Lorbrena is a drug owned by Pfizer Inc. It is protected by 4 US drug patents filed from 2018 to 2022 out of which none have expired yet. Lorbrena's patents have been open to challenges since 02 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 04, 2038. Details of Lorbrena's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11299500 | Crystalline form of lorlatinib free base hydrate |
Oct, 2038
(13 years from now) | Active |
| US10420749 | Crystalline form of lorlatinib free base |
Jul, 2036
(11 years from now) | Active |
| US8680111 | Macrocyclic derivatives for the treatment of diseases |
Mar, 2033
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11020376 | Crystalline form of lorlatinib free base |
Jul, 2036
(11 years from now) | Active |
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 Lorbrena's patents.
Latest Legal Activities on Lorbrena's Patents
Given below is the list of recent legal activities going on the following patents of Lorbrena.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Feb, 2023 | US10420749 |
| Recordation of Patent Grant Mailed Critical | 12 Apr, 2022 | US11299500 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Apr, 2022 | US11299500 |
| Email Notification Critical | 24 Mar, 2022 | US11299500 |
| Issue Notification Mailed Critical | 23 Mar, 2022 | US11299500 |
| Dispatch to FDC | 09 Mar, 2022 | US11299500 |
| Application Is Considered Ready for Issue Critical | 09 Mar, 2022 | US11299500 |
| Issue Fee Payment Verified Critical | 08 Mar, 2022 | US11299500 |
| Issue Fee Payment Received Critical | 08 Mar, 2022 | US11299500 |
| Electronic Review Critical | 13 Dec, 2021 | US11299500 |
FDA has granted several exclusivities to Lorbrena. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lorbrena, 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 Lorbrena.
Exclusivity Information
Lorbrena holds 6 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Lorbrena's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 02, 2023 |
| New Indication(I-847) | Mar 03, 2024 |
| Orphan Drug Exclusivity(ODE-217) | Nov 02, 2025 |
| Orphan Drug Exclusivity(ODE-218) | Nov 02, 2025 |
| Orphan Drug Exclusivity(ODE-219) | Nov 02, 2025 |
| Orphan Drug Exclusivity(ODE-349) | Mar 03, 2028 |
US patents provide insights into the exclusivity only within the United States, but Lorbrena 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 Lorbrena's family patents as well as insights into ongoing legal events on those patents.
Lorbrena's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lorbrena's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lorbrena Generics:
There are no approved generic versions for Lorbrena as of now.
About Lorbrena
Lorbrena is a drug owned by Pfizer Inc. It is used for treating adult patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. Lorbrena uses Lorlatinib as an active ingredient. Lorbrena was launched by Pfizer in 2018.
Can you believe Lorbrena received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Lorbrena was approved by FDA for market use on 02 November, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Lorbrena is 02 November, 2018, its NCE-1 date is estimated to be 02 November, 2022.
Active Ingredient:
Lorbrena uses Lorlatinib as the active ingredient. Check out other Drugs and Companies using Lorlatinib ingredient
Treatment:
Lorbrena is used for treating adult patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive.
Dosage:
Lorbrena is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 25MG | TABLET | Prescription | ORAL |