NEOSTIGMINE METHYLSULFATE Drug Patent Profile
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When do Neostigmine Methylsulfate patents expire, and what generic alternatives are available?
Neostigmine Methylsulfate is a drug marketed by Adaptis, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Sagent Pharms Inc, and Umedica. and is included in eighteen NDAs.
The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Neostigmine Methylsulfate
A generic version of NEOSTIGMINE METHYLSULFATE was approved as neostigmine methylsulfate by FRESENIUS KABI USA on January 8th, 2015.
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Summary for NEOSTIGMINE METHYLSULFATE
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 18 |
| Finished Product Suppliers / Packagers: | 23 |
| Raw Ingredient (Bulk) Api Vendors: | 104 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,171 |
| Drug Prices: | Drug price information for NEOSTIGMINE METHYLSULFATE |
| What excipients (inactive ingredients) are in NEOSTIGMINE METHYLSULFATE? | NEOSTIGMINE METHYLSULFATE excipients list |
| DailyMed Link: | NEOSTIGMINE METHYLSULFATE at DailyMed |
Recent Clinical Trials for NEOSTIGMINE METHYLSULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Seoul National University Hospital | N/A |
| Alexandria University | Phase 4 |
| Kasr El Aini Hospital | Phase 4 |
Pharmacology for NEOSTIGMINE METHYLSULFATE
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for NEOSTIGMINE METHYLSULFATE
Anatomical Therapeutic Chemical (ATC) Classes for NEOSTIGMINE METHYLSULFATE
US Patents and Regulatory Information for NEOSTIGMINE METHYLSULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sagent Pharms Inc | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 216542-001 | Feb 17, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 207042-001 | Dec 28, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sagent Pharms Inc | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 216542-002 | Feb 17, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 207042-002 | Dec 28, 2015 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Adaptis | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 210652-001 | Oct 1, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | NEOSTIGMINE METHYLSULFATE | neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 208405-001 | Apr 26, 2017 | AP | RX | 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 |
