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  1. Generic Drugs

Competitive Generic Therapy Approvals

The Office of Generic Drugs is providing a public list of all approved abbreviated new drug application (ANDAs) for drug products that received a Competitive Generic Therapy (CGT) designation under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and is also noting which ANDAs on this list cover drug products that were also eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.  This list will be updated on a bi-weekly basis with new ANDA approvals where at least one of the drug products, i.e., one of the strengths, in the approved application received a CGT designation.

The Agency is including the following information for individual drug products on the CGT Approvals List:

  • Reference Listed Drug (RLD) Name and New Drug Application (NDA) Number
    This column reflects the proprietary name, if any, of the RLD and its NDA number.
  • ANDA Number
  • ANDA Applicant
  • Active Ingredient Name, Dosage Form, Strength
    This column reflects the established (nonproprietary) name of the active ingredient(s) in the drug product, as well as the product’s dosage form and strength(s).
  • Date of Approval
    This column indicates the date on which an ANDA for a CGT-designated drug product(s) received final approval.
  • Eligible for CGT Exclusivity
    In this column, drug products that, at the time of approval, were eligible for CGT exclusivity will be indicated with a “Yes,” while drug products that were not eligible for CGT exclusivity at the time of approval will be indicated with a “No.”  Certain products in ANDAs designated as CGTs can qualify for CGT exclusivity if the applicant is a “first approved applicant” as defined in section 505(j)(5)(B)(v) of the FD&C Act.  There is only one exclusivity period available for each CGT, and receiving a CGT designation does not ensure that a drug product will be eligible for CGT exclusivity.  For example, a drug product in an ANDA that receives a CGT designation will not be eligible for CGT exclusivity if there were unexpired patents or exclusivities listed in the Orange Book at the time of the original submission of the ANDA for the CGT-designated drug product.
  • CGT Exclusivity Forfeiture
    This column indicates whether or not a drug product that was eligible for CGT exclusivity upon approval forfeited eligibility because it was not commercially marketed within 75 days after the date of approval of the ANDA (see section 505(j)(5)(D)(iv) of the FD&C Act).  A forfeiture event is indicated with “Yes.”  Non-forfeiture is indicated with “No.”  If the forfeiture determination has not yet been made, the column will be blank, and if the CGT was not eligible for exclusivity upon approval, the column will reflect “N/A.”
  • Date of First Commercial Marketing of CGT with Exclusivity
    This column reflects the date of first commercial marketing of a CGT by a first approved applicant of a drug product that was eligible for CGT exclusivity and did not forfeit its eligibility.  The 180-day CGT exclusivity period described under section 505(j)(5)(B)(v) of the FD&C Act is triggered by the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.  This 180-day CGT exclusivity period, once triggered, blocks the approval of an ANDA for a drug that is the same as the CGT.  If the CGT was not granted exclusivity, or the exclusivity was forfeited, the column will reflect “N/A.”

FDA intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity.  FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition, and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT).  By providing the commercial marketing start date for CGT exclusivity periods, this list will also provide useful information to applicants whose ANDAs have been blocked from final approval by CGT exclusivity regarding when the exclusivity period will expire.  To note, FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) also posts a Competitive Generic Therapy (CGT) code in the “Exclusivity Data” section of the Orange Book for the approved drug products eligible for 180-day CGT exclusivity upon any first approved applicant’s commercial marketing, indicating the date the 180-day CGT exclusivity will expire.

Competitive Generic Therapy Approvals

  RLD Name and NDA Number ANDA Number ANDA Applicant Active Ingredient Name, Dosage Form, Strength  Date of Approval Eligible for CGT Exclusivity CGT Exclusivity Forfeiture Date of First Commercial Marketing of CGT with Exclusivity
40 Parafon Forte DSC Tablets, NDA 011529 212898 Teva Pharmaceuticals USA, Inc. Chlorzoxazone Tablets USP, 375 mg and 750 mg 6/18/2020 No    
39 Albenza Tablets, NDA 020666 211636 Lupin Limited Albendazole Tablets USP, 200 mg 6/10/2020 Yes    
38 Revatio for Oral Suspension, NDA 203109 211534 Teva Pharmaceuticals USA, Inc. Sildenafil for Oral Suspension, 10 mg/mL 5/29/2020 No N/A N/A
37 Parafon Forte DSC Tablets, NDA 011529 212185 Glenmark Pharmaceuticals Limited Chlorzoxazone Tablets USP, 375 mg and 750 mg 5/26/2020 No N/A N/A
36 Bentyl (Dicyclomine Hydrochloride), NDA 007961 212286 Hikma Pharmaceuticals USA Inc. Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL 5/22/2020 Yes No 5/22/2020
35 Migranal Nasal Spray, NDA 020148 212907 Cipla Limited Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 5/20/2020 Yes No 5/23/2020
34 K-Dur (Potassium Chloride), NDA 019439 
 
212861  Amneal  Potassium Chloride Extended-Release Tablets USP, 15 mEq  5/8/2020 Yes    
33 Butrans (Buprenorphine), NDA
021306 
211586  Amneal  Buprenorphine Transdermal System, 7.5 mcg/hr  4/14/2020  Yes  No  4/16/2020
32 Narcan, NDA 16636  
 
213209  Dr. Reddy's Laboratories Limited  Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL)  3/16/2020  Yes  No 3/18/2020
31 Depen, NDA 19854 211497 Teva Pharmaceuticals USA, Inc. Penicillamine Tablets USP, 250mg 2/13/2020 Yes Yes N/A
30 Mestinon, NDA 15193 212702 Amneal Pyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL 1/10/2020 No N/A N/A
29 Valium, NDA 016087 211998 Beloteca, Inc. Diazepam Injection USP, 50 mg/10 mL (5 mg/mL) 12/26/2019 Yes Yes N/A
28 Proglycem Oral Suspension, NDA 017453 211050 e5 Pharma, LLC Diazoxide Oral Suspension USP, 50 mg/mL, 12/20/2019 Yes No 12/20/2019
27 Triamcinolone Acetonide, ANDA 089595 212384 Encube Triamcinolone Acetonide Ointment USP, 0.05% 11/29/2019 Yes No 12/2/2019
26 Amicar, NDA 15197 212492 Amneal  Aminocaproic Acid Tablets USP, 500 mg 11/27/2019 Yes No 12/3/2019
25 Chlorzoxazone Tablets, ANDA 40861 212253 Novitium Pharma Chlorzoxazone Tablets USP, 375 mg and 750 mg 11/27/2019 Yes No 11/27/2019
24 Revatio, NDA 203109 212440 Alkem Laboratories  Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A
23 Revatio, NDA 203109 212883 Ajanta Pharma Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A
22 Butalbital and Acetaminophen, ANDA 207313 213115 Granules Butalbital and Acetaminophen Capsules, 50 mg/300 mg 11/25/2019 Yes No 1/30/2020
21 Eryped, NDA 050207 211991 Par Pharmaceutical Inc.  Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL 10/23/2019 Yes No 11/11/2019
20 Rapamune, NDA 21083 211406 Apotex Sirolimus Oral Solution, 1 mg/mL 10/22/2019 No N/A N/A
19 Digoxin, NDA 21648 213000 Novitium Pharma Digoxin Oral Solution USP, 0.05 mg/mL 10/4/2019 Yes No 10/4/2019
18 Elidel, NDA 21302 211769 Glenmark Pimecrolimus Cream, 1%  8/29/2019 No N/A N/A
17 Orfadin, NDA 21232 211041 Novitium Pharma Nitisinone Capsules, 2 mg, 5 mg and 10 mg  8/26/2019 No N/A N/A
16 Amicar, NDA 15230 212780 Amneal Aminocaproic Acid Oral Solution USP, 0.25 g/mL                                                                                               8/23/2019 Yes No 8/30/2019
15 Aleve PM, NDA 205352 211830 Apotex Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg 8/22/2019 Yes Yes N/A
14 Levocarnitine, NDA 19257 211676 Novitium Pharma Levocarnitine Sugar Free Oral Solution, 1 g/mL  8/14/2019 Yes No 10/16/2019
13 Daptomycin, NDA 208385 212667 Accord Daptomycin for Injection, 350 mg/vial 7/12/2019 Yes No 7/16/2019
12 Hemabate, NDA 17989 211941 Dr. Reddy's Laboratories Carboprost Tromethamine Injection, 250 mcg/mL 7/2/2019 Yes No 7/2/2019
11 Cuprimine, NDA 19853 210976 Watson Penicillamine Capsule, 250 mg 6/24/2019 Yes No 6/25/2019
10 Revatio, NDA 203109 212260 Novitium Pharma Sildenafil Citrate for Oral Suspension, 10 mg/mL 5/31/2019 Yes No 5/31/2019
9 Navane, NDA 16584 211642 Novitium Pharma Thiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg  4/5/2019 Yes No 4/5/2019
8 Methergine, NDA 06035 211455 Teva Methylergonovine Maleate Tablets, 0.2 mg 3/20/2019 No N/A N/A
7 Mestinon, NDA 15193 211694 Novitium Pharma Pyridostigmine Bromide Oral Syrup, 60 mg/5 mL 3/8/2019 Yes No 3/8/2019
6 Rapamune, NDA 21083 211040 Novitium Pharma Sirolimus Solution, 1 mg/mL 1/28/2019 No N/A N/A
5 Westcort, NDA 01872 211750 Glenmark Hydrocortisone Valerate Ointment, 0.2 % 12/14/2018 Yes No 1/17/2019
4 Levo-Dromoran, NDA 08720 211484 Par Pharmaceuticals Levorphanol Tartrate Tablet, 2 mg 12/13/2018 No N/A N/A
3 Amphetamine, ANDA 200166 211139 Amneal Amphetamine Sulfate Tablet, 5 mg and 10 mg 9/26/2018 Yes No 9/27/2018 (5 mg)
10/1/2018 (10 mg)
2 Methergine, NDA 06035 211483 Amneal  Methylergonovine Maleate Tablets, 0.2 mg 9/10/2018 Yes No 9/21/2018
1 Potassium Chloride, NDA 206814 211067 Apotex Potassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL 8/8/2018 Yes No 8/29/2018 (20 mg)
9/7/2018 (40 mg) 
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