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BLA

LONAPEGSOMATROPIN-TCGD | B761177 | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S

9 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

August 25, 2033(2610 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 25, 2033	Active	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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
kaleo, Inc. v. Ascendis Pharma Endocrinology, Inc. et al 1:2025cv01210 2 patentssomatropin (growth hormone)	D. Del.	2025-09-29	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 761177 | 14 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

lonapegsomatropin-tcgd

Applicant

Ascendis Pharma Endocrinology Division A/S

Approval Date

25-Aug-21

Presentations

3MG — Single-Dose Cartridge (Subcutaneous)

0.7MG — Single-Dose Cartridge (Subcutaneous)

1.4MG — Single-Dose Cartridge (Subcutaneous)

1.8MG — Single-Dose Cartridge (Subcutaneous)

2.1MG — Single-Dose Cartridge (Subcutaneous)

2.5MG — Single-Dose Cartridge (Subcutaneous)

3.6MG — Single-Dose Cartridge (Subcutaneous)

4.3MG — Single-Dose Cartridge (Subcutaneous)

5.2MG — Single-Dose Cartridge (Subcutaneous)

6.3MG — Single-Dose Cartridge (Subcutaneous)

7.6MG — Single-Dose Cartridge (Subcutaneous)

9.1MG — Single-Dose Cartridge (Subcutaneous)

11MG — Single-Dose Cartridge (Subcutaneous)

13.3MG — Single-Dose Cartridge (Subcutaneous)

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jul 28, 2025	SUPPL -8	View Letter (PDF)
Jul 11, 2025	SUPPL -9	View Letter (PDF)
Oct 21, 2022	SUPPL -1	View Letter (PDF)
Aug 27, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.