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Generic Dsuvia Availability

Dsuvia is a brand name of sufentanil, approved by the FDA in the following formulation(s):

DSUVIA (sufentanil citrate - tablet;sublingual)

  • Manufacturer: ACELRX PHARMS
    Approval date: November 2, 2018
    Strength(s): EQ 0.03MG BASE [RLD]

Has a generic version of Dsuvia been approved?

No. There is currently no therapeutically equivalent version of Dsuvia available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dsuvia. 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 FAQs.

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.

  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 10,245,228
    Issued: April 2, 2019
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
      ✓ 
      Drug product
  • Small-volume oral transmucosal dosage forms
    Patent 10,342,762
    Issued: July 9, 2019
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Small-volume oral transmucosal dosage forms or NanoTabs® comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs® to administer a drug for the treatment of acute, post-operative or breakthrough pain.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Drug product
  • Patent 10,507,180

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
      ✓ 
      Drug product
  • Patent 10,896,751

    Patent expiration dates:

    • March 16, 2030
      ✓ 
      Drug product
  • Small-volume oral transmucosal dosage forms
    Patent 8,202,535
    Issued: June 19, 2012
    Inventor(s): Palmer; Pamela & Schreck; Thomas & Tzannis; Stelios & Hamel; Larry & Poutiatine; Andrew I.
    Assignee(s): Acelrx Pharmaceuticals, Inc.

    Small-volume oral transmucosal dosage forms or NanoTabs® comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs® to administer a drug for the treatment of acute, post-operative or breakthrough pain.

    Patent expiration dates:

    • October 22, 2030
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 8,226,978
    Issued: July 24, 2012
    Inventor(s): Palmer; Pamela & Schreck; Thomas & Tzannis; Stelios & Hamel; Larry & Poutiatine; Andrew I. & Rampersaud; Charles & Edwards; Bruce
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, methods and systems for administration of small volume sufentanil-containing drug dosage forms to the oral mucosa of a subject are disclosed.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
      ✓ 
      Drug product
  • Small-volume oral transmucosal dosage
    Patent 8,231,900
    Issued: July 31, 2012
    Inventor(s): Palmer; Pamela & Schreck; Thomas & Tzannis; Stelios & Hamel; Larry & Poutiatine; Andrew I.
    Assignee(s): Acelrx Pharmaceutical, Inc.

    Small-volume oral transmucosal dosage forms or NanoTabs® comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs® to administer a drug for the treatment of acute, post-operative or breakthrough pain.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Drug product
  • Bioadhesive drug formulations for oral transmucosal delivery
    Patent 8,252,328
    Issued: August 28, 2012
    Inventor(s): Tzannis; Stelios & Palmer; Pamela & Schreck; Thomas & Hamel; Larry & Poutiatine; Andrew I.
    Assignee(s): Acelrx Pharmaceuticals, Inc.

    Formulations for controlled delivery of oral transmucosal medications are provided. The formulations are characterized as hydrogel-forming or eroding-types which are bioadhesive and provide for controlled and sustained release of the medication such that enhanced bioavailability and efficacy is provided.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Drug product
  • Bioadhesive drug formulations for oral transmucosal delivery
    Patent 8,252,329
    Issued: August 28, 2012
    Inventor(s): Tzannis; Stelios & Hamel; Larry & Palmer; Pamela & Schreck; Thomas & Poutiatine; Andrew I.
    Assignee(s): Acelrx Pharmaceuticals, Inc.

    Bioadhesive drug formulations that adhere to an oral mucosal membrane of a subject are provided together with single dose applicators and devices for delivering the drug formulations to the oral mucosa, and methods for using the same.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Drug product
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 8,535,714
    Issued: September 17, 2013
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
      ✓ 
      Drug product
  • Storage and dispensing devices for administration of oral transmucosal dosage forms
    Patent 8,574,189
    Issued: November 5, 2013
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.

    Patent expiration dates:

    • March 16, 2030
      ✓ 
      Drug product
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 8,778,393
    Issued: July 15, 2014
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, methods and systems for administration of small volume sufentanil-containing drug dosage forms to the oral mucosa of a subject are disclosed.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Small-volume oral transmucosal dosage forms
    Patent 8,778,394
    Issued: July 15, 2014
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Small-volume oral transmucosal dosage forms or NanoTabs® comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs® to administer a drug for the treatment of acute, post-operative or breakthrough pain.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Bioadhesive drug formulations for oral transmucosal delivery
    Patent 8,865,211
    Issued: October 21, 2014
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Bioadhesive drug formulations that adhere to an oral mucosal membrane of a subject are provided together with single dose applicators and devices for delivering the drug formulations to the oral mucosa, and methods for using the same.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 8,865,743
    Issued: October 21, 2014
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

    Patent expiration dates:

    • October 22, 2030
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Sufentanil solid dosage forms comprising oxygen scavengers and methods of using the same
    Patent 8,945,592
    Issued: February 3, 2015
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions and methods effective to minimize or eliminate the presence of oxidative degradation products in solid dosage forms comprising sufentanil are provided.

    Patent expiration dates:

    • July 29, 2031
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      Drug product
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 9,320,710
    Issued: April 26, 2016
    Assignee(s): AcelRX Pharmaceuticals, Inc.

    Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Patent use: TREATMENT OF ACUTE PAIN
  • Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
    Patent 9,744,129
    Issued: August 29, 2017
    Assignee(s): AcelRx Pharmaceuticals, Inc.

    Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.

    Patent expiration dates:

    • January 5, 2027
      ✓ 
      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • November 2, 2021 - NEW PRODUCT

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.