I will summarize the gist of my understanding based on the collected snippets from various

sources mentioned at the end of this post.

• All the patent codes apply to the Innovator’s branded drug.
• All the exclusivity codes, except for PC (Patent Challenge) applies to the Innovator’s branded
drug.
• For exclusivity code, PC (Patent Challenge) it comes into effect for the FTF ANDA applicant
implying the 180-day exclusivity.
• Exclusivity codes such as NCE and ODE are significant in the respect that they indicate with a
high probability that probable FTF ANDA applicant is likely to submit the ANDA at “NCE-1” (i.e.
4 years after NCE approval, and 1 yr before expiry) and notify the Innovator who in turn will
initiate the Para IV Litigation.
o Thus, as Ankit indicates in his excellent “Key molecules” reports more often than not the
sources for Para IV information is from litigation dockets/research reports. (rather than depending
on Exclusivity code which reflects after the fact post the Final Approval)

All the information below are re-formatted and curated from their original sources.

Hatch‐Waxman Amendments

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Grand bargain for Brand and Generic Industries

• Brand Industry Gains:
– 5‐year New Chemical Entity (NCE) Exclusivity
– 3‐year New Clinical Studies Exclusivity
– Patent Term Extension to account for time patented product is under review by FDA
• Generic Industry Gains:
– Ability to challenge brand drug patents prior to marketing in court
– 180‐day Generic Drug Exclusivity

What brand must do: “list” patents

• NDA sponsor must identify in NDA those patents reasonably related to drug product, drug
substance, or method of using drug for which approval is sought.
• FDA “lists” patents identified by NDA sponsors in “Orange Book” (OB).
• NDA referred to as “reference listed drug” or RLD.

What generics must do: “certify”

• Certify with respect to each patent listed for that RLD in the OB:
• patent information has not been filed (“paragraph I certification”) = FDA can approve ANDA
when ready
• the patent has expired (“paragraph II certification”) = FDA can approve ANDA when ready
• the date the patent will expire (“paragraph III certification”) = FDA can approve ANDA when
patent expires and ANDA is ready
• the patent is invalid or not infringed by the drug product proposed in the ANDA (“paragraph IV
certification”) = complex approval landscape

What follows from PIV certification

• After FDA notifies applicant that ANDA is sufficiently complete to review, applicant must notify
NDA/patent holder of Paragraph IV certification.
• NDA sponsor can sue when it receives notice.
• Infringement lawsuit can start prior to ANDA approval and marketing
• If NDA sponsor sues within 45 days of notice, ANDA approval is stayed for 30 months.
– Runs from date of notification or expiration of NCE exclusivity
– May be lengthened or shortened by the court
• No lawsuit with 45 days = FDA can approve ANDA when ready

All possible Para IV Outcomes

Tentative Approval
• ANDA ready for approval but blocked by patent, exclusivity, or stay = only eligible for tentative
approval (TA)
• Full approval not automatic after TA – must show ANDA still meets requirements for approval at
time of full approval,
• TA’d ANDAs must request full approval

180‐day Exclusivity
• Reward for ANDA applicants that challenge patents, potentially hastening generic market entry
• 180‐day exclusivity is only available to “First to File” (FTF) ANDAs containing PIV certification
• Commonly there are multiple FTFs = shared exclusivity for FTF cohort
• Subject to forfeiture

New Chemical Entity (NCE) Exclusivity

– Five year data exclusivity from the date of first NDA approval for products containing chemical
entities never previously approved by FDA
– ANDAs with Paragraph IV certification may be submitted four years after regulatory
approval (NCE -1),but may not receive approval until the expiration of the exclusivity period

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What’s shared exclusivity?

If multiple ANDAs are submitted for the same drug on the same day, the 180-day market
exclusivity is shared between the first two generic companies. Actavis (ACT) shared 16 out the
total 49 market exclusivities in 2012. To an extent, shared exclusivity diluted the attractiveness of
the exclusivity. However, FTFs still holds a charm.

Guidance for Industry 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same
Day, July 2003
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm07
2851.pdf 5
FDA intends to apply a multiple first applicant approach to eligibility for 180-day exclusivity by
considering all substantially complete ANDAs, amendments, and supplements containing a
paragraph IV certification to a listed patent that are submitted to the OGD document room on the
same day as being first applicants, when no paragraph IV certification to the patent has been
submitted on any previous day, as long as the applications comply with the applicable
requirements for submission. FDA considers this approach to be an appropriate interpretation of
the statutory language and consistent with the goals of the Hatch-Waxman Amendments. This
approach will provide all applicants submitting patent challenges on the same day an opportunity
to share in exclusivity; it permits submission by U.S. mail or courier or delivery service; it permits,
but does not require, submission in person; it avoids the random aspect of a lottery or mail
room date stamp approach; it will prevent disputes over who’s first, which rely on video
and other evidence; and it will preserve the safety and security of the applicants and FDA
property and staff.
Consistent with FDA’s current practice, submission by facsimile or email is not considered
officially submitted for purposes of determining the date of submission.
The approach to 180-day exclusivity described in this guidance will apply only in cases in which
multiple ANDA applicants submit paragraph IV certifications challenging the same listed patent or
patents on the same first day. The Agency recognizes the highly competitive nature of the
generic drug approval process and the possibility of substantial profits for the recipient of 180-
day exclusivity. There is no public health reason to encourage and reward competition over being
the first to submit a paragraph IV certification within minutes or seconds of another such
applicant. The Agency believes that, where there are multiple filings on the same first day, the
multiple first applicant approach is consistent with language of section 505(j)(5)(B)(iv) and with
the intent of both the 180-day exclusivity provision and the Hatch-Waxman Amendments.

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3. How long is exclusivity granted for?

It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a “change” if criteria are met
 Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
4. Why does the exclusivity expire before the patent?
Patent before exclusivity?
Why does a particular drug product only have patents?
Only have exclusivity?
Have neither?
• Patents can be expired before drug approval, issued after drug approval, and anywhere
in between.
• Exclusivity is granted upon approval of a drug product if the statutory requirements are
met.
• Some drugs have both patent and exclusivity protection while others have just one or
none.
• Patents and exclusivity may or may not run concurrently and may or may not
encompass the same claims.
• Exclusivity is not added to the patent life.
• Expired patents and exclusivity are not included in the published list.

Forfeiture of FTF 180-day exclusivity

In December of 2003, the passage of the Medicare Modernization Act included the Forfeiture
provisions. The MMA identified 6 forfeiture events which, if any occurred, would have the FDA
deny a first-filer ANDA its 180 days of market exclusivity.

These six events are, in short:

(1) Failure to Market: if the first applicant fails to market its product under a variety of
circumstances and time frames. (2) Withdrawal of Application: If the first applicant withdraws its
application or it is deemed to have been incomplete. (3) Amendment of Certification: if the first
applicant amends or withdraws its patent certifications.
(4) Failure to Obtain Tentative Approval: if the first applicant fails to obtain tentative approval for
its ANDA within 30 months after it was filed.
(5) Agreement: if the first applicant enters into an agreement that violates antitrust law.
(6) Expiration of Patents: if the relevant patents expire.

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Sources
FAQ on Patents and Exclusivities
http://www.fda.gov/drugs/developmentapprovalprocess/ucm079031.htm  3

Transcript http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm315519.htm  1
Para IV Forfeitures http://www.paragraphfour.com/explained/basics.htm  3

Market Realist - Excellent Long read http://marketrealist.com/2015/03/para-iv-filing-rewarding-

generic-company/ 2

Commentary on Forfeiture due to 30 month

lapsehttp://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/06/fda-petitioned-on-180-
day-exclusivity-forfeiture-for-tentative-approvals-that-occur-on-the-30-month-.html  1

Reuters PPT -
First to File and Beyond: Paragraph IV Business
Strategieshttp://thomsonreuters.com/content/dam/openweb/documents/pdf/pharma-life-
sciences/misc/burck-paragraph-iv-webinar.pdf  2

USFDA - GpHA Quarterly GDUFA Review with Detailed explanation of Hatch‐Waxman

Amendmentshttp://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareD
evelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UC
M442070.pdf 1