Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

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Atropine sulfate; diphenoxylate hydrochloride - Generic Drug Details

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What are the generic drug sources for atropine sulfate; diphenoxylate hydrochloride and what is the scope of freedom to operate?

Atropine sulfate; diphenoxylate hydrochloride is the generic ingredient in ten branded drugs marketed by Scherer Rp, Medpointe Pharm Hlc, West-ward Pharms Int, 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, Lederle, 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, and Halsey, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine sulfate; diphenoxylate hydrochloride. Twenty-five suppliers are listed for this compound.

Summary for atropine sulfate; diphenoxylate hydrochloride
Pharmacology for atropine sulfate; diphenoxylate hydrochloride

US Patents and Regulatory Information for atropine sulfate; diphenoxylate hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith Labs DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 210571-001 Aug 31, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Medpointe Pharm Hlc COLONAID atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085737-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Halsey LOW-QUEL atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085211-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Medpointe Pharm Hlc COLONAID atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 085735-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial   Start Trial
West-ward Pharms Int DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 087708-001 May 3, 1982 RX No Yes   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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Serving leading biopharmaceutical companies globally:

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