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Last Updated: October 7, 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-one 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
University of California, San FranciscoPhase 2
Puma Biotechnology, Inc.Phase 2
Napo Pharmaceuticals, Inc.Phase 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
Winder Labs Llc DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 211362-001 Jan 27, 2021 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Sa DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE atropine sulfate; diphenoxylate hydrochloride TABLET;ORAL 210789-001 Jun 3, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alpharma Us Pharms LOMANATE atropine sulfate; diphenoxylate hydrochloride SOLUTION;ORAL 085746-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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