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BLA

INSULIN RECOMBINANT HUMAN | B022472 | MANNKIND

3 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

June 27, 2026(6 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 27, 2026	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 22472 | 3 presentations

351(a) ReferenceLicensedCDERPowder

Proper Name

insulin human

Applicant

Mannkind Corporation

Approval Date

27-Jun-14

Presentations

4UNITS/INH — Single-Dose Cartridge (Inhalation)

8UNITS/INH — Single-Dose Cartridge (Inhalation)

12UNITS/INH — Single-Dose Cartridge (Inhalation)

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	SUPPL -29	View Letter (PDF)
Jan 26, 2026	SUPPL -27	View Letter (PDF)
Jan 26, 2026	SUPPL -27	View Letter (PDF)
Feb 6, 2023	SUPPL -23	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -11	View Letter (PDF)
Mar 23, 2020	SUPPL -2	View Letter (PDF)
Mar 23, 2020	SUPPL -18	View Letter (PDF)
Mar 23, 2020	SUPPL -17	View Letter (PDF)
Mar 23, 2020	SUPPL -5	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)
Mar 23, 2020	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 4 UNITS/INH

▴

POWDER;INHALATION | Approved: 2014-06-27 00:00:00

No patent or exclusivity listings for this strength.

#002 — 8 UNITS/INH

▾

POWDER;INHALATION | Approved: 2014-06-27 00:00:00

#003 — 12 UNITS/INH

▾

POWDER;INHALATION | Approved: 2014-06-27 00:00:00