Lupin Pharmaceutkals,Inc.

Transcription

1 Lupin Pharmaceutkals,Inc A 8 : 43 VIA FEDERAL EXPRESS Division of Documents Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD CITIZEN PETITION On behalf of Lupin Limited ("Lupin"), the undersigned submits this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDC Act), as well as 21 U.S.C , and 10.30, requesting that the Commissioner of the U.S. Food and Drug Administration formally determine that Teva Pharmaceuticals ("Teva") has forfeited its 180-day marketing exclusivity period for generic versions of Avapro brand irbesartan tablets, 75 mg, 150 mg and 300 mg. Lupin is a subsequent ANDA filer for these drug products that is directly affected by this issue and thus seeks expedited consideration of the petition to avoid delaying generic competition. P. D027? HARBORPLACE TOWER, 111 SOUTH CALVERT STREET, 21ST FLOOR, BALTIMORE, MD TEL: FAX:

2 Page 2 Lupin has expected to obtain final FDA approval to market its generic versions of Avaproe-brand tablets, with such approval to be effective on March 30, Lupin now understands that such approval will be delayed until Teva has enjoyed a 180-day patentchallenge exclusivity, an exclusivity to which Teva should not be entitled. I. Action Requested This petition requests that FDA issue a formal determination that Teva has forfeited its 180-day exclusivity related to ANDA No , under 21 U.S.C. 355(j)(5)(D)(i)(IV). As discussed below, Teva failed to obtain tentative approval of its ANDA within 30 months from the date on which its application was filed, and none of the exceptions to that forfeiture provision applies. This petition also requests that the Commissioner expedite consideration of this petition to ensure that Lupin is granted final approval to market its generic irbesartan tablets on March 30, II. STATE OF GROUNDS A. Factual Background We set forth the following relevant background facts based on public filings and other publicly available information. 1. The Reference listed Drug: Avapro Brand Irbesartan Tablets Sanofi Aventis US ("Sanofi") is the current owner of NDA No for Avapro0- brand irbesartan tablets. According to the electronic version of the Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"), U.S. Patent Nos. 5,270,317 ("the '317 patent") and 6,342,247 ("the '247 patent") are listed in reference to this drug. The

3 Page 3 Orange Book indicates that the '317 expired on September 30, 2011 and the associated pediatric exclusivity is scheduled to expire on March 30, The '247 patent is scheduled to expire on June 7, 2015 with pediatric exclusivity expiring on December 7, Teva's Paragraph IV "First Applicant" ANDA Based on publicly accessible documents, it appears that Teva was the "first applicant" to file a substantially complete ANDA, No , that contains a paragraph IV certification that seeks approval of a generic version of Avaproe-brand tablets. Teva's ANDA apparently was filed on May 25, 2004, the date on which the first ANDA for a generic version of the Avapro -brand product containing a Paragraph IV Certification was filed according to the FDA's Paragraph IV website. Because the first Paragraph IV ANDA for a generic version of Avaprot-brand tablets was submitted after December 8, 2003, 180-day exclusivity for generic versions of Avaproe-brand tablets is governed by the current requirements set forth in the FDA Act, codified at 21 U.S.C. 355(j)(5)(B)(iv) and (j)(5)(d), including its forfeiture provisions. See Pub. L. No , 1102(b)(1). B. Teva Forfeited Its Exclusivity By Failing to Obtain Timely Tentative Approval Teva has forfeited its 180-day exclusivity rights for a generic version of Avapro0-brand tablets because it failed to obtain tentative approval of its ANDA within 30 months after the date on which the application was filed. The statutory provision governing Teva's forfeiture for failure to obtain timely tentative approval states: (IV) Failure to obtain tentative approval. The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the

4 Page 4 21 U.S.C. 355(J)(5)(D)(i)(1V) failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed. Section 505(q) of the statue also provides that, in some instances, a "first applicant" does not forfeit exclusivity for failing to obtain tentative approval within 30 months if a petition related to that ANDA delayed its approval: If the filing of an application resulted in first-applicant status under subsection 00(5)(D)(1)(IV) and approval of the application was delayed because of a petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final agency action on the petition (inclusive of such beginning and ending dates), without regard to whether the Secretary grants, in whole or in part, or denies, in whole or in part, the petition. 21 U.S.C. 355(q)(1)(G) (emphasis added). This forfeiture exception, however, applies only to petitions that raise an issue of public health with respect to the "first applicant" ANDA: The Secretary shall not delay approval of a pending application submitted under subsection (b)(2) or (j) because of any request to take any form of action relating to the application, either before or during consideration of the request, unless (i) the request is in writing and is a petition submitted to the Secretary pursuant to section or of title 21, Code of Federal Regulations (or any successor regulations); and (ii) the Secretary determines, upon reviewing th petition, that a delay is necessary to protect the public health. 21 U.S.C. 355(q)(1)(A) (emphasis added) Based on the plain language of these statutory provisions, a first applicant forfeits its 180- day exclusivity if it fails to obtain tentative approval of its ANDA application within 30 months from the ANDA filing date, unless (1) there was a change in or review of the requirements for

5 Page 5 approval of that ANDA that occurred after the ANDA had been filed, or (2) a petition delayed approval of the first applicant's ANDA because such a delay was necessary to protect the public health. Teva forfeited its 180-day exclusivity under these provisions. Teva's ANDA was filed on May 25, The ANDA filing date plus 30 months was November 25, Teva received tentative approval on March 28, Its failure to obtain tentative approval by the November 25, 2006 deadline constitutes a statutory forfeiture. Neither statutory forfeiture exception applies here. First, Teva's failure to obtain tentative approval within the 30-month period may not be excused due to a "change in or a review of the requirements for approval of the application imposed after the date on which the application is filed." 21 U.S.C. 355(j)(5)(D)(i)(IV). Based on publicly accessible documents, there is nothing to indicate any change in or review of the approval requirements since May 25, 2004, the date Teva's ANDA was filed, that could have been delayed approval of that ANDA. Teva thus has no basis to rely on the forfeiture exception. Second, Teva caimot argue that "approval of [its] application was delayed because of a petition" and that such delay was "necessary to protect the public health." 21 U.S.C. 355 (q)(1)(a)(ii), (G). The statue defines "petition" as one "submitted to the Secretary pursuant to section or of title 21, Code of Federal Regulations (or any successor regulations." Id. 355(q)(1)(A)(i). Such petitions include a citizen petition (21 C.F.R ) and a petition to stay administrative action (21 C.F.R ). But no such petition has been filed, relevant to Teva's ANDA.

6 Page 6 C. The FDA Should Expedite Consideration Of This Petition To Avoid Delaying Generic Competition Lupin seeks expedited c onsideration of this petition to ensure a timely launch of its generic products upon final approval. The FDA has previously indicated that it will make a forfeiture determination if a subsequent applicant becomes eligible for approval within 180-days after the first applicant begins commercial marketing. That is the situation here. Lupin as well as at least seven other ANDA filers (besides Teva) hold tentative approvals of ANDAs that are related to generic versions of Avaproe-brand irbesartan. Upon i nformation and belief, at least some of the ANDA filers, including Lupin, submitted Paragraph IV Certifications with respect to the '247 patent and were not sued. Accordingly, the '247 patent calmot be a basis for precluding the grant of final FDA approval for such ANDA filers. Upon information and belief, those commonly-situated ANDAs relating to generic irbesartan tablets should be entitled to obtain final approval upon the expiration of the pediatric exclusivity period that is associated with the '317 patent. That pediatric exclusivity expires on March 30, We thus seek a formal determination of Teva's forfeiture to ensure that generic competition for Avaproe-brand products is not delayed. Lupin, like all generic drug manufacturers, needs time to ramp-up immediately for commercial marketing. To be sure, such activities can begin only upon a formal Agency determination that Teva's ANDA will not stand in the way of Lupin's launch. Resolving this straightforward petition as soon as possible will substantially enhance Lupin's ability (as well as the ability of all other ANDA filers that are similarly situated) to

7 Page 7 launch its generic products immediate upon final approval. Such a ruling would not only benefit Lupin, it would prevent undue delay in public access to lower-priced generic al ternatives to Av aprot-brand products. Lupin thus seeks a prompt and formal de termination as to Teva's eligibility for 180-day generic drug exclusivity. Upon information and belief, the FDA already reached an internal de termination with respect to whether Teva has forfeited its 180-day patent-challenge exclusivity, but the Agency i ntentionally is delaying publication of that determination. In view of the wide-reaching implications of such a d etermination and the imminent March 30, 2012 date, Lupin again r espectfully requests an immediate response to this petition. III. ENVIR ONMENTAL IMPACT Under 21 C.F.R. 25.3(a), the relief requested by this petition is categorically exempt from the requirement for the preparation of an enviromnental assessment or an environmental impact statement, IV. ECONOMIC IMPACT According to 21 C.F.R (b), information on economic impact is to be submitted only when requested by the Commissioner following review of the petition. Such information will be promptly submitted upon request. V. CERTIFICATION Pursuant to 21 C.F.R (b), the undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the

8 Page 8 petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. Sincerely, LESLIE SANDS Director Regulatory Affairs (USA) LUPIN PHARMACEUTICALS, INC. Harborplace Tower, 111 South Calvert Street, 21 st Floor, Baltimore, Maryland TEL: FAX:

9 Page 1 of 2 Front (410) Origin ID: ODMA Feasz Office Manager LUPIN PHARMACEUTICALS, INC law; HARBORPLACE TOWER 111 S. CALVERT STREET BALTIMORE, MD JI SHIP TO: (311) BILL SENDER Div of Dockets Management, DHHS FDA 5630 FISHERS LN RM 1061 Ship Date: 16MAR12 ActiNgt 1.0 LB CAD: ANET3250 Deltiery Address Bar Code Ref # Ctiee Petition Invoice 0 PO Dept# ROCKVILLE, MD TRX# [ OBTA MON - 19 MAR A2 PRIORITY OVERNIGHT MD-US IAD II 12G15105/A278 II After printing this label: 1. Use the 'Print' button on this page to print your label to your laser or inkjet printer. 2. Fold the printed page along the horizontal line. 3. Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned. Warning: Use oniy the printed original label for shipping, Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges, along with the cancellation of your FedEx account number. Use otkisaystern constitutes your agreement to the service conditions in the curent FedEx Service Guide, available on fedex.com.fedex will not be responsible for any claim in excess of $100 per package, whether the rest-tit-cif loss, damage, delay, non-letivery,rnisdewery,or rag -05-f- r-5-- na on, unless yordedare a nigher vevetpay an seasonal cnarge, tro3%---rnerrysuramatiuss-artrffle-a timely claim.limitations found in the current FedEx Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic value of the package, loss of sales, income interest, profit, attorney's fees, costs, and other forms of damage whether direct, incidentalconsequential, or special is limited to the greater of $100 or the authorized declared value. Recovery cannot exceed actual documented loss.maximum for items of extraordinary value is $500, e.g. jewelry, precious metals, negotiable instruments and other items listed in our ServiceGuide. Written claims must be filed within strict time limits, see current FedEx Service Guide. 3/16/2012