Rapamune is a drug owned by Pf Prism Cv. It is protected by 7 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 28, 2022. Details of Rapamune'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). | |||
|
US5989591 (Pediatric) | Rapamycin formulations for oral administration |
Sep, 2018
(8 years ago) |
Expired
|
| US5989591 | Rapamycin formulations for oral administration |
Mar, 2018
(8 years ago) |
Expired
|
|
US5536729 (Pediatric) | Rapamycin formulations for oral administration |
Mar, 2014
(12 years ago) |
Expired
|
|
US5100899 (Pediatric) | Methods of inhibiting transplant rejection in mammals using rapamycin and derivatives and prodrugs thereof |
Jan, 2014
(12 years ago) |
Expired
|
| US5536729 | Rapamycin formulations for oral administration |
Sep, 2013
(13 years ago) |
Expired
|
| US5100899 | Methods of inhibiting transplant rejection in mammals using rapamycin and derivatives and prodrugs thereof |
Jul, 2013
(13 years ago) |
Expired
|
|
US5403833 (Pediatric) | Methods of inhibiting transplant rejecton in mammals using rapamycin and derivatives and prodrugs thereof |
Oct, 2012
(14 years ago) |
Expired
|
FDA has granted several exclusivities to Rapamune. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Rapamune, 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
Rapamune.
Exclusivity Information
Rapamune holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Rapamune's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | May 28, 2022 |
| Orphan Drug Exclusivity(ODE-92) | May 28, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Rapamune 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 Rapamune's family patents as well as insights into
ongoing legal events
on those patents.
Rapamune's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Rapamune:
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:
Rapamune's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 28, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rapamune Generic API suppliers:
Sirolimus is the generic name for the brand Rapamune. 11 different companies have already filed for the generic of Rapamune, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rapamune's generic
How can I launch a generic of Rapamune before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rapamune's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rapamune'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 Rapamune -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 28 Sep, 2010 | 11 Mar, 2018 | Eligible | 08 Jan, 2014 | Less | |
| 17 Dec, 2009 | 11 Mar, 2018 | Extinguished | Less |
Alternative Brands for Rapamune
Rapamune which is used for preventing transplant rejection in patients undergoing organ transplantation., has several other brand drugs using the same active ingredient (Sirolimus). 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, Rapamune's active ingredient. Check the complete list of approved generic manufacturers for Rapamune
About Rapamune
Rapamune is a drug owned by Pf Prism Cv. It is used for preventing transplant rejection in patients undergoing organ transplantation. Rapamune uses Sirolimus as an active ingredient. Rapamune was launched by Pf Prism Cv in 2010.
Approval Date:
Rapamune was approved by FDA for market use on 25 January, 2010.
Active Ingredient:
Rapamune uses Sirolimus as the active ingredient. Check out other Drugs and Companies using Sirolimus ingredient
Treatment:
Rapamune is used for preventing transplant rejection in patients undergoing organ transplantation.
Dosage:
Rapamune is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 0.5MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 1MG/ML | SOLUTION | Prescription | ORAL |