MYFORTIC Drug Patent Profile

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Which patents cover Myfortic, and when can generic versions of Myfortic launch?

Myfortic is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in MYFORTIC is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myfortic

A generic version of MYFORTIC was approved as mycophenolic sodium by APOTEX INC on August 21^st, 2012.

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Summary for MYFORTIC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	118
Drug Prices:	Drug price information for MYFORTIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MYFORTIC
What excipients (inactive ingredients) are in MYFORTIC?	MYFORTIC excipients list
DailyMed Link:	MYFORTIC at DailyMed

Drug patent expirations by year for MYFORTIC

Recent Clinical Trials for MYFORTIC

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 4
Nantes University Hospital	Phase 4
Regimmune Corporation	Phase 1

See all MYFORTIC clinical trials

Pharmacology for MYFORTIC

Drug Class	Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYFORTIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	180 mg	050791	1	2009-06-03
MYFORTIC	Delayed-release Tablets	mycophenolic sodium	360 mg	050791	1	2009-02-02

US Patents and Regulatory Information for MYFORTIC

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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	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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 MYFORTIC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
Novartis	MYFORTIC	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MYFORTIC

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

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Country	Patent Number	Title	Estimated Expiration
Greece	1002893	ΦΑΡΜΑΚΕΥΤΙΚΕΣ ΣΥΝΘΕΣΕΙΣ ΜΕ ΕΝΤΕΡΙΚΗ ΕΠΙΚΑΛΥΨΗ (ENTERIC COATED PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	9738689		⤷ Sign Up
Norway	322891		⤷ Sign Up
Japan	2000503665		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MYFORTIC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0892640	91094	Luxembourg	⤷ Sign Up	91094, EXPIRES: 20181010
0892640	SPC017/2004	Ireland	⤷ Sign Up	SPC017/2004, 20060201, EXPIRES: 20171023
0892640	SPC/GB04/030	United Kingdom	⤷ Sign Up	SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640	CA 2004 00024	Denmark	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description