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Last Updated: October 24, 2021

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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 Meridian Medcl Techn, Abbvie, Rafa Labs Ltd, Us Army, Akorn, Alcon Labs Inc, Accord Hlthcare, Hospira, Intl Medication Sys, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Hikma Pharms, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Eci Pharms Llc, Fosun Pharma, Heather, Hikma, Inwood Labs, Kv Pharm, Lannett, Leading Pharma Llc, Lederle, Mayne Pharma Inc, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, Halsey, Mylan Institutional, Wyeth Ayerst, and Meridian Medcl, and is included in sixty 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.

Drug Prices for atropine

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Recent Clinical Trials for atropine

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

SponsorPhase
Aya Sabry Mohamed MohamedPhase 4
University of Southern CaliforniaPhase 4
Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityN/A

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
Vangard LO-TROL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 088009-001 Mar 25, 1983 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upsher Smith Labs DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 210571-001 Aug 31, 2018 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Akorn ATROPINE SULFATE atropine sulfate SOLUTION/DROPS;OPHTHALMIC 206289-001 Jul 18, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira ATROPINE SULFATE atropine sulfate SOLUTION;INTRAVENOUS 021146-005 Aug 17, 2017 AP RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Inwood Labs DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085509-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Merck
Boehringer Ingelheim
Colorcon
AstraZeneca

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