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 |
|---|---|
| Napo Pharmaceuticals, Inc. | Phase 2 |
| University of California, San Francisco | Phase 2 |
| Puma Biotechnology, 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bayshore Pharms Llc | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 210819-001 | Nov 13, 2018 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Fosun Pharma | LONOX | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085311-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm Industries | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085506-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Strides Pharma | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 040357-001 | May 2, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Specgx Llc | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 213335-001 | Oct 6, 2020 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Inwood Labs | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085509-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Kv Pharm | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085659-001 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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