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    October 26, 2015

Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of Healthcare and Insurance

Division of Corporation Finance

Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

    Re:
    Elite Pharmaceuticals, Inc.

    Form 10-K for the Fiscal Year Ended March 31, 2015

    Filed June 15, 2015

    Form 10-Q for the Quarterly Period Ended June 30, 2015

    Filed August 10, 2014

    File No. 001-15697

Dear Mr. Rosenberg:

Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the comments contained in your September 25, 2015 comment letter concerning the above referenced Company filings.
Headings and comment numbers below correspond to the headings and comment numbers in the comment letter.

COMMENT NO. 1.

Form 10-K for the Fiscal Year Ended March 31, 2015

Research and Development, page 12

1.          Notwithstanding your policy not to
disclose research and development activities for competitive reasons, we believe disclosing information about each of your key
development programs is important to an understanding of your operations and prospects. In this regard, we realize that you disclose
some information about your development projects on your website. Please provide us proposed disclosure to be included in Business
and MD&A in future periodic reports that provides the following information for each of your key research and development projects:

 · The current status of the project;

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

 · The costs incurred during each period presented and to date on the project;

 · The anticipated completion dates;

 · The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial
position and liquidity if the project is not completed timely; and finally

 · The period in which material net cash inflows from significant projects are expected to commence.

If you do not track your research and development
costs by project, please disclose that fact and explain why you do not maintain and evaluate research and development costs by
project. Provide other quantitative or qualitative disclosure that indicates the amount of your resources being used on the project.
Regarding anticipated completion dates, disclose the amount or range of estimated costs and timing to complete the phase in process
and each future phase. To the extent that information is not estimable, disclose those facts and circumstances indicating the uncertainties
that preclude you from making reasonable estimate.

RESPONSE.

The
Company plans to include the following discussion in future periodic reports.

Research
and Development

Elite’s
research and development activities are primarily focused on developing its proprietary abuse deterrent technology and the development
of a range of abuse deterrent opioid products that utilize this technology.

Elite’s
proprietary abuse-deterrent technology, utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate
capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol
dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased
while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate
beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is
intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing
the incentive for abuse or misuse by recreational drug abusers.

The
first product to utilize our abuse deterrent technology, ELI-200, has successfully completed Phase III studies, and, subject to
the risks described below, the Company believes that it will be able to file a New Drug Application (“NDA”) with the
FDA during this fiscal year. The Company believes that, when this application is accepted by the FDA and subject to the risks described
below, it will be granted expedited review by the FDA, and accordingly believes that any such approval could be received during
the fiscal year ended March 31, 2017.

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

The
Company believes that the abuse deterrent technology can be applied to and incorporated into a wide range of opioids used today
for pain management and has, to date, identified 10 additional products for potential development. All of these products are at
early stages of development, with research and development activities mainly consisting of in-house process development and laboratory
studies. Extensive efficacy and safety studies, similar to those conducted for ELI-200 have not yet been conducted for these other
products. As a result, costs incurred in relation to the development of these 10 products have not been material.

Research
and development costs were $xxx million, $14.8 million, and $4.0 million for the fiscal years ended March 31, 2016, 2015 and 2014,
respectively, with such costs relating almost entirely to the development of ELI-200, the first product developed by Elite that
incorporates the technology. [to be revised based upon the historical facts when the 2016 financial statements are prepared]

On
June 4, 2015, the Company entered into a sales and distribution licensing agreement which included a payment of $5 million to Elite
for prior research and development activities, with such representing the first material net cash inflows being generated by ELI-200.
The agreement also includes an additional $10 million to be paid upon the filing with and approval by the FDA of the NDA, and license
fees based on the commercial sales achieved by ELI-200, once marketing authorization has been granted by the FDA. Please note,
as further detailed below, there can be no assurances of the Company filing an NDA and receiving marketing authorization for ELI-200,
and accordingly, there can be no assurances that the Company will earn and receive the additional $10 million or future license
fees. If the Company does not receive these payments or fees, it most likely will materially adversely affect our financial condition.

Please
note that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently
requests that additional information be submitted. The effect of such request and subsequent submission can significantly extend
the time for the NDA review process. Until an NDA is actually approved, there can be no assurances that the information requested
and submitted will be considered adequate by the FDA to justify approval. The packaging and labeling of our developed products
are also subject to FDA regulation. Based on the foregoing, it is impossible to anticipate the amount of time that will be needed
to obtain FDA approval to market any product. In addition, there can be no assurances of the Company filing the required application(s)
with the FDA or of the FDA approving such application(s) if filed, and the Company’s ability to successfully develop and
commercialize products incorporating its abuse deterrent technology is subject to a high level of risk as detailed in “Item
1A-Risk Factors-Risks Related to our Business” of this Annual Report on Form 10-K.

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

COMMENT NO. 2.

Notes to Consolidated Financial Statements

Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F-11

2.          Please provide us proposed revised
disclosure to be included in future periodic reports that clarifies how you apply the guidance in ASC 605-25, Multiple-Element
Arrangements, in recognizing revenue under your various licensing, manufacturing and

development agreements.

RESPONSE.

The
Company will add the following disclosure to the Revenue Recognition section of the Summary of Significant Accounting Policies
footnote:

“The
Company enters into licensing, manufacturing and development agreements which may include multiple revenue generating activities,
including, without limitation, milestones, license fees, product sales and services. These multiple elements are assessed in accordance
ASC 605-25 Revenue Recognition for Multiple-Element Arrangements in order to determine whether particular components of
the arrangement represent separate units of accounting.

An
arrangement component is considered to be a separate unit of accounting if the deliverable relating to the component has value
to the customer on a standalone basis, and if the arrangement includes a general right of return relative to the delivered item,
delivery or performance of the undelivered item is considered probable and substantially in control of the Company.

The
Company recognizes payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s)
have stand-alone value and the fair value can be determined, with the arrangement being accordingly accounted for as a separate
unit of accounting. If such delivered item(s) are considered to either not have stand-alone value, or if the fair value cannot
be determined, the arrangement is accounted for as a single unit of accounting, and the payments received are recognized as revenue
over the estimated period of when performance obligations relating to the item(s) will be performed.

Whenever
the Company determines that an arrangement should be accounted for as a single unit of accounting, we determine the period over
which the performance obligations will be performed and revenue will be recognized. If we cannot reasonably estimate the timing
and the level of effort to complete our performance obligations under a multiple-element arrangement, revenues are then recognized
on a straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.”

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

COMMENT NO. 3.

Note 4 – Intangible Assets, page F-14

3.          You disclose that you begin
amortization of your ANDA and patent intangibles upon receipt of approval of site transfers and the patent, respectively. Please
tell us why you have not amortized any of your intangible assets when, at a minimum, it appears that you have 10 issued patents
as disclosed on page 13 and that two of the products that appear to be included in your ANDA intangible (Phentermine HCl 37.5mg
tablets and Phendimetrazine Tartrate 35mg tables) were launched in April 2011 and November 2012, respectively, based on information
in the table on page 5. In your response, please provide the following information for your ANDA intangible assets:

 · The name of each asset;

 · The amount capitalized for each asset;

 · The date of acquisition;

 · The date of receipt of approval of site transfer (if applicable);

 · The date of your product launch (if applicable); and

 · The effective date of any manufacturing agreements with other parties to produce the product (including
those agreements to produce product only until you receive regulatory approval on site transfer).

RESPONSE.

Intangible Assets – ANDA’s

The
Company believes that the ANDA’s are indefinite lived assets, with amortization not permitted, as per ASC-350-30-35-1.

ASC
350-30-35-1 requires that the accounting for a recognized intangible be based on its useful life, with those intangibles with
indefinite useful lives not being amortized.

The
Company defines the useful life of an intangible asset to be the period over which the asset is expected to contribute directly
or indirectly to future cash flows, in accordance with ASC-350-30-35-2.

The
Company has determined that the ANDA’s have an indefinite life, with such determination including analysis of the following
pertinent factors:

 a. The Company has expectations of the ongoing and continued
use of the assets, with no foreseeable period of discontinuance (ASC 350-30-35-3a).

 b. Other assets or groups of assets to which the respective
ANDA’s may relate have no known or foreseeable limitations to useful life (ASC-350-30-35-3b).

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

 c. ANDA’s have no expiration date or renewal requirements
and there are no other known or foreseeable legal, regulatory or contractual provisions that may limit useful life (ASC-350-30-35-3c
and ASC-350-30-35-3d).

 d. The Company knows of no known or foreseeable obsolescence,
demand, competition or other economic factors, such as known technological advances, legislative actions, changes in regulatory
environments or changes in distribution channels, that would result in a limitation of useful life (ASC-305-35-3e).

 e. The extent of maintenance expenditures required to obtain
future cash flows from the ANDA’s are minimal and insignificant for the foreseeable future (ASC-305-35-3f).

ASC
350-30-35-4 further stipulates that if there are no legal, regulatory, contractual, competitive, economic, or other factors
that limit the useful life of an intangible asset for a period that extends beyond the foreseeable horizon, than the useful life
of the intangible assets is indefinite.

The
ANDA’s are accordingly determined to be indefinite lived assets, with amortization not permitted, as per ASC-350-30-35-1.

The
Company will revise disclosures in future periodic reports to reflect the foregoing.

Please
also find the following information requested in your correspondence:

    Name of ANDA
    Amount
 Capitalized
    Acquisition
    Site
 Transfer
 Approval
    Product
 Launch
    Agreement
 to Produce
 the Product

    Phentermine 37.5mg
      450,000
      Sept 2010
    April 2011
    April 2011
    Sept 2010

    Isradipine 2.5mg and 5mg
      1,063,374
      Aug 2013
    Jan 2015
    Jan 2015
    Oct 2013

    Phendimetrazine 35mg
      206,088
      Aug 2013
    n/a
    Nov 2012
    Oct 2013

    Hydroxyzine 10mg
      129,824
      Aug 2013
    April 2015
    April 2015
    Oct 2013

    Hydroxyzine 25mg
      434,784
      Aug 2013
    April 2015
    April 2015
    Oct 2013

    Hydroxyzine 50mg
      222,867
      Aug 2013
    April 2015
    April 2015
    Oct 2013

    7 Undisclosed Generics
      3,540,379
      Aug 2013
    n/a
    n/a
    Oct 2013

Intangible
Assets – Patents

Intangible
assets relating to patents are amortized over the useful life of the patent, in accordance with subtopic ASC-350-30.

The
useful life of the patents are determined by the period over which the patent is expected to contribute to the future cash flows
of the Company (ASC-350-30-35-2). The Company estimates the useful life of the patents based on an analysis of those pertinent
factors detailed in subtopic ASC-350-30-35-3, as follows:

    165 Ludlow Avenue • Northvale, NJ 07647 • Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com

 a. The expected use of the patents are determined as the period
during which the rights granted by our patents have utility to Elite (ASC-350-30-35-3a). The rights granted by patents,
which are defined in the U.S. Constitution and further clarified in judicial rulings and regulations, allow Elite to exclude others
from commercializing drugs covered by our patents, but have no application to research and development or preparation of FDA filings,
whether such activities are conducted by Elite or by third parties.

Article
1 Section 8 Clause 8 of the United States Constitution states: “To promote the Progress of Science and useful Arts, by