SecProbe.io

CORRESP
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December 21, 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, 2015

Form 10-Q/A for the Quarterly Period
Ended September 30, 2015

Filed November 10, 2015

   File No. 001-15697

Dear Mr. Rosenberg:

Elite Pharmaceuticals, Inc. (the "Company")
hereby responds to the comments contained in your November 20 2015 comment letter (the “November 2015 Letter”) concerning
the above referenced Company filings. Headings and comment numbers below correspond to the headings and comment numbers in the
November 2015 Letter. Please note that the Company’s response to Comment No. 6 in the November 2015 Letter also includes
the Company’s further response to Comments 4 and 5 contained in the Commission’s September 25, 2015 comment letter
(the September 2015 Letter”).

COMMENT
NO. 1.

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

Notes to Consolidated Financial Statements

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

 1. Refer to our prior comment 2. Please revise your proposed disclosures to
discuss your allocation of arrangement consideration to the separate units of accounting. In this regard, revise your policy that
indicates that revenue is recognized when “fair value can be determined” to indicate that arrangement consideration
is allocated at the inception of the arrangement based on relative selling prices. See ASC 605-25-30-2. Include a discussion of
the significant factors, inputs, assumptions and methods used to determine selling price for the significant deliverables under
multiple-element revenue arrangements, including whether the determination was based on vendor-specific objective evidence, third
party evidence or best estimate of selling price. Refer to ASC 605-25-50-2(e).

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

      -1-

RESPONSE.

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

“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.”

Arrangement
consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price
(the relative selling price method). When applying the relative selling price method, the selling price of each deliverable is
determined using vendor-specific objective evidence of selling price, if such exists; otherwise, third-part evidence of selling
price. If neither vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company
uses its best estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether
we can determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information
that is reasonable available without undue cost and effort.

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

      -2-

When
determining the selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers
any or all of the following, depending on information available or information that could be reasonably available without undue
cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically,
factors considered can include, without limitation and as appropriate, size of market for specific a product, number of suppliers
and other competitive market factors, forecast market shares and gross profits, barriers/time frames to market entry/launch, intellectual
property rights and protections, exclusive or non-exclusive arrangements, costs of similar/identical deliverables from third parties,
contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, profit allocations, and
other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable.

COMMENT
NO. 2.

Note 4 – Intangible Assets, page F-14

 2. Refer to your response to our prior comment 3. It appears that your direct
experience with the products related to your ANDA’s is limited, with four products launched during 2015. Please provide your
analysis of known or foreseeable obsolescence, demand, competition or other economic factors that would support your assertion
that the ANDA’s have indefinite lives. Include in your response the date of FDA approval for the branded product the ANDA
is based on, the date the product became generic, the treatment indication, and other factors supporting your conclusions. Also,
please confirm whether any capitalized patent costs are related to the ANDA assets.

RESPONSE.

The
FDA Orange Book lists the following in relation to our generic products:

    Product

    Approval

Of Branded

    1st Generic

    Indication

    Phentermine HCl 37.5mg tablet

    Prior to 1982

    1997

    Bariatric

    Phentermine HCl 15mg capsule

    Prior to 1982

    1983

    Bariatric

    Phentermine HCl 30mg capsule

    Prior to 1982

    1983

    Bariatric

    Isradipine

    1990

    2006

    Hypertension

    Hydroxyzine HCl

    Prior to 1982

    1986

    Antihistamine / Allergy

    Phendimetrazine Tartrate

    Prior to 1982

    Prior to 1982

    Bariatric

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

      -3-

Please
note that none of the capitalized patent costs relate to ANDA’s.

With
regards to the Company’s determination that the above ANDA’s are indefinitely lived, we present the following:

 a. Elite receives current demand (in the
form of purchase orders) and forecast demand (in the form of forecasts that range from 1 to 3 years) from its marketing partners.
This tangible data does not indicate or foresee any obsolescence, significant future impairment in demand, or other economic factors
that would indicate an impairment or impending expiration of the generic products as viable commercial products. To the contrary,
product sales are increasing, as demonstrated by our financial statements, and future expectations remain positive.

 b. These generic products have well established
and stable markets. The Phentermines, Hydroxyzine and Phendimetrazine have all been on the market for more than 33 years and Isradipine
for 25 years. We have no knowledge or evidence of any legislative actions or changes in regulatory environments that can be cited
to support the determination of these product approvals being rescinded in a certain time frame.

 c. The indications for which these generic
products are therapeutically relevant are widespread health concerns in the United States, as opposed to rare conditions suffered
by small percentages of the population. The Company has no known or foreseeable knowledge of these indications being removed from
the health issues from a large portion of the population that can be cited to support the determination of these products being
impaired as a result of the indications to which they apply being no longer in existences.

 d. The Company is also not aware of any
technological improvements, discoveries or new drug filings related to products that would result in significant impairment to
the commercial life of our generics. In addition, the efficacy, supply and manufacture of each of these products is well established
and efficient, due to their length of time and breadth in the market. While not meeting a strict definition of a commodity, they
are the types of products that perform in a similar manner, albeit within the regulatory environment in which pharmaceuticals operate.
The efficacy, efficiency and pricing achieved as a result of these factors provide an additional barrier to the introduction of
new technologies, which would have to bear the significant costs relating to the development, filing and approval of a New Drug
Application and then compete on price, supply and efficacy with these commodity type generic products.

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

      -4-

 e. Please also refer to our comments on
this topic in our prior correspondence dated October 26, 2015 which provides additional analysis on the Company’s determination
being compliant with the relevant aspects of subtopic ASC-350.

COMMENT
NO. 3.

Note 20 – Concentrations, page F-32

 3. Refer to your response to our prior comment 7. It appears that your revenue
related to NDA’s is due to the Epic Collaborative Agreement and that you do not currently have any NDA product sales. Please
provide us proposed disclosure to be included in future periodic reports of your revenue by product or group of products as required
by ASC 280-10-50-40, or explain to us why it is impractical to do so. Additionally, please revise your proposed disclosure to clarify
whether you manage your business as one segment or if the disaggregation of revenues between NDA and ANDA products represents two
reportable segments.

RESPONSE.

The
Company will add the following disclosure to the Concentrations footnote in future reports:

The Company disaggregates its product revenues
into the type of marketing authorization relating to each product, specifically the following two reportable segments:

 1. ANDA’s for generic products; or

 2. NDA’s for branded products.

During the xxx and xxx months ended [DATE],
the Company recognized $XXXk and $XXXk from the sale of generic products with ANDA marketing authorization, respectively. During
the xxx and xxx months ended [DATE], the Company recognized $XXXk and $XXXk from the sale of generic products with NDA marketing
authorization, respectively.

COMMENT
NO. 4.

Note 22 – Related Party Transaction –
Manufacturing and License Agreement with Epic Pharma

LLC, page F-34

 4. Refer to your response to our prior comment 8. Notwithstanding your receipt
of confidential treatment for specific rates used to calculate your license fees under your license, manufacturing and development
agreements, investors are entitled to an understanding of the material terms of each of your material agreements. Please revise
your disclosure to provide a range of potential rates for the license fees the parties may be obligated to pay under these agreements.
Please ensure that your disclosed range is within a ten per-cent range (e.g. “10-20%”, “single-digits”,
“twenties”, as applicable). Please note that we are requesting disclosure of the range of potential license fees not
disclosure of specific rates.

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

      -5-

RESPONSE.

The
Company will add the range of rates as requested.

COMMENT
NO. 5.

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

Notes to Condensed Consolidated Financial Statements

Note 12 – Collaborative Agreement with Epic
Pharma LLC, page F-12

 5. Refer to your response to our prior comment 9. Please address the following
additional comments:

 · Tell us why you do not appear to identify the exclusive license to market
and sell ELI-200 in the U.S. as a deliverable under your agreement with Epic.

 · Tell us whether this license was conveyed to Epic upon execution of the
agreement on June 4, 2015 and, if not, tell us when the license was or will be conveyed.

 · Although your prior research and development activities associated with
ELI-200 reasonably contributed to the value inherent in the rights to ELI-200 and your ability to license these rights to Epic,
explain how the past research and development activities are a deliverable and have standalone value to Epic. In this regard, as
Epic only has license rights to market and sell ELI-200 it appears that the license rights are dependent upon the success of your
future development services.

 · Tell us whether and how Epic can exploit its license rights prior to regulatory
approval of ELI-200. Tell us whether Epic can sell its license to someone else or whether it can sublicense the rights.

 · Provide us proposed revised disclosure to be included in future periodic
reports that describes your accounting for the agreement in accordance with ASC 605-25. Disclose the significant deliverables within
the arrangement, the timing of delivery, the performance provisions, and whether and how separate units of accounting were identified
as stipulated in ASC 605-25-50-2. In that regard, your current disclosure appears to follow disclosure requirements of ASC 605-28.

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

      -6-

RESPONSE

The
Company has investigated the matters raised in the Commission’s comment letter and during our conversations with the Staff
and has determined that restatement of the Current Reports on Form 10-Q for the quarters ended June 30, 2015 and September 30,
2015 are required due to an error in accounting that was made with respect to the recording of the license fee received pursuant
to the collaborative agreement with Epic Pharma LLC. Item 4.02 of Form 8-K was filed on December 4, 2015 and we are preparing the
required forms 10-Q/A.

The
Company’s discovery of the accounting error and determination of the proper accounting was based on the following analysis:

Deliverable Elements

Based on the Agreement and the guidance
noted in:

 · Accounting Standards Codification 605-25, Revenue Recognition – Multiple Element Arrangements
(“ASC 605-25”)

 · E&Y Revenue Recognition – Multiple E