DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Drug Patent Profile
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When do Diphenoxylate Hydrochloride And Atropine Sulfate patents expire, and what generic alternatives are available?
Diphenoxylate Hydrochloride And Atropine Sulfate is a drug marketed by Hikma, 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, and Winder Labs Llc. and is included in twenty-eight NDAs.
The generic ingredient in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE is atropine sulfate; diphenoxylate hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
Summary for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
US Patents: | 0 |
Applicants: | 27 |
NDAs: | 28 |
Finished Product Suppliers / Packagers: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 7 |
Clinical Trials: | 1 |
Patent Applications: | 80 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE? | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE excipients list |
DailyMed Link: | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE at DailyMed |
Recent Clinical Trials for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Puma Biotechnology, Inc. | Phase 2 |
Napo Pharmaceuticals, Inc. | Phase 2 |
University of California, San Francisco | Phase 2 |
See all DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE clinical trials
Pharmacology for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Drug Class | Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist |
Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
US Patents and Regulatory Information for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | SOLUTION;ORAL | 087708-001 | May 3, 1982 | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pvt Form | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085766-001 | 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 |