Question 1

Is there a generic for Sirolimus?

Accepted Answer

Yes. The FDA Orange Book lists 11 approved generic (ANDA) applications for Sirolimus, referencing the brand HYFTOR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Sirolimus?

Accepted Answer

HYFTOR (NDA 213478, NOBELPHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sirolimus?

Accepted Answer

The Orange Book lists 7 patents against Sirolimus products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Sirolimus have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Sirolimus. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Sirolimus are approved?

Accepted Answer

Sirolimus is approved in the following dosage forms: gel, powder, solution, tablet.

Product	Applicant	Application	TE	Approved
HYFTORRLD	NOBELPHARMA	NDA 213478	—	Mar 22, 2022
FYARRORLD	AADI	NDA 213312	—	Nov 22, 2021
RAPAMUNERLD×4	PF PRISM CV	NDA 021110	AB	Jan 25, 2010
RAPAMUNERLD	PF PRISM CV	NDA 021083	AA	Sep 15, 1999

Product	Applicant	Application	TE	Approved
SIROLIMUS	RISING	ANDA 215116	AA	Jul 15, 2025
SIROLIMUS	HETERO LABS LTD V	ANDA 215080	AA	Sep 16, 2024
SIROLIMUS×3	ZYDUS PHARMS	ANDA 201676	AB	Feb 15, 2023
SIROLIMUS	MSN	ANDA 216728	AA	Jan 19, 2023
SIROLIMUS	TORRENT	ANDA 215016	—	Dec 27, 2021
SIROLIMUS×3	ALKEM LABS LTD	ANDA 214753	AB	Mar 12, 2021
SIROLIMUS×3	GLENMARK PHARMS LTD	ANDA 208691	AB	Oct 16, 2020
SIROLIMUS	APOTEX	ANDA 211406	AA	Oct 22, 2019
SIROLIMUS	AMNEAL	ANDA 211212	AA	Oct 18, 2019
SIROLIMUS	NOVITIUM PHARMA	ANDA 211040	AA	Jan 28, 2019
SIROLIMUS×2	DR REDDYS	ANDA 201578	AB	Oct 27, 2014

Patent	Expires	In	Type
8911786	Feb 14, 2029	in 2 yr 8 mo	ProductU-3259
10206887	Apr 15, 2030	in 3 yr 11 mo	Product
12061183	Mar 05, 2036	in 9 yr 10 mo	Product
10705070	Mar 05, 2036	in 9 yr 10 mo	Product
12133844	Jun 29, 2036	in 10 yr 2 mo	U-4040
10973806	Jun 29, 2036	in 10 yr 2 mo	U-3258
11497737	Oct 28, 2040	in 14 yr 7 mo	Product

Sirolimus

Brand (NDA) products · gel, powder, solution, tablet

Generic (ANDA) products (11)

Marketing exclusivity (2)

Listed patents (7)

Sirolimus — frequently asked questions

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