Ibrance is a drug owned by Pfizer Inc. It is protected by 6 US drug patents filed from 2015 to 2021. Out of these, 3 drug patents are active and 3 have expired. Ibrance's patents have been open to challenges since 03 February, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2036. Details of Ibrance'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. | |||
| US10723730 | Solid forms of a selective CDK4/6 inhibitor |
Feb, 2034
(9 years from now) | Active |
| USRE47739 | 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones |
Mar, 2027
(2 years from now) | Active |
| US6936612 | 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| US7208489 | 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones |
Jan, 2023
(1 year, 10 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11065250 | Solid dosage forms of palbociclib |
Aug, 2036
(11 years from now) | Active |
| US7456168 | 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones |
Jan, 2023
(1 year, 10 months 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 Ibrance's patents.
Latest Legal Activities on Ibrance's Patents
Given below is the list of recent legal activities going on the following patents of Ibrance.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Dec, 2023 | US10723730 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 20 Jul, 2021 | US11065250 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Jul, 2021 | US11065250 |
| Email Notification Critical | 01 Jul, 2021 | US11065250 |
| Issue Notification Mailed Critical | 30 Jun, 2021 | US11065250 |
| Dispatch to FDC | 21 Jun, 2021 | US11065250 |
| Issue Fee Payment Received Critical | 17 Jun, 2021 | US11065250 |
| Issue Fee Payment Verified Critical | 17 Jun, 2021 | US11065250 |
| Application Is Considered Ready for Issue Critical | 17 Jun, 2021 | US11065250 |
| Mail Response to 312 Amendment (PTO-271) Critical | 11 Jun, 2021 | US11065250 |
FDA has granted several exclusivities to Ibrance. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ibrance, 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 Ibrance.
Exclusivity Information
Ibrance holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Ibrance's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-725) | Feb 19, 2019 |
| New Chemical Entity Exclusivity(NCE) | Feb 03, 2020 |
Several oppositions have been filed on Ibrance's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ibrance's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ibrance patents.
Ibrance's Oppositions Filed in EPO
Ibrance has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 12, 2019, by Galenicum Health S.L.U.. This opposition was filed on patent number EP14705884A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP18186675A | Jan, 2022 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP18186675A | Jan, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP18186675A | Jan, 2022 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP18186675A | Jan, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Generics [UK] Limited | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Synthon BV | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Hexal AG | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Galenicum Health S.L. | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Hoffmann Eitle | Granted and Under Opposition |
| EP16726192A | Aug, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14705884A | Jun, 2019 | Generics (UK) Ltd | Granted and Under Opposition |
| EP14705884A | Jun, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14705884A | Jun, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Ibrance 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 Ibrance's family patents as well as insights into ongoing legal events on those patents.
Ibrance's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ibrance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ibrance Generic API suppliers:
Palbociclib is the generic name for the brand Ibrance. 1 company has already filed for the generic of Ibrance. Check out the entire list of companies who have already received approval for Ibrance's generic
How can I launch a generic of Ibrance before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ibrance's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ibrance's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ibrance -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mg, 100 mg and 125 mg | 04 Feb, 2019 | 12 | 22 Jan, 2023 | Extinguished | |
| 75 mg, 100 mg and 125 mg | 24 Nov, 2020 | 1 | 28 Feb, 2034 |
About Ibrance
Ibrance is a drug owned by Pfizer Inc. It is used for treating HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant. Ibrance uses Palbociclib as an active ingredient. Ibrance was launched by Pfizer in 2019.
Approval Date:
Ibrance was approved by FDA for market use on 01 November, 2019.
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 Ibrance is 01 November, 2019, its NCE-1 date is estimated to be 03 February, 2019.
Active Ingredient:
Ibrance uses Palbociclib as the active ingredient. Check out other Drugs and Companies using Palbociclib ingredient
Treatment:
Ibrance is used for treating HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant.
Dosage:
Ibrance is available in the following dosage forms - tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 125MG | TABLET | Prescription | ORAL |
| 100MG | CAPSULE | Prescription | ORAL |
| 75MG | CAPSULE | Prescription | ORAL |