FDA approvaloutcome: successconf 1.00

memantine and donepezil hydrochlorides — FDA approval

$ANIP · ANI PHARMACEUTICALS INC

Event date

December 15, 2023

904 days ago

Sponsor runway

cash-flow +

$311.2M liquid

Evidence

“openFDA ORIG (UNKNOWN) approval of MEMANTINE AND DONEPEZIL HYDROCHLORIDES — application ANDA208237”

Source ↗

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)

Ticker	Drug	Date	Outcome
$INCY	zynyz	2026-05-18	success
$INCY	jakafi xr	2026-05-01	success
$AXSM	auvelity	2026-04-30	success
$INCY	zynyz	2026-03-30	success
$BIIB	spinraza	2026-03-27	success
$CORT	lifyorli	2026-03-25	success
$RYTM	imcivree	2026-03-19	success
$ASND	yuviwel	2026-02-27	success
$BMRN	palynziq	2026-02-27	success
$ETON	desmoda	2026-02-25	success

Recent insider activity· ±90 days

10 insiders · 0 buys · 39 sells

Sell10b5-1

2024-03-13

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

250 @ $66.54$17K

Sell

2024-03-11

CAREY STEPHEN P.

SVP & CFO

7,787 @ $65.55$510K

Sell10b5-1

2024-03-11

Gassert Chad

SVP - CORP. DEV. & STRATEGY

20,000 @ $65.81$1.32M

Sell

2024-03-08

Lalwani Nikhil

PRESIDENT & CEO

16,292 @ $67.13$1.09M

Sell10b5-1

2024-03-08

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

10,000 @ $67.17$672K

Tax

2024-03-07

CAREY STEPHEN P.

SVP & CFO

4,216 @ $66.71$281K

Tax

2024-03-07

Lalwani Nikhil

PRESIDENT & CEO

17,060 @ $66.71$1.14M

Sell10b5-1

2024-03-07

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

15,085 @ $66.35$1.00M

Tax

2024-03-07

Marken James G.

SVP OPS & PROD DEV

2,034 @ $66.71$136K

Tax

2024-03-07

Gutwerg Ori

SVP, GENERICS

2,494 @ $66.71$166K

Tax

2024-03-07

Mutz Christopher

HEAD OF RARE DISEASE

2,110 @ $66.71$141K

Sell

2024-03-07

Marken James G.

SVP OPS & PROD DEV

24,338 @ $66.37$1.62M

Sell10b5-1

2024-03-06

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

14,822 @ $65.47$970K

Sell

2024-03-06

Lalwani Nikhil

PRESIDENT & CEO

28,965 @ $65.52$1.90M

Sell

2024-03-05

Mutz Christopher

HEAD OF RARE DISEASE

5,000 @ $66.00$330K

Sell10b5-1

2024-03-05

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

10,093 @ $65.35$660K

Sell

2024-03-04

Pera Antonio R

Director

7,000 @ $65.20$456K

Tax

2024-02-29

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

1,122 @ $67.67$76K

Tax

2024-02-29

Marken James G.

SVP OPS & PROD DEV

1,058 @ $67.67$72K

Tax

2024-02-29

Lalwani Nikhil

PRESIDENT & CEO

10,014 @ $67.67$678K

Tax

2024-02-29

Mutz Christopher

HEAD OF RARE DISEASE

1,275 @ $67.67$86K

Tax

2024-02-29

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

1,173 @ $67.67$79K

Tax

2024-02-29

Davis Krista

SVP, CHIEF HR OFFICER

1,173 @ $67.67$79K

Tax

2024-02-29

Gutwerg Ori

SVP, GENERICS

1,570 @ $67.67$106K

Tax

2024-02-29

CAREY STEPHEN P.

SVP & CFO

1,914 @ $67.67$130K

Tax

2024-02-29

Gassert Chad

SVP - CORP. DEV. & STRATEGY

1,635 @ $67.67$111K

Tax

2024-02-15

Gutwerg Ori

SVP, GENERICS

1,244 @ $57.55$72K

Tax

2024-02-15

Mutz Christopher

HEAD OF RARE DISEASE

1,261 @ $57.55$73K

Grant

2024-02-14

Mutz Christopher

HEAD OF RARE DISEASE

18,790 @ ——

Grant

2024-02-14

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

14,763 @ ——

Grant

2024-02-14

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

9,842 @ ——

Grant

2024-02-14

Marken James G.

SVP OPS & PROD DEV

10,066 @ ——

Grant

2024-02-14

Marken James G.

SVP OPS & PROD DEV

6,710 @ ——

Grant

2024-02-14

Gutwerg Ori

SVP, GENERICS

14,763 @ ——

Grant

2024-02-14

Gutwerg Ori

SVP, GENERICS

9,842 @ ——

Grant

2024-02-14

Gassert Chad

SVP - CORP. DEV. & STRATEGY

13,421 @ ——

Grant

2024-02-14

Gassert Chad

SVP - CORP. DEV. & STRATEGY

8,946 @ ——

Grant

2024-02-14

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

13,421 @ ——

Grant

2024-02-14

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

8,946 @ ——

Grant

2024-02-14

Mutz Christopher

HEAD OF RARE DISEASE

12,526 @ ——

Grant

2024-02-14

Lalwani Nikhil

PRESIDENT & CEO

80,530 @ ——

Grant

2024-02-14

Lalwani Nikhil

PRESIDENT & CEO

53,686 @ ——

Grant

2024-02-14

CAREY STEPHEN P.

SVP & CFO

21,474 @ ——

Grant

2024-02-14

CAREY STEPHEN P.

SVP & CFO

14,316 @ ——

Grant

2024-02-14

Davis Krista

SVP, CHIEF HR OFFICER

12,079 @ ——

Grant

2024-02-14

Davis Krista

SVP, CHIEF HR OFFICER

8,052 @ ——

Sell10b5-1

2024-02-13

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

250 @ $56.04$14K

Sell10b5-1

2024-01-23

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

15,000 @ $56.44$847K

Sell10b5-1

2024-01-22

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

5,692 @ $55.95$318K

Sell10b5-1

2024-01-19

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

4,524 @ $55.57$251K

+ 23 more

Date	Insider	Action	Shares	Price	Value
2024-03-13	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	250	$66.54	$17K
2024-03-11	CAREY STEPHEN P.SVP & CFO	Sell	7,787	$65.55	$510K
2024-03-11	Gassert ChadSVP - CORP. DEV. & STRATEGY	Sell10b5-1	20,000	$65.81	$1.32M
2024-03-08	Lalwani NikhilPRESIDENT & CEO	Sell	16,292	$67.13	$1.09M
2024-03-08	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	10,000	$67.17	$672K
2024-03-07	CAREY STEPHEN P.SVP & CFO	Tax	4,216	$66.71	$281K
2024-03-07	Lalwani NikhilPRESIDENT & CEO	Tax	17,060	$66.71	$1.14M
2024-03-07	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	15,085	$66.35	$1.00M
2024-03-07	Marken James G.SVP OPS & PROD DEV	Tax	2,034	$66.71	$136K
2024-03-07	Gutwerg OriSVP, GENERICS	Tax	2,494	$66.71	$166K
2024-03-07	Mutz ChristopherHEAD OF RARE DISEASE	Tax	2,110	$66.71	$141K
2024-03-07	Marken James G.SVP OPS & PROD DEV	Sell	24,338	$66.37	$1.62M
2024-03-06	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	14,822	$65.47	$970K
2024-03-06	Lalwani NikhilPRESIDENT & CEO	Sell	28,965	$65.52	$1.90M
2024-03-05	Mutz ChristopherHEAD OF RARE DISEASE	Sell	5,000	$66.00	$330K
2024-03-05	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	10,093	$65.35	$660K
2024-03-04	Pera Antonio RDirector	Sell	7,000	$65.20	$456K
2024-02-29	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Tax	1,122	$67.67	$76K
2024-02-29	Marken James G.SVP OPS & PROD DEV	Tax	1,058	$67.67	$72K
2024-02-29	Lalwani NikhilPRESIDENT & CEO	Tax	10,014	$67.67	$678K
2024-02-29	Mutz ChristopherHEAD OF RARE DISEASE	Tax	1,275	$67.67	$86K
2024-02-29	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Tax	1,173	$67.67	$79K
2024-02-29	Davis KristaSVP, CHIEF HR OFFICER	Tax	1,173	$67.67	$79K
2024-02-29	Gutwerg OriSVP, GENERICS	Tax	1,570	$67.67	$106K
2024-02-29	CAREY STEPHEN P.SVP & CFO	Tax	1,914	$67.67	$130K
2024-02-29	Gassert ChadSVP - CORP. DEV. & STRATEGY	Tax	1,635	$67.67	$111K
2024-02-15	Gutwerg OriSVP, GENERICS	Tax	1,244	$57.55	$72K
2024-02-15	Mutz ChristopherHEAD OF RARE DISEASE	Tax	1,261	$57.55	$73K
2024-02-14	Mutz ChristopherHEAD OF RARE DISEASE	Grant	18,790	—	—
2024-02-14	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Grant	14,763	—	—
2024-02-14	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Grant	9,842	—	—
2024-02-14	Marken James G.SVP OPS & PROD DEV	Grant	10,066	—	—
2024-02-14	Marken James G.SVP OPS & PROD DEV	Grant	6,710	—	—
2024-02-14	Gutwerg OriSVP, GENERICS	Grant	14,763	—	—
2024-02-14	Gutwerg OriSVP, GENERICS	Grant	9,842	—	—
2024-02-14	Gassert ChadSVP - CORP. DEV. & STRATEGY	Grant	13,421	—	—
2024-02-14	Gassert ChadSVP - CORP. DEV. & STRATEGY	Grant	8,946	—	—
2024-02-14	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Grant	13,421	—	—
2024-02-14	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Grant	8,946	—	—
2024-02-14	Mutz ChristopherHEAD OF RARE DISEASE	Grant	12,526	—	—
2024-02-14	Lalwani NikhilPRESIDENT & CEO	Grant	80,530	—	—
2024-02-14	Lalwani NikhilPRESIDENT & CEO	Grant	53,686	—	—
2024-02-14	CAREY STEPHEN P.SVP & CFO	Grant	21,474	—	—
2024-02-14	CAREY STEPHEN P.SVP & CFO	Grant	14,316	—	—
2024-02-14	Davis KristaSVP, CHIEF HR OFFICER	Grant	12,079	—	—
2024-02-14	Davis KristaSVP, CHIEF HR OFFICER	Grant	8,052	—	—
2024-02-13	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	250	$56.04	$14K
2024-01-23	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	15,000	$56.44	$847K
2024-01-22	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	5,692	$55.95	$318K
2024-01-19	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	4,524	$55.57	$251K

+ 23 more transactions

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