SUFENTANIL CITRATE - Generic Drug Details

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What are the generic sources for sufentanil citrate and what is the scope of freedom to operate?

Sufentanil citrate is the generic ingredient in three branded drugs marketed by Rising, Hikma, Hospira, Watson Labs, and Vertical Pharms, and is included in five NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sufentanil citrate has one hundred and five patent family members in twenty countries.

There are five drug master file entries for sufentanil citrate. Three suppliers are listed for this compound.

Summary for SUFENTANIL CITRATE

International Patents:	105
US Patents:	21
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	7
Patent Applications:	1,067
What excipients (inactive ingredients) are in SUFENTANIL CITRATE?	SUFENTANIL CITRATE excipients list
DailyMed Link:	SUFENTANIL CITRATE at DailyMed

Recent Clinical Trials for SUFENTANIL CITRATE

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

Sponsor	Phase
Brugmann University Hospital	Phase 3
Jiangang Song	N/A
West China Hospital	Phase 4

See all SUFENTANIL CITRATE clinical trials

Pharmacology for SUFENTANIL CITRATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for SUFENTANIL CITRATE

Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for SUFENTANIL CITRATE

N01AH	Opioid anesthetics
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

US Patents and Regulatory Information for SUFENTANIL CITRATE

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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
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertical Pharms	DSUVIA	sufentanil citrate	TABLET;SUBLINGUAL	209128-001	Nov 2, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma	SUFENTANIL CITRATE	sufentanil citrate	INJECTABLE;INJECTION	074413-001	Dec 15, 1995	AP	RX	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 SUFENTANIL CITRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050-001	May 4, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SUFENTANIL CITRATE

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Country	Patent Number	Title	Estimated Expiration
South Korea	101445891		⤷ Sign Up
European Patent Office	2114383	FORMES DOSIFIÉES DE PETIT VOLUME DE MÉDICAMENT CONTENANT DU SUFENTANIL S'ADMINISTRANT PAR VOIE TRANS-MUQUEUSE ORALE POUR LE TRAITEMENT DE LA DOULEUR (SMALL VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS CONTAINING SUFENTANIL FOR TREATMENT OF PAIN)	⤷ Sign Up
Portugal	3072504		⤷ Sign Up
Spain	2348688		⤷ Sign Up
Canada	2673856	FORMES DOSIFIEES DE PETIT VOLUME DE MEDICAMENT CONTENANT DU SUFENTANIL S'ADMINISTRANT PAR VOIE TRANS-MUQUEUSE ORALE POUR LE TRAITEMENT DE LA DOULEUR (SMALL VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS CONTAINING SUFENTANIL FOR TREATMENT OF PAIN)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SUFENTANIL CITRATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2114383	SPC/GB16/004	United Kingdom	⤷ Sign Up	PRODUCT NAME: SUFENTANIL; REGISTERED: UK EU/1/15/1042 20150922
2114383	CA 2016 00007	Denmark	⤷ Sign Up	PRODUCT NAME: SUFENTANIL, HERUNDER SUFENTANIL SOM CITRAT; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383	CR 2016 00007	Denmark	⤷ Sign Up	PRODUCT NAME: SUFENTANIL; REG. NO/DATE: EU/1/15/1042/001-006 20150922
2114383	122016000023	Germany	⤷ Sign Up	PRODUCT NAME: SUFENTANIL, WAHLWEISE IN FORM VON SUFENTANILCITRAT; REGISTRATION NO/DATE: EU/1/15/1042 20150918
2114383	300797	Netherlands	⤷ Sign Up	PRODUCT NAME: SUFENTANIL, DESGEWENST IN DE VORM VAN SUFENTANILCITRAAT; REGISTRATION NO/DATE: EU/1/15/1042 20150922
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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