You are here: Home > Research & Development > Product Pipeline

  Product Pipeline and Commercial Products

 
 R&D Home
  
 
Technology
 
 Products
 
 Partners & Licensing
 
 Patents

Product Pipeline

Programs Under Development

Branded Products (a)

Therapeutic Category

NDA / ANDA

Development Stage (b)

Partnered

ELI-154
Oxycodone CR
Once a day

NA

Pain

NDA

Phase III pending

No

ELI-216
Abuse Resistance Product for use with oxycodone or other opioids

N/A

Pain

NDA

Phase III pending

No

Undisclosed
Twice a day

Undisclosed

Anti-infective

ANDA

Pilot BE study complete

No

Undisclosed
Once a day

Undisclosed

Gastrointestinal

ANDA

Pilot BE study complete

Yes

 

Commercial Products

Commercial
 
Product

Branded Products (a)

Therapeutic Category

Commercial
Status

Partner

Lodrane®
Once a Day

N/A

Allergy

Launched

ECR Pharmaceuticals

Lodrane 24D ®
Once a day

N/A

Allergy

Launched

ECR Pharmaceuticals

Phentermine HCl 37.5 mg tablets Adipex-P® 37.5 mg Bariatric Launched Precision Dose, Inc. / TAGI
Hydromorphone Hydrochloride
8 mg tablets
Dilaudid®
8 mg
Pain FDA Approved, Launch pending Precision Dose, Inc. / TAGI
Naltrexone Hydrochloride
50 mg
ReVia® and Depade® Opioid Receptor Antagonist FDA Approved, Launch pending Precision Dose, Inc. / TAGI

(a)    The name of our competitor’s branded product.  N/A

(b)   Preclinical testing refers to studies done before initiation of any human studies. Pilot Phase I studies for the NDA products are generally preliminary studies done in healthy human subjects to assess the tolerance/safety and pharmacokinetics (PK) of the product. Additional larger studies in humans will be required prior to submission of this product to the FDA for review. Pilot bioequivalence (BE) studies are initial studies done in humans for generic products and are used to assess the likelihood of achieving bioequivalence for generic products. Larger pivotal bioequivalence studies will be required prior to submission of the product for FDA for review.

 

Elite Pharmaceuticals, Inc. 165 Ludlow Ave., Northvale, NJ 07647    Phone:  201-750-2646  Fax:  201-750-2755 
E Mail:  webmaster@elitepharma.com