Actonel is a brand name of risedronate, approved by the FDA in the following formulation(s):
ACTONEL (risedronate sodium - tablet; oral)
Manufacturer: WARNER CHILCOTT
Approval date: March 27, 1998
Strength(s): 30MG [AB]
Manufacturer: WARNER CHILCOTT
Approval date: April 14, 2000
Strength(s): 5MG [AB]
Manufacturer: WARNER CHILCOTT
Approval date: May 25, 2002
Strength(s): 35MG [RLD][AB]
Manufacturer: WARNER CHILCOTT
Approval date: April 22, 2008
Strength(s): 150MG [RLD]
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✓
- December 10, 2013✓✓✓
- December 10, 2013✓✓✓
- December 10, 2013✓✓✓
- June 10, 2014✓
- December 10, 2013
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✓
- January 17, 2019✓
- July 17, 2018
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✓
- January 17, 2019✓
- July 17, 2018
Dosage forms of risedronate
Patent 6,096,342
Issued: August 1, 2000
Inventor(s): Dansereau; Richard John & Mosher; Russell Youker & Axelrod; Douglas Wayne & Sietsema; William Kendall
Assignee(s): The Procter & Gamble Company
The present invention is directed to a novel enteric-coated oral dosage form of a risedronate active ingredient comprised of a safe and effective amount of a pharmaceutical compostion which is comprised of a risedronate active ingredient and pharmaceutically-acceptable excipients. Said dosage forms prohibit the exposure of the risedronate active ingredient to the epithelial and mucosal tissues of the buccal cavity, pharynx, esophagus, and stomach and thereby protects said tissues from erosion, ulceration or other like irritation. Accordingly, the said dosage forms effect the delivery to the lower intestinal tract of said human or other mammal of a safe and effective amount of the risedronate active ingredient, and substantially alleviate the esophagitis or esophageal irritation which sometimes accompanies the oral administration of risedronate active ingredients.Patent expiration dates:
- November 22, 2011
- November 22, 2011✓
- November 22, 2011✓✓
- May 22, 2012✓
- November 22, 2011
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✓
- December 10, 2018✓
- June 10, 2018
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✓
- January 17, 2019✓
- July 17, 2018
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✓
- February 14, 2019✓
- August 14, 2018
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✓
- November 6, 2023✓
- May 6, 2023
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✓
- November 6, 2023✓
- May 6, 2023
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:
- October 16, 2010 - PEDIATRIC EXCLUSIVITY
- April 22, 2011 - NEW STRENGTH
- October 22, 2011 - PEDIATRIC EXCLUSIVITY
- July 23, 2012 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
- January 23, 2013 - PEDIATRIC EXCLUSIVITY
See also...
- Actonel Consumer Information (Drugs.com)
- Actonel Consumer Information (Wolters Kluwer)
- Actonel Consumer Information (Cerner Multum)
- Actonel Advanced Consumer Information (Micromedex)
- Actonel AHFS DI Monographs (ASHP)
- Risedronate Delayed-Release Tablets Consumer Information (Wolters Kluwer)
- Risedronate Tablets Consumer Information (Wolters Kluwer)
- Risedronate Consumer Information (Cerner Multum)
- Risedronate Advanced Consumer Information (Micromedex)
- Risedronate Sodium AHFS DI Monographs (ASHP)
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