Regular Insulin, Human Inhalant Powder

Brand(s)
Afrezza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-07-02)
Oldest Current Product
2014-07-11
License(s)
NDA
RxNORM
INHALANT POWDER\REGULAR INSULIN, HUMAN
FDAOB
INHALATION\POWDER\INSULIN RECOMBINANT HUMAN\rdfq
SPL Active
RESPIRATORY (INHALATION)\POWDER, METERED\INSULIN HUMAN
SPL Moiety
RESPIRATORY (INHALATION)\POWDER, METERED\INSULIN HUMAN

product(s) by strength(s)

regular insulin, human 4 unt inhalant powder

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245874AfrezzaNDASanofi-Aventis U.S. Llc2014-07-11INSULIN HUMANRESPIRATORY (INHALATION)POWDER, METEREDNDA02247276fb46f1-82db-40da-ba19-b3a7b0bd78ff

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1NDA021868EXUBERATruePFIZER INC2006-01-27p6546929, METHOD OF ADMINISTERING INSULIN VIA INHALATION
p5740794, SUBSTANCE
p6685967, SUBSTANCE
p6582728, SUBSTANCE
p6257233, METHOD OF ADMINISTERING INSULIN VIA INHALATION
p6543448, SUBSTANCE
NDA021868_001, NDA021868_002
2NDA022472AFREZZASANOFI AVENTIS2014-06-27p8394414, PULMONARY ADMINISTRATION OF PARTICLES COMPRISING A DIKETOPIPERAZINE AND INSULIN., SUBSTANCE
p8146588, SUBSTANCE
p6663898, SUBSTANCE
p8778403, ADMINISTRATION OF FDKP MICROPARTICLES COMPRISING INSULIN., SUBSTANCE
p7305986, SUBSTANCE
p6444226, ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH A DIKETOPIPERAZINE., SUBSTANCE
p6428771, PULMONARY ADMINISTRATION OF PARTICLES COMPRISING A DIKETOPIPERAZINE AND INSULIN., SUBSTANCE
p7276534, ADMINISTRATION OF A COMPOSITION COMPRISING A DIKETOPIPERAZINE AND INSULIN., SUBSTANCE
p8551528, SUBSTANCE
p8729019, SUBSTANCE
p8227409, ADMINISTRATION OF FDKP MICROPARTICLES COMPRISING INSULIN., SUBSTANCE
p7943178, ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE., SUBSTANCE
p8119593, TREATMENT OF A PATIENT HAVING DIABETES MELLITUS WITH A PRANDIAL RAPID ACTING INSULIN.
p8215300, SUBSTANCE
p8424518, SUBSTANCE
p8889099, PULMONARY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN BOUND TO A COMPLEXING AGENT., SUBSTANCE
p8133514, SUBSTANCE
p7464706, SUBSTANCE
p6906030, SUBSTANCE
p7943572, 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.
p6652885, ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.
p8258095, TREATMENT OF A PATIENT HAVING DIABETES MELLITUS WITH A PRANDIAL RAPID ACTING INSULIN.
p8734845, SUBSTANCE
p8623817, TREATMENT OF A PATIENT HAVING DIABETES MELLITUS WITH A PRANDIAL RAPID ACTING INSULIN.
p8636001, SUBSTANCE
p8912193, ADMINISTRATION OF FDKP MICROPARTICLES COMPRISING INSULIN., SUBSTANCE
p8499757, SUBSTANCE
p6071497, PULMONARY ADMINISTRATION OF PARTICLES COMPRISING A DIKETOPIPERAZINE AND INSULIN., SUBSTANCE
p8485180, SUBSTANCE
p8389470, PULMONARY ADMINISTRATION OF A COMPISITION COMPRISING INSULIN BOUND TO A DIKETOPIPERAZINE., SUBSTANCE
p7648960, ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES OF A DIKETOPIPERAZINE.
p8156936, SUBSTANCE
NEW PRODUCT [2017-06-27]NDA022472_001, NDA022472_002, NDA022472_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021868_001discontinuedINSULIN RECOMBINANT HUMAN (1MG/INH)POWDERFalse2006-01-27EXUBERA
2NDA021868_002discontinuedINSULIN RECOMBINANT HUMAN (3MG/INH)POWDERFalse2006-01-27EXUBERA
3NDA022472_001RXINSULIN RECOMBINANT HUMAN (4 UNITS/INH)POWDERFalse2014-06-27AFREZZA
4NDA022472_002RXINSULIN RECOMBINANT HUMAN (8 UNITS/INH)POWDERTrue2014-06-27AFREZZA
5NDA022472_003RXINSULIN RECOMBINANT HUMAN (12 UNITS/INH)POWDERFalse2015-04-17AFREZZA

patent(s)

#idexpiration dateapplication(s)
1p5740794 (view patent)2015-04-21NDA021868
2p6071497 (view patent)2015-05-15NDA022472
3p6257233 (view patent)2019-05-14NDA021868
4p6428771 (view patent)2015-05-15NDA022472
5p6444226 (view patent)2020-06-29NDA022472
6p6543448 (view patent)2014-09-21NDA021868
7p6546929 (view patent)2019-05-14NDA021868
8p6582728 (view patent)2020-06-24NDA021868
9p6652885 (view patent)2020-06-29NDA022472
10p6663898 (view patent)2014-09-30NDA022472
11p6685967 (view patent)2018-09-11NDA021868
12p6906030 (view patent)2014-09-30NDA022472
13p7276534 (view patent)2014-09-30NDA022472
14p7305986 (view patent)2023-01-16NDA022472
15p7464706 (view patent)2023-03-02NDA022472
16p7648960 (view patent)2020-06-29NDA022472
17p7943178 (view patent)2020-06-29NDA022472
18p7943572 (view patent)2026-08-10NDA022472
19p8119593 (view patent)2029-08-11NDA022472
20p8133514 (view patent)2014-09-30NDA022472
21p8146588 (view patent)2023-04-24NDA022472
22p8156936 (view patent)2023-01-16NDA022472
23p8215300 (view patent)2022-11-24NDA022472
24p8227409 (view patent)2031-03-08NDA022472
25p8258095 (view patent)2029-08-11NDA022472
26p8389470 (view patent)2020-06-29NDA022472
27p8394414 (view patent)2015-05-15NDA022472
28p8424518 (view patent)2031-10-17NDA022472
29p8485180 (view patent)2030-03-25NDA022472
30p8499757 (view patent)2032-02-19NDA022472
31p8551528 (view patent)2030-06-11NDA022472
32p8623817 (view patent)2029-09-18NDA022472
33p8636001 (view patent)2032-07-12NDA022472
34p8729019 (view patent)2028-12-26NDA022472
35p8734845 (view patent)2030-06-11NDA022472
36p8778403 (view patent)2030-06-11NDA022472
37p8889099 (view patent)2020-06-29NDA022472
38p8912193 (view patent)2029-06-12NDA022472

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
176fb46f1-82db-40da-ba19-b3a7b0bd78ff (view SPL)These highlights do not include all the information needed to use AFREZZA safely and effectively. See full prescribing information for AFREZZA. AFREZZA (insulin human) Inhalation Powder Initial U.S. Approval: 2014prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-07-025000245874, 000245882, 000245884, 000245894

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII