ATROPINE Drug Patent Profile
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When do Atropine patents expire, and what generic alternatives are available?
Atropine is a drug marketed by Abbvie, Rafa Labs Ltd, Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, and Hikma. and is included in twenty-one NDAs.
The generic ingredient in ATROPINE is atropine sulfate. 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 profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atropine
A generic version of ATROPINE was approved as atropine sulfate by HOSPIRA on July 9th, 2001.
Summary for ATROPINE
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 21 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 406 |
| Patent Applications: | 2,024 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ATROPINE |
| What excipients (inactive ingredients) are in ATROPINE? | ATROPINE excipients list |
| DailyMed Link: | ATROPINE at DailyMed |
Recent Clinical Trials for ATROPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Abant Izzet Baysal University | Phase 4 |
| Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited | Phase 1 |
| Ann & Robert H Lurie Children's Hospital of Chicago | Phase 2 |
Medical Subject Heading (MeSH) Categories for ATROPINE
Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE
US Patents and Regulatory Information for ATROPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL | 213561-001 | Dec 1, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Abbvie | ATROPINE | atropine | SOLUTION;INTRAMUSCULAR | 071295-001 | Jan 30, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Am Regent | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 216120-002 | May 26, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Intl Medication Sys | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 212461-001 | Oct 5, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amneal | ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 214752-001 | Jul 14, 2022 | AT | RX | No | Yes | ⤷ 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 |
