Generic Actonel Availability

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

ACTONEL (risedronate sodium - tablet; oral)

Has a generic version of Actonel been approved?

A generic version of Actonel 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 Actonel and have been approved by the FDA:

risedronate sodium tablet; oral

  • Manufacturer: TEVA PHARMS
    Approval date: October 5, 2007
    Strength(s): 30MG [AB], 35MG [AB], 5MG [AB]

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

  • Pharmaceutical compositions containing geminal diphosphonates
    Patent 5,583,122
    Issued: December 10, 1996
    Inventor(s): Benedict; James J. & Perkins; Christopher M.
    Assignee(s): The Procter & Gamble Company
    Pharmaceutical compositions, useful for treating abnormal calcium and phosphate metabolism, which contain geminal-diphosphonic acid compounds; and a method of treating diseases characterized by abnormal calcium and phosphate metabolism utilizing these pharmaceutical compositions.
    Patent expiration dates:
    • December 10, 2013
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      Patent use: METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
    • December 10, 2013
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      Patent use: ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 10, 2013
      ✓ 
      Patent use: METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • December 10, 2013
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      Patent use: PREVENTION AND TREATMENT OF OSTEOPOROSIS
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      Drug substance
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      Drug product
    • June 10, 2014
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      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 5,994,329
    Issued: November 30, 1999
    Inventor(s): Daifotis; Anastasia G. & Santora, II; Arthur C. & Yates; A. John
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
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      Patent use: PREVENTION AND TREATMENT OF OSTEOPOROSIS
    • January 17, 2019
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      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 6,015,801
    Issued: January 18, 2000
    Inventor(s): Daifotis; Anastasia G. & Yates; A. John & Santora, II; Arthur C.
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for caring out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
      ✓ 
      Patent use: PREVENTION AND TREATMENT OF OSTEOPOROSIS
    • January 17, 2019
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      Pediatric exclusivity
  • Film-coated tablet for improved upper gastrointestinal tract safety
    Patent 6,165,513
    Issued: December 26, 2000
    Inventor(s): Dansereau; Richard John & Bekker; Petrus Jakobus
    Assignee(s): The Procter & Gamble Co.
    A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.
    Patent expiration dates:
    • June 10, 2018
    • June 10, 2018
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      Drug product
    • December 10, 2018
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      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 6,432,932
    Issued: August 13, 2002
    Inventor(s): Anastasia G.; Daifotis & Arthur C.; Santora, II & A. John; Yates
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • July 17, 2018
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      Patent use: 35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN; 35 MG ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
    • January 17, 2019
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      Pediatric exclusivity
  • Method for inhibiting bone resorption
    Patent 6,465,443
    Issued: October 15, 2002
    Inventor(s): Anastasia G.; Daifotis & Arthur C.; Santora, II & A. John; Yates
    Assignee(s): Merck & Co., Inc.
    Disclosed are methods for inhibiting bone resorption in mammals while minimizing the occurrence of or potential for adverse gastrointestinal effects. Also disclosed are pharmaceutical compositions and kits for carrying out the therapeutic methods disclosed herein.
    Patent expiration dates:
    • August 14, 2018
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      Drug product
    • February 14, 2019
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      Pediatric exclusivity
  • Method of treatment using bisphosphonic acid
    Patent 7,192,938
    Issued: March 20, 2007
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffmann-La Roche Inc.
    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
    Patent expiration dates:
    • May 6, 2023
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      Patent use: PREVENTION AND TREATMENT OF OSTEOPOROSIS
    • November 6, 2023
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      Pediatric exclusivity
  • Method of treatment using bisphosphonic acid
    Patent 7,718,634
    Issued: May 18, 2010
    Inventor(s): Bauss; Frieder & Pichler; Bernhard & Turley; Stephen
    Assignee(s): Hoffman-La Roche Inc.
    The present invention refers to a pharmaceutical composition of a bisphosphonic acid or salt thereof, and an excipient thereof, and a method of treating disorder characterized by pathologically increased bone resorption comprising orally administering at least 150% of the expected efficious daily dose of a bisphosphonic acid or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients thereof and administering the dose at a period of one two or three consecutive days per month.
    Patent expiration dates:
    • May 6, 2023
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      Patent use: TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
    • November 6, 2023
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      Pediatric exclusivity

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:
    • July 23, 2012 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • January 23, 2013 - PEDIATRIC EXCLUSIVITY

See also...

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.
ABProducts 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.
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