VASOPRESSIN - Generic Drug Details
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What are the generic sources for vasopressin and what is the scope of freedom to operate?
Vasopressin
is the generic ingredient in four branded drugs marketed by Am Regent, Amneal, Amphastar Pharms Inc, Cipla, Dr Reddys, Eagle Pharms, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Baxter Hlthcare Corp, Long Grove Pharms, Endo Operations, and Parke Davis, and is included in thirteen NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for vasopressin. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for VASOPRESSIN
| US Patents: | 14 |
| Tradenames: | 4 |
| Applicants: | 13 |
| NDAs: | 13 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 15 |
| Clinical Trials: | 251 |
| Drug Prices: | Drug price trends for VASOPRESSIN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASOPRESSIN |
| What excipients (inactive ingredients) are in VASOPRESSIN? | VASOPRESSIN excipients list |
| DailyMed Link: | VASOPRESSIN at DailyMed |
Recent Clinical Trials for VASOPRESSIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Basel, Switzerland | Phase 2 |
| Kingman Regional Medical Center | Phase 4 |
| University of Alberta | Phase 1 |
Generic filers with tentative approvals for VASOPRESSIN
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for VASOPRESSIN
| Physiological Effect | Decreased Diuresis Vasoconstriction |
Paragraph IV (Patent) Challenges for VASOPRESSIN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VASOSTRICT | Injection | vasopressin | 20 units/100 mL | 204485 | 1 | 2022-12-20 |
| VASOSTRICT | Injection | vasopressin | 40 units/100 mL and 60 units/100 mL | 204485 | 1 | 2022-02-28 |
| VASOSTRICT | Injection | vasopressin | 200 units/10 mL | 204485 | 1 | 2018-06-29 |
| VASOSTRICT | Injection | vasopressin | 20 units/mL, 1 mL | 204485 | 1 | 2018-03-23 |
US Patents and Regulatory Information for VASOPRESSIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | VASOPRESSIN IN SODIUM CHLORIDE 0.9% | vasopressin | SOLUTION;INTRAVENOUS | 217569-001 | Sep 29, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-004 | Apr 15, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-006 | Apr 12, 2023 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-004 | Apr 15, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-003 | Apr 15, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-005 | Apr 21, 2021 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Endo Operations | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-005 | Apr 21, 2021 | AP | 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 |
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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.
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