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Generic Cialis Availability

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

CIALIS (tadalafil - tablet;oral)

  • Manufacturer: LILLY
    Approval date: November 21, 2003
    Strength(s): 5MG [RLD] [AB], 10MG [RLD] [AB], 20MG [RLD] [AB1]
  • Manufacturer: LILLY
    Approval date: January 7, 2008
    Strength(s): 2.5MG [RLD] [AB]

Has a generic version of Cialis been approved?

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

tadalafil tablet;oral

  • Manufacturer: TEVA PHARMS USA
    Approval date: May 22, 2018
    Strength(s): 2.5MG [AB], 5MG [AB], 10MG [AB], 20MG [AB1]

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

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.

  • Tetracyclic derivatives; process of preparation and use
    Patent 5,859,006
    Issued: January 12, 1999
    Inventor(s): Daugan; Alain Claude-Marie
    Assignee(s): ICOS Corporation

    A compound of formula (I) ##STR1## and salts and solvates thereof, in which: R.sup.0 represents hydrogen, halogen or C.sub.1-6 alkyl; R.sup.1 represents hydrogen, C.sub.1-6 alkyl, C.sub.2-6 alkenyl, C.sub.2-6 alkynyl, haloC.sub.1-6 alkyl, C.sub.3-8 cycloalkyl, C.sub.3-8 cycloalkylC.sub.1-3 alkyl, arylC.sub.1-3 alkyl or heteroarylC.sub.1-3 alkyl; R.sup.2 represents an optionally substituted monocyclic aromatic ring selected from benzene, thiophene, furan and pyridine or an optionally substituted bicyclic ring ##STR2## attached to the rest of the molecule via one of the benzene ring carbon atoms and wherein the fused ring A is a 5- or 6-membered ring which may be saturated or partially or fully unsaturated and comprises carbon atoms and optionally one or two heteroatoms selected from oxygen, sulphur and nitrogen; and R.sup.3 represents hydrogen or C.sub.1-3 alkyl, or R.sup.1 and R.sup.3 together represent a 3- or 4-membered alkyl or alkenyl chain. A compound of formula (I) is a potent and selective inhibitor of cyclic guanosine 3', 5'-monophosphate specific phosphodiesterase (cGMP specific PDE) having a utility in a variety of therapeutic areas where such inhibition is beneficial, including the treatment of cardiovascular disorders.

    Patent expiration dates:

    • May 21, 2018
      ✓ 
      Pediatric exclusivity
  • Beta-carboline drug products
    Patent 6,821,975
    Issued: November 23, 2004
    Inventor(s): Neil R.; Anderson & Kerry J.; Hartauer & Martha A.; Kral & Gregory A.; Stephenson
    Assignee(s): Lilly ICOS LLC

    A compound of structural formula (I), and pharmaceutically acceptable salts and solvates thereof, wherein the compound is in free drug particulate form, is disclosed.

    Patent expiration dates:

    • November 19, 2020
      ✓ 
      Patent use: ERECTILE DYSFUNCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • November 19, 2020
      ✓ 
      Patent use: TREATMENT OF SEXUAL DYSFUNCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • November 19, 2020
      ✓ 
      Patent use: TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • May 19, 2021
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      Pediatric exclusivity
  • Compositions comprising phosphodiesterase inhabitors for the treatment of sexual disfunction
    Patent 6,943,166
    Issued: September 13, 2005
    Inventor(s): Pullman; William Ernest & Whitaker; John Steven
    Assignee(s): Lilly ICOS LLC.

    The present invention relates to highly selective phosphodieterase (PDE) enzyme inhibitors and to their use in pharmaceutical articles of manufacture. In particular, the present invention relates to potent inhibitors of cyclic guanosine 3′,5′-monophosphate specific phosphodiesterase type 5 (PDE5) that when incorporated into a pharmaceutical product at about 1 to about 20 mg unit dosage are useful for the treatment of sexual dysfunction.

    Patent expiration dates:

    • April 26, 2020
      ✓ 
      Patent use: TREATMENT OF ERECTILE DYSFUNCTION
    • April 26, 2020
      ✓ 
      Patent use: TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
    • April 26, 2020
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      Patent use: TREATMENT OF SEXUAL DYSFUNCTION
    • October 26, 2020
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      Pediatric exclusivity
  • β-carboline pharmaceutical compositions
    Patent 7,182,958
    Issued: February 27, 2007
    Inventor(s): Oren; Peter L. & Anderson; Neil R. & Kral; Martha A.
    Assignee(s): Lilly Icos LLC.

    Formulations containing a PDE5 inhibitor, a water-soluble diluent, a lubricant, a hydrophilic binder, a disintegrant, and optional microcrystalline cellulose and/or a wetting agent, and their use in treating sexual dysfunction, are disclosed.

    Patent expiration dates:

    • April 26, 2020
      ✓ 
      Patent use: TREATMENT OF ERECTILE DYSFUNCTION
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • April 26, 2020
      ✓ 
      Patent use: TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
    • October 26, 2020
      ✓ 
      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:

    • February 15, 2021 - INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY
    • August 15, 2021 - PEDIATRIC EXCLUSIVITY

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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