New Generic Drugs Hitting the Market in 2019

A new group of generic medications are hitting the prescription drug market in 2019. At ScriptSave, we get a lot of questions about generic medications vs. brand name prescription drugs. “A” rated generics meet the same quality standards as brand name prescription drugs and so they provide the same medical benefits. A drug that is “A” rated by the FDA as a generic equivalent contains identical active ingredients as the brand name drug, the same dosage as the brand name drug, and delivers the same concentrations of drug to the bloodstream within the same amount of time. So what are the differences and what’s coming to a pharmacy near you?

Are Generic Drugs the Same as Brand Name?

Yes, generic drugs are “copies” of the brand name medication that was developed by a company other than the one that originally brought the branded medication to market. Generic drugs are available for a fraction of the price of brand name medications, so consumers are naturally eager for the generics to hit the market. Per the FDA guidelines, a generic drug application must first display the following parameters:

• The generic drug is “pharmaceutically equivalent” to the brand
• The manufacturer is capable of making the drug correctly
• The manufacturer is capable of making the drug consistently
• The “active ingredient” is the same as that of the brand
• The right amount of the active ingredient gets to the place in the body where it has effect
• The “inactive” ingredients of the drug are safe
• The drug does not break down over time
• The container in which the drug will be shipped and sold is appropriate
• The label is the same as the brand-name drug’s label
• Relevant patents or legal exclusivities are expired²

How Long Does It Take for a Drug to Become Generic?

After an application for a patent of a new drug is filed with the United States, it is granted patent exclusivity for 20 years.  The path to generic drugs coming to market was made cheaper, easier, and faster after the introduction of the Drug Price Competition and Patent-Term Restoration Act of 1984 or known as the Hatch-Waxman Act. This allowed companies to submit an abbreviated new drug application (ANDA). About one year before the expiration of the patent drug, companies that are wanting to manufacture the generic drug will submit the ANDA to the FDA. Generally, after that patent has expired and the ANDA is approved, a generic counterpart can be introduced into the market.¹

First Generic Drug Approvals for 2019

Currently, the FDA has approved 16 first-time generics in 2019 between different manufacturers (each manufacturer must submit their own ANDA). These include:

• pyridostigmine bromide syrup—Mestinon Syrup
  • Improves muscle strengths in patients with myasthenia gravis
  • Novitium Pharma LLC—03/08/2019
• levofloxacin ophthalmic solution, 1.5%—Iquix Ophthalmic Solution
  • Treatment of corneal ulcer caused by certain bacteria
  • Micro Labs Limited, India—02/27/2019
• deferiprone tablets, 500mg—Ferriprox Tablets
  • Treatment of transfusional iron overload due to thalassemia syndromes
  • Taro Pharmaceuticals Industries Limited—02/08/2019
• sevelamer hydrochloride tablets, 400mg, 800mg—Renagel Tablets
  • Control of serum phosphorus in patient with chronic kidney disease
  • Glenmark Pharmaceuticals Limited—02/08/2019
• levomilnacipran extended-release capsules, 20mg, 40mg, 80mg, 120mg—Fetzima
  • Treatment of major depressive disorder (MDD)
  • Amneal Pharmaceuticals Company GmbH—02/04/2019
• acyclovir cream, 5%—Zovirax Cream
  • Treatment of recurrent cold sores in immunocompetent patients over 12 years of age
  • Perrigo UK FINCO Limited Partnership—02/04/2019
• Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP) 100mcg/50mcg, 250mcg/50mcg, 500mcg/50mcg—Advair Diskus
  • Treatment of asthma in patient over 4 years of age and COPD maintenance (250mcg/50mcg)
  • Mylan Pharmaceuticals Inc.—01/30/2019
• sirolimus oral solution, 1 mg/mL—Rapamune
  • Prophylaxis of kidney organ rejection in patient over 13 years of age
  • Novitium Pharma LLC—01/28/2019
• vigabatrin tablets USP, 500mg—Sabril Tablets
  • Treatment of refractory complex partial seizures (CPS) in patients over 10 years of age that have failed multiple alternative treatments
  • Teva Pharmaceuticals USA, Inc.—01/14/2019
• ingenol mebutate gel, 0.05%, 0.015%—Picato Gel
  • Treatment of topical acne
  • Perrigo UK PINCO Limited Partnership—01/07/2019 (0.015%) and 01/09/2019 (0.05%)
• lurasidone hydrochloride tablets, 20mg, 40mg, 60mg, 80mg, 120mg—Latuda Tablets
  • Treatment of schizophrenia and depressive episodes associated with bipolar disorder in adults
  • Torrent Pharmaceuticals Limited, Accord Healthcare Inc., Lupin Limited, InvaGen Pharmaceuticals, Inc., Amneal Pharmaceuticals Company GmbH—01/03/2019³

Newest Generics of 2019

• As of 03/12/2019, the FDA approved a new generic of Diovan (valsartan) among the vast recalls from multiple manufacturers, this was granted to Alkem Laboratories Limited.⁴
• Lannett announced FDA approval for aspirin and extended-release dipyridamole capsules, 25mg/200mg—Aggrenox Capsules for secondary prevention of stroke and transient ischemic attacks (TIA) on 03/27/2019.⁵

Forecasted Generics for the Remainder of 2019

• ranolazine—Ranexa
  • Treatment of chest pain
• aliskiren—Tekturna
  • Treatment of high blood pressure
• pregabalin—Lyrica
  • Treatment of nerve diseases, fibromyalgia, controls central seizures
• thalidomide—Thalomid
  • Treatment of multiple myeloma, leprosy
• Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic—Osmoprep
  • Laxative for use prior to colonoscopy, cleans out colon
• naloxone injection—Evzio
  • Treatment of overdoses
• diclofenac epolamine—Flector patches
  • Treatment of pain/inflammation
• treprostinil—Remodulin
  • Treatment of high blood pressure in the lungs
• cyclosporine—Restasis
  • Treatment of dry eyes
• travoprost—Travatan Z
  • Treatment of glaucoma
• formoterol/mometasone—Dulera
  • Treatment of asthma
• pramlintide acetate—Symlin
  • Used to lower blood sugar in patients with type 1 or type 2 diabetes
• solifenacin—Vesicare
  • Treatment of urinary disorders
• methylnaltrexone bromide—Relistor
  • Treatment of opioid induced constipation^6,7

The Impact of Generics

It is a long, grueling process for a brand name medication to finally be released to the market as a generic, taking in excess of 20 years. Generic medications are instrumental in helping alleviate the financial burden of prescription medication costs in patients. Each year, the effect continues to grow. In the first quarter 2019, there is already a large impact with new generic medications coming to market. This impact is forecast to continue throughout the year, especially with the possibility of heavy hitters such as Lyrica and Restasis.

References:

1. “S.1538 – 98th Congress (1983-1984): An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise the Procedures for New Drug Applications, to Amend Title 35, United States Code, to Authorize the Extension of the Patents for Certain Regulated Products, and for Other Purposes.” gov, 24 Sept. 1984, www.congress.gov/bill/98th-congress/senate-bill/01538.
2. Center for Drug Evaluation and Research. “Generic Drugs – What Is the Approval Process for Generic Drugs?” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/genericdrugs/ucm506040.htm .
3. Center for Drug Evaluation and Research. “First Generic Drug Approvals.” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/
   ANDAGenericDrugApprovals/default.htm.
4. Office of the Commissioner. “Press Announcements – FDA Provides Update on Its Ongoing Investigation into ARB Drug Products; Reports on Finding of a New Nitrosamine Impurity in Certain Lots of Losartan and Product Recall.” U S Food and Drug Administration Home Page, Office of the Commissioner, fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm.
5. “Generic Drug for Stroke Prevention Granted FDA Approval.” Pharmacy Times, pharmacytimes.com/news/genericdrug-granted-fda-approval.
6. “Pipeline Report Generic Drugs .” Welldynerx. welldynerx.com/content/uploads/2019/02/Generic-Drugs-Feb-2019-2-12-19.pdf.
7. “Upcoming Generic Drugs.” Corporate Pharmacy Services, corporatepharmacy.com/page/upcoming_generic_drugs.