Applicant, as named in the Orange Book

Boehringer Ingelheim

Part of Boehringer Ingelheim

Company and ticker: cliffwatch mapping, checked against SEC EDGAR

Next listed expiry: Striverdi Respimat on 19 Jan 2027. 16 products with live protection, 6 without.

Products with listed protection

Drug	Ingredient	Earliest generic entry	Basis
Striverdi Respimat NDA 203108 olodaterol hydrochloride	olodaterol hydrochloride	19 Jan 2027 patent	patent
Stiolto Respimat NDA 206756 olodaterol hydrochloride; tiotropium bromide	olodaterol hydrochloride; tiotropium bromide	13 Sep 2028 patent	patent
Ofev NDA 205832 · 2 strengths nintedanib esylate	nintedanib esylate	7 Dec 2029 patent	patent
Gilotrif NDA 201292 · 3 strengths afatinib dimaleate	afatinib dimaleate	5 Jan 2031 patent	patent
Spiriva Respimat NDA 021936 · 2 strengths tiotropium bromide	tiotropium bromide	16 Apr 2031 patent	patent
Pradaxa NDA 022512 · 3 strengths dabigatran etexilate mesylate	dabigatran etexilate mesylate	20 Jul 2031 patent	patent
Synjardy NDA 206111 · 4 strengths empagliflozin; metformin hydrochloride	empagliflozin; metformin hydrochloride	17 Nov 2034 patent	patent
Jardiance NDA 204629 · 2 strengths empagliflozin	empagliflozin	11 Dec 2034 patent	patent
Synjardy Xr NDA 208658 · 4 strengths empagliflozin; metformin hydrochloride	empagliflozin; metformin hydrochloride	11 Dec 2034 patent	patent
Glyxambi NDA 206073 · 2 strengths empagliflozin; linagliptin	empagliflozin; linagliptin	8 Dec 2037 patent	patent
Jentadueto NDA 201281 · 3 strengths linagliptin; metformin hydrochloride	linagliptin; metformin hydrochloride	8 Dec 2037 patent	patent
Jentadueto Xr NDA 208026 · 2 strengths linagliptin; metformin hydrochloride	linagliptin; metformin hydrochloride	8 Dec 2037 patent	patent
Tradjenta NDA 201280 linagliptin	linagliptin	8 Dec 2037 patent	patent
Trijardy Xr NDA 212614 · 4 strengths empagliflozin; linagliptin; metformin hydrochloride	empagliflozin; linagliptin; metformin hydrochloride	8 Dec 2037 patent	patent
Jascayd NDA 218764 · 2 strengths nerandomilast	nerandomilast	22 Oct 2038 patent, carve-out possible	patent, carve-out possible
Hernexeos NDA 219042 zongertinib	zongertinib	21 Jul 2041 patent	patent

Recent events

Ofev · Generic tentatively approved · ANDA 215123, Eugia Pharma SpecltsTentative approval 4 Feb 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 220118, Biocon PharmaApproved 19 Aug 2026Detected 25 Oct 2026
Jardiance · Generic tentatively approved · ANDA 212371, Aurobindo Pharma LimitedTentative approval 21 May 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 218472, Humanwell PuracapApproved 9 Jul 2026Detected 25 Oct 2026
Mexitil · Generic approved · ANDA 219987, Macleods PharmsApproved 23 Mar 2026Detected 25 Oct 2026
Jardiance · Generic approved · ANDA 212330, Invagen PharmsApproved 22 Sep 2026Detected 25 Oct 2026
Atrovent Hfa · First generic approved · ANDA 217953, Armstrong PharmsApproved 23 Feb 2026Detected 25 Oct 2026
Atrovent Hfa · Generic approved · ANDA 217953, Armstrong PharmsApproved 23 Feb 2026Detected 25 Oct 2026
Mexitil · Generic approved · ANDA 214598, Zydus PharmsApproved 23 Sep 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 219926, Macleods PharmsApproved 3 Aug 2026Detected 25 Oct 2026
Ofev · First generic approved · ANDA 219283, Dr ReddysApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 219283, Dr ReddysApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · First generic approved · ANDA 212609, CiplaApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 212609, CiplaApproved 2 Apr 2026Detected 25 Oct 2026
Trijardy Xr · Generic tentatively approved · ANDA 217049, Zydus Pharms Usa IncTentative approval 25 Nov 2025Detected 25 Oct 2026
Jentadueto · Generic approved · ANDA 208459, MsnApproved 3 Nov 2025Detected 25 Oct 2026
Tradjenta · Generic approved · ANDA 208457, MsnApproved 3 Nov 2025Detected 25 Oct 2026
Ofev · First generic approved · ANDA 219819, DexcelApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 219819, DexcelApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · First generic approved · ANDA 219227, ApotexApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 219227, ApotexApproved 2 Apr 2026Detected 25 Oct 2026
Tradjenta · Generic approved · ANDA 208431, MylanApproved 3 Nov 2025Detected 25 Oct 2026
Tradjenta · Generic approved · ANDA 208433, Teva Pharms UsaApproved 27 May 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 212555, Glenmark Pharms LtdApproved 9 Jul 2026Detected 25 Oct 2026
Tradjenta · Generic approved · ANDA 208428, Dr ReddysApproved 3 Nov 2025Detected 25 Oct 2026
Jentadueto · Generic approved · ANDA 208427, Dr ReddysApproved 3 Nov 2025Detected 25 Oct 2026
Tradjenta · Generic approved · ANDA 208415, Aurobindo Pharma LtdApproved 3 Nov 2025Detected 25 Oct 2026
Gilotrif · Generic tentatively approved · ANDA 210804, Msn Pharmaceuticals IncTentative approval 18 Feb 2026Detected 25 Oct 2026
Ofev · First generic approved · ANDA 216915, SandozApproved 2 Apr 2026Detected 25 Oct 2026
Ofev · Generic approved · ANDA 216915, SandozApproved 2 Apr 2026Detected 25 Oct 2026
Gilotrif · First generic approved · ANDA 210750, Hetero Labs Ltd VApproved 14 Jul 2026Detected 25 Oct 2026
Gilotrif · Generic approved · ANDA 210750, Hetero Labs Ltd VApproved 14 Jul 2026Detected 25 Oct 2026
Gilotrif · First generic approved · ANDA 210725, ApotexApproved 14 Jul 2026Detected 25 Oct 2026
Gilotrif · Generic approved · ANDA 210725, ApotexApproved 14 Jul 2026Detected 25 Oct 2026
Tradjenta · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jentadueto · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jentadueto · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jentadueto · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jardiance · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jardiance · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Synjardy Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jentadueto Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026
Jentadueto Xr · Exclusivity expires within 90 days PEDExclusivity expires 20 Dec 2026Detected 24 Oct 2026

Products without listed protection (6)

Drug	Ingredient	Earliest generic entry	Basis
Aptivus NDA 021814 tipranavir	tipranavir	open now no listed protection	no listed protection
Atrovent Hfa NDA 021527 ipratropium bromide	ipratropium bromide	open now no listed protection	no listed protection
Combivent Respimat NDA 021747 albuterol sulfate; ipratropium bromide	albuterol sulfate; ipratropium bromide	open now no listed protection	no listed protection
Micardis Hct NDA 021162 · 3 strengths hydrochlorothiazide; telmisartan	hydrochlorothiazide; telmisartan	open now no listed protection	no listed protection
Pradaxa NDA 214358 · 6 strengths dabigatran etexilate mesylate	dabigatran etexilate mesylate	open now no listed protection	no listed protection
Spiriva NDA 021395 tiotropium bromide	tiotropium bromide	open now no listed protection	no listed protection