Generic Tlando Availability

Last updated on May 7, 2025.

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

TLANDO (testosterone undecanoate - capsule;oral)

Manufacturer: VERITY
Approval date: March 28, 2022
Strength(s): 112.5MG ^[RLD]

Is there a generic version of Tlando available?

No. There is currently no therapeutically equivalent version of Tlando available in the United States.

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

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.

High-strength testosterone undecanoate compositions
Patent 10,226,473
Issued: March 12, 2019
Inventor(s): Giliyar Chandrashekar & Chickmath Basawaraj & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivansan
Assignee(s): Lipocine Inc.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cto serum testosterone Cof about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Crange for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
High-strength testosterone undecanoate compositions
Patent 10,716,794
Issued: July 21, 2020
Inventor(s): Giliyar Chandrashekar & Chickmath Basawaraj & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivansan
Assignee(s): Lipocine Inc.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cto serum testosterone Cof about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Crange for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
Steroidal compositions
Patent 11,304,960
Issued: April 19, 2022
Inventor(s): Giliyar; Chandrashekar et al.
Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Patent expiration dates:
- January 8, 2029
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
  ✓
  Drug product
High-strength testosterone undecanoate compositions
Patent 11,311,555
Issued: April 26, 2022
Inventor(s): Giliyar; Chandrashekar et al.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C.sub.max to serum testosterone C.sub.ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C.sub.ave range for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
High-strength testosterone undecanoate compositions
Patent 11,364,249
Issued: June 21, 2022
Inventor(s): Giliyar; Chandrashekar et al.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C.sub.max to serum testosterone C.sub.ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C.sub.ave range for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
High-strength testosterone undecanoate compositions
Patent 11,433,083
Issued: September 6, 2022
Inventor(s): Giliyar; Chandrashekar et al.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone C.sub.max to serum testosterone C.sub.ave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration C.sub.ave range for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
Fixed dose oral testosterone undecanoate compositions and use thereof
Patent 11,464,735
Issued: October 11, 2022
Inventor(s): Patel; Mahesh V. et al.
Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.
Patent expiration dates:
- April 28, 2041
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
  ✓
  Drug product
Oral testosterone undecanoate therapy
Patent 11,559,530
Issued: January 24, 2023
Inventor(s): Chidambaram; Nachiappan et al.
The present disclosure provides methods and compositions for testosterone replacement therapy. The methods and compositions employ a fixed dose dosing regimen that does not require titration or dose adjustments and that can provide a therapeutically effective amount of a testosterone ester while avoiding unacceptably high testosterone levels.
Patent expiration dates:
- November 28, 2037
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
Fixed dose oral testosterone undecanoate compositions and use thereof
Patent 12,011,503
Issued: June 18, 2024
Inventor(s): Patel; Mahesh V. et al.
Disclosed are effective fixed dose oral testosterone undecanoate compositions for use in regimens without dose titration and methods for treatment of patients in need of testosterone replacement therapy. Also disclosed are criteria for continuation and discontinuation of such regimens, based on single serum T concentration levels measured at a steady state at predetermined times after initiation of said regimen and at a predetermined number of hours after administration of a morning dose of the regimen.
Patent expiration dates:
- October 16, 2040
  ✓
  Patent use: METHODS OF ADMINISTERING TESTOSTERONE UNDECANOATE FOR RESTORING TESTOSTERONE CONCENTRATION IN A HYPOGONADAL MALE SUBJECT
  ✓
  Drug product
- October 16, 2040
  ✓
  Patent use: METHODS OF CONTINUING OR DISCONTINUING A DOSAGE REGIMEN OF A TESTOSTERONE UNDECANOATE PHARMACEUTICAL COMPOSITION TO A HYPOGONADAL MALE SUBJECT
  ✓
  Drug product
Steroidal compositions
Patent 8,778,922
Issued: July 15, 2014
Inventor(s): Giliyar Chandrashekar & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivasan
Assignee(s): Lipocine Inc.
Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Patent expiration dates:
- January 8, 2029
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
  ✓
  Drug product
Steroidal compositions
Patent 8,865,695
Issued: October 21, 2014
Inventor(s): Giliyar Chandrashekar & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivasan
Assignee(s): Lipocine Inc.
Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.
Patent expiration dates:
- January 8, 2029
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
High-strength testosterone undecanoate compositions
Patent 9,943,527
Issued: April 17, 2018
Inventor(s): Giliyar Chandrashekar & Chickmath Basawaraj & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivansan
Assignee(s): Lipocine Inc.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cto serum testosterone Cof about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Crange for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
High-strength testosterone undecanoate compositions
Patent 9,949,985
Issued: April 24, 2018
Inventor(s): Giliyar Chandrashekar & Chickmath Basawaraj & Chidambaram Nachiappan & Patel Mahesh V. & Venkateshwaran Srinivansan
Assignee(s): Lipocine Inc.
The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cto serum testosterone Cof about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Crange for a male subject is provided.
Patent expiration dates:
- November 30, 2030
  ✓
  Patent use: TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

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:
- March 28, 2025 - NEW PRODUCT

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Glossary

Term	Definition
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.

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Moderate abuse potential 3

Approval History Drug history at FDA

WADA Class Anti-Doping Classification

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