Afrezza is a drug owned by Mannkind Corp. It is protected by 48 US drug patents filed from 2014 to 2019. Out of these, 29 drug patents are active and 19 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 12, 2032. Details of Afrezza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8636001 | Dry powder inhaler and system for drug delivery |
Jul, 2032
(7 years from now) | Active |
| US8499757 | Dry powder inhaler and system for drug delivery |
Feb, 2032
(7 years from now) | Active |
| US8424518 | Dry powder inhaler and system for drug delivery |
Oct, 2031
(6 years from now) | Active |
| US9597374 | Use of ultrarapid acting insulin |
Oct, 2031
(6 years from now) | Active |
| US8227409 | Diketopiperazine microparticles with defined isomer contents |
Mar, 2031
(6 years from now) | Active |
| US9358352 | Dry powder drug delivery system and methods |
Feb, 2031
(6 years from now) | Active |
| US10500159 | Apparatus and method for cryogranulating a pharmaceutical composition |
Nov, 2030
(5 years from now) | Active |
| US10201672 | Dry powder inhaler and system for drug delivery |
Aug, 2030
(5 years from now) | Active |
| US8778403 | Diketopiperazine microparticles with defined specific surface areas |
Jun, 2030
(5 years from now) | Active |
| US8734845 | Diketopiperazine microparticles with defined specific surface areas |
Jun, 2030
(5 years from now) | Active |
| US8551528 | Diketopiperazine microparticles with defined specific surface areas |
Jun, 2030
(5 years from now) | Active |
| US8485180 | Dry powder drug delivery system |
Mar, 2030
(5 years from now) | Active |
| US9511198 | Dry powder inhaler and system for drug delivery |
Feb, 2030
(5 years from now) | Active |
| US9339615 | Dry powder inhaler and system for drug delivery |
Oct, 2029
(4 years from now) | Active |
| US8623817 | Method of treating diabetes type 2 by administering ultrarapid acting insulin |
Sep, 2029
(4 years from now) | Active |
| US8119593 | Method of treating diabetes type 2 by metformin and an ultrarapid acting insulin |
Aug, 2029
(4 years from now) | Active |
| US8258095 | Method of controlling glycemia by ultrarapid acting insulin without adjusting an insulin dose for meal content |
Aug, 2029
(4 years from now) | Active |
| US10046031 | Use of ultrarapid acting insulin |
Aug, 2029
(4 years from now) | Active |
| US9943571 | Use of ultrarapid acting insulin |
Aug, 2029
(4 years from now) | Active |
| US9393372 | Dry powder drug delivery system |
Jul, 2029
(4 years from now) | Active |
| US9446133 | Dry powder inhaler and system for drug delivery |
Jun, 2029
(4 years from now) | Active |
| US10342938 | Dry powder drug delivery system |
Jun, 2029
(4 years from now) | Active |
| US8912193 | Dry powder inhaler and system for drug delivery |
Jun, 2029
(4 years from now) | Active |
| US9192675 | Dry powder inhaler and system for drug delivery |
Jun, 2029
(4 years from now) | Active |
| US9662461 | Dry powder drug delivery system and methods |
Jun, 2029
(4 years from now) | Active |
| US8729019 | Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents |
Dec, 2028
(4 years from now) | Active |
| US9717689 | Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents |
Sep, 2026
(1 year, 8 months from now) | Active |
| US9283193 | Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents |
Sep, 2026
(1 year, 8 months from now) | Active |
| US7943572 | Superior control of blood glucose in diabetes treatment |
Aug, 2026
(1 year, 7 months from now) | Active |
| US8146588 | Unit dose capsules and dry powder inhaler |
Apr, 2023
(1 year, 7 months ago) |
Expired
|
| US7464706 | Unit dose cartridge and dry powder inhaler |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US8156936 | Unit dose capsules and dry powder inhaler |
Jan, 2023
(1 year, 11 months ago) |
Expired
|
| US7305986 | Unit dose capsules for use in a dry powder inhaler |
Jan, 2023
(1 year, 11 months ago) |
Expired
|
| US8215300 | Unit dose cartridge and dry powder inhaler |
Nov, 2022
(2 years ago) |
Expired
|
| US8950397 | Unit dose cartridge and dry powder inhaler |
Jul, 2021
(3 years ago) |
Expired
|
| US6652885 | Purification and stabilization of peptide and protein pharmaceutical agents |
Jun, 2020
(4 years ago) |
Expired
|
| US7648960 | Method for delivery of monomeric or dimeric insulin complexed to diketopiperazine microparticles |
Jun, 2020
(4 years ago) |
Expired
|
| US8389470 | Methods and compositions for delivering peptides |
Jun, 2020
(4 years ago) |
Expired
|
| US7943178 | Methods and compositions for delivering peptides |
Jun, 2020
(4 years ago) |
Expired
|
| US8889099 | Methods and compositions for delivering peptides |
Jun, 2020
(4 years ago) |
Expired
|
| US6444226 | Purification and stabilization of peptide and protein pharmaceutical agents |
Jun, 2020
(4 years ago) |
Expired
|
| US8394414 | Method for drug delivery to the pulmonary system |
May, 2015
(9 years ago) |
Expired
|
| US6428771 | Method for drug delivery to the pulmonary system |
May, 2015
(9 years ago) |
Expired
|
| US6071497 | Microparticles for lung delivery comprising diketopiperazine |
May, 2015
(9 years ago) |
Expired
|
| US7276534 | Carbon-substituted diketopiperazine delivery systems |
Sep, 2014
(10 years ago) |
Expired
|
| US6906030 | Carbon-substituted diketopiperazine delivery systems |
Sep, 2014
(10 years ago) |
Expired
|
| US6663898 | Carbon-substituted diketopiperazine delivery systems |
Sep, 2014
(10 years ago) |
Expired
|
| US8133514 | Carbon-substituted diketopiperazine delivery systems |
Sep, 2014
(10 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Afrezza's patents.
Latest Legal Activities on Afrezza's Patents
Given below is the list of recent legal activities going on the following patents of Afrezza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jun, 2024 | US9511198 |
| Expire Patent Critical | 20 May, 2024 | US8156936 |
| Expire Patent Critical | 06 May, 2024 | US8146588 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2024 | US9446133 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 04 Mar, 2024 | US8258095 |
| Maintenance Fee Reminder Mailed Critical | 26 Feb, 2024 | US8215300 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jan, 2024 | US8227409 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jan, 2024 | US9393372 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Dec, 2023 | US9358352 |
| Maintenance Fee Reminder Mailed Critical | 04 Dec, 2023 | US8156936 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Afrezza and ongoing litigations to help you estimate the early arrival of Afrezza generic.
Afrezza's Litigations
Afrezza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 17, 1997, against patent number US6428771. The petitioner , challenged the validity of this patent, with STEINER et al as the respondent. Click below to track the latest information on how companies are challenging Afrezza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9597374 | June, 2014 |
Decision
(17 Aug, 2016) | Anders Hasager Boss et al | |
| US7305986 | December, 2006 |
Decision
(30 Apr, 2007) | Solomon S. Steiner et al | |
| US6428771 | November, 1997 |
Decision
(29 May, 2001) | STEINER et al | |
FDA has granted some exclusivities to Afrezza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Afrezza, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Afrezza.
Exclusivity Information
Afrezza holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Afrezza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 27, 2017 |
US patents provide insights into the exclusivity only within the United States, but Afrezza is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Afrezza's family patents as well as insights into ongoing legal events on those patents.
Afrezza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Afrezza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 12, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Afrezza Generics:
There are no approved generic versions for Afrezza as of now.
Alternative Brands for Afrezza
Afrezza which is used for treating diabetes mellitus through inhalation of a dry powder medicament containing insulin., has several other brand drugs using the same active ingredient (Insulin Recombinant Human). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Lilly |
| |||
| Pfizer |
|
About Afrezza
Afrezza is a drug owned by Mannkind Corp. It is used for treating diabetes mellitus through inhalation of a dry powder medicament containing insulin. Afrezza uses Insulin Recombinant Human as an active ingredient. Afrezza was launched by Mannkind in 2014.
Approval Date:
Afrezza was approved by FDA for market use on 27 June, 2014.
Active Ingredient:
Afrezza uses Insulin Recombinant Human as the active ingredient. Check out other Drugs and Companies using Insulin Recombinant Human ingredient
Treatment:
Afrezza is used for treating diabetes mellitus through inhalation of a dry powder medicament containing insulin.
Dosage:
Afrezza is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12 UNITS/INH | POWDER | Prescription | INHALATION |
| 8 UNITS/INH | POWDER | Prescription | INHALATION |
| 4 UNITS/INH | POWDER | Prescription | INHALATION |