Humalog Patent Expiration

Humalog is a drug owned by Eli Lilly And Co. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2015. Details of Humalog'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).
US5474978 Insulin analog formulations
Jun, 2014

(10 years ago)

Expired
US5514646 Insulin analogs modified at position 29 of the B chain
May, 2013

(11 years ago)

Expired


FDA has granted several exclusivities to Humalog. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Humalog, 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 Humalog.

Exclusivity Information

Humalog holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Humalog's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
NR(NR) Oct 12, 2015

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Humalog 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 Humalog's family patents as well as insights into ongoing legal events on those patents.

Humalog's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Humalog's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Humalog Generics:

There are no approved generic versions for Humalog as of now.

Alternative Brands for Humalog

Humalog which is used for controlling hyperglycemia in patients with diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Lispro Recombinant). 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 Treatment Area
Lilly
Humalog Pen

(uses Insulin Lispro Recombinant)

Used for controlling hyperglycemia in patients with diabetes mellitus.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Insulin Lispro Recombinant. Given below is the list of those drugs and companies owning them.







About Humalog

Humalog is a drug owned by Eli Lilly And Co. It is used for controlling hyperglycemia in patients with diabetes mellitus. Humalog uses Insulin Lispro Recombinant as an active ingredient. Humalog was launched by Lilly in 2019.

Approval Date:

Humalog was approved by FDA for market use on 15 November, 2019.

Active Ingredient:

Humalog uses Insulin Lispro Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Lispro Recombinant ingredient

Treatment:

Humalog is used for controlling hyperglycemia in patients with diabetes mellitus.

Dosage:

Humalog is available in injectable form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
100 UNITS/ML INJECTABLE Prescription INJECTION