MYCOPHENOLIC SODIUM - Generic Drug Details

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What are the generic sources for mycophenolic sodium and what is the scope of patent protection?

Mycophenolic sodium is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, Wanbang Biopharms, and Novartis, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for MYCOPHENOLIC SODIUM

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	21
DailyMed Link:	MYCOPHENOLIC SODIUM at DailyMed

Recent Clinical Trials for MYCOPHENOLIC SODIUM

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

Sponsor	Phase
AstraZeneca	Phase 3
University Hospital, Tours	Phase 4
Lee's Pharmaceutical Limited	Phase 4

See all MYCOPHENOLIC SODIUM clinical trials

Pharmacology for MYCOPHENOLIC SODIUM

Drug Class	Antimetabolite Immunosuppressant

Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM

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 MYCOPHENOLIC SODIUM

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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
Wanbang Biopharms	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	216637-002	May 29, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocon Pharma	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	214630-002	Nov 29, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocon Pharma	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	217031-002	Nov 29, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	091558-001	Aug 21, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rk Pharma	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	091248-002	Jan 8, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	202555-001	Aug 23, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Twi Pharms	MYCOPHENOLIC SODIUM	mycophenolic sodium	TABLET, DELAYED RELEASE;ORAL	214289-001	Nov 3, 2021	AB	RX	No	No	⤷ 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 MYCOPHENOLIC SODIUM

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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
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

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