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)

Patents Expiration Patented Use

Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Jan 16, 2023
Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Mar 2, 2023
Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Aug 10, 2026 U-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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Aug 11, 2029 U-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
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Apr 24, 2023
Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Jan 16, 2023
Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Aug 11, 2029 U-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
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Oct 17, 2031
Pat. No. 8485180 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Mar 25, 2030
Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Feb 19, 2032
Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Jun 11, 2030
Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Sep 18, 2029 U-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
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 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
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 14, 2014; 003: May 15, 2015 Dec 26, 2028
Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015 Jun 11, 2030
Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jul 24, 2014 Jun 11, 2030 U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8889099 DP* Methods and compositions for delivering peptides
Claim Types: Method of administration; Formulation
Pat. Sub. Date(s): All strengths: Dec 17, 2014 Jun 29, 2020 U-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
Pat. Sub. Date(s): All strengths: Aug 18, 2015 Jun 12, 2029 U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler
Claim Types: Device
Pat. Sub. Date(s): All strengths: Apr 25, 2016 Jul 20, 2021
Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): All strengths: Dec 23, 2015 Jun 12, 2029 U-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
Pat. Sub. Date(s): All strengths: Apr 12, 2016 Sep 14, 2026
Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: May 31, 2016 Oct 20, 2029
Pat. No. 9358352 DP* Dry powder drug delivery system and methods
Claim Types: Device; Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Jun 30, 2016 Feb 15, 2031 U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9393372 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Aug 3, 2016 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
Pat. Sub. Date(s): All strengths: Oct 19, 2016 Jun 12, 2029 U-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
Pat. Sub. Date(s): All strengths: Jan 5, 2017 Feb 16, 2030 U-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
Pat. Sub. Date(s): All strengths: Apr 11, 2017 Oct 8, 2031 U-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
Pat. Sub. Date(s): All strengths: Jun 26, 2017 Jun 12, 2029 U-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
Pat. Sub. Date(s): All strengths: Aug 28, 2017 Sep 14, 2026
Pat. No. 9943571 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 15, 2018 Aug 11, 2029 U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 10046031 Use of ultrarapid acting insulin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 12, 2018 Aug 11, 2029 U-2383: Method of controlling glycemia in a diabetic patient with delayed or prolonged food absorpbtion by administering 50 to 75% of a predetermined dose of insulin-FDKP at mealtime, and administering remainder of dose 30-120 minutes after beginning of meal
Pat. No. 10201672 DP* Dry powder inhaler and system for drug delivery
Claim Types: Device
Pat. Sub. Date(s): All strengths: Mar 4, 2019 Aug 2, 2030
Pat. No. 10342938 DP* Dry powder drug delivery system
Claim Types: Device
Pat. Sub. Date(s): All strengths: Jul 23, 2019 Jun 12, 2029
Pat. No. 10500159 DP* Apparatus and method for cryogranulating a pharmaceutical composition
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Dec 19, 2019 Nov 2, 2030

Patents	Expiration	Patented Use
Pat. No. 6444226 DP* Purification and stabilization of peptide and protein pharmaceutical agents Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Jan 16, 2023
Pat. No. 7464706 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Mar 2, 2023
Pat. No. 7648960 Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Aug 10, 2026	U-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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Aug 11, 2029	U-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 Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Apr 24, 2023
Pat. No. 8156936 DP* Unit dose capsules and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Jan 16, 2023
Pat. No. 8215300 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Aug 11, 2029	U-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 Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Oct 17, 2031
Pat. No. 8485180 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Mar 25, 2030
Pat. No. 8499757 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Feb 19, 2032
Pat. No. 8551528 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Jun 11, 2030
Pat. No. 8623817 Method of treating diabetes type 2 by administering ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 24, 2014	Sep 18, 2029	U-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 Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	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 Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 14, 2014; 003: May 15, 2015	Dec 26, 2028
Pat. No. 8734845 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 24, 2014; 002: Jul 24, 2014; 003: May 15, 2015	Jun 11, 2030
Pat. No. 8778403 DP* Diketopiperazine microparticles with defined specific surface areas Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Jul 24, 2014	Jun 11, 2030	U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8889099 DP* Methods and compositions for delivering peptides Claim Types: Method of administration; Formulation Pat. Sub. Date(s): All strengths: Dec 17, 2014	Jun 29, 2020	U-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 Pat. Sub. Date(s): All strengths: Aug 18, 2015	Jun 12, 2029	U-1538: Administration of FDKP microparticles comprising insulin.
Pat. No. 8950397 DP* Unit dose cartridge and dry powder inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 25, 2016	Jul 20, 2021
Pat. No. 9192675 DP* Dry powder inhaler and system for drug delivery Claim Types: Device; Drug in a container Pat. Sub. Date(s): All strengths: Dec 23, 2015	Jun 12, 2029	U-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 Pat. Sub. Date(s): All strengths: Apr 12, 2016	Sep 14, 2026
Pat. No. 9339615 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): All strengths: May 31, 2016	Oct 20, 2029
Pat. No. 9358352 DP* Dry powder drug delivery system and methods Claim Types: Device; Drug in a container; Method of administration Pat. Sub. Date(s): All strengths: Jun 30, 2016	Feb 15, 2031	U-1861: Use of an inhaler to administer dry powder medicament
Pat. No. 9393372 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	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 Pat. Sub. Date(s): All strengths: Oct 19, 2016	Jun 12, 2029	U-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 Pat. Sub. Date(s): All strengths: Jan 5, 2017	Feb 16, 2030	U-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 Pat. Sub. Date(s): All strengths: Apr 11, 2017	Oct 8, 2031	U-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 Pat. Sub. Date(s): All strengths: Jun 26, 2017	Jun 12, 2029	U-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 Pat. Sub. Date(s): All strengths: Aug 28, 2017	Sep 14, 2026
Pat. No. 9943571 Use of ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 15, 2018	Aug 11, 2029	U-1537: Treatment of a patient having diabetes mellitus with a prandial rapid acting insulin.
Pat. No. 10046031 Use of ultrarapid acting insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 12, 2018	Aug 11, 2029	U-2383: Method of controlling glycemia in a diabetic patient with delayed or prolonged food absorpbtion by administering 50 to 75% of a predetermined dose of insulin-FDKP at mealtime, and administering remainder of dose 30-120 minutes after beginning of meal
Pat. No. 10201672 DP* Dry powder inhaler and system for drug delivery Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 4, 2019	Aug 2, 2030
Pat. No. 10342938 DP* Dry powder drug delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 23, 2019	Jun 12, 2029
Pat. No. 10500159 DP* Apparatus and method for cryogranulating a pharmaceutical composition Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Dec 19, 2019	Nov 2, 2030

DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 15 March 2020
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