ABSTRAL Drug Patent Profile

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

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA.

The generic ingredient in ABSTRAL is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abstral

A generic version of ABSTRAL was approved as fentanyl citrate by HIKMA on July 11^th, 1984.

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Summary for ABSTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for ABSTRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL
What excipients (inactive ingredients) are in ABSTRAL?	ABSTRAL excipients list
DailyMed Link:	ABSTRAL at DailyMed

Drug patent expirations by year for ABSTRAL

Recent Clinical Trials for ABSTRAL

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Institute of Mountain Emergency Medicine	Phase 4

See all ABSTRAL clinical trials

Paragraph IV (Patent) Challenges for ABSTRAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19

US Patents and Regulatory Information for ABSTRAL

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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
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	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 ABSTRAL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ABSTRAL

See the table below for patents covering ABSTRAL around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2236133	Composition pharmaceutique contenant le Fentanyl pour le traitement de la douleur aiguë ou percée par la voie sub-linguale (Pharmaceutical composition comprising fentanyl for the treatment of acute or breakthrough pain by sublingual administration)	⤷ Sign Up
Spain	2289829		⤷ Sign Up
Estonia	200800028		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ABSTRAL

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	92636	Luxembourg	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	300714	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0383579	C960030	Netherlands	⤷ Sign Up	PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for ABSTRAL

Recent Clinical Trials for ABSTRAL

Paragraph IV (Patent) Challenges for ABSTRAL

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