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Last Updated: August 8, 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, Hikma Pharms, 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

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

SponsorPhase
Ain Shams UniversityN/A
Rho, Inc.Phase 1
Biomedical Advanced Research and Development AuthorityPhase 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
Scherer Rp DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride CAPSULE;ORAL 086440-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms LOMANATE atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 085746-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Vangard LO-TROL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 088009-001 Mar 25, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
R And S Pharma DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085035-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sebela Ireland Ltd MOTOFEN atropine sulfate; difenoxin hydrochloride TABLET;ORAL 017744-002 Approved Prior to Jan 1, 1982 RX Yes Yes   Start Trial   Start Trial   Start Trial
Hospira ATROPINE SULFATE ANSYR PLASTIC SYRINGE atropine sulfate SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, ENDOTRACHEAL 021146-002 Jul 9, 2001 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Institutional ENLON-PLUS atropine sulfate; edrophonium chloride INJECTABLE;INJECTION 019677-001 Nov 6, 1991 DISCN 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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