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VASOSTRICT Drug Profile
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When do Vasostrict patents expire, and when can generic versions of Vasostrict launch?
Vasostrict is a drug marketed by Par Sterile Products and is included in one NDA. There are six 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. Three suppliers are listed for this compound. Additional details are available on the vasopressin profile page.
US ANDA Litigation and Generic Entry Outlook for Vasostrict
Vasostrict was eligible for patent challenges on December 31st, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 30th, 2035. This may change due to patent challenges or generic licensing.
There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Historic data indicate that 48% of cases that proceed to trial are decided in favor of the generic patent challenger.
Summary for VASOSTRICT
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 |
Recent Litigation for VASOSTRICT
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Par Pharmaceutical, Inc. v. Amneal Pharmaceuticals Company GmbH | 2019-04-18 |
| Par Pharmaceutical, Inc. v. Amphastar Pharmaceuticals, Inc. | 2018-12-20 |
| PAR PHARMACEUTICAL, INC. v. SANDOZ INC. | 2018-10-11 |
Synonyms for VASOSTRICT
| 11034-16-5 |
| 12678-42-1 |
| 196116-EP2272972A1 |
| 196116-EP2272973A1 |
| 196116-EP2277872A1 |
| ADH (hormone) |
| D00101 |
| EINECS 234-236-2 |
| HSDB 3412 |
| Intertocin |
| Inyectable de vasopresina [INN-Spanish] |
| LS-161408 |
| Pitressin (TN) |
| Pituitrin |
| Pituitrin P |
| SCHEMBL1172390 |
| Solute injectable de vasopressine [INN-French] |
| Tonephin |
| UNII-Y87Y826H08 |
| Vasopressin (JP17/USP) |
| Vasopressin, unspecified |
| Vasopressina |
| Vasopressina [DCIT] |
| Vasopressine |
| Vasopressini injectio [INN-Latin] |
| Vasopressins |
| Vasopressinum |
| Y87Y826H08 |
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 | Y | 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 | 204485-001 | Apr 17, 2014 | 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 | 204485-001 | Apr 17, 2014 | 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 | 204485-002 | Dec 17, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
