Generic Subsys Availability
Last updated on Sep 11, 2024.
Subsys is a brand name of fentanyl, approved by the FDA in the following formulation(s):
SUBSYS (fentanyl - spray;sublingual)
-
Manufacturer: BTCP PHARMA
Approval date: January 4, 2012
Strength(s): 0.1MG (discontinued) [RLD], 0.2MG (discontinued) [RLD], 0.4MG (discontinued) [RLD], 0.6MG (discontinued) [RLD], 0.8MG (discontinued) [RLD] -
Manufacturer: BTCP PHARMA
Approval date: August 30, 2012
Strength(s): 1.2MG (discontinued) [RLD], 1.6MG (discontinued) [RLD]
All of the above formulations have been discontinued.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Subsys. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
-
Sublingual fentanyl spray
Patent 10,016,403
Issued: July 10, 2018
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): INSYS DEVELOPMENT COMPANY, INC.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓
- January 25, 2027
-
Sublingual fentanyl spray
Patent 10,610,523
Issued: April 7, 2020
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): BTCP PHARMA, LLCThe present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓
- January 25, 2027
-
Sublingual fentanyl spray
Patent 8,486,972
Issued: July 16, 2013
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Parikh Neha & Kattookaran Linet
Assignee(s): Insys Therapeutics, Inc.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- April 27, 2030✓
- April 27, 2030
-
Sublingual fentanyl spray
Patent 8,486,973
Issued: July 16, 2013
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): Insys Therapeutics, Inc.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- April 27, 2030✓
- April 27, 2030
-
Sublingual fentanyl spray
Patent 8,835,459
Issued: September 16, 2014
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): Insys Therapeutics, Inc.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓
- January 25, 2027
-
Sublingual fentanyl spray and methods of treating pain
Patent 8,835,460
Issued: September 16, 2014
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): Insys Therapeutics, Inc.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓✓
- January 25, 2027
-
Sublingual fentanyl spray
Patent 9,241,935
Issued: January 26, 2016
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): Insys Pharma, Inc.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓
- January 25, 2027
-
Method of treating pain by administering sublingual fentanyl spray
Patent 9,289,387
Issued: March 22, 2016
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): INSYS DEVELOPMENT COMPANY, INC.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓✓
- January 25, 2027
-
Sublingual fentanyl spray and methods of use to treat pain
Patent 9,642,797
Issued: May 9, 2017
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): INSYS DEVELOPMENT COMPANY, INC.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓✓
- January 25, 2027
-
Sublingual fentanyl spray
Patent 9,642,844
Issued: May 9, 2017
Inventor(s): Kottayil S. George & Goskonda Venkat R. & Zhu Zhongyuan & Kattookaran Linet & Parikh Neha
Assignee(s): INSYS DEVELOPMENT COMPANY, INC.The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Patent expiration dates:
- January 25, 2027✓
- January 25, 2027
More about Subsys (fentanyl)
- Subsys consumer information
- Check interactions
- Compare alternatives
- Reviews (12)
- Latest FDA alerts (14)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: Opioids (narcotic analgesics)
- Breastfeeding
- En español
Related treatment guides
Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.