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  7. Competitive Generic Therapy Approvals
  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
80 Thorazine Tablets, NDA 009149 212144 Glenmark Pharmaceuticals Limited Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg 3/23/2021 Yes No 3/24/2021
79 Cardizem SR Extended-Release Capsules, NDA 019471 212317 Glenmark Pharmaceuticals Limited Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg 3/22/2021 Yes    
78 Atropine Sulate Injection, NDA 09260 213424 Accord Healthcare Inc. Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial 3/19/2021 Yes No 3/25/2021
77 Kenalog, NDA 011600 212356 Strides Pharma Inc. Triamcinolone Acetonide Ointment USP, 0.05% 3/4/2021 No N/A N/A
76 Lotemax, NDA 020583 212450 Sun Pharmaceutical Industries Limited Loteprednol Etabonate Ophthalmic Suspension, 0.5% 2/26/2021 Yes    
75 Ortho Evra, NDA 021180 213950  Amneal Norelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day 2/25/2021  Yes No 2/26/2021
74 Northera NDA 203202 211818 Zydus Pharmaceuticals (USA) Inc. Droxidopa Capsules, 100 mg, 200 mg, 300 mg 2/18/2021  No N/A N/A
73 Lotemax, NDA 202872 212080 Akorn Operating Company LLC Loteprednol Etabonate Ophthalmic Gel, 0.5% 2/10/2021  No N/A N/A
72 Jadenu, NDA 207968 214194 Amneal Deferasirox Oral Granules, 180 mg and 360 mg 2/9/2021  No N/A N/A
71 Kenalog, NDA 011600 212460  Perrigo Israel Pharmaceuticals Ltd.  Triamcinolone Acetonide Ointment USP, 0.05%  2/5/2021  No N/A N/A
70 Sabril, NDA 020427 211359 Dr. Reddy's Laboratories Limited  Vigabatrin Tablets USP, 500 mg  1/29/2021  Yes  No  2/1/2021
69 Eveko, NDA 209905 212186 Glemark Pharmaceuticals Limited Amphetamine Sulfate Tablets USP, 5 mg and 10 mg 1/27/2021  No N/A N/A
68 Mexitil, NDA 018873 214352 RiconPharma LLC Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg 1/25/2021 No N/A N/A
67 Argatroban Injection, NDA 203049 214235 Caplin Steriles Limited Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial 1/21/2021 Yes    
66 Narcan, NDA 016636 213279 Aurobindo Pharma Limited Naloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes 1/14/2021 No N/A N/A
65 Taytulla, NDA 204426 212706 Slayback Pharma LLC Merzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg) 12/18/2020 Yes No 1/18/2021
64 Jublia Topical Solution, NDA 203567 211827 Teva Pharmaceuticals USA, Inc.
Efinaconazole Topical Solution, 10%
12/16/2020 No N/A N/A
63 Amicar, NDA 015197 211629 ANI Pharmaceuticals, Inc. Aminocaproic Acid Tablets USP, 500 mg 12/14/2020 No N/A N/A
62 Morphine Sulfate Tablets, NDA 022207 212451 Alkem Laboratories Morphine Sulfate Tablets, 15 mg and 30 mg 12/3/2020 Yes No 2/11/2020
61 Depen Tablets, NDA 019854 212933 Lupin Limited Penicillamine Tablets USP, 250 mg 11/30/2020 No N/A N/A
60 Alinia Tablets, NDA 021497 213820 Rising Pharma Holding, Inc. Nitazoxanide Tablets, 500 mg 11/27/2020 Yes No 12/7/2020
59 Kenalog, NDA 011600 213619 Cintex Services, LLC Triamcinolone Acetonide Ointment USP, 0.05% 11/10/2020  No N/A N/A
58 Parafon Forte DSC Tablets, NDA 011529 212743 Par Pharmaceutical, Inc. Chlorzoxazone Tablets USP, 750 mg 11/2/2020 No N/A N/A
57 Timoptic-XE, NDA 020330 212942 Alembic Pharmaceuticals Limited Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% 10/22/2020 Yes No 11/25/2020
56 Librax Capsules, NDA 012750 213530 ECI Pharmaceuticals, LLC Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 10/20/2020 Yes No 10/26/2020
55 Kerydin 5% Topical Solution, NDA 204427 211848 Perrigo Pharma International DAC Tavaborole Topical Solution, 5% 10/13/2020 No N/A N/A
54 Monurol, NDA 050717 212548 Xiromed Pharma Espana, S.L. Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet 10/6/2020 Yes No 10/6/2020
53 Firazyr Injection, NDA 022150 213054 Dr. Reddy's Laboratories Limited Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe 10/5/2020 No N/A N/A
52 Claritin RediTabs, NDA 021993 212795 Tenshi Kaizen Private Limited. Loratadine Orally Disintegrating Tablets USP, 5 mg 9/18/2020 Yes Yes N/A
51 Parafon Forte DSC Tablets, NDA 011529 212053 i3 Pharmaceuticals Chlorzoxazone Tablets USP, 375 mg and 750 mg 9/14/2020 No N/A N/A
50 Taclonex, NDA 22185 212367 Perrigo Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% 9/11/2020 No N/A N/A
49 Nascobal, NDA 21642 212458 Perrigo Cyanocobalamin Nasal Solution 500 mcg/spray 9/9/2020 No N/A N/A
48 Daptomycin, NDA 208385  211403 Dr. Reddy's Laboratories Inc. Daptomycin for Injection, 350 mg per vial (single-dose vial) 
 
8/31/2020  No  N/A N/A
47 Revatio, NDA 203109 213041 AptaPharma, Inc. Sildenafil for Oral Suspension, 10mg/mL 8/6/2020 No N/A N/A
46 Cuprimine, NDA 019853 211867 Dr Reddy's Laboratories, Inc. Penicillamine Capsules USP, 250 mg 8/4/2020 No N/A N/A
45 Metro I.V., NDA 018900 212435 Gland Pharma Limited Metronidazole Injection USP, 500 mg/100 mL (5 mg/mL) 8/3/2020 Yes Yes N/A
44 Demser, NDA 017871 213734 Amneal Metyrosine Capsules USP, 250 mg 7/24/2020 Yes No 7/30/2020
43 Mexitil, NDA 018873 213500 CrossMedika SA Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg 7/22/2020 Yes No 7/22/2020
42 Parafon Forte DSC Tablets, NDA 011529 212898 Teva Pharmaceuticals USA, Inc. Chlorzoxazone Tablets USP, 375 mg and 750 mg 6/17/2020 No N/A N/A
41 Albenza Tablets, NDA 020666 211636 Lupin Limited Albendazole Tablets USP, 200 mg 6/10/2020 Yes Yes N/A
40 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
39 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
38 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
37 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
36 K-Dur (Potassium Chloride), NDA 019439 
 
212861  Amneal  Potassium Chloride Extended-Release Tablets USP, 15 mEq  5/8/2020 Yes Yes N/A
35 Butrans (Buprenorphine), NDA
021306 
211586  Amneal  Buprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour 4/14/2020  Yes (7.5 mcg/hour);
No (20 mcg/hour);
No (15 mcg/hour);
No (10 mcg/hour); No (5 mcg/hour)
No  4/16/2020
34 Adrenalin, NDA 204640 211880 International Medication Systems, Limited Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) 4/24/2020 No N/A N/A
33 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
32 Tepadina, NDA 208264 213049 MSN Pharmaceuticals Inc. Thiotepa for Injection USP, 15mg/vial and 100 mg/vial 3/4/2020 No N/A N/A
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 Yes (400 mg) 11/11/2019 (200 mg)
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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