Generic Alphagan P Availability

Alphagan P is a brand name of brimonidine ophthalmic, approved by the FDA in the following formulation(s):

ALPHAGAN P (brimonidine tartrate - solution/drops;ophthalmic)

  • Manufacturer: ALLERGAN
    Approval date: March 16, 2001
    Strength(s): 0.15% [RLD] [AT]
  • Manufacturer: ALLERGAN
    Approval date: August 19, 2005
    Strength(s): 0.1% [RLD]

Has a generic version of Alphagan P been approved?

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

QOLIANA (brimonidine tartrate solution/drops;ophthalmic)

  • Manufacturer: ALCON PHARMS LTD
    Approval date: May 22, 2006
    Strength(s): 0.15% [AT]

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

  • Compositions containing therapeutically active components having enhanced solubility
    Patent 6,562,873
    Issued: May 13, 2003
    Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
    Assignee(s): Allergan, Inc.
    Compositions which include therapeutically active components, solubility enhancing components other than cyclodextrins, and oxy-chloro components, wherein the oxy-chloro components are substantially effective as preservatives. In one embodiment, the oxy-chloro components are useful for preserving the therapeutically active components. In one embodiment, the oxy-chloro components include chlorite components. In a useful embodiment, the solubility enhancing components include carboxymethylcellulose.
    Patent expiration dates:
    • July 10, 2021
    • July 10, 2021
      ✓ 
      Drug product
    • January 10, 2022
      ✓ 
      Pediatric exclusivity
  • Compositions containing &agr;-2-adrenergic agonist components
    Patent 6,627,210
    Issued: September 30, 2003
    Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
    Assignee(s): Allergan, Inc.
    Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
    Patent expiration dates:
    • July 18, 2021
      ✓ 
      Drug product
    • January 18, 2022
      ✓ 
      Pediatric exclusivity
  • Compositions containing alpha-2-adrenergic agonist components
    Patent 6,641,834
    Issued: November 4, 2003
    Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
    Assignee(s): Allergan Sales, Inc.
    Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
    Patent expiration dates:
    • July 28, 2021
      ✓ 
      Drug product
    • January 28, 2022
      ✓ 
      Pediatric exclusivity
  • Compositions containing alpha-2-adrenergic agonist components
    Patent 6,673,337
    Issued: January 6, 2004
    Inventor(s): Orest; Olejnik & Edward D. S.; Kerslake
    Assignee(s): Allergan, Inc.
    Compositions useful for improving effectiveness of alpha-2-adrenergic agonist components include carrier components, alpha-2-adrenergic agonist components, solubility enhancing components which aid in solubilizing the alpha-2-adrenergic agonist components. In one embodiment, the alpha-2-adrenergic agonist components include alpha-2-adrenergic agonists. In another embodiment, the solubility enhancing components include carboxymethylcellulose.
    Patent expiration dates:
    • July 26, 2021
      ✓ 
      Drug product
    • January 26, 2022
      ✓ 
      Pediatric exclusivity

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.
ATTopical products. There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data.
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