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Last Updated: August 13, 2020

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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 nineteen branded drugs marketed by Us Army, Akorn, Alcon Labs Inc, Hospira, Fresenius Kabi Usa, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, Hikma, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms Inc, Ascot, Bayshore Pharms Llc, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading Pharma Llc, Lederle, Mayne Pharma Inc, Mylan, Par Pharm, Parke Davis, Pvt Form, R And S Pharma, Roxane, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Vangard, Superpharm, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for ATROPINE SULFATE

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SponsorPhase
Ain Shams UniversityN/A
Biomedical Advanced Research and Development AuthorityPhase 1
Rho, Inc.Phase 1

See all ATROPINE SULFATE clinical trials

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
Wyeth Ayerst MEPERIDINE AND ATROPINE SULFATE atropine sulfate; meperidine hydrochloride INJECTABLE;INJECTION 085121-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085506-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Institutional ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019678-001 Nov 6, 1991 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086727-001 Approved Prior to Jan 1, 1982 AA RX 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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Moodys

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