pharm Hlc COLONAID atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 085735-001 Approved Prior to Jan 1, 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

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