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FRAGMIN Drug Profile

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

Fragmin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.

Summary for FRAGMIN

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	33
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FRAGMIN
What excipients (inactive ingredients) are in FRAGMIN?	FRAGMIN excipients list
DailyMed Link:	FRAGMIN at DailyMed

See drug prices for FRAGMIN

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for FRAGMIN

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

020287

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FRAGMIN

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

Sponsor	Phase
Sunnybrook Health Sciences Centre	Phase 3
Sunnybrook Research Institute	Phase 3
Asan Medical Center	Phase 2

See all FRAGMIN clinical trials

Pharmacology for FRAGMIN

Drug Class

Anti-coagulant Low Molecular Weight Heparin

US Patents and Regulatory Information for FRAGMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;INJECTION	020287-008	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-009	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-005	Apr 4, 2002		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-010	May 1, 2007		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-001	Dec 22, 1994		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998		RX	Yes	No

Expired US Patents for FRAGMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-001	Dec 22, 1994
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996

International Patents for FRAGMIN

Country	Patent Number	Estimated Expiration
Denmark	380280
Norway	150801
World Intellectual Property Organization (WIPO)	8001383
U.S.S.R.	1209033
Netherlands	930104
Japan	S6344764
Canada	1136620