Generic Nuvigil Availability
NUVIGIL (armodafinil - tablet;oral)
Approval date: June 15, 2007
Strength(s): 50MG [AB], 150MG [AB], 250MG [RLD] [AB]
Has a generic version of Nuvigil been approved?
A generic version of Nuvigil has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Nuvigil and have been approved by the FDA:
Manufacturer: MYLAN PHARMS INC
Approval date: June 1, 2012
Strength(s): 50MG [AB], 150MG [AB], 250MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nuvigil. 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.
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.
Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Issued: November 7, 2006
Inventor(s): Neckebrock; Olivier & Leproust; Pierre
Assignee(s): Cephalon France
The invention relates to a process for the preparation of crystalline forms of the optical enantiomers of modafinil, comprising stages comprising: i) dissolving one of the optical enantiomers of modafinil in a solvent other than ethanol, ii) crystallising the modafinil enantiomer, iii) recovering the crystalline form of the modafinil enantiomer so obtained. The invention also relates to a process for the preparation of the optical enantiomers of modafinil.Patent expiration dates:
- December 18, 2023✓✓
- June 18, 2024✓
- December 18, 2023
Pharmaceutical formulations of modafinil
Issued: November 20, 2007
Inventor(s): Corvari; Vincent & Grandolfi; George & Parikh; Alpa
Assignee(s): Cephalon Inc.
The present invention is related to compositions of modafinil, including compositions of modafinil and one or more diluents, disintegrants, binders and lubricants, and the processes for their preparation thereof.Patent expiration dates:
- November 29, 2023✓
- May 29, 2024✓
- November 29, 2023
Acetamide derivative having defined particle size
Issued: January 15, 2002
Inventor(s): Peter E.; Grebow & Vincent; Corvari & David; Stong
Assignee(s): Cephalon, Inc.
Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug.Patent expiration dates:
- October 6, 2014✓✓
- April 6, 2015✓
- October 6, 2014
- Nuvigil Consumer Information (Drugs.com)
- Nuvigil Consumer Information (Wolters Kluwer)
- Nuvigil Consumer Information (Cerner Multum)
- Nuvigil Advanced Consumer Information (Micromedex)
- Nuvigil AHFS DI Monographs (ASHP)
- Armodafinil Consumer Information (Wolters Kluwer)
- Armodafinil Consumer Information (Cerner Multum)
- Armodafinil Advanced Consumer Information (Micromedex)
- Armodafinil AHFS DI Monographs (ASHP)
|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.|
|AB||Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.|