Orange Book CompanionŽ
Biologic Tradenames starting with "A"

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.

ADLYXIN (SOLUTION) (SUBCUTANEOUS) LIXISENATIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: SANOFI-AVENTIS US NDA No.: 208471 Prod. No.: 001 RX (0.15MG/3ML (0.05MG/ML)); 002 RX (0.3MG/3ML (0.1MG/ML))

Patents	Expiration	Patented Use
Pat. No. RE45313 DS* DP* Exendin variant peptides Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Aug 3, 2016	Jul 12, 2020
Pat. No. 8475414 DP* Medication delivery device and method for operating a medication delivery device Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 3, 2016	Dec 28, 2030	U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 8882721 DP* Drive assembly suitable for use in a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	Jun 28, 2031
Pat. No. 8915888 DP* Dosing and drive mechanism for drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	Jun 8, 2030	U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9072836 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	Mar 15, 2032
Pat. No. 9084853 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	Oct 5, 2031
Pat. No. 9308329 DP* Medication delivery device and method for operating a medication delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 3, 2016	Dec 28, 2030	U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9408893 Pharmaceutical combination for use in glycemic control in diabetes type 2 patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 9, 2016	Aug 27, 2032	U-1894: Combination treatment with a glitazone for improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 9440029 DP* Drive mechanism for a drug delivery device and drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 29, 2016	Jan 30, 2032
Pat. No. 9511193 DP* Assembly and indicator for a drug delivery device Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 29, 2016	Jan 19, 2032
Pat. No. 9707176 DP* Pharmaceutical composition comprising a GLP-1 agonist and methionine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 3, 2017	Nov 11, 2030
Pat. No. 9821032 Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 19, 2017	May 9, 2032	U-2200: Combination treatment with insulin glargine with or without metformin for improvement of glycemic control in Type 2 diabetes mellitus patients
Pat. No. 9855388 DP* Dosing and drive mechanism for drug delivery device Claim Types: Device; Process; Method of administration Pat. Sub. Date(s): All strengths: Jan 12, 2018	Apr 24, 2029	U-1881: Improvement in glycemic control in Type 2 diabetes mellitus patients by use of a pen injector
Pat. No. 9981013 Use of AVE0010 for the treatment of diabetes mellitus type 2 Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 8, 2018	Aug 30, 2030	U-2297: Improvement of glycemic control in Type 2 diabetes patients by administering a starting dose of 10 mcg for 14 days and increasing to a maintenance dose of 20 mcg on day 15
Pat. No. 10028910 DP* Pharmaceutical composition comprising a GLP-1-agonist and methionine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 30, 2018	Nov 11, 2030
Pat. No. 10201663 DP* Assembly for a drug delivery device Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Jul 9, 2019	Mar 10, 2034
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 27, 2021

ADMELOG (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) INSULIN LISPRO
Drug Classes: insulin analog
NDA Applicant: SANOFI-AVENTIS US NDA No.: 209196 Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Dec 11, 2020

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Dec 11, 2020

ADMELOG SOLOSTAR (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) INSULIN LISPRO
Drug Classes: insulin analog
NDA Applicant: SANOFI-AVENTIS US NDA No.: 209196 Prod. No.: 002 RX (300 UNITS/3ML (100 UNITS/ML))

Patents Expiration Patented Use

Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Sep 23, 2027

Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Sep 15, 2024

Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 3, 2024

Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Apr 12, 2025

Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Jun 5, 2024

Pat. No. 9011391 DP* Pen-type injector
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 26, 2024 U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Aug 17, 2024

Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Aug 28, 2024

Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Aug 16, 2024

Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Aug 19, 2024

Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 11, 2018 Apr 8, 2033

Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 2, 2024

Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Mar 30, 2018 Mar 4, 2024 U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve

Exclusivity Expiration Exclusivity Description

Exclusivity Code: NP - New product Dec 11, 2020

Patents	Expiration	Patented Use
Pat. No. 7918833 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Sep 23, 2027
Pat. No. 8512297 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Sep 15, 2024
Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 3, 2024
Pat. No. 8603044 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 8679069 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Apr 12, 2025
Pat. No. 8992486 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Jun 5, 2024
Pat. No. 9011391 DP* Pen-type injector Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 26, 2024	U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve
Pat. No. 9233211 DP* Relating to a pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9408979 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9526844 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Aug 17, 2024
Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Aug 28, 2024
Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Aug 16, 2024
Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Aug 19, 2024
Pat. No. 9717852 DP* Cartridge holder and pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Jul 11, 2018	Apr 8, 2033
Pat. No. 9775954 DP* Pen-type injector Claim Types: Device Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 2, 2024
Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Mar 30, 2018	Mar 4, 2024	U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	Dec 11, 2020

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

APIDRA (INJECTABLE) (INTRAVENOUS, SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML)) NDA No.: 021629 Prod. No.: 002 DISC (300 UNITS/3ML (100 UNITS/ML))

Patents Expiration Patented Use

Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None Jan 25, 2023 U-471: Method of treating a patient suffering from diabetes mellitus

Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None Mar 22, 2022

Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None Mar 22, 2022 U-471: Method of treating a patient suffering from diabetes mellitus

Patents	Expiration	Patented Use
Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: None	Jan 25, 2023	U-471: Method of treating a patient suffering from diabetes mellitus
Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation Pat. Sub. Date(s): All strengths: None	Mar 22, 2022
Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None	Mar 22, 2022	U-471: Method of treating a patient suffering from diabetes mellitus

APIDRA SOLOSTAR (INJECTABLE) (SUBCUTANEOUS) INSULIN GLULISINE RECOMBINANT
Drug Classes: insulin analog
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 003 RX (300 UNITS/3ML)

Patents Expiration Patented Use

Pat. No. 6960561 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Process
Pat. Sub. Date(s): 003: None Jan 25, 2023 U-471: Method of treating a patient suffering from diabetes mellitus

Pat. No. 7452860 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation
Pat. Sub. Date(s): 003: None Mar 22, 2022

Pat. No. 7696162 DP* Zinc-free and low-zinc insulin preparations having improved stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: None Mar 22, 2022 U-471: Method of treating a patient suffering from diabetes mellitus

Pat. No. 7918833 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: None Sep 23, 2027

Pat. No. 8512297 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 21, 2013 Sep 15, 2024

Pat. No. 8556864 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Nov 6, 2013 Mar 3, 2024

Pat. No. 8603044 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 6, 2014 Mar 2, 2024

Pat. No. 8679069 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 25, 2014 Apr 12, 2025

Pat. No. 8992486 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 9, 2015 Jun 5, 2024

Pat. No. 9011391 Pen-type injector
Claim Types: Method of use
Pat. Sub. Date(s): 003: May 1, 2015 Mar 26, 2024 U-1832: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a threaded drive sleeve

Pat. No. 9233211 DP* Relating to a pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 13, 2016 Mar 2, 2024

Pat. No. 9408979 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Sep 15, 2016 Mar 2, 2024

Pat. No. 9526844 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 27, 2016 Mar 2, 2024

Pat. No. 9533105 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Jan 3, 2017 Aug 17, 2024

Pat. No. 9561331 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Feb 7, 2017 Aug 28, 2024

Pat. No. 9604008 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 28, 2017 Mar 2, 2024

Pat. No. 9604009 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Mar 28, 2017 Aug 16, 2024

Pat. No. 9610409 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 4, 2017 Mar 2, 2024

Pat. No. 9623189 DP* Relating to drive mechanisms suitable for use in drug delivery devices
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 18, 2017 Aug 19, 2024

Pat. No. 9717852 DP* Cartridge holder and pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 11, 2018 Apr 8, 2033

Pat. No. 9775954 DP* Pen-type injector
Claim Types: Device
Pat. Sub. Date(s): 003: Oct 3, 2017 Mar 2, 2024

Pat. No. 9827379 DP* Drive mechanisms suitable for use in drug delivery devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Nov 28, 2017 Mar 2, 2024 U-2146: Improvement in glycemic control in diabetes mellitus patients by use of a pen injector with a rotating drive sleeve