Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Prevents organ rejection. Sold as Rapamune, Fyarro, Hyftor, Scomara. Every FDA application for this active ingredient: 5 branded and 11 generic.
As of Nov 14, 2026, FDA lists 16 applications for Sirolimus (sold as Rapamune, Fyarro, Hyftor and others), first approved Sep 15, 1999, with 12 new uses approved and 2 published complete response letters.
First approved: Sep 15, 1999
Applications: 16
New uses approved: 12
Complete response letters: 2
Medicare spending, 2025: $20.5M
Orphan exclusivity until: Mar 22, 2029
First approved in the EU: Mar 13, 2001
First approved in Japan: Jul 4, 2014
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Sirolimus
Part D
$15.9M
-9%
8,670
Rapamune
Part B
$2.4M
-45%
6,168
Hyftor
Part D
$2.2M
+59%
109
Rapamune
Part D
$0K
-100%
0
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
SIROLIMUS 0.5 MG TABLET: $0.833 per unitGeneric · -54% in a year
SIROLIMUS 1 MG TABLET: $0.713 per unitGeneric · -52% in a year
SIROLIMUS 1 MG/ML SOLUTION: $4.21 per MLGeneric · -14% in a year
SIROLIMUS 2 MG TABLET: $2.35 per unitGeneric · -51% in a year
First approved in Japan 178 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Rapalimus, new approval(1) A drug with a new indication and a new dosage in an additional dosage form and (2) a drug with a new indication and a new dosage, for the treatment of… · Nobelpharma Co., Ltd. · Jan 18, 2024 · Review report
RapalimusA drug with a new indication and a new dosage for the treatment of refractory lymphatic disease (lymphangioma [lymphatic malformation], lymphangiomatosis,… · Nobelpharma Co., Ltd. · Sep 27, 2021
Rapalimus, new approvalA drug with a new route of administration indicated for the treatment of skin lesions associated with tuberous sclerosis complex. · Nobelpharma Co., Ltd. · Mar 23, 2018 · Review report
Rapalimus, new ingredientA drug with a new active ingredient indicated for the treatment of lymphangioleiomyomatosis. · Nobelpharma Co., Ltd. · Jul 4, 2014 · Review report
Clinical Trials
406 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Novitium Pharma
Apotex
Zydus Pharms