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Fentanyl Citrate Patent Expiration

Fentanyl Citrate is Used for managing breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy. It was first introduced by Rising Pharma Holdings Inc in its drug Sublimaze Preservative Free on Approved Prior to Jan 1, 1982. Other drugs containing Fentanyl Citrate are Actiq, Fentora, Abstral, Fentanyl Citrate, Lazanda, Onsolis, Fentanyl. 16 different companies have introduced drugs containing Fentanyl Citrate.


Fentanyl Citrate Patents

Given below is the list of patents protecting Fentanyl Citrate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lazanda US9731869 Container Jan 26, 2032 Btcp Pharma
Fentora US7862832 Generally linear effervescent oral fentanyl dosage form and methods of administering Jun 15, 2028 Cephalon
Fentora US7862833 Effervescent oral opiate dosage forms and methods of administering opiates Jun 15, 2028 Cephalon
Onsolis US9579288 Tesofensine and beta blocker combination formulations Jul 23, 2027 Adalvo
Onsolis US9597288 Transmucosal delivery devices with enhanced uptake Jul 23, 2027 Adalvo
Fentora US8092832 Generally linear effervescent oral fentanyl dosage form and methods of administering Dec 30, 2024

(Expired)

 Cephalon
Fentora US8119158 Effervescent oral fentanyl dosage form and methods of administering fentanyl Dec 30, 2024

(Expired)

 Cephalon
Lazanda US8216604 Method of managing or treating pain Oct 03, 2024

(Expired)

 Btcp Pharma
Lazanda US8889176 Method of managing or treating pain Jan 16, 2024

(Expired)

 Btcp Pharma
Lazanda US9078814 Intranasal spray device containing pharmaceutical composition Jan 08, 2024

(Expired)

 Btcp Pharma
Lazanda US9814705 Intranasal spray device containing pharmaceutical composition Jan 08, 2024

(Expired)

 Btcp Pharma
Onsolis US7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Jan 22, 2020

(Expired)

 Adalvo
Abstral US6759059 Fentanyl composition for the treatment of acute pain Sep 24, 2019

(Expired)

 Sentynl Theraps Inc
Abstral US6761910 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

 Sentynl Theraps Inc
Abstral US7910132 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

 Sentynl Theraps Inc
Fentora US6200604 Sublingual buccal effervescent Mar 26, 2019

(Expired)

 Cephalon
Fentora US6974590 Sublingual buccal effervescent Mar 26, 2019

(Expired)

 Cephalon
Fentora US8728441 Sublingual buccal effervescent Mar 26, 2019

(Expired)

 Cephalon
Fentora US8753611 Sublingual buccal effervescent Mar 26, 2019

(Expired)

 Cephalon
Fentora US8765100 Transmucosal effervescent Mar 26, 2019

(Expired)

 Cephalon
Lazanda US6432440 Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces Apr 20, 2018

(Expired)

 Btcp Pharma
Onsolis US6159498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces Oct 18, 2016

(Expired)

 Adalvo



Fentanyl Citrate's Family Patents

Family Patents

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Fentanyl Citrate Generic API Manufacturers

Several generic applications have been filed for Fentanyl Citrate. The first generic version for Fentanyl Citrate was by Abbott Laboratories Hosp Products Div and was approved on Apr 30, 1990. And the latest generic version is by Dr Reddys Laboratories Sa and was approved on Aug 22, 2022.

Given below is the list of companies who have filed for Fentanyl Citrate generic, along with the locations of their manufacturing plants worldwide.


1. ABBOTT

Abbott Laboratories Hosp Products Div has filed for 1 generic for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Abbott.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML

injectable Discontinued INJECTION N/A Apr 30, 1990


Manufacturing Plant Locations
New

Abbott's manufacturing plants are situated in 7 countries - United States, Netherlands, United Kingdom, Norway, Germany, France, Ireland. Given below are the details of these plant locations as well as the firm names of Abbott as present at those locations.

Country City Firm Name
United States
Scarborough Abbott Diagnostics Scarborough, Inc.
Barceloneta Abbott Diagnostics International, Ltd.
Plymouth Abbott
Alameda Abbott Diabetes Care, Inc.
Clearwater ABBOTT BLACKSTONE CO.
Barceloneta Abbott Healthcare (Puerto Rico) Ltd.
Netherlands
Olst Abbott Biologicals BV
United Kingdom
Witney ABBOTT DIABETES CARE LIMITED
Norway
Oslo Abbott Diagnostics Technologies AS
Germany
Wiesbaden Abbott GmbH
France
Chatillon Sur Chalaronne Abbott Healthcare SAS
Ireland
Cootehill ABBOTT IRELAND LIMITED
Co. Longford Abbott Ireland Diagnostics Division
Donegal ABBOTT IRELAND DIABETES CARE
Sligo Abbott Ireland
Sligo Abbott Ireland Limited





2. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017
EQ 0.3MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017
EQ 0.4MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017
EQ 0.6MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017
EQ 0.8MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017
EQ 0.1MG BASE

tablet Discontinued SUBLINGUAL N/A Nov 17, 2017





3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Fentanyl Citrate. This eq 0.05mg base/ml version comes by the name FENTANYL CITRATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML

injectable Discontinued INJECTION N/A Feb 3, 1998





4. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022
EQ 0.1MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022
EQ 0.4MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022
EQ 0.3MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022
EQ 0.8MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022
EQ 0.6MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Aug 22, 2022





5. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML

injectable Prescription INJECTION AP Sep 1, 2020


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Wilson Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Grand Island Fresenius Kabi USA, LLC





6. HOSPIRA

Hospira Inc has filed for 1 generic for Fentanyl Citrate. This eq 0.05mg base/ml version comes by the name FENTANYL CITRATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML

injectable Discontinued INJECTION N/A Sep 24, 1991


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Lake Forest Hospira Inc
Rocky Mount Hospira, Inc.
Mcpherson Hospira, Inc., A Pfizer Company
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Clayton Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





7. PAR PHARM

Par Pharmaceutical Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Par Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.4MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.6MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.8MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 1.2MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 1.6MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009


Manufacturing Plant Locations
New

Par Pharm's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Par Pharm as present at those locations.

Country City Firm Name
United States
Stratford Par Pharmaceutical Inc.
Hauppauge Par Pharmaceuticals





8. SPECGX LLC

Specgx Llc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.2MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.4MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.6MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 0.8MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 1.2MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009
EQ 1.6MG BASE

troche/lozenge Discontinued TRANSMUCOSAL N/A Oct 30, 2009


Manufacturing Plant Locations
New

Specgx Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Specgx Llc as present at those locations.

Country City Firm Name
United States
Greenville SpecGx LLC
Raleigh SpecGx LLC
Saint Louis SpecGx LLC





9. WATSON LABS

Watson Laboratories Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 0.05MG BASE/ML

injectable Discontinued INJECTION N/A Jun 30, 1992
EQ 0.6MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Jan 7, 2011
EQ 0.2MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Jan 7, 2011
EQ 0.4MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Jan 7, 2011
EQ 0.8MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Jan 7, 2011
EQ 0.1MG BASE

tablet Discontinued BUCCAL, SUBLINGUAL N/A Jan 7, 2011