Avmapki Fakzynja Co-pack (copackaged) is a drug owned by Verastem Inc. It is protected by 6 US drug patents filed in 2025 out of which none have expired yet. Avmapki Fakzynja Co-Pack (Copackaged)'s patents will be open to challenges from 08 May, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 29, 2042. Details of Avmapki Fakzynja 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. | |||
| US7928109 | Sulfonyl amide derivatives for the treatment of abnormal cell growth |
Aug, 2029
(4 years from now) | Active |
| US8247411 | Sulfonyl amide derivatives for the treatment of abnormal cell growth |
Apr, 2028
(2 years from now) | Active |
| US7897792 | Coumarin derivative having antitumor activity |
Feb, 2027
(1 year, 6 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11873296 | Solid forms of a dual RAF/MEK inhibitor |
Dec, 2042
(17 years from now) | Active |
| US11517573 | Therapeutic compositions, combinations, and methods of use |
Sep, 2040
(15 years from now) | Active |
| US11400090 | Coumarin derivative for therapy or prophylaxis of a cell proliferative disorder |
Oct, 2038
(13 years from now) | Active |
FDA has granted several exclusivities to Avmapki Fakzynja Co-pack (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Avmapki Fakzynja 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 Avmapki Fakzynja Co-pack (copackaged).
Exclusivity Information
Avmapki Fakzynja Co-pack (copackaged) holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Avmapki Fakzynja Co-pack (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 08, 2030 |
US patents provide insights into the exclusivity only within the United States, but Avmapki Fakzynja 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 Avmapki Fakzynja Co-pack (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Avmapki Fakzynja Co-pack (copackaged)'s Family Patents
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Generic Launch
Generic Release Date:
Avmapki Fakzynja Co-pack (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 29, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avmapki Fakzynja Co-pack (copackaged) Generics:
There are no approved generic versions for Avmapki Fakzynja Co-pack (copackaged) as of now.
About Avmapki Fakzynja Co-pack (copackaged)
Avmapki Fakzynja Co-Pack (Copackaged) is a drug owned by Verastem Inc. Avmapki Fakzynja Co-Pack (Copackaged) uses Avutometinib Potassium; Defactinib Hydrochloride as an active ingredient. Avmapki Fakzynja Co-Pack (Copackaged) was launched by Verastem Inc in 2025.
Approval Date:
Avmapki Fakzynja Co-pack (copackaged) was approved by FDA for market use on 08 May, 2025.
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 Avmapki Fakzynja Co-pack (copackaged) is 08 May, 2025, its NCE-1 date is estimated to be 08 May, 2029.
Active Ingredient:
Avmapki Fakzynja Co-pack (copackaged) uses Avutometinib Potassium; Defactinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Avutometinib Potassium; Defactinib Hydrochloride ingredient
Dosage:
Avmapki Fakzynja Co-pack (copackaged) is available in capsule, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.8MG BASE;EQ 200MG BASE | CAPSULE, TABLET | Prescription | ORAL |