Dalteparin sodium - Generic Drug Details

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What are the generic sources for dalteparin sodium and what is the scope of freedom to operate?

Dalteparin sodium is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for dalteparin sodium. One supplier is listed for this compound.

Summary for dalteparin sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	17
What excipients (inactive ingredients) are in dalteparin sodium?	dalteparin sodium excipients list
DailyMed Link:	dalteparin sodium at DailyMed

Recent Clinical Trials for dalteparin sodium

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

Sponsor	Phase
Imperial College London	Phase 4
Xijing Hospital	Phase 2/Phase 3
PharmaDiall Ltd.	Phase 2

See all dalteparin sodium clinical trials

Pharmacology for dalteparin sodium

Drug Class	Anti-coagulant Low Molecular Weight Heparin

Medical Subject Heading (MeSH) Categories for dalteparin sodium

Anticoagulants
Fibrinolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for dalteparin sodium

B01AB	Heparin group
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for dalteparin 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
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-010	May 1, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-006	Apr 4, 2002		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-009	May 1, 2007		RX	Yes	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 dalteparin sodium

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

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