Kisqali Femara Co-pack (copackaged) is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 9 US drug patents filed from 2017 to 2024 out of which none have expired yet. Kisqali Femara Co-Pack (Copackaged)'s patents have been open to challenges since 13 March, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 14, 2036. Details of Kisqali Femara Co-pack (copackaged)'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. | |||
| US9193732 | Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-D]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof |
Nov, 2031
(6 years from now) | Active |
| US8415355 | Pyrrolopyrimidine compounds and their uses |
Mar, 2031
(6 years from now) | Active |
| US8685980 | Pyrrolopyrimidine compounds and their uses |
May, 2030
(5 years from now) | Active |
| US8324225 | Pyrrolopyrimidine compounds and their uses |
Jun, 2028
(3 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). | |||
| US12064434 | Ribociclib tablet |
Apr, 2036
(11 years from now) | Active |
| US10799506 | Ribociclib tablet |
Apr, 2036
(11 years from now) | Active |
| US9868739 | Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof |
Nov, 2031
(6 years from now) | Active |
| US8962630 | Pyrrolopyrimidine compounds and their uses |
Dec, 2029
(5 years from now) | Active |
| US9416136 | Pyrrolopyrimidine compounds and their uses |
Aug, 2029
(4 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 Kisqali Femara Co-pack (copackaged)'s patents.
Latest Legal Activities on Kisqali Femara Co-pack (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Kisqali Femara Co-pack (copackaged).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 May, 2024 | US8324225 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Mar, 2024 | US10799506 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Jan, 2024 | US9416136 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 May, 2023 | US9193732 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Aug, 2022 | US8962630 |
| Patent Term Extension Certificate Critical | 27 Apr, 2022 | US8415355 |
| Notice of Final Determination -Eligible | 18 Mar, 2022 | US8415355 |
| Withdrawal of Application for PTE Critical | 17 Mar, 2022 | US8324225 |
| Withdrawal of Application for PTE Critical | 17 Mar, 2022 | US8685980 |
| Withdrawal of Application for PTE Critical | 17 Mar, 2022 | US8962630 |
FDA has granted several exclusivities to Kisqali Femara Co-pack (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kisqali Femara Co-pack (copackaged), 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 Kisqali Femara Co-pack (copackaged).
Exclusivity Information
Kisqali Femara Co-pack (copackaged) holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Kisqali Femara Co-pack (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 13, 2022 |
| New Patient Population(NPP) | Dec 10, 2024 |
| New Indication(I-951) | Sep 17, 2027 |
US patents provide insights into the exclusivity only within the United States, but Kisqali Femara Co-pack (copackaged) 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 Kisqali Femara Co-pack (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Kisqali Femara Co-pack (copackaged)'s Family Patents
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Generic Launch
Generic Release Date:
Kisqali Femara Co-pack (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 14, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kisqali Femara Co-pack (copackaged) Generics:
There are no approved generic versions for Kisqali Femara Co-pack (copackaged) as of now.
How can I launch a generic of Kisqali Femara Co-pack (copackaged) before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kisqali Femara Co-pack (copackaged)'s patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kisqali Femara Co-pack (copackaged)'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 Kisqali Femara Co-pack (copackaged) -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg and 2.5 mg | 15 Mar, 2021 | 4 | 14 Apr, 2036 |
About Kisqali Femara Co-pack (copackaged)
Kisqali Femara Co-Pack (Copackaged) is a drug owned by Novartis Pharmaceuticals Corp. It is used for the initial endocrine-based therapy in adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Kisqali Femara Co-Pack (Copackaged) uses Letrozole; Ribociclib Succinate as an active ingredient. Kisqali Femara Co-Pack (Copackaged) was launched by Novartis in 2017.
Approval Date:
Kisqali Femara Co-pack (copackaged) was approved by FDA for market use on 04 May, 2017.
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 Kisqali Femara Co-pack (copackaged) is 04 May, 2017, its NCE-1 date is estimated to be 13 March, 2021.
Active Ingredient:
Kisqali Femara Co-pack (copackaged) uses Letrozole; Ribociclib Succinate as the active ingredient. Check out other Drugs and Companies using Letrozole; Ribociclib Succinate ingredient
Treatment:
Kisqali Femara Co-pack (copackaged) is used for the initial endocrine-based therapy in adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Dosage:
Kisqali Femara Co-pack (copackaged) is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG;EQ 200MG BASE | TABLET | Prescription | ORAL |