Anticipated Availability of First Time Generics 360506 PDF

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Download Anticipated Availability of First Time Generics 360506 PDF

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−This Clinical Resource gives subscribers additional insight related to the Recommendations published in−

May 2020 ~ Resource #360506 of

Anticipated Availability of First-Time Generics ―To help explain the benefits of generic drugs to your patients, the FDA has patient education materials available at https://www.fda.gov/drugs/generic-drugs/patient-education ―

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Afinitor (Novartis) Amicar (Clover) Apriso (Valeant) Brisdelle (Noven) Carafate (Allergan) Colcrys (Takeda) Daraprim (Vyera) Dymista (Meda) Dyrenium (Concordia) Emend (Merck)

Everolimus tablets

Par

Generic now available

Aminocaproic acid syrup

Amneal

Generic now available

Mesalamine extended-release capsule Paroxetine mesylate 7.5 mg capsule Sucralfate oral suspension

Mylan

Generic now available

Solco (Prinston)

Generic now available

Amneal

Generic now available

Colchicine tablet

Mylan

Generic now available

Pyrimethamine

Dr. Reddy’s (Cerovene)

Generic now available

Azelastine and fluticasone nasal spray Triamterene

Apotex

Generic now available

TruPharma (Agnitio)

Generic now available

Fosaprepitant injection

Apotex, Athenex (Sungen), Baxter, BE Pharms, BluePoint (Apotex), Cipla (BE Pharms), Dr. Reddy’s (MSN), Fresenius Kabi, Meitheal (BE Pharms), Mylan, Northstar (MSN), Novadoz (MSN), Teva

Generic now available

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 2 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

EpiPen Jr. (Mylan) Evomela (Acrotech) Forteo (Eli Lilly) Halog (Sun) Herceptin (Roche) Jadenu (Novartis) Moxeza (Alcon) Nexium (AstraZeneca) Noxafil (Merck) NuvaRing (Organon Sub Merck) Orfadin (Swedish Orphan) ProAir HFA (3M) Proglycem (Teva) Proventil HFA (Teva) Silenor (Somaxon) Soolantra (Galderma)

Epinephrine

Teva

Generic now available

Melphalan 50 mg single-dose vial

Teva

Generic now available

Teriparatide

Alvogen

Halocinonide 0.1% cream

Mylan

Generic now available (authorized generic) Generic now available

Trastuzumab

Amgen (Kanjinti, biosimilari), Mylan (Ogivri; biosimilar i), Pfizer (Trazimera, biosimilar1 ) Alembic, Amneal, Cipla, Dr. Reddy’s (MSN), Teva, Xiromed (Piramal), Zydus Lupin

Generic now available

Esomeprazole powder for oral suspension Posaconazole delayed-release tablet Ethinyl estradiol/etonogestrel vaginal insert Nitisinone capsule

Cipla

Generic now available

Lannett (Sinotherapeutics)

Generic now available

Amneal (Eluryng)

Generic now available

Par (Novitium)

Generic now available

Albuterol inhaler

Perrigo

Generic now available

Diazoxide oral suspension

E5 Pharma

Generic now available

Albuterol inhaler

Cipla

Generic now available

Doxepin tablet

Mylan

Generic now available

Ivermectin 1% cream

Teva

Generic now available

Deferasirox tablet Moxifloxacin ophthalmic solution

Generic now available Generic now available

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 3 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Tepadina (Adienne SA) Travatan Z (Alcon) Vimovo (Horizon) Zohydro (Pernix) Zortress (Novartis) Aptensio XR (Rhodes) Dexilant (Takeda) Desonate (Bayer) Atripla (Gilead) Truvada (Gilead)

Thiotepa 15 mg, 100 mg singledose vials Travoprost 0.004% ophthalmic solution Naproxen/Esomeprazole magnesium delayed-release tablet Hydrocodone bitartrate extendedrelease capsule Everolimus

Novadoz (MSN)

Generic now available

Apotex, Mylan

Generic now available

Dr. Reddy’s

Generic now available

Alvogen

Generic now available

West-Ward (Hikma)

Generic now available

Methylphenidate extended-release capsules Dexlansoprazole

Teva

June 2020

Impax,f,104 Par, TWif,93

June 202059

Desonide 0.05% gel

Teresina Holdings

August 2020 (or earlierd)21

Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate Emtricitabine/Tenofovir disoproxil fumarate tablet

September 202024

Avandia (GlaxoSmithKline) Farxiga (AstraZeneca)

Rosiglitazone

Kuvan (BioMarin) Chantix (Pfizer) Kaletra (Abbott)

Sapropterin

Aurobindo, Cipla, Hetero, Macleods, Matrix, Teva Amneal, Aurobindo, Cipla, Hetero, Laurus, Lupin,f,25 Matrix, Mylan, Strides Arcolab, Teva, Zydus Dr. Reddy’s, Hikma, Mylan, Roxane, Sandoz, Teva Aizant, Ajanta, Alembic, Alkem, Apotex, Biocon, Glenmark, Hetero, Inventia, Micro Labs, Sandoz, Sun, Teva Dr. Reddy’s, Par, Sandoz

Varenicline

Apotex, Mylan, Teva

November 2020 (or earlierd)49

Lopinavir/Ritonavir tablet

Aurobindo, Cipla, Hetero, Macleods, Matrix, Mylan

November 2020101

Dapagliflozin

September 202020

October 2020 (or earlierd)21 October 2020100

October 2020 (or earlier)47,125

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 4 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Absorica (Ranbaxy) Epiduo Forte (Galderma) Latuda (Sunovion)

Isotretinoin

Tevaf,88

December 2020 (or earlier)88

Adapalene 0.3%/Benzoyl peroxide 2.5% Lurasidone

Perrigo, Taro, Teva

December 202059 December 202059

Ofirmev (Mallinckrodt) Saphris (Forest) Viibryd (Forest) Amitiza (Sucampo) Mycamine (Astellas) Sutent (Pfizer) Zomig (AstraZeneca) Ferriprox (Apopharma) Fycompa (Eisai) Perforomist (Mylan) Bystolic (Forest)

Acetaminophen injection

Accord, Alkem, Amneal, Aurobindo, Emcure, First Time U.S. Generics, InvaGen, Lupin, MSN, Par, Piramal, Sun, Teva, Torrent, Zydus Custopharm (Perrigo), Sandoz

December 2020130

Vilazodone

Alembic, Amneal,f,130 Breckenridge,f,130 Hikma,f,130 Sigmapharm Accord, Alembic, Teva

Lubiprostone

Amneal, Anchen,f,115 Dr. Reddy’s,h,115 Parf,115

January 2021115

Micafungin

Apotex, Fresenius Kabi

January 2021 (or earliere)81,117

Sunitinib

Mylan

February 2021

Zolmitriptan nasal spray

Lannettf,128

May 2021

Deferiprone

Taro

June 2021 (or earliere)74

Perampanel

Accord, Taro, Teva

June 2021122

Formoterol inhalation solution

Teva

June 2021

Nebivolol

Alkem, Amerigen, Glenmark, Hetero,f,67 Indchemie Health, Micro Labs, Reyoung, Teva, Torrent

September 2021 (or earlier)67

Asenapine

December 2020 (or earlier)31

202124

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 5 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Emtriva (Gilead) Jevtana (Sanofi Aventis)

Emtricitabine capsule

Aurobindo, Cipla, Matrix, Micro Labs

September 20214

Cabazitaxel

September 202158

Brovana (Sunovion) Pradaxa (Boehringer Ingelheim) Revlimid (Celgene) Vimpat (UCB)

Arformoterol

Accord, Apotex, BPI Labs, Breckenridge, Dr. Reddy’s,f,6 Fresenius Kabi,f,151 Glenmark,h,121 Mylan Cipla, Teva Alembic, Alkem, Glenmark, Hetero,h,44 Mylan,f,3 Teva Allerganf,23

December 20213

March 20225

Zipsor (Assertio) Alimta (Lilly)

Diclofenac potassium liquid-filled capsule Pemetrexed

Tablet: Accord, Alembic, Amneal, Aurobindo, Glenmark, MSN, Mylan, Sun, Teva Oral solution: Amneal, Apotex, Aurobindo, Glenmark Bionpharma, Strides Pharma, Tevaf,95

May 2022

Banzel (Eisai)

Rufinamide

Velcade (Millennium)

Bortezomib

Iressa (AstraZeneca) Janumet (Merck)

Gefitinib

Accord, Apotex, APP, Biocon, Dr. Reddy’s, Hospira, Jiangsu Hansoh, Mylan, Qilu, Sun, Teva Tablet: Glenmark, Hetero,h,80 Hikma, Lupin,f,145 Mylan, West-Ward Suspension: Bionpharma, Hikma Accord, Apotex, Dr. Reddy’s, Eugia, Fresenius Kabi, Hong Kong King Friend Industrial, Hospira, MSN, Mylan, Pharmascience, Qilu, Shilpa, Teva, Zydusf,91 Apotex, Cipla

Sitagliptin/Metformin

Apotex, Sandoz, Teva, Zydus

July 2022124

Dabigatran Lenalidomide Lacosamide

November 202124

March 202223

March 2022 (or earlier)95

May 2022 (or earlier)48,145

May 202224

July 2022

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 6 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Janumet XR (Merck) Januvia (Merck)

Sitagliptin/Metformin extendedrelease tablet Sitagliptin

Anchen, Teva

July 2022124

Apotex, Mylan, Sandoz, Sun, Teva, Zydus

July 2022124

Toviaz (Pfizer)

Fesoterodine extended-release tablet

July 2022 (or earliere)11,63

Bethkis (Chiesi)

Tobramycin inhalation solution

Accord, Alembic, Alkem, Amerigen, Amneal, Aurobindo, Dr. Reddy’s, Impax,h,97 Lupin, Mylan,f,63 Sandoz, Sun, Teva, Torrent, Wockhardt,h,82 Zydus Teva

Folotyn (Spectrum) Selzentry (Pfizer) Rayos (Horizon) Treanda (Cephalon)

Pralatrexate

Teva

November 2022149

Maraviroc

Hetero, Sandoz

November 2022 (or earlierd)21

Prednisone delayed-release tablet

Teva

December 2022 (or earlier)36

Bendamustine 25 mg/vial, 100 mg/vial (powder for solution)

Accord, Apotex, Breckinridge, Celerity, Glenmark, Hetero,f,107 Hospira, InnoPharma, Mylan, Sagent,f,107 Spectrum, Wockhardt MicroLabs, Sandoz

December 202216

Par

January 202324

Amgen (Amjevita, biosimilari), Boehringer Ingelheim (Cyltezo, biosimilari), Fresenius Kabi (biosimilari),146 Mylan (biosimilari),148 Pfizer (Abrilada, biosimilari), Samsung Bioepis (Hadlima, biosimilari), Sandoz (Hyrimoz, biosimilar i) Qilu

January 2023113

Zioptan (Oak) Cambia (Assertio) Humira (AbbVie)

Tafluprost

Ibrance (Pfizer)

Palbociclib

Diclofenac potassium oral solution 50 mg Adalimumab

September 2022

December 2022152

January 2023 (or earlierd)21

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 7 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Noxafil (Merck) Trokendi XR (Supernus) Xyrem (Jazz) Vyvanse (Shire) Afinitor Disperz (Novartis) Aubagio (Sanofi)

Posaconazole injection

Fresenius Kabi, Mylan, Par

January 202324

Topiramate extended-release capsule Sodium oxybate

Zydus

January 2023118 January 202324

Lisdexamfetamine

Amneal, Hikma, Ohm, Par,h,92 Ranbaxy,f,143 Specgx, Sun, f,153 Wockhardtf,143 Amneal, Mylan, Roxane, Sandoz, Teva

Everolimus

Mylan

March 2023 (or earliere)10

Teriflunomide

March 202324

Suprep (Braintree) Edurant (Janssen) Livalo (Kowa) Mozobil (Genzyme) Myrbetriq (Astellas) Victoza (Novo Nordisk) Gralise (Depomed) Omidria (Omeros) Restasis (Allergan)

Magnesium sulfate anhydrous, potassium sulfate, sodium sulfate Rilpivirine

Accord, Alembic, Alvogen, Amneal, Apotex, Aurobindo, Glenmark, MSN, Mylan, Sandoz, Teva, Torrent, Zydus Breckenridge, Lupin (Novel), Paddock (Perrigo), Taro Strides Arcolab

May 2023 (or earlier)136

Plerixafor

Amneal. Aurobindo, Lupin, Mylan, Orient, Sawai, Zydusf,136 Zydusf,112

Mirabegron

Aurobindo, Lupin, Sawai, Zydus

November 2023 (or earliere)99

Liraglutide

Tevaf,108

December 2023 (or earlier)108

Gabapentin

Incepta,f,98 Teva, Zydus,f,98

January 2024 (or earlier)62,98

Ketorolac/phenylephrine ocular solution Cyclosporine ophthalmic emulsion

Gland, Lupin, Par

January 2024 (or earlier,e but not before June 2021)19 February 2024 (or earlier)30,33

Pitavastatin calcium

Akorn,h,33 Famy,f,33 InnoPharma,f,30 Mylan,h,33 Tevah,33

February 202355

March 2023 April 202365

July 2023

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 8 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Daliresp (AstraZeneca)

Roflumilast

March 2024 (or earlier155)

Relistor (Valeant) Isentress (Merck) Bepreve (Bausch) Sprycel (Bristol-Myers Squibb) Brilinta (AstraZeneca)

Methylnaltrexone injection

Alkem, Apotex,h,72 Breckenridge, Hetero, Micro Labs, MSN, Mylan, Prinston, Strides Pharma, Torrent Mylan

Raltegravir tablet

Hetero

May 202424

Bepotastine ophthalmic solution 1.5% Dasatinib

Apotex, Micro Labs, Mylan, Sandoz

September 2024 (or earliere)8

Apotex

September 2024

Ticagrelor

October 202410

Abilify (Otsuka) Fentora (Cephalon [Teva]) Qsymia (Vivus) Namzaric (Forest) Nucynta (Depomed)

Aripiprazole orally disintegrating tables 20 mg, 30 mg Fentanyl citrate buccal tablet

Alembic, Alkem, Amneal, Beijing Tide, HEC Pharm, Hisun Pharm, Micro Labs, Prinston, Sandoz, Teva Teva, Zydus Impax,f,57 Mylan, Sandoz,f,106 Teva

December 2024 (or earliere)57

Phentermine/Topiramate extended-release capsule Donepezil/Memantine

Dr. Reddy’s,f,46 Tevaf,41

December 2024 (or earlier)41

Amneal, Macleods

January 2025131

Tapentadol tablet

June 2025

Nucynta ER (Depomed) Ravicti (Horizon) Rytary (Amneal)

Tapentadol extended-release tablet Glycerol phenylbutyrate liquid

Tablet: Alkem, Collegium, Rhodes, Roxane, Teva Oral solution: Collegium, Teva Teva, West-Ward Par

July 2025 (or earlier)119

Tevaf,94

July 2025 (or earlier)94

Levodopa/carbidopa

April 2024 (or earlierd)77

December 2024 (or earliere)86

June 2025

More. . . Copyright © 2020 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 pharmacist.therapeuticresearch.com ~ prescriber.therapeuticresearch.com ~ pharmacytech.therapeuticresearch.com

(Clinical Resource #360506: Page 9 of 23)

Branda (Manufacturer)

Generic Name

Generic Manufacturer(s)b,1

Anticipated Availabilityc

Prolensa (Bausch and Lomb) Jentadueto (Boehringer Ingelheim) Tradjenta (Boehringer Ingelheim)

Bromfenac 0.07% ophthalmic solution Linagliptin/Metformin

Perrigo

September 2025 (or earliere)42,71 November 202578

Complera (Gilead) Xeljanz (PF Prism) Natazia (Bayer) Aplenzin (Valeant) Nuedexta (Avanir) Kerydin (Anacor) Samsca (Otsuka) Bosulif (PF Prism CV) Gilenya (Novartis)

Emtricitabine, Rilpivirine, Tenofovir Tofacitinib

Accord, Dr. Reddy’s,h,158 HEC Pharm, Intas,h,50 MSN Labs, Mylan, Zydus Accord, Aurobindo, Dr. Reddy’s,h,120 HEC, InvaGen, MSN, Mylan, Prinston, Sun, Teva, Zydus Mylan Breckenridge, Micro Labs, Prinston, Sun

December 2025 (or earlierd)73

Dienogest/estradiol valerate

Lupin (Nudovra), Teva

May 202622

Bupropion hydrobromide extended-release tablet Dextromethorphan/Quinidine

Paddock,h,105 Par,f,83 Teva

June 2026 (or earliere)38,83 July 2026 (or earlier)54,85,103

Tavaborole

Impax,f,116 Par, Sandoz,f,103 Teva, Wockhardtf,85 Taro

Tolvaptan

Ascend

September 2026 (or earliere)30

Bosutinb

MSN

Fingolimod

Kyprolis (Onyx) Aveed (Endo)

Carfilzomib

Accord, Alkem, Aurobindo, Biocon, Bionpharma, Ezra, First Time US Generics, Glenmark, HEC, MSN, Par, Strides Pharma, Sun, Teva, Torrent, Zydus Apotex, Dr. Reddy’s, Natco (Breckenridge),f,9 Qilu Paddock

November 2026 (or earlier,e but not before December 2025)18 2027 (or earlier)102

Linagliptin

Testosterone undecanoate

November 202578

Decembe...