ATROPINE SULFATE Drug Patent Profile
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When do Atropine Sulfate patents expire, and when can generic versions of Atropine Sulfate launch?
Atropine Sulfate is a drug marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, and Hikma. and is included in nineteen NDAs.
The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Atropine Sulfate
A generic version of ATROPINE SULFATE was approved as atropine sulfate by HOSPIRA on July 9th, 2001.
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Questions you can ask:
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Summary for ATROPINE SULFATE
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 19 |
| Finished Product Suppliers / Packagers: | 22 |
| Raw Ingredient (Bulk) Api Vendors: | 138 |
| Clinical Trials: | 50 |
| Patent Applications: | 4,131 |
| 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 |
| Shandong University of Traditional Chinese Medicine | N/A |
| Shanghai Eye Disease Prevention and Treatment Center | 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
ATROPINE SULFATE is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting ATROPINE SULFATE
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Us Army | ATROPINE SULFATE | atropine sulfate | AEROSOL, METERED;INHALATION | 020056-001 | Sep 19, 1990 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 021146-002 | Jul 9, 2001 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset Theraps Llc | ATROPINE SULFATE | atropine sulfate | SOLUTION;INTRAVENOUS | 215969-002 | Jul 3, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Somerset | ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 217791-001 | Apr 29, 2024 | AT2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch And Lomb Inc | ATROPINE SULFATE | atropine sulfate | SOLUTION/DROPS;OPHTHALMIC | 213581-001 | Mar 15, 2022 | RX | Yes | Yes | ⤷ 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 |
