Generic Solodyn Availability
Last updated on Apr 10, 2024.
Solodyn is a brand name of minocycline, approved by the FDA in the following formulation(s):
SOLODYN (minocycline hydrochloride - tablet, extended release;oral)
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Manufacturer: BAUSCH
Approval date: May 8, 2006
Strength(s): EQ 45MG BASE (discontinued) [RLD], EQ 90MG BASE (discontinued) [RLD], EQ 135MG BASE (discontinued) [RLD] -
Manufacturer: BAUSCH
Approval date: July 23, 2009
Strength(s): EQ 65MG BASE [RLD] [AB], EQ 115MG BASE [RLD] [AB] -
Manufacturer: BAUSCH
Approval date: August 27, 2010
Strength(s): EQ 55MG BASE [RLD] [AB], EQ 80MG BASE [RLD] [AB], EQ 105MG BASE [RLD] [AB]
Has a generic version of Solodyn been approved?
A generic version of Solodyn 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 Solodyn and have been approved by the FDA:
minocycline hydrochloride tablet, extended release;oral
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Manufacturer: ALKEM LABS LTD
Approval date: September 28, 2016
Strength(s): EQ 80MG BASE [AB], EQ 105MG BASE [AB] -
Manufacturer: ALKEM LABS LTD
Approval date: March 16, 2018
Strength(s): EQ 65MG BASE [AB], EQ 115MG BASE [AB] -
Manufacturer: ALKEM LABS LTD
Approval date: December 19, 2019
Strength(s): EQ 55MG BASE [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: June 13, 2016
Strength(s): EQ 80MG BASE [AB], EQ 105MG BASE [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: September 28, 2018
Strength(s): EQ 65MG BASE [AB], EQ 115MG BASE [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: August 21, 2019
Strength(s): EQ 55MG BASE [AB] -
Manufacturer: CHARTWELL RX
Approval date: November 30, 2011
Strength(s): EQ 55MG BASE [AB] -
Manufacturer: SIDMAK LABS INDIA
Approval date: December 30, 2015
Strength(s): EQ 80MG BASE [AB], EQ 105MG BASE [AB] -
Manufacturer: SIDMAK LABS INDIA
Approval date: October 7, 2022
Strength(s): EQ 55MG BASE [AB], EQ 65MG BASE [AB], EQ 115MG BASE [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Solodyn. 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: Generic Drug FAQ.
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.
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Patent 7,541,347
Patent expiration dates:
- April 2, 2027✓
- April 2, 2027
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Patent 7,544,373
Patent expiration dates:
- April 2, 2027✓
- April 2, 2027
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Patent 7,790,705
Patent expiration dates:
- June 24, 2025✓
- June 24, 2025
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Patent 7,919,483
Patent expiration dates:
- March 7, 2027✓
- March 7, 2027
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Minocycline oral dosage forms for the treatment of acne
Patent 8,252,776
Issued: August 28, 2012
Inventor(s): Wortzman Mitchell & Plott R. Todd & Bhatia Kuljit & Patel Bhiku
Assignee(s): Medicis Pharmaceutical CorporationMinocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
Patent expiration dates:
- June 24, 2025✓
- June 24, 2025
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Minocycline oral dosage forms for the treatment of acne
Patent 8,268,804
Issued: September 18, 2012
Inventor(s): Wortzman Mitchell & Plott R. Todd & Bhatia Kuljit & Patel Bhiku
Assignee(s): Medicis Pharmaceutical CorporationMinocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
Patent expiration dates:
- June 24, 2025✓
- June 24, 2025
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Extended-release minocycline dosage forms
Patent 8,722,650
Issued: May 13, 2014
Inventor(s): Wortzman Mitchell & Plott R. Todd & Newhard Steven B. & Watt David
Assignee(s): Medicis Pharmaceutical CorporationAn oral dosage form has the following: an amount of minocycline selected from the group consisting of 55 mg, 80 mg, and 105 mg; an amount of lactose monohydrate; an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is at least 8.3 to about 9.8% hydroxypropoxylated. The minocycline in the oral dosage form has a dissolution profile or release rates about 35% to about 50% in 1 hour, about 60% to about 75% in 2 hours, and at least about 90% in 4 hours. There is also provided a method of treating acne in a human and a method of assisting a physician in prescribing a dose of minocycline for the treatment of acne.
Patent expiration dates:
- June 24, 2025✓
- June 24, 2025
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Method for the treatment of acne and certain dosage forms thereof
Patent 9,192,615
Issued: November 24, 2015
Inventor(s): Wortzman Mitchell & Plott R. Todd & Newhard Steven B. & Watt David
Assignee(s): Medicis Pharmaceutical CorporationAn oral dosage form, including 65 mg of minocycline, an amount of lactose monohydrate, and an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is hydroxypropylmethylcellulose that is about 8.9+/−0.2% hydroxypropoxylated. An oral dosage form, including 115 mg of minocycline, an amount of lactose monohydrate, and an amount of hydroxypropylmethylcellulose. The hydroxypropylmethylcellulose is hydroxypropylmethylcellulose that is about 8.9+/−0.2% hydroxypropoxylated.
Patent expiration dates:
- November 17, 2031✓
- November 17, 2031
More about Solodyn (minocycline)
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Patient resources
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Professional resources
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Glossary
Term | Definition |
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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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.