RAPAMUNE Drug Patent Profile

When do Rapamune patents expire, and what generic alternatives are available?

Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs.

The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rapamune

A generic version of RAPAMUNE was approved as sirolimus by ZYDUS PHARMS on January 8^th, 2014.

Summary for RAPAMUNE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	230
Patent Applications:	3,445
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RAPAMUNE
What excipients (inactive ingredients) are in RAPAMUNE?	RAPAMUNE excipients list
DailyMed Link:	RAPAMUNE at DailyMed

See drug prices for RAPAMUNE

Recent Clinical Trials for RAPAMUNE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
West China Hospital	Phase 2
Haukeland University Hospital	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2

See all RAPAMUNE clinical trials

Pharmacology for RAPAMUNE

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Anatomical Therapeutic Chemical (ATC) Classes for RAPAMUNE

L01EG	Mammalian target of rapamycin (mTOR) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for RAPAMUNE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAPAMUNE	Tablets	sirolimus	0.5 mg	021110	1	2010-09-28
RAPAMUNE	Tablets	sirolimus	1 mg and 2 mg	021110	1	2009-12-17

US Patents and Regulatory Information for RAPAMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	AA	RX	Yes	Yes
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	AB	RX	Yes	Yes
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	AB	RX	Yes	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000	AB	RX	Yes	No
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004		DISCN	Yes	No

Expired US Patents for RAPAMUNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-001	Aug 25, 2000
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999

EU/EMA Drug Approvals for RAPAMUNE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Rapamune	sirolimus	EMEA/H/C/000273 Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued., , Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,	Authorised	no	no	no	2001-03-13
Plusultra pharma GmbH	Hyftor	sirolimus	EMEA/H/C/005896 Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.	Authorised	no	no	yes	2023-05-15

International Patents for RAPAMUNE

See the table below for patents covering RAPAMUNE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9303452	NANOPARTICULAS DE NSAID MODIFICADAS SUPERFICIALMENTE.
Germany	69309056
South Korea	100200061
Mexico	9303950	NANOPARTICULAS ANTICANCERIGENAS MODIFICADAS EN SU SUPERFICIE.
Denmark	0401747

Supplementary Protection Certificates for RAPAMUNE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0648494	C300055	Netherlands		PRODUCT NAME: SIROLIMUS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; NATL. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: CH CH/55243 20000926
0648494	SPC020/2001	Ireland		SPC020/2001: 20050808, EXPIRES: 20150925
0648494	24/2001	Austria		PRODUCT NAME: SIROLIMUS; NAT. REGISTRATION NO/DATE: EU/1/01/171/001 - EU/1/01/171/005 20010313; FIRST REGISTRATION: LI 5524301 20000926
0763039	PA2008009,C0763039	Lithuania		PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
0763039	SPC/GB08/025	United Kingdom		PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119