DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE Drug Patent Profile
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Which patents cover Diphenoxylate Hydrochloride And Atropine Sulfate, and when can generic versions of Diphenoxylate Hydrochloride And Atropine Sulfate launch?
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-one suppliers are listed for this compound. Additional details are available on the atropine sulfate; diphenoxylate hydrochloride profile page.
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Summary for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
| US Patents: | 0 |
| Applicants: | 27 |
| NDAs: | 28 |
| Finished Product Suppliers / Packagers: | 19 |
| Raw Ingredient (Bulk) Api Vendors: | 7 |
| Clinical Trials: | 1 |
| Patent Applications: | 60 |
| 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 |
|---|---|
| Napo Pharmaceuticals, Inc. | Phase 2 |
| University of California, San Francisco | Phase 2 |
| Puma Biotechnology, Inc. | 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | SOLUTION;ORAL | 087708-001 | May 3, 1982 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pvt Form | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085766-001 | 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 |
