OXYTOCIN - Generic Drug Details

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What are the generic drug sources for oxytocin and what is the scope of freedom to operate?

Oxytocin is the generic ingredient in six branded drugs marketed by Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Sagent Pharms Inc, Abbott, Endo Operations, Novartis, and Rtrx, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for oxytocin. Five suppliers are listed for this compound.

Sponsor	Phase
University Hospital, Gentofte, Copenhagen	N/A
University of Colorado, Denver	Phase 2
Karolinska Institutet	Phase 2

Sponsor

Phase

University Hospital, Gentofte, Copenhagen

N/A

University of Colorado, Denver

Phase 2

Karolinska Institutet

Phase 2

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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
Abbott	OXYTOCIN 20 USP UNITS IN DEXTROSE 5%	oxytocin	INJECTABLE;INJECTION	019185-002	Mar 29, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbott	OXYTOCIN 5 USP UNITS IN DEXTROSE 5%	oxytocin	INJECTABLE;INJECTION	019185-001	Mar 29, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	OXYTOCIN	oxytocin	INJECTABLE;INJECTION	018243-002	Jan 10, 2007	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261-003	Sep 5, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	OXYTOCIN	oxytocin	INJECTABLE;INJECTION	077453-001	Jan 24, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	PITOCIN	oxytocin	INJECTABLE;INJECTION	018261-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rtrx	SYNTOCINON	oxytocin	SOLUTION;NASAL	012285-001	Approved Prior to Jan 1, 1982		DISCN	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

US Patents:	0
Tradenames:	6
Applicants:	9
NDAs:	9
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	762
Patent Applications:	6,627
Drug Prices:	Drug price trends for OXYTOCIN
What excipients (inactive ingredients) are in OXYTOCIN?	OXYTOCIN excipients list
DailyMed Link:	OXYTOCIN at DailyMed

Drug Class	Oxytocic
Physiological Effect	Increased Uterine Smooth Muscle Contraction or Tone