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OMONTYS PRESERVATIVE FREE (PEGINESATIDE ACETATE) | LOERadar

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OMONTYS PRESERVATIVE FREE

NDA

PEGINESATIDE ACETATE | N202799 | TAKEDA PHARMACEUTICALS USA INC

8 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (2)Today

Today

Jun. 2, 2026

Jun. 2, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 6, 2012	SUPPL -1	View Letter (PDF)
Mar 27, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

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#007 — EQ 10MG BASE/ML (EQ 10MG BASE/ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#008 — EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#001 — EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)

2 patents0 exclusivities▴

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7550433	Jun 2, 2026	—	—	—		—
7919461	Jun 2, 2026	—	—	—		—

#002 — EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#003 — EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#004 — EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#005 — EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012

#006 — EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)

2 patents0 exclusivities▾

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 27, 2012