KEI examples of government rights in Orange Book Patents, Feb 6, 2024

	A	B	C	D	E	F	G	H	M	N	O	P	Q	R	S	T	U	V	W	X	Y	Z	AA	AB	AC	AD	AE	AF	AG	AH	AI	AJ	AK	AL	AM	AN	AO	AP	AQ	AR	AS	AT	AU	AV	AW	AX	AY	AZ	BA	BB	BC	BD	BE	BF	BG	BH	BI	BJ	BK	BL	BM	BN	BO	BP
1	Drug	INN	NDA number	Date of first NDA	Year of initial NDA	mixed	yes	no	OB1	Gi	OB2	Gi	OB3	Gi	OB4	Gi	OB5	Gi	OB6	Gi	OB7	Gi	OB8	Gi	OB9	Gi	OB10	Gi	OB11	Gi	OB12	Gi	OB13	Gi	OB14	Gi	OB15	GI	OB16	GI	OB17	GI	OB18	GI	OB19	GI	OB20	GI	OB21	GI	OB22	GI	OB23	GI	OB24	GI	OB25	GI	OB26	GI	OB27	GI	OB28	GI

2	Videx	didanosine		1991-10-09	1991	TRUE	3	1	4,861,759	yes	5,254,539	yes	5,616,566	yes	5,880,106	no
3	Zerit	stavudine	020412	1994-06-24	1994	TRUE	1	1	4,978,655	yes	7,135,465	no
4	Photofrin	porfimer sodium	020451	1995-12-27	1995	FALSE	5	0	4,649,151	yes	4,866,168	yes	4,932,934	yes	5,028,621	yes	5,145,863	yes
5	Norvir	ritonavir	20680	1996-03-01	1996	TRUE	6	13	5,484,801	no	5,541,206	yes	5,635,523	yes	5,648,497	yes	5,674,882	yes	5,846,987	yes	5,886,036	yes	5,948,436	no	6,037,157	no	6,232,333	no	6,703,403	no	7,141,593	no	7,148,359	no	7,364,752	no	7,432,294	no	8,268,349	no	8,399,015	no	8,470,347	no	8,691,878	no
6	Xalatan	latanoprost	20597	1996-06-05	1996	TRUE	1	4	4,599,353	yes	5,296,504	no	5,422,368	no	6,429,226	no	7,163,959	no
7	Zemplar	paricalcitol	020819	1998-04-17	1998	TRUE	3	2	5,246,925	yes	5,587,497	yes	5,597,815	yes	6,136,799	no	6,361,758	no
8	Hectorol	doxercalciferol	020862	1999-06-09	1999	TRUE	1	5	5,602,116	no	5,707,980	no	5,861,386	no	5,869,473	yes	6,903,083	no	7,148,211	no
9	Cetrotide	cetrorelix acetate	21197	2000-08-11	2000	TRUE	2	3	4,800,191	yes	5,198,533	yes	6,319,192	no	6,863,891	no	7,605,121	no
10	Kaletra	lopinavir/rv	021251	2000-09-15	2000	TRUE	6	22	5,484,801	no	5,541,206	yes	5,635,523	yes	5,648,497	yes	5,674,882	yes	5,846,987	yes	5,886,036	yes	5,914,332	no	5,948,436	no	6,037,157	no	6,232,333	no	6,284,767	no	6,458,818	no	6,521,651	no	6,703,403	no	6,911,214	no	7,141,593	no	7,148,359	no	7,364,752	no	7,432,294	no	8,025,899	no	8,268,349	no	8,309,613	no	8,377,952	no	8,399,015	no	8,470,347	no	8,501,219	no	8,691,878	no
11	Fuzeon	enfuvirtide	21481	2003-03-13	2003	TRUE	1	2	5,464,933	yes	6,133,418	no	6,475,491	no
12	Gleevec	imatinib mesylate	21588	2003-04-18	2003	TRUE	1	4	5,521,184	no	6,894,051	no	6,958,335	yes	7,544,799	no	RE43932	no
13	Emtriva	emtricitabine	021500	2003-07-02	2003	FALSE	6	0	5,210,085	yes	5,814,639	yes	5,914,331	yes	6,642,245	yes	6,703,396	yes	7,402,588	yes
14	Crestor	rosuvastatin calcium	21366	2003-08-12	2003	TRUE	2	4	RE37314	no	6,316,460	no	6,589,959	no	6,858,618	no	7,030,152	yes	7,964,614	yes
15	Namenda	memantine hydrochloride	21487	2003-10-16	2003	TRUE	1	8	5,061,703	no	5,614,560	yes	5,061,703	no	8,039,009	no	8,173,708	no	8,283,379	no	8,329,752	no	8,362,085	no	8,598,233	no
16	Plenaxis	abarelix	21320	2003-11-25	2003	TRUE	3	3	5,843,901	yes	5,968,895	no	6,180,608	no	6,423,686	yes	6,455,499	yes	6,699,833	no
17	Clolar	clofarabine	21673	2004-12-28	2004	TRUE	2	1	4,918,179	yes	5,384,310	no	5,661,136	yes
18	Lyrica	pregabalin	021446	2004-12-30	2004	TRUE	2	5	5,563,175	yes	RE41920	no	6,001,876	no	6,197,819	yes	8,945,620	no	9,144,559	no	10,022,447	no
19	Byetta	exenatide injection	021773	2005-04-28	2005	TRUE	1	7	5,424,286	yes	6,858,576	no	6,872,700	no	6,902,744	no	6,956,026	no	7,297,761	no	7,521,423	no	7,741,269	no
20	Prezista	darunavir	021976	2006-06-23	2006	TRUE	1	5	5,843,946	no	6,037,157	no	6,248,775	no	6,335,460	no	6,703,403	no	7,470,506	yes
21	Zolinza	vorinostat	21911	2006-10-06	2006	TRUE	7	4	6,087,367	no	RE38506	no	7,399,787	yes	7,456,219	yes	7,652,069	yes	7,732,490	yes	7,851,509	yes	8,067,472	yes	8,093,295	no	8,101,663	yes	8,450,372	no
22	Januvia	sitagliptin phosphate	21995	2006-10-16	2006	TRUE	3	4	6,303,661	no	6,699,871	no	6,890,898	yes	7,078,381	yes	7,125,873	no	7,326,708	no	7,459,428	yes
23	Vimpat	lacosamide	022253	2008-10-28	2008	FALSE	2	0	5,654,301	yes	RE38551	yes
24	Folotyn	pralatrexate	22468	2009-09-24	2009	FALSE	3	0	6,028,071	yes	7,622,470	yes	8,299,078	yes
25	Ella	ulipristal acetate	22474	2010-08-13	2010	TRUE	3	5	8,426,392	no	8,512,745	no	8,735,380	no	8,962,603	no	9,283,233	yes	9,844,510	no	10,159,681	yes	10,772,897	yes
26	Tradjenta	linagliptin	201280	2011-05-02	2011	TRUE	3	12	6,303,661	no	6,890,898	yes	7,078,381	yes	7,407,955	no	7,459,428	yes	8,119,648	no	8,178,541	no	8,673,927	no	8,846,695	no	8,853,156	no	8,883,805	no	9,173,859	no	9,486,526	no	10,034,877	no	11,033,552	no
27	Surfaxin	lucinactant, which is a combination of four active ingredients—sinapultide, colfosceril palmitate, POPG (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol), and palmitic acid	21746	2012-03-06	2012	FALSE	1	0	5,407,914	yes
28	Amyvid	FLORBETAPIR F-18	202008	2012-04-06	2012	FALSE	2	0	7,687,052	yes	8,506,929	yes
29	Xtandi	enzalutamide	203415	2012-08-31	2012	TRUE	3	1	7,709,517	yes	8,183,274	yes	9,126,941	yes	11,839,689	no
30	Kazano	alogliptin benzoate; metformin hydrochloride	203414	2013-01-25	2013	TRUE	3	14	5,965,584	no	6,150,383	no	6,150,384	no	6,166,042	no	6,166,043	no	6,172,090	no	6,211,205	no	6,303,640	no	6,303,661	no	6,329,404	no	6,890,898	yes	7,078,381	yes	7,459,428	yes	7,807,689	no	8,173,663	no	8,288,539	no	8,900,638	no
31	Nesina	alogliptin benzoate	022271	2013-01-25	2013	TRUE	3	10	6,150,383	no	6,211,205	no	6,303,640	no	6,303,661	no	6,329,404	no	6,890,898	yes	7,078,381	yes	7,459,428	yes	7,807,689	no	8,173,663	no	8,288,539	no	8,697,125	no	9,375,498	no
32	Oseni	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE	022426	2013-01-25	2013	TRUE	3	15	5,965,584	no	6,150,383	no	6,150,384	no	6,166,042	no	6,166,043	no	6,172,090	no	6,211,205	no	6,271,243	no	6,303,640	no	6,303,661	no	6,329,404	no	6,890,898	yes	7,078,381	yes	7,459,428	yes	7,807,689	no	8,173,663	no	8,288,539	no	8,637,079	no
33	Lymphoseek	technetium (Tc 99m) tilmanocept	202207	2013-03-13	2013	TRUE	1	1	6,409,990	yes	9,439,985	no
34	Vizamyl	Flutemetamol F-18	203137	2013-10-25	2013	TRUE	3	2	7,270,800	yes	7,351,401	no	8,236,282	yes	8,691,185	yes	8,916,131	no
35	Neuraceq	Florbetaben F-18	204677	2014-03-19	2014	FALSE	1	0	7,807,135	yes
36	Cerdelga	eliglustat tartrate	205494	2014-08-19	2014	TRUE	2	5	6,916,802	yes	7,196,205	no	7,253,185	yes	7,615,573	no	10,888,544	no	10,888,547	no	11,458,119	no
37	Genvoya	cobicistat;elvitegravir;emtricitabine;tenofovir alafenamide fumarate	207561	2015-11-05	2015	TRUE	4	11	5,814,639	yes	5,914,331	yes	6,642,245	yes	6,703,396	yes	7,176,220	no	7,390,791	no	7,635,704	no	7,803,788	no	8,148,374	no	8,633,219	no	8,754,065	no	8,981,103	no	9,296,769	no	9,891,239	no	10,039,718	no
38	Axumin	fluciclovine F-18	208054	2016-05-27	2016	TRUE	1	7	5,808,146	yes	9,387,266	no	10,010,632	no	10,124,079	no	10,716,868	no	10,933,147	no	10,953,112	no	10,967,077	no
39	Exondys 51	eteplirsen	206488	2016-09-19	2016	TRUE	4	7	8,486,907	yes	9,018,368	no	9,243,245	no	9,416,361	no	9,506,058	no	RE47769	yes	10,337,003	no	10,364,431	no	RE47751	yes	RE48468	no	10,781,451	yes
40	Spinraza	nusinersen	209531	2016-12-23	2016	TRUE	4	7	6,166,197	no	6,210,892	n	7,101,993	n	7,838,657	yes	8,110,560	yes	8,361,977	yes	8,980,853	n	9,717,750	n	9,926,559	n	10,266,822	yes	10,436,802	n
41	Biktarvy	bictegravir, emtricitabine & tenofovir alafenamide	210251	2018-02-07	2018	TRUE	2	10	6,642,245	yes	6,703,396	y	7,390,791	n	7,803,788	n	8,754,065	n	9,216,996	n	9,296,769	n	9,708,342	n	9,732,092	n	10,385,067	n	10,548,846	n	11,744,802	n
42	Erleada	apalutamide	210951	2018-02-14	2018	TRUE	4	6	8,445,507	yes	8,802,689	yes	9,388,159	yes	9,481,663	no	9,884,054	no	9,987,261	yes	10,052,314	no	10,702,508	no	10,849,888	no	RE49353	no
43	Olumiant	baricitinib	207924	2018-05-31	2018	TRUE	3	3	8,158,616	no	8,420,629	no	9,089,574	no	9,737,469	y	11,045,474	y	11,806,555	y
44	Tpoxx	tecovirimat	208627	2018-07-13	2018	FALSE	9	0	7,737,168	yes	8,039,504	yes	8,124,643	yes	8,530,509	y	8,802,714	yes	9,233,097	yes	9,339,466	yes	9,907,859	yes	10,576,165	yes
45	Orilissa	elagolix sodium	210450	2018-07-23	2018	TRUE	3	7	7,056,927	yes	7,176,211	yes	7,419,983	yes	10,537,572	no	10,682,351	no	11,344,551	n	11,542,239	no	11,690,845	no	11,690,854	no	11,707,464	no
46	Xerava	eravacycline dihydrochloride	211109	2018-08-27	2018	TRUE	2	2	8,796,245	n	8,906,887	n	10,961,190	yes	11,578,044	y
47	Spravato	esketamine hydrochloride	211243	2019-03-05	2019	TRUE	2	4	8,785,500	yes	9,592,207	yes	10,869,844	no	11,173,134	no	11,311,500	no	11,446,260	no
48	Vyndaqel	Vyndaqel	211996	2019-05-03	2019	FALSE	4	0	7,214,695	yes	7,214,696	yes	8,168,663	yes	8,653,119	y
49	Vyleesi	breemelanotide injection	210557	2019-06-21	2019	TRUE	0	5	6,794,489	no	9,352,013	no	9,700,592	no	10,286,034	no	11,590,209	no
50	Vyondys 53	golodirsen	211970	2019-12-12	2019	FALSE	8	0	9,024,007	yes	RE47691	yes	9,994,851	yes	10,227,590	yes	10,266,827	yes	10,421,966	yes	10,968,450	yes	10,995,337	yes
51	Zeposia	ozanimod hydrochloride	209899	2020-03-25	2020	TRUE	3	2	8,481,573	yes	8,796,318	yes	9,382,217	yes	10,239,846	no	11,680,050	no
52	Zokinvy	lonafarnib	213969	2020-11-20	2020	FALSE	2	0	7,838,531	yes	8,828,356	yes
53	Cosela	trilaciclib	214200	2021-02-12	2021	TRUE	11	1	8,598,186	yes	8,598,197	yes	9,487,530	yes	9,957,267	yes	10,085,992	yes	10,189,849	yes	10,189,850	yes	10,927,120	yes	10,966,984	yes	11,040,042	yes	11,529,352	no	11,717,523	yes
54	Amondys 45	casimersen	213016	2021-02-25	2021	TRUE	2	4	9,228,187	no	9,447,415	yes	9,758,783	no	10,287,586	no	10,781,450	no	RE48960	yes
55	Empaveli	pegcetacoplan	215014	2021-05-14	2021	TRUE	3	7	7,888,323	yes	7,989,589	yes	9,169,307	yes	10,035,822	no	10,125,171	no	10,875,893	no	11,040,107	no	11,292,815	no	11,661,441	no	11,844,841	no
56	Pylarify	piflufolastat F18	214793	2021-05-26	2021	TRUE	3	1	8,487,129	no	8,778,305	yes	9,861,713	yes	10,947,197	yes
57	Lybalvi	olanzapine and samidorphan	213378	2021-05-28	2021	TRUE	1	11	7,262,298	yes	8,778,960	no	9,119,848	no	9,126,977	no	9,517,235	no	10,300,054	no	10,716,785	no	11,185,541	no	11,241,425	no	11,351,166	no	11,707,466	no	11,793,805	no
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