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VASOSTRICT Drug Profile
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When do Vasostrict patents expire, and what generic alternatives are available?
Vasostrict is a drug marketed by Par Sterile Products and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in VASOSTRICT is vasopressin. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
US ANDA Litigation and Generic Entry Outlook for Vasostrict
A generic version of VASOSTRICT was approved as vasopressin by AM REGENT on August 3rd, 2020.
Summary for VASOSTRICT
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 2 |
| Patent Applications: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VASOSTRICT |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASOSTRICT |
| DailyMed Link: | VASOSTRICT at DailyMed |
Generic Entry Opportunity Date for VASOSTRICT
Generic Entry Date for VASOSTRICT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VASOSTRICT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Endo Pharmaceuticals | Phase 1 |
| Advocate Health Care | N/A |
Paragraph IV (Patent) Challenges for VASOSTRICT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VASOSTRICT | SOLUTION;INTRAVENOUS | vasopressin | 204485 | 2018-06-29 |
| VASOSTRICT | SOLUTION;INTRAVENOUS | vasopressin | 204485 | 2018-03-23 |
US Patents and Regulatory Information for VASOSTRICT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-001 | Apr 17, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-004 | Apr 15, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-002 | Dec 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-003 | Apr 15, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-001 | Apr 17, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-003 | Apr 15, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Par Sterile Products | VASOSTRICT | vasopressin | SOLUTION;INTRAVENOUS | 204485-004 | Apr 15, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
