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
US Patents: | 0 |
Tradenames: | 10 |
Applicants: | 36 |
NDAs: | 39 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 5 |
Clinical Trials: | 1 |
Patent Applications: | 122 |
DailyMed Link: | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 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
Drug Class | Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes 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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