But Congress also was clear that “tentative approval” does not equate to “approval.” Compare 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd)(BB) (“A drug that is granted tentative approval . . . is not an approved drug and shall not have an effective approval until the Secretary issues an approval . . .”) with 21 U.S.C. § 355(e) (“The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application . . .”); see also 21 C.F.R. § 314.107(b)(3)(v) (“Tentative approval of an application does not constitute ‘approval’”); Barr Laboratories, Inc. Case 1:14-cv-01923-BAH Document 22-1 Filed 11/18/14 Page 41 of 59Case 1:14-cv-01923-BAH Document 3 Filed 1 /18/14 Page 41 of 59 38 v. Thompson, 238 F. Supp. 2d 236, 246 (D.D.C. 2002) (“While certain benefits may flow even from ANDA approvals with delayed effective dates, they are in no sense tantamount to the benefits accruing when NDAs or ANDAs are approved with immediate effective dates.”)

Defendants know that Lilly did not compete with Lantus during the Class Period, because Sanofi filed multiple patent infringement lawsuits to stall approval of Lilly’s competing drug, Abasria.7 Under FDA regulations, the filing of these lawsuits triggered a 30-month delay for Abasria approval, stalling its U.S. launch. 21 C.F.R. § 314.107(b)(3).8 During the third quarter of 2014, tired of the corruption that marked Viehbacher’s tenure as CEO and with the illicit program to boost Lantus pricing no longer yielding results, Sanofi’s Board began to discuss replacing Viehbacher. ¶¶ 11, 78.

Sandoz will not lose this exclusivity—once its exclusivity period begins, Sandoz will enjoy 180 days of marketing exclusivity, during which period FDA is prohibited from approving any ANDAs containing the same Paragraph IV certification. 21 C.F.R. § 314.107(c)(1). Despite Sandoz’s efforts to muddy the scope of its exclusivity, Sandoz cannot keep ANDA applicants who submitted section viii statements, such as Par and Mylan, off the market.

Cephalon had a weak patent – one that was narrow and of doubtful validity (FAC ¶¶ 41-45) – but it could and Case 2:08-cv-02141-MSG Document 45 Filed 09/14/2009 Page 51 of 56 Tamoxifen, 466 F.3d at 214 (“under procedures in effect at the time [of settlement],”47 the agreement between Zeneca, the branded drug firm, and Barr, the first generic filer, “appeared to ensure . . . that [Barr] was not eligible for the [180-day] exclusivity period.”); see Cipro, 261 F. Supp. 2d at 243 (“the Settlement Agreements here did not make a ‘bottleneck’ for future ANDA IV filers”); see also 21 C.F.R. § 314.107(c)(1) (1997), revoked, Effective Date of Approval of Abbreviated New Drug Application, 63 Fed. Reg. 59710 (Nov. 5, 1998).

Biovail received the 300 mg Notice on January 26, 2005. 3 On March 16, 2005, IMPAX, in accordance with 21 C.F.R. § 314.107(f)(2), notified FDA that "Biovail Laboratories, Inc. initiated a lawsuit for the 150 mg strength only, within the 45- day period as provided for in section 505(j)(4)(B)(iii) [sic] of the [FDCA]." See Exh.