Product profile · United States

VASOSTRICT

· Patent Litigation & Settlement History ↓

IngredientVASOPRESSIN

Application typeNDA

Application204485

Product001

Dosage formSOLUTION

RouteINTRAVENOUS

Strength20UNITS/ML (20UNITS/ML)

Approval date2014-04-17

Marketing statusPrescription

Status event—

ApplicantPH HEALTH

Product source

Current GenericRadar decision

Year2021

SelectionEXISTING_GENERIC

ReviewDISQUALIFIED

Anchor typeFINAL_ANDA

Anchor date2021-12-15

Patent anchor—

Exclusivity anchor—

Protection date—

First Final ANDA2021-12-15

Status event—

Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.

Patent estate

Patent	Effective date	Official listing	TRUE_DS	DS grade	Claim classification / basis	PTE	PED	Family
9375478	2035-01-30	U U-1857	—	—	—	—	—	—
9687526	2035-01-30	U U-1857	—	—	—	—	—	—
9744209	2035-01-30	U U-1857	—	—	—	—	—	—
9744239	2035-01-30	U U-1857	—	—	—	—	—	—
9750785	2035-01-30	DP —	—	—	—	—	—	—

Regulatory exclusivity

Code	Start date	End date	Scope	Entire product	All indications	Full coverage date	Combination	Source
No exclusivity facts are recorded in this product snapshot.

2026-10-10 · NO_RECORD_IN_CURRENT_SNAPSHOT · Historical coverage: NOT_COMPLETE

Generic approval evidence

Application / product	Event	Final date	Tentative date	Applicant	Authorized generic	Exact mapping	Source
211538 / 001	FINAL_APPROVAL · FINAL_APPROVED	2021-12-15	—	EAGLE PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
211857 / 001	FINAL_APPROVAL · FINAL_APPROVED	2022-07-18	—	AMPHASTAR PHARMACEUTICALS INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
212944 / 001	FINAL_APPROVAL · FINAL_APPROVED	2022-08-05	—	AMNEAL EU LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
214314 / 001	FINAL_APPROVAL · FINAL_APPROVED	2022-08-15	—	EUGIA PHARMA SPECIALITIES LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
213206 / 001	FINAL_APPROVAL · FINAL_APPROVED	2023-05-26	—	FRESENIUS KABI USA LLC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
216963 / 001	FINAL_APPROVAL · FINAL_APPROVED	2024-02-09	—	GLAND PHARMA LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
213988 / 001	FINAL_APPROVAL · FINAL_APPROVED	2024-05-08	—	DR REDDYS LABORATORIES LTD	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source
212068 / 001	FINAL_APPROVAL · FINAL_APPROVED	2026-05-06	—	SANDOZ INC	N	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source

Market Entry Information

API filings, authorized generics and linked regulatory milestones.

API Master Files & Certifications 0 records

Ingredient-level registrations from linked public manufacturer portfolios. A filing does not establish supply to this finished product. DMFs are not FDA approvals.

API	Holder / manufacturer	Holder country	Filing type	Number	Status	Filed date	Available for reference	Source	Last verified
No master-file or certification records are linked through public manufacturer portfolios.

Authorized Generics 0 records

Authorized generics are shown separately from independent ANDA approvals.

Application / product	Applicant	Event / status	First marketed	Product mapping	Source	Last verified
No authorized-generic records are linked to this product.

Tentative ANDA Approvals 0 records

Tentative approval is not final approval. Historical tentative approvals remain visible after a linked final approval.

Application / product	Applicant	Event / status	Tentative date	Follow-up final approval	Product mapping	Source	Last verified
No tentative-approval records are linked to this product.

Paragraph IV Challenges 0 records

Paragraph IV challenges below are sourced from legal records separately from FDA approvals. An ANDA filing, lawsuit or settlement does not establish final approval or commercial launch.

Application / product	Applicant	Event / status	Certification event date	Product mapping	Source	Last verified
No structured Paragraph IV certification events are linked in the available approval evidence.

Final ANDA Approvals 8 records

Approval dates do not establish commercial launch. Product mapping is shown for each linked record.

Application / product	Applicant	Event / status	Final approval date	Product mapping	Source	Last verified
211538 / 001	EAGLE PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2021-12-15	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
211857 / 001	AMPHASTAR PHARMACEUTICALS INC	FINAL_APPROVAL · FINAL_APPROVED	2022-07-18	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
212944 / 001	AMNEAL EU LTD	FINAL_APPROVAL · FINAL_APPROVED	2022-08-05	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
214314 / 001	EUGIA PHARMA SPECIALITIES LTD	FINAL_APPROVAL · FINAL_APPROVED	2022-08-15	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
213206 / 001	FRESENIUS KABI USA LLC	FINAL_APPROVAL · FINAL_APPROVED	2023-05-26	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
216963 / 001	GLAND PHARMA LTD	FINAL_APPROVAL · FINAL_APPROVED	2024-02-09	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
213988 / 001	DR REDDYS LABORATORIES LTD	FINAL_APPROVAL · FINAL_APPROVED	2024-05-08	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—
212068 / 001	SANDOZ INC	FINAL_APPROVAL · FINAL_APPROVED	2026-05-06	EXACT_PRODUCT · PENDING_PRODUCT_MAPPING	Source	—

Decision evidence (1)

Type	Date	Role	Basis	Source
GENERIC	2021-12-15	TERMINAL_GENERIC_BASIS	Exact product/strength Final ANDA confirmed. Date is earliest verified official product approval for the batch. AG and tentative excluded. Approval date is not commercial launch date. No DS classification asserted.	Source

Independent legal-event information

Litigation & Settlement History

Settlement launch rights generally apply only to the named parties and product scope. These records do not change GenericRadar patent/exclusivity anchors or current decisions.

No litigation or settlement record currently linked to this product.