AFINITOR Drug Patent Profile

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

Afinitor is a drug marketed by Novartis and Novartis Pharm and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-nine patent family members in thirty-one countries.

The generic ingredient in AFINITOR is everolimus. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the everolimus profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Afinitor

A generic version of AFINITOR was approved as everolimus by HIKMA on April 12^th, 2018.

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Summary for AFINITOR

International Patents:	229
US Patents:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	181
Patent Applications:	4,495
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AFINITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AFINITOR
What excipients (inactive ingredients) are in AFINITOR?	AFINITOR excipients list
DailyMed Link:	AFINITOR at DailyMed

Drug patent expirations by year for AFINITOR

Recent Clinical Trials for AFINITOR

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

Sponsor	Phase
Fudan University	Phase 3
Nationwide Children's Hospital	Phase 2
Stemline Therapeutics, Inc.	Phase 1/Phase 2

See all AFINITOR clinical trials

Pharmacology for AFINITOR

Drug Class	Kinase Inhibitor mTOR Inhibitor Immunosuppressant
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Paragraph IV (Patent) Challenges for AFINITOR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AFINITOR	Tablets	everolimus	2.5 mg, 5 mg, and 7.5 mg	022334	1	2014-12-10
AFINITOR	Tablets	everolimus	10 mg	022334	1	2014-06-18

US Patents and Regulatory Information for AFINITOR

AFINITOR is protected by one US patents.

Patents protecting AFINITOR

Neuroendocrine tumor treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-003	Jul 9, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AFINITOR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-001	Mar 30, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	⤷ Sign Up	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-004	Mar 30, 2012	⤷ Sign Up	⤷ Sign Up
Novartis	AFINITOR	everolimus	TABLET;ORAL	022334-002	Mar 30, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for AFINITOR

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novartis Europharm Limited	Afinitor	everolimus	EMEA/H/C/001038 Hormone-receptor-positive advanced breast cancerAfinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.Neuroendocrine tumours of pancreatic originAfinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.Neuroendocrine tumours of gastrointestinal or lung originAfinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.Renal-cell carcinomaAfinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.	Authorised	no	no	no	2009-08-02
Novartis Europharm Limited	Votubia	everolimus	EMEA/H/C/002311 Renal angiomyolipoma associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.The evidence is based on analysis of change in sum of angiomyolipoma volume.Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC)Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in disease‑related symptoms, has not been demonstrated.	Authorised	no	no	no	2011-09-02
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for AFINITOR

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

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Country	Patent Number	Title	Estimated Expiration
Japan	5165199		⤷ Sign Up
Argentina	026102	UN PROCESO PARA ESTABILIZAR UN MOCROLIDO DE POLIETILENO, UNA MEZCLA DE FORMA SOLIDA, UNA COMPOSICION FARMACEUTICA, UN DERIVADO DE RAPAMICINA Y UN PROCESOPARA SU PURIFICACION	⤷ Sign Up
Spain	2288033		⤷ Sign Up
Norway	2015010		⤷ Sign Up
Australia	1657300		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AFINITOR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663916	SPC001/2010	Ireland	⤷ Sign Up	SPC001/2010: 20101001, EXPIRES: 20180717
3342411	301032	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
3351246	LUC00138	Luxembourg	⤷ Sign Up	PRODUCT NAME: EVEROLIMUS; AUTHORISATION NUMBER AND DATE: EU/1/09/538/001-008 20120725
3351246	PA2019521	Lithuania	⤷ Sign Up	PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-008 20120723
2269604	PA2016035	Lithuania	⤷ Sign Up	PRODUCT NAME: EVEROLIMUZAS; REGISTRATION NO/DATE: EU/1/09/538/001-006 20090803
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description