Orange Book Companion
Orange Book Champion: AFREZZA

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


AFREZZA (POWDER) (INHALATION) INSULIN RECOMBINANT HUMAN
Drug Classes: insulin analog
NDA Applicant: MANNKIND      NDA No.: 022472  Prod. No.: 001 RX (4 UNITS/INH); 002 RX (8 UNITS/INH); 003 RX (12 UNITS/INH)
PatentsExpirationPatented Use
Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Formulation; Method of use; Process
Jun 29, 2020U-1534: Administration of a composition comprising insulin complexed with a diketopiperazine.
Pat. No. 6652885 Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Method of use
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7305986 DP* Unit dose capsules for use in a dry powder inhaler
Claim Types: Device
Jan 16, 2023 
Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device; Method of administration
Mar 2, 2023 
Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles
Claim Types: Method of use
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7943178 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Product-by-process
Jun 29, 2020U-1535: Administration of a composition comprising insulin complexed with microparticles of a diketopiperazine.
Pat. No. 7943572 Superior control of blood glucose in diabetes treatment
Claim Types: Method of administration
Aug 10, 2026U-1539: Pulmonary administration of an insulin composition comprising FDKP at the beginning of a meal to a patient also being treated with a long-acting insulin.
Pat. No. 8119593 Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin
Claim Types: Method of administration
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8146588 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Apr 24, 2023 
Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Jan 16, 2023 
Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Nov 24, 2022 
Pat. No. 8258095 Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content
Claim Types: Method of administration
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8389470 DP* Methods and compositions for delivering peptides
Claim Types: Method of use; Formulation
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8424518 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Oct 17, 2031 
Pat. No. 8485180 DP* Dry powder drug delivery system
Claim Types: Device
Mar 25, 2030 
Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Feb 19, 2032 
Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Jun 11, 2030 
Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin
Claim Types: Method of use
Sep 18, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 8636001 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Jul 12, 2032 
Pat. No. 8729019 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Dec 26, 2028 
Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Jun 11, 2030 
Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Device; Method of administration
Jun 11, 2030U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8889099 DP* Methods and compositions for delivering peptides
Claim Types: Method of administration; Formulation
Jun 29, 2020U-1621: Pulmonary administration of a composition comprising insulin bound to a complexing agent.
Pat. No. 8912193 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Method of use; Product-by-process; Method of administration
Jun 12, 2029U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Jul 20, 2021 
Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device; Drug in a container
Jun 12, 2029U-1788: Treatment of patient having diabetes mellitus via oral inhalation of fdkp microparticles comprising insulin
Pat. No. 9283193 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Sep 14, 2026 
Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Oct 20, 2029 
Pat. No. 9358352 DP* Dry powder drug delivery system and methods
Claim Types: Device; Drug in a container; Method of administration
Feb 15, 2031U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9393372 DP* Dry powder drug delivery system
Claim Types: Device
Jul 4, 2029 
Pat. No. 9446133 DP* Dry powder inhaler and system for drug delivery
Claim Types: Composition; Formulation; Method of use; Method of administration
Jun 12, 2029U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9511198 Dry powder inhaler and system for drug delivery
Claim Types: Method of use
Feb 16, 2030U-1929: Treatment of diabetes mellitus with an inhaled insulin to improve glycemic control using a dry powder inhalation system comprising an inhaler, a cartridge and a dry powder medicament comprising insulin in a single inhalation
U-1930: Method of aerosolizing/deagglomerating an insulin dry powder for use in treating diabetes mellitus via oral inhalation using an inhaler with a cartridge containing the insulin dry powder.
Pat. No. 9597374 Use of ultrarapid acting insulin
Claim Types: Method of use
Oct 8, 2031U-1987: Method of controlling glycemia in diabetics by administering an initial dose of insulin-FDKP with a meal; determining blood glucose level 1-2 hrs after and administering a supplemental dose of insulin-FDKP if postprandial glucose level is >140 mg/dl
Pat. No. 9662461 DP* Dry powder drug delivery system and methods
Claim Types: Device; Method of administration
Jun 12, 2029U-2019: Method of delivering to a patient with diabetes mellitus in a single inhalation, greater than 75% of a dry powder dose comprising insulin and fumaryl diketopiperazine using a high resistance to flow dry powder inhaler.
Pat. No. 9717689 DP* Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
Claim Types: Formulation
Sep 14, 2026 
Pat. No. 9943571 Use of ultrarapid acting insulin
Claim Types: Method of use
Aug 11, 2029U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 22 September 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide