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Generic Vyvanse Availability

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

VYVANSE (lisdexamfetamine dimesylate - capsule;oral)

  • Manufacturer: SHIRE DEVELOPMENT
    Approval date: February 23, 2007
    Strength(s): 30MG, 50MG, 70MG [RLD]
  • Manufacturer: SHIRE DEVELOPMENT
    Approval date: December 10, 2007
    Strength(s): 20MG, 40MG, 60MG
  • Manufacturer: SHIRE DEVELOPMENT
    Approval date: October 30, 2014
    Strength(s): 10MG

Has a generic version of Vyvanse been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vyvanse. 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: About generic drugs.

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.

  • Abuse-resistant amphetamine compounds
    Patent 7,105,486
    Issued: September 12, 2006
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Rob & Piccariello; Thomas
    Assignee(s): New River Pharmaceuticals Inc.
    The invention describes compounds, compositions and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
  • Abuse resistant lysine amphetamine compounds
    Patent 7,223,735
    Issued: May 29, 2007
    Inventor(s): Mickle; Travis & Krishnan; Suma & Moncrief; James Scott & Lauderback; Christopher & Bishop; Barney & Oberlender; Rob & Piccariello; Thomas
    Assignee(s): New River Pharmaceuticals Inc.
    The present invention describes compounds, compositions and methods of using the same comprising lysine covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,655,630
    Issued: February 2, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Drug substance
  • Abuse-resistant amphetamine prodrugs
    Patent 7,659,253
    Issued: February 9, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,659,254
    Issued: February 9, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
  • Abuse resistant lysine amphetamine compounds
    Patent 7,662,787
    Issued: February 16, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Rob & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The present invention describes compounds, compositions and methods of using the same comprising lysine covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Drug substance
  • Abuse-resistant amphetamine prodrugs
    Patent 7,662,788
    Issued: February 16, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Abuse-resistant amphetamine prodrugs
    Patent 7,671,030
    Issued: March 2, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,671,031
    Issued: March 2, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Abuse-resistant amphetamine prodrugs
    Patent 7,674,774
    Issued: March 9, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,678,770
    Issued: March 16, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
  • Abuse-resistant amphetamine prodrugs
    Patent 7,678,771
    Issued: March 16, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
    • February 24, 2023
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,687,466
    Issued: March 30, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,687,467
    Issued: March 30, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,700,561
    Issued: April 20, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,713,936
    Issued: May 11, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Abuse-resistant amphetamine prodrugs
    Patent 7,718,619
    Issued: May 18, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Abuse-resistant amphetamine prodrugs
    Patent 7,723,305
    Issued: May 25, 2010
    Inventor(s): Mickle; Travis & Krishnan; Suma & Bishop; Barney & Lauderback; Christopher & Moncrief; James Scott & Oberlender; Robert & Piccariello; Thomas & Paul; Bernhard J. & Verbicky; Christopher A.
    Assignee(s): Shire LLC
    The invention describes compounds, compositions, and methods of using the same comprising a chemical moiety covalently attached to amphetamine. These compounds and compositions are useful for reducing or preventing abuse and overdose of amphetamine. These compounds and compositions find particular use in providing an abuse-resistant alternative treatment for certain disorders, such as attention deficit hyperactivity disorder (ADHD), ADD, narcolepsy, and obesity. Oral bioavailability of amphetamine is maintained at therapeutically useful doses. At higher doses bioavailability is substantially reduced, thereby providing a method of reducing oral abuse liability. Further, compounds and compositions of the invention decrease the bioavailability of amphetamine by parenteral routes, such as intravenous or intranasal administration, further limiting their abuse liability.
    Patent expiration dates:
    • February 24, 2023
      ✓ 
      Patent use: INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      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:
    • January 30, 2018 - MODERATE TO SEVERE BINGE EATING DISORDER (BED)
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Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.

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