Applicant, as named in the Orange Book

Bayer Hlthcare

Next listed expiry: Natazia on 30 Jan 2028. 15 products with live protection, 14 without.

Products with listed protection

Drug	Ingredient	NDA	Earliest generic entry	Basis
Natazia dienogest; estradiol valerate	dienogest; estradiol valerate	022252	30 Jan 2028	patent, carve-out possible
Astepro Allergy azelastine hydrochloride	azelastine hydrochloride	213872	4 Jun 2028	patent
Children's Astepro Allergy azelastine hydrochloride	azelastine hydrochloride	213872	4 Jun 2028	patent
Nexavar sorafenib tosylate	sorafenib tosylate	021923	10 Sep 2028	patent
Kyleena levonorgestrel	levonorgestrel	208224	16 Sep 2029	patent, carve-out possible
Mirena levonorgestrel	levonorgestrel	021225	16 Sep 2029	patent, carve-out possible
Skyla levonorgestrel	levonorgestrel	203159	16 Sep 2029	patent, carve-out possible
Beyaz drospirenone; ethinyl estradiol; levomefolate calcium	drospirenone; ethinyl estradiol; levomefolate calcium	022532	17 Jul 2030	patent
Safyral drospirenone; ethinyl estradiol; levomefolate calcium	drospirenone; ethinyl estradiol; levomefolate calcium	022574	17 Jul 2030	patent
Angeliq · 2 strengths drospirenone; estradiol	drospirenone; estradiol	021355	22 Oct 2031	patent
Stivarga regorafenib	regorafenib	203085	9 Jul 2032	patent
Adempas · 5 strengths riociguat	riociguat	204819	18 Feb 2034	patent
Kerendia · 3 strengths finerenone	finerenone	215341	29 Jul 2035	patent
Vitrakvi · 2 strengths larotrectinib sulfate	larotrectinib sulfate	210861	16 May 2037	patent, carve-out possible
Lynkuet elinzanetant	elinzanetant	219469	14 May 2045	patent, carve-out possible

25 Oct 2026Gadavist · Generic approved 29 Jun 2026
25 Oct 2026Angeliq · First generic approved 28 Oct 2025
25 Oct 2026Angeliq · Generic approved 28 Oct 2025
25 Oct 2026Gadavist · Generic approved 11 Jun 2026
25 Oct 2026Kerendia · Generic tentatively approved 27 Aug 2026
25 Oct 2026Avelox · Generic approved 2 Mar 2026
25 Oct 2026Climara Pro · First generic approved 19 Oct 2026
25 Oct 2026Climara Pro · Generic approved 19 Oct 2026
25 Oct 2026Gadavist · Generic approved 8 Jun 2026
24 Oct 2026Levitra · Enters 12-month window basis: patent, carve-out possible23 Jul 2027
24 Oct 2026Levitra · Enters 12-month window basis: patent, carve-out possible23 Jul 2027
24 Oct 2026Levitra · Enters 12-month window basis: patent, carve-out possible23 Jul 2027
24 Oct 2026Levitra · Enters 12-month window basis: patent, carve-out possible23 Jul 2027

Products without listed protection (14)

Drug	Ingredient	NDA	Earliest generic entry	Basis
Aleve Pm diphenhydramine hydrochloride; naproxen sodium	diphenhydramine hydrochloride; naproxen sodium	205352	open now	no listed protection
Cipro · 2 strengths ciprofloxacin	ciprofloxacin	020780	open now	no listed protection
Cipro · 2 strengths ciprofloxacin hydrochloride	ciprofloxacin hydrochloride	019537	open now	no listed protection
Climara · 6 strengths estradiol	estradiol	020375	open now	no listed protection
Climara Pro estradiol; levonorgestrel	estradiol; levonorgestrel	021258	open now	no listed protection
Eovist · 2 strengths gadoxetate disodium	gadoxetate disodium	022090	open now	no listed protection
Gadavist · 6 strengths gadobutrol	gadobutrol	201277	open now	no listed protection
Menostar estradiol	estradiol	021674	open now	no listed protection
Ultravist (Pharmacy Bulk) · 2 strengths iopromide	iopromide	021425	open now	no listed protection
Ultravist 300 iopromide	iopromide	020220	open now	no listed protection
Ultravist 370 iopromide	iopromide	020220	open now	no listed protection
Xofigo radium ra-223 dichloride	radium ra-223 dichloride	203971	open now	no listed protection
Yasmin drospirenone; ethinyl estradiol	drospirenone; ethinyl estradiol	021098	open now	no listed protection
Yaz drospirenone; ethinyl estradiol	drospirenone; ethinyl estradiol	021676	open now	no listed protection