ATROPINE SULFATE - Generic Drug Details
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What are the generic drug sources for atropine sulfate and what is the scope of patent protection?
Atropine sulfate
is the generic ingredient in seventeen branded drugs marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, Hikma, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, 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, Halsey, Mylan Institutional, Abbvie, and Wyeth Ayerst, and is included in sixty-four NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for atropine sulfate. Twenty-two suppliers are listed for this compound.
Summary for ATROPINE SULFATE
| US Patents: | 0 |
| Tradenames: | 17 |
| Applicants: | 54 |
| NDAs: | 64 |
| Drug Master File Entries: | 12 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 50 |
| Patent Applications: | 6,407 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ATROPINE SULFATE? | ATROPINE SULFATE excipients list |
| DailyMed Link: | ATROPINE SULFATE at DailyMed |
Recent Clinical Trials for ATROPINE SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited | Phase 1 |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
| Shandong University of Traditional Chinese Medicine | N/A |
Pharmacology for ATROPINE SULFATE
| Drug Class | Anticholinergic Cholinergic Muscarinic Antagonist |
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE SULFATE
US Patents and Regulatory Information for ATROPINE SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| R And S Pharma | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085035-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Amneal | ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 214752-001 | Jul 14, 2022 | AT1 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Medpointe Pharm Hlc | COLONAID | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085737-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Gd Searle Llc | LOMOTIL | atropine sulfate; diphenoxylate hydrochloride | SOLUTION;ORAL | 012699-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | atropine sulfate; diphenoxylate hydrochloride | TABLET;ORAL | 085876-001 | 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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