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BLA

TESAMORELIN ACETATE | B022505 | THERATECHNOLOGIES

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

November 10, 2022(1331 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 10, 2022	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

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

Purple Book (Biologics)

BLA 22505 | 3 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

tesamorelin

Applicant

Theratechnologies Inc.

Approval Date

10-Nov-10

1MG — Single-Dose Vial (Subcutaneous)

2MG — Single-Dose Vial (Subcutaneous)

11.6MG — Multi-Dose Vial (Subcutaneous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1MG BASE/VIAL

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POWDER;SUBCUTANEOUS | Approved: 2010-11-10 00:00:00

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE/VIAL

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POWDER;SUBCUTANEOUS | Approved: 2010-11-10 00:00:00