BUTORPHANOL TARTRATE - Generic Drug Details

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

Butorphanol tartrate is the generic ingredient in four branded drugs marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apothecon, Apotex, Rising, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for butorphanol tartrate. Four suppliers are listed for this compound.

Summary for BUTORPHANOL TARTRATE

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	7
Patent Applications:	6,833
Drug Prices:	Drug price trends for BUTORPHANOL TARTRATE
What excipients (inactive ingredients) are in BUTORPHANOL TARTRATE?	BUTORPHANOL TARTRATE excipients list
DailyMed Link:	BUTORPHANOL TARTRATE at DailyMed

See drug prices for BUTORPHANOL TARTRATE

Recent Clinical Trials for BUTORPHANOL TARTRATE

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

Sponsor	Phase
Shanghai Zhongshan Hospital	N/A
Jiangsu Hengrui Pharmaceutical Co., Ltd.	Phase 4
The First Affiliated Hospital with Nanjing Medical University	Phase 4

See all BUTORPHANOL TARTRATE clinical trials

Pharmacology for BUTORPHANOL TARTRATE

Drug Class	Opioid Agonist/Antagonist
Mechanism of Action	Competitive Opioid Antagonists Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for BUTORPHANOL TARTRATE

Analgesics, Opioid
Antitussive Agents
Narcotic Antagonists
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for BUTORPHANOL TARTRATE

N02AF	Morphinan derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for BUTORPHANOL TARTRATE

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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
Baxter Hlthcare Corp	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	075695-002	Oct 23, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074620-002	Jan 22, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074626-002	Jan 23, 1997	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078247-001	Apr 29, 2009		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

Expired US Patents for BUTORPHANOL TARTRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991	⤷ Sign Up	⤷ Sign Up
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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