First-Time Generics: How is the Industry Faring?

First-time generic drugs are an important measure of the new generic drugs entering the US market. So how did the US generic industry fare in 2016, and what first-time generics have been approved by the FDA in 2017 to date? DCAT Value Insights examines the numbers and products..

First-time generic drugs are the first approval by the FDA that permits a manufacturer to market a generic drug product in the US. In 2016, the FDA approved 73 first-time generics and in 2017, the FDA has thus far approved 11 first-time generics. So how do these numbers compare with previous years, and what have been some of the key market entries?.

First-time generics in 2017
Thus far, the US Food and Drug Administration (FDA) has approved 11 first-time generic drugs for the US market (see Table I). None of the first-time generics represent key blockbuster drugs on the innovator side, but several are noteworthy in terms of recent patent litigation impacting entry into the US market. In March 2017, Accorda Therapeutics, Inc. won one patent battle and lost others relating to its multiple sclerosis drug, Ampyra (dalfampridine) for which Teva/Actavis and Aurobindo both received generic drug approval. A federal district court upheld a patent (US Patent No. 5,540), which pertains to the formulation of dalfampridine, extended-release tablets, 10 mg and which is set to expire in July 2018, but invalidated four other patents (US Patent Nos. 8,663,685, 8,007,826, 8,440,703, and 8,354,437, which pertain to Ampyra. Accorda said it would appeal those rulings.

In April 2017, Jazz Pharmaceuticals announced that certain of its subsidiaries have entered into agreements with Hikma Pharmaceuticals PLC and related entities resolving patent litigation related to Xyrem (sodium oxybate) oral solution. The litigation, which has been pending in the US. District Court for the District of New Jersey since 2010, resulted from the submission by Roxane Laboratories Inc (which was subsequently acquired by Hikma) of an abbreviated new drug application (ANDA) to the FDA seeking approval to market a generic version of Xyrem. Xyrem is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness in narcolepsy. In connection with the settlement, Jazz has granted Hikma and its wholly owned subsidiary, West-Ward Pharmaceuticals Corp, the right to sell an authorized generic version of Xyrem in the United States under the Xyrem new drug application  commencing on January 1, 2023, or earlier under certain circumstances customary for settlement agreements of this nature. Similar patent litigation brought by Jazz Pharmaceuticals against four other companies that have filed ANDAs with the FDA seeking approval to market a generic version of Xyrem remains pending in the US District Court for the District of New Jersey.

Table I: First-Time Generics Approved by the US Food and Drug Administration (as of March 31, 2017)
Company Active ingredient); Innovator product name (when provided) Indication
Actavis Laboratories FL, Inc.* Dalfampridine Extended-Release Tablets, 10 mg; Ampyra To improve walking in patients with multiple scleros
Alvogen Malta Operations Ltd. Melphalan Tablets USP, 2 mg; Alkeran Palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary
Amneal Pharmaceuticals LLC Memantine and Donepezil Hydrochlorides Extended Release Capsules, 14 mg/10 mg, 28 mg/10 mg; Namzaric To treat moderate-to-severe dementia of the Alzheimer’s type
Aurobindo Pharma Limited Dalfampridine Extended-Release Tablets, 10 mg; Ampyra To improve walking in patients with multiple sclerosis
Aurobindo Pharma Limited Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL, 1000 mg/100 mL, 1500 mg/100 mL Antiepileptic drug indicated for adjunct therapy in adults (≥ 16 years of age) with certain seizure types when oral administration is temporarily not feasible
Belcher Pharmaceuticals, LLC Cefixime for oral suspension USP, 500 mg/5 mL; Suprax To reduce the development of drug-resistant bacteria and maintain the effectiveness for oral suspension
Lupin Inc. Sodium sulfate, potassium sulfate, and magnesium sulfate oral solution, 17.5 g/3.13 g/1.6 g per 6 ounces; Suprep Bowel Prep Kit For cleansing of the colon in preparation for colonscopy in adults
Nostrum Laboratories, Inc. Venlafaxine Hydrochloride Extended-release Tablets, 225 mg (base) For treatment of major depressive disorder and social anxiety disorder
Pack Pharmaceuticals, LLC Zileuton Extended-Release Tablets, 600 mg; Zyflo CR For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older
Roxane Laboratories, Inc. Sodium Oxybate Oral Solution, 500 mg/mL ; Xyrem For the treatment of cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy
Teva Pharmaceuticals USA, Inc. Logilia Ulipristal Acetate, 30 mg; Ella For prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure

* Teva Pharmaceutical Industries acquired the generics business of Allergan in 2016. Actavis had formerly acquired Allergan and had taken the Allergan name. Hikma acquired Roxane Laboratories, the generics business of Boehringer Ingelheim, in 2016.

Source: US Food and Drug Administration and company information.

First-time generics in 2016
In 2016, the FDA’s Office of Generic Drugs in the Center for Drug Evaluation and Research generated the highest number of approvals in the history of FDA’s generic drug program, more than 800 generic drug approvals, including both full approvals and tentative approvals. (Tentative approvals are granted to applications ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug.) Last year’s performance surpassed 2015’s previous record of 726. Many of these approvals were for “first-time generic drugs,” meaning the introduction of a generic counterpart for a brand-name product for which there was previously no generic. In 2016, the FDA approved 73 first-time generic drugs, Key first-time generic approvals of innovator drug in 2016 included: AstraZeneca’s Crestor (rosuvastatin), an anti-cholesterol drug; Daiichi Sankyo’s Benicar (olmesartan) for treating high-blood pressure; Merck & Co.’s Nasonex (mometasone furoate (nasal spray) for preventing and treating seasonal and year-round allergy symptoms; Pfizer’s Viagra (sildenafil), a drug to treat erectile dysfunction; Pfizer’s Tikosyn (dofetilide), an antiarrhythmic agent; and Roche’s Tamiflu (oseltamivir), an antiviral drug to treat influenza.

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