An ANDA contains data submitted to the FDA to review and approve a generic drug product. Once approved, a generic manufacturer can produce and market a safe, low-cost alternative to the innovator drug. All approved drugs are listed in the Orange Book. ANDAs have four types of submissions: Paragraph I for drugs with no listed patents allowing immediate approval; Paragraph II for off-patent drugs; Paragraph III where generics agree not to market until patents expire; and Paragraph IV for generics believing patents are invalid allowing earlier market entry. The examples show drugs with Paragraph III certifications and their patent expiration dates.

1. Paragraph III ANDA Filing
BY- Harishankar Sahu
MBA PM07
IIHMR,University,Jaipur

2. Abbreviated New Drug Application
• An (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation
and Research, provides for the review and ultimate approval of a generic drug
product.
• Once approved, an applicant may manufacture and market the generic drug product
to provide a safe, effective, low cost alternative to the world wide.
• All approved products, both innovator and generic, are listed in FDA's Approved Drug
Products with Therapeutic Equivalence Evaluations (Orange Book).

3. Generic Drug Approval
 In 1970 FDA established the ANDA as a
mechanism for the review and approval of generic
versions.
 Before 1978, generic product applicants were
required to submit complete safety and efficacy
through clinical trials.
 Post 1978, applicants were required to submit
published reports of such trials documenting safety
and efficacy.
Neither of these approaches was considered
3

4. INNOVATOR VS GENERICS
4
S.N. PARAMETERS INNOVATOR DRUG GENERIC DRUG
1. Active ingredients Same
Same
2. Safety & efficacy Same
Same
3. Quality & strength Same
Same
4. Performance and standards Same
Same
5. Costs/prescription Highly expensive
Less expensive
6. FDA inspection of
manufacturing facilities Yes
Yes
7. FDA reviews reports of
adverse reactions Yes
Yes
8. FDA reviews drug labeling Yes
No
9. Extensive research and

5. ANDA
CERTIFICATION
CLAUSES
PARAGR
APH
I
PARAGR
APH II
PARAGR
APH III
PARAGR
APH IV

6. Para I
No listed patent.
FDA may approve generics immediately, one or more applicants may enter
Para II
A Para II filing is made when the drug is already off patent.
Para III
Paragraph III Certification indicates that the generic manufacturer will stay off
market until the patents expire.
Para IV A Para IV filing for the launch of generic drug is made when the applicant
believes its product or where the applicant believes such patents are not valid or
enforceable.
ANDA has four types of submissions.

7. Examples of PARAGRAPH III
Tradename: TRIFERIC
Applicant: Rockwell Medical Inc
Ingredient: ferric pyrophosphate citrate
Dosage SOLUTION;IV (INFUSION)
Ingredient-type Iron
Mechanism of Action Phosphate Chelating Activity
Approval Date: Jan 23, 2015
Patent Expiration: Apr 17, 2029
Summary for NDA: 206317
1

8. Examples of PARAGRAPH III
Summary for NDA: 021060
2
Tradename: PRIALT
Applicant: Jazz Pharms Intl
Ingredient: ziconotide acetate
Dosage INJECTABLE
Ingredient-type ANALGESIA
Mechanism of Action N-Calcium Channel Receptor
Antagonists
Approval Date: Dec 28, 2004
Patent Expiration: Oct 1, 2024

9. Examples of PARAGRAPH III
Summary for NDA: 020950
3 Tradename: DUONEB
Applicant: Mylan Speclt
Ingredients albuterol sulfate; ipratropium
bromide
Dosage SOLUTION;INHALATION
Ingredient-type TREATMENT OF BRONCHOSPASM
ASSOCIATED WITH COPD
Mechanism of Action Cholinergic Antagonists
Adrenergic beta2-Agonists
Approval Date: Mar 21, 2001
Patent Expiration: Dec 28, 2021

10. Examples of PARAGRAPH III
Summary for NDA: 020950
4
Tradename: CIPRO XR
Applicant: Bayer Hlthcare
Ingredient: ciprofloxacin hydrochloride
Dosage TABLET, EXTENDED
RELEASE;ORA
Ingredient-type Quinolones
Mechanism of Action inhibition of the enzymes
topoisomerase II
Approval Date: Aug 28, 2003
Patent Expiration: Dec 23, 2021
Summary for NDA: 021473

11. REFERENCE
• http://WWW.FDA.GOV/CDER/OGD/ .
• http://www.fda.gov/newsevents/testimony/u
cm115033.htm.
• Astrazeneca v. Apotex, et. al (Fed. Cir. 2012)