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Last Updated: March 28, 2024

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for atropine sulfate; diphenoxylate hydrochloride and what is the scope of patent protection?

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

Twenty-two suppliers are listed for this compound.

Summary for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Recent Clinical Trials for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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

SponsorPhase
Puma Biotechnology, Inc.Phase 2
Napo Pharmaceuticals, Inc.Phase 2
University of California, San FranciscoPhase 2

See all ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE clinical trials

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 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086057-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 040357-001 May 2, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leading DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 213413-001 Feb 20, 2020 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Parke Davis DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 087131-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Medpointe Pharm Hlc COLONAID atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 085737-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lederle DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 086950-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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