Hyftor is a drug owned by Nobelpharma Co Ltd. It is protected by 1 US drug patent filed in 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 11, 2045. Details of Hyftor'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). | |||
| US12740970 | Rapamycin-Containing Pharmaceutical Composition |
Apr, 2045
(18 years from now) | Active |
FDA has granted several exclusivities to Hyftor. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Hyftor, 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
Hyftor.
Exclusivity Information
Hyftor holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Hyftor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 22, 2025 |
| Orphan Drug Exclusivity(ODE-391) | Mar 22, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Hyftor 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 Hyftor's family patents as well as insights into
ongoing legal events
on those patents.
Hyftor's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Hyftor:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Hyftor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 11, 2045 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hyftor Generic API suppliers:
Sirolimus is the generic name for the brand Hyftor. 11 different companies have already filed for the generic of Hyftor, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hyftor's generic
Alternative Brands for Hyftor
There are several other brand drugs using the same active ingredient (Sirolimus) as Hyftor. 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sirolimus, Hyftor's active ingredient. Check the complete list of approved generic manufacturers for Hyftor
About Hyftor
Hyftor is a drug owned by Nobelpharma Co Ltd. Hyftor uses Sirolimus as an active ingredient. Hyftor was launched by Nobelpharma in 2022.
Approval Date:
Hyftor was approved by FDA for market use on 22 March, 2022.
Active Ingredient:
Hyftor uses Sirolimus as the active ingredient. Check out other Drugs and Companies using Sirolimus ingredient
Dosage:
Hyftor is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2% | GEL | Prescription | TOPICAL |