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INNOHEP

NDA

TINZAPARIN SODIUM | N020484 | LEO PHARMA AS

1 strength0 unique patents0 unique exclusivities

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Thromboprophylaxis in Lower Limb Immobilisation NCT06370273	Phase 3	Recruiting	Queen Mary University of London	10,044	2024-11-12 → 2028-08-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

LEO PHARMACEUTICAL PRODUCTS LTDInactiveTINZAPARIN SODIUM DRUG SUBSTANCE

DMF 105961993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 20,000 IU/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jul 14, 2000

No patent or exclusivity listings for this strength.