Lanthanum carbonate - Generic Drug Details

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What are the generic drug sources for lanthanum carbonate and what is the scope of patent protection?

Lanthanum carbonate is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa, Barr, Invagen Pharms, and Natco Pharma Ltd, and is included in five NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lanthanum carbonate has ninety-one patent family members in thirty-one countries.

There are nine drug master file entries for lanthanum carbonate. Six suppliers are listed for this compound.

Summary for lanthanum carbonate

International Patents:	91
US Patents:	4
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	43
Patent Applications:	1,525
Drug Prices:	Drug price trends for lanthanum carbonate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lanthanum carbonate
What excipients (inactive ingredients) are in lanthanum carbonate?	lanthanum carbonate excipients list
DailyMed Link:	lanthanum carbonate at DailyMed

See drug prices for lanthanum carbonate

Recent Clinical Trials for lanthanum carbonate

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

Sponsor	Phase
Medical Universtity of Lodz	Phase 4
Medical University of Lodz	Phase 4
Universitair Ziekenhuis Brussel	Phase 3

See all lanthanum carbonate clinical trials

Pharmacology for lanthanum carbonate

Drug Class	Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for lanthanum carbonate

V03AE	Drugs for treatment of hyperkalemia and hyperphosphatemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for LANTHANUM CARBONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FOSRENOL	Oral Powder	lanthanum carbonate	750 mg and 1000 mg	204734	1	2015-11-25
FOSRENOL	Chewable Tablet	lanthanum carbonate	500 mg, 750 mg and 1000 mg	021468	3	2008-10-27

US Patents and Regulatory Information for lanthanum carbonate

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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
Invagen Pharms	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	206868-002	Jan 24, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090977-002	Jan 27, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Natco Pharma Ltd	LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090978-001	Aug 11, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	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 lanthanum carbonate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-002	Oct 26, 2004	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-001	Oct 26, 2004	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-004	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	POWDER;ORAL	204734-002	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	FOSRENOL	lanthanum carbonate	TABLET, CHEWABLE;ORAL	021468-003	Nov 23, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for lanthanum carbonate

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Country	Patent Number	Title	Estimated Expiration
Hungary	E029382		⤷ Sign Up
Cyprus	1117082		⤷ Sign Up
European Patent Office	2645995	CAPSULE ET FORMULATIONS DE POUDRE CONTENANT DES COMPOSÉS DE LANTHANE (CAPSULE AND POWDER FORMULATIONS CONTAINING LANTHANUM COMPOUNDS)	⤷ Sign Up
Austria	460169		⤷ Sign Up
Spain	2478258		⤷ Sign Up
Portugal	2172205		⤷ Sign Up
China	103237543	Capsule and powder formulations containing lanthanum compounds	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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