Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 021729  Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)

Patents	Expiration	Change
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Pat. Sub. Date(s): None Claim Types: Composition; Product-by-process; Process	Dec 16, 2024 *PED	This patent is no longer listed for this product

ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.: 202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)

Patents	Expiration	Change
Pat. No. 7807680 DP* Controlled release sterile injectable aripiprazole formulation and method Pat. Sub. Date(s): None Claim Types: Formulation; Process	Oct 19, 2024	This patent is no longer listed for this product
Pat. No. 8030313 Controlled release sterile injectable aripiprazole formulation and method Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia Use Code: U-543: Treatment of schizophrenia	Oct 19, 2024	This patent is no longer listed for this product
Pat. No. 8722679 DP* Controlled release sterile injectable aripiprazole formulation and method Pat. Sub. Date(s): None Claim Types: Formulation	Oct 19, 2024	This patent is no longer listed for this product

ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 207202  Prod. No.: 001 DISC (2MG); 002 DISC (5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG)

Patents	Expiration	Change
Pat. No. 8017615 DP* Low hygroscopic aripiprazole drug substance and processes for the preparation thereof Pat. Sub. Date(s): None Claim Types: Composition; Product-by-process; Process	Jun 16, 2024	This patent is no longer listed for this product

ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL [GENERIC AB]
Drug Classes: microtubule inhibitor
NDA Applicant: BRISTOL-MYERS      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)

Patents	Expiration	Change
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1117: Treatment of breast cancer Use Code: U-1290: Treatment of lung cancer Use Code: U-1434: Treatment of pancreatic cancer	Jun 9, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents Pat. Sub. Date(s): None Claim Types: Formulation; Drug in a container; Method of administration Use Code: U-1092: Treatment of breast cancer Use Code: U-1290: Treatment of lung cancer Use Code: U-1434: Treatment of pancreatic cancer	Jun 9, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1290: Treatment of lung cancer Use Code: U-1434: Treatment of pancreatic cancer	Jun 9, 2024 *PED	This patent is no longer listed for this product

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE      NDA No.: 021528  Prod. No.: 001 RX (0.4%)

Patents	Expiration	Change
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient	Nov 28, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery	Nov 28, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1441: A method of treating or reducing ocular pain and burning/stinging	Nov 28, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Formulation	May 28, 2024	This patent is no longer listed for this product
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1626: A method of treating or preventing ocular pain and burning	May 28, 2024	This patent is no longer listed for this product
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of use; Method of administration Use Code: U-1662: A method of treating ocular pain	May 28, 2024	This patent is no longer listed for this product
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1800: A method of treating ocular pain and/or enhancing ocular comfort	May 28, 2024	This patent is no longer listed for this product

ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
NDA Applicant: ABBVIE      NDA No.: 022427  Prod. No.: 001 RX (0.45%)

Patents	Expiration	Change
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same Pat. Sub. Date(s): None Claim Types: Formulation	Aug 5, 2024	This patent is no longer listed for this product

ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS      NDA No.: 022549  Prod. No.: 001 RX (10MG)

Patents	Expiration	Change
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound Pat. Sub. Date(s): None Claim Types: Device; Process	Aug 18, 2024	This patent is no longer listed for this product
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery Pat. Sub. Date(s): None Claim Types: Process	Oct 28, 2024	This patent is no longer listed for this product
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same Pat. Sub. Date(s): None Claim Types: Device; Drug in a container	May 21, 2024	This patent is no longer listed for this product
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same Pat. Sub. Date(s): None Claim Types: Device	May 20, 2024	This patent is no longer listed for this product

ADLARITY (SYSTEM) (TRANSDERMAL) DONEPEZIL HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: CORIUM      NDA No.: 212304  Prod. No.: 001 RX (5MG/DAY); 002 RX (10MG/DAY)

Patents	Expiration	Change
Pat. No. 12161767 DS* DP* Systems and methods for long term transdermal administration Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Device; Method of administration Use Code: U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type	Dec 30, 2036	New patent for this product
Pat. No. 12168075 Systems comprising a composite backing and methods for long term transdermal administration Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Method of use; Method of administration Use Code: U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type	Dec 30, 2036	New patent for this product

ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.: 209936  Prod. No.: 001 DISC (60MG/VIAL)

Patents	Expiration	Change
Pat. No. 7511041 DS* DP* Fused azole-pyrimidine derivatives Pat. Sub. Date(s): None Claim Types: Compound; Composition	May 13, 2024	This patent is no longer listed for this product

ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.: 022055  Prod. No.: 001 DISC (1%)

Patents	Expiration	Change
Pat. No. 8207191 Process, salts, composition and use Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes	Aug 30, 2024	This patent is no longer listed for this product

ALYFTREK (TABLET) (ORAL) DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
NDA Applicant: VERTEX PHARMS INC      NDA No.: 218730  Prod. No.: 001 RX (50MG;20MG;EQ 4MG BASE)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition	May 20, 2027	New patent for this product
Pat. No. 7645789 DS* DP* Indole derivatives as CFTR modulatorsPat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Formulation	May 1, 2027	New patent for this product
Pat. No. 7776905 DS* DP* Modulators of ATP-binding cassette transport Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Kit	Jun 3, 2027	New patent for this product
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Aug 5, 2027	New patent for this product
Pat. No. 8354427 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4091: Treatment of cystic fibrosis in patients aged 6 years and older who have an r117h mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Jul 6, 2026	New patent for this product
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Composition; Compound	Dec 28, 2026	New patent for this product
Pat. No. 8415387 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Nov 12, 2027	New patent for this product
Pat. No. 8598181 Modulators of ATP-binding cassette transpor Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	May 1, 2027	New patent for this product
Pat. No. 8623905 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Formulation; Kit	May 1, 2027	New patent for this product
Pat. No. 8629162 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4084: Treatment of a moderate to mild clinical phenotype of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a pharmaceutical composition comprising vnz, tez, and d-iva	Jun 24, 2025	New patent for this product
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Formulation	Dec 28, 2026	New patent for this product
Pat. No. 8865902 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition	May 17, 2032	New patent for this product
Pat. No. 9181192 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4094: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a composition comprising vnz, tez, and d-iva with at least 90% isotopic enrichment for each deuterium atom	May 17, 2032	New patent for this product
Pat. No. 9512079 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4098: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vnz, tez, and a composition according to claim 3 of U.S. 9,512,079	May 17, 2032	New patent for this product
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-4080: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a solid pharmaceutical composition comprising vnz, tez, amorphous d-iva, and <30% crystalline d-iva	Dec 28, 2026	New patent for this product
Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use; Formulation Use Code: U-4080: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a solid pharmaceutical composition comprising vnz, tez, amorphous d-iva, and <30% crystalline d-iva	Dec 28, 2026	New patent for this product
Pat. No. 9974781 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use; Composition Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10022352 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use; Composition Use Code: U-4081: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene with an effective amount of a pharmaceutical composition comprising vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10047053 DS* Deuterated CFTR potentiators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Product-by-process	May 17, 2032	New patent for this product
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4087: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vnz, d-iva, and a composition according to claim 1 of us10081621	Mar 25, 2031	New patent for this product
Pat. No. 10239867 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Formulation	Aug 13, 2029	New patent for this product
Pat. No. 11066417 DS* DP* Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Process; New polymorph, salt or hydrate	Feb 14, 2039	New patent for this product
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4095: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a composition according to claim 1 of us11564916, vnz, and tez	Aug 13, 2029	New patent for this product
Pat. No. 11578062 DP* Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4096: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, deutivacaftor, and a solid dispersion according to claim 1 of U.S. 11,578,062	Mar 25, 2031	New patent for this product
Pat. No. 11639347 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 11866450 Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: Method of use Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Feb 14, 2039	New patent for this product
Pat. No. 11873300 DS* DP* Crystalline forms of CFTR modulators Pat. Sub. Date(s): 001: Jan 17, 2025 Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-4083: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor calcium salt hydrate form d, tezacaftor, and deutivacaftor	Aug 13, 2040	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 20, 2029	New exclusivity for this product

ALYFTREK (TABLET) (ORAL) DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM
NDA Applicant: VERTEX PHARMS INC      NDA No.: 218730  Prod. No.: 002 RX (125MG;50MG;EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition	May 20, 2027	New patent for this product
Pat. No. 7645789 DS* DP* Indole derivatives as CFTR modulatorsPat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Formulation	May 1, 2027	New patent for this product
Pat. No. 7776905 DS* DP* Modulators of ATP-binding cassette transport Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Kit	Jun 3, 2027	New patent for this product
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Aug 5, 2027	New patent for this product
Pat. No. 8354427 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4091: Treatment of cystic fibrosis in patients aged 6 years and older who have an r117h mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Jul 6, 2026	New patent for this product
Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Composition; Compound	Dec 28, 2026	New patent for this product
Pat. No. 8415387 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Nov 12, 2027	New patent for this product
Pat. No. 8598181 Modulators of ATP-binding cassette transpor Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	May 1, 2027	New patent for this product
Pat. No. 8623905 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Formulation; Kit	May 1, 2027	New patent for this product
Pat. No. 8629162 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4084: Treatment of a moderate to mild clinical phenotype of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a pharmaceutical composition comprising vnz, tez, and d-iva	Jun 24, 2025	New patent for this product
Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation	Dec 28, 2026	New patent for this product
Pat. No. 8865902 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition	May 17, 2032	New patent for this product
Pat. No. 9012496 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4097: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene, comprising concurrent coadministration of the compositions of claim 1 of U.S. 9,012,496 further comprising vnz	Jul 15, 2033	New patent for this product
Pat. No. 9181192 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4094: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a composition comprising vnz, tez, and d-iva with at least 90% isotopic enrichment for each deuterium atom	May 17, 2032	New patent for this product
Pat. No. 9512079 DS* DP* Deuterated CFTR potentiators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4098: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vnz, tez, and a composition according to claim 3 of U.S. 9,512,079	May 17, 2032	New patent for this product
Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-4080: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a solid pharmaceutical composition comprising vnz, tez, amorphous d-iva, and <30% crystalline d-iva	Dec 28, 2026	New patent for this product
Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use; Formulation Use Code: U-4080: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a solid pharmaceutical composition comprising vnz, tez, amorphous d-iva, and <30% crystalline d-iva	Dec 28, 2026	New patent for this product
Pat. No. 9974781 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use; Composition Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10022352 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use; Composition Use Code: U-4081: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation in the CFTR gene with an effective amount of a pharmaceutical composition comprising vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10047053 DS* Deuterated CFTR potentiators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Product-by-process	May 17, 2032	New patent for this product
Pat. No. 10058546 Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6- -fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4093: Treatment of CF in patients 6 years and older with at least one F508DEL or g551d and an a455e, 2789+5g->a, or 3849+10kbc->t CFTR mutation, comprising concurrent coadministration of the compositions of claim 1 of U.S. 10058546 further comprising vnz	Jul 15, 2033	New patent for this product
Pat. No. 10081621 DP* Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-- fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxa- mide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4087: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vnz, d-iva, and a composition according to claim 1 of us10081621	Mar 25, 2031	New patent for this product
Pat. No. 10206877 DP* Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4092: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vnz and a composition according to claim 1 of U.S. 10206877	Apr 14, 2035	New patent for this product
Pat. No. 10239867 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation	Aug 13, 2029	New patent for this product
Pat. No. 11066417 DS* DP* Modulators of cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Process; New polymorph, salt or hydrate	Feb 14, 2039	New patent for this product
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4095: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with a composition according to claim 1 of us11564916, vnz, and tez	Aug 13, 2029	New patent for this product
Pat. No. 11578062 DP* Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4096: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, deutivacaftor, and a solid dispersion according to claim 1 of U.S. 11,578,062	Mar 25, 2031	New patent for this product
Pat. No. 11639347 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4090: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with an effective amount of vanzacaftor, tezacaftor, and deutivacaftor	Apr 9, 2027	New patent for this product
Pat. No. 11866450 Modulators of Cystic Fibrosis Transmembrane Conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use Use Code: U-4082: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor, tezacaftor, and deutivacaftor	Feb 14, 2039	New patent for this product
Pat. No. 11873300 DS* DP* Crystalline forms of CFTR modulators Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process Use Code: U-4083: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vanzacaftor calcium salt hydrate form d, tezacaftor, and deutivacaftor	Aug 13, 2040	New patent for this product
Pat. No. 11951212 DP* Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Formulation; Method of use Use Code: U-4089: Treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with vnz and a composition according to claim 1 of us11951212	Apr 14, 2035	New patent for this product
Pat. No. 12186306 Methods of treatment for cystic fibrosis Pat. Sub. Date(s): 002: Jan 17, 2025 Claim Types: Method of use; New polymorph, salt or hydrate Use Code: U-4088: Treatment of CF in patients aged 6 years and older who have at least one F508DEL mutation or another responsive mutation in the CFTR gene with 21.4 mg of vnz calcium salt hydrate form d, 100 mg of tez, and 250 mg of d-iva daily	Jan 10, 2043	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 20, 2029	New exclusivity for this product

AMITIZA (CAPSULE) (ORAL) LUBIPROSTONE [GENERIC AB]
Drug Classes: chloride channel activator
NDA Applicant: SUCAMPO PHARMA LLC      NDA No.: 021908  Prod. No.: 002 RX (8MCG)

Patents	Expiration	Change
Pat. No. 7795312 Method for treating abdominal discomfort Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome	Sep 17, 2024	This patent is no longer listed for this product

ANJESO (SOLUTION) (INTRAVENOUS) MELOXICAM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BAUDAX      NDA No.: 210583  Prod. No.: 001 DISC (30MG/ML (30MG/ML)**)

Patents	Expiration	Change
Pat. No. 10463673 DP* Nanoparticulate meloxicam formulations Pat. Sub. Date(s): None Claim Types: Formulation; Method of administration Use Code: U-2750: Management of moderate-to-severe pain by intravenous injection	Feb 24, 2024	This patent is no longer listed for this product
Pat. No. 10471067 DP* Nanoparticulate meloxicam formulations Pat. Sub. Date(s): None Claim Types: Formulation; Method of administration Use Code: U-2750: Management of moderate-to-severe pain by intravenous injection	Feb 24, 2024	This patent is no longer listed for this product

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)

Patents	Expiration	Change
Pat. No. 12168021 Methods for treating pulmonary non-tuberculous mycobacterial infections Pat. Sub. Date(s): 001: Jan 15, 2025 Claim Types: Method of use Use Code: U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen	May 15, 2035	New patent for this product
Pat. No. 12168022 Methods for treating pulmonary non-tuberculous mycobacterial infections Pat. Sub. Date(s): 001: Jan 15, 2025 Claim Types: Method of use Use Code: U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen	May 15, 2035	New patent for this product
Pat. No. 8802137 DP* Sustained release of antiinfectives Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen	Apr 8, 2024	This patent is no longer listed for this product
Pat. No. 9827317 DP* Sustained release of antiinfectives Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen	Apr 8, 2024	This patent is no longer listed for this product

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [Has competitive generic]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.: 021937  Prod. No.: 001 DISC (600MG;200MG;300MG)

Patents	Expiration	Change
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older Use Code: U-750: Treatment of HIV-1 infection in adults	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product

ATTRUBY (TABLET) (ORAL) ACORAMIDIS HYDROCHLORIDE
NDA Applicant: BRIDGEBIO PHARMA      NDA No.: 216540  Prod. No.: 001 RX (EQ 356MG BASE)

Patents	Expiration	Change
Pat. No. 9913826 Compounds and compositions that bind and stabilize transthyretin and their use for inhibiting transthyretin amyloidosis and protein-protein interactions Pat. Sub. Date(s): 001: Dec 18, 2024 Claim Types: Method of use Use Code: U-4046: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM)	May 5, 2031	New expiration date. Was previously Mar 14, 2033
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-506: Treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization	Nov 22, 2031	New exclusivity for this product

AURYXIA (TABLET) (ORAL) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS      NDA No.: 205874  Prod. No.: 001 RX (EQ 210MG IRON)

Patents	Expiration	Change
Pat. No. 7767851 DS* DP* Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Product-by-process; Composition; Formulation	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8299298 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Pat. Sub. Date(s): None Claim Types: Formulation	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8338642 DS* DP* Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation; Method of use Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8609896 DP* Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Composition; Formulation	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8754257 DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Composition; Formulation	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8754258 DP* Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Formulation	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8846976 Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 8901349 Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 9050316 Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 9328133 DS* DP* Ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Composition; Formulation; Method of use Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product
Pat. No. 9757416 DS* DP* Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same Pat. Sub. Date(s): None Claim Types: Method of administration Use Code: U-1577: Control of serum phosphorous levels	Feb 18, 2024	This patent is no longer listed for this product

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY); 002 RX (EQ 0.15MG/DELIVERY); 003 RX (EQ 0.1MG/DELIVERY)

Patents	Expiration	Change
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device; Method of use	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Nov 23, 2024	This patent is no longer listed for this product

BACLOFEN (SOLUTION) (ORAL) BACLOFEN [Has competitive generic]
Drug Classes: gamma-aminobutyric acid (GABA)-ergic agonist
NDA Applicant: RUBICON      NDA No.: 214445  Prod. No.: 001 RX (5MG/5ML)

Exclusivity	Expiration	Change
Exclusivity Code: PC - Patent challenge	Jul 14, 2025	New exclusivity for this product

BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: dopamine-2 (D2) antagonist
NDA Applicant: ACACIA      NDA No.: 209510  Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))

Patents	Expiration	Change
Pat. No. 12005042 Rescue treatment of post operative nausea and vomiting Pat. Sub. Date(s): All strengths: Jan 8, 2025 Claim Types: Method of use Use Code: U-1744: Prevention of post-operative nausea and vomiting Use Code: U-2754: Treatment of post-operative nausea and vomiting Use Code: U-3467: Prevention and treatment of post-operative nausea and vomiting	Feb 9, 2038	New patent for this product
Pat. No. 12194022 Use of amisulpride as an anti-emetic Pat. Sub. Date(s): All strengths: Jan 29, 2025 Claim Types: Method of use Use Code: U-1744: Prevention of post-operative nausea and vomiting Use Code: U-3467: Prevention and treatment of post-operative nausea and vomiting	Mar 10, 2031	New patent for this product

BELRAPZO (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 205580  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 12138248 DP* Formulations of bendamustine Pat. Sub. Date(s): 001: Jan 27, 2025 Claim Types: Drug in a container; Formulation; Formulation claimed by its inherent performace characteristics	Jan 28, 2031	New patent for this product

BENDEKA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.: 208194  Prod. No.: 001 RX (100MG/4ML (25MG/ML))

Patents	Expiration	Change
Pat. No. 12138248 DP* Formulations of bendamustine Pat. Sub. Date(s): 001: Jan 27, 2025 Claim Types: Drug in a container; Formulation; Formulation claimed by its inherent performace characteristics	Jan 28, 2031	New patent for this product

BIKTARVY (TABLET) (ORAL) BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 210251  Prod. No.: 001 RX (EQ 50MG BASE;200MG;EQ 25MG BASE); 002 RX (EQ 30MG BASE;120MG;EQ 15MG BASE)

Patents	Expiration	Change
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)] Prodrugs of phosphonate nucleotide analogues Pat. Sub. Date(s): 001: Feb 26, 2018; 002: Oct 28, 2021 Claim Types: Compound; Composition; Formulation	Jul 7, 2025 *PED	New expiration date. Was previously Oct 17, 2025 *PED

BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 203341  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 500MG BASE); 003 RX (EQ 400MG BASE)

Patents	Expiration	Change
Pat. No. RE42376 DS* [Extended 1663 days (4.6 years)] Substituted 3-cyanoquinolines Pat. Sub. Date(s): None Claim Types: Compound; Composition	Oct 13, 2024 *PED	This patent is no longer listed for this product

BOSULIF (CAPSULE) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.: 217729  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. RE42376 DS* DP* [Extended 1663 days (4.6 years)] Substituted 3-cyanoquinolines Pat. Sub. Date(s): None Claim Types: Compound; Composition	Oct 13, 2024 *PED	This patent is no longer listed for this product

BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210496  Prod. No.: 002 RX (75MG)

Patents	Expiration	Change
Pat. No. 8541575 DS* DP* 3,4-diarylpyrazoles as protein kinase inhibitors Pat. Sub. Date(s): 002: Jul 25, 2018 Claim Types: Compound; Method of use; Composition; Kit Use Code: U-2335: Treatment of melanoma Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test Use Code: U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Feb 26, 2030	New Use Code
Pat. No. 9314464 Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): 002: Jul 25, 2018 Claim Types: Method of use Use Code: U-2336: Treatment of melanoma mediated by a B-Raf protein kinase Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test Use Code: U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Jul 4, 2031	New Use Code
Pat. No. 9474754 Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor Pat. Sub. Date(s): 002: May 7, 2020 Claim Types: Formulation; Method of use Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Aug 5, 2033	New Use Code
Pat. No. 9850230 Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): 002: Jul 25, 2018 Claim Types: Method of use Use Code: U-2334: Treatment of melanoma with a BRAF mutation Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test Use Code: U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Aug 27, 2030	New Use Code
Pat. No. 10005761 Compounds and compositions as protein kinase inhibitors Pat. Sub. Date(s): 002: Jul 25, 2018 Claim Types: Method of use Use Code: U-2335: Treatment of melanoma Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-2803: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA- approved test Use Code: U-3738: BRAFTOVI is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with metastatic non small cell lung cancer with a braf V600E mutation, as detected by an FDA-approved test Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Aug 27, 2030	New Use Code
Pat. No. 10258622 Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate Pat. Sub. Date(s): 002: May 7, 2020 Claim Types: Method of use Use Code: U-2802: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy Use Code: U-4051: BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (MCRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Nov 21, 2032	New Use Code

BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM [GENERIC AP]
NDA Applicant: MSD SUB MERCK      NDA No.: 022225  Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))

Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Jun 12, 2028 PED	New expiration date. Was previously Jun 25, 2024

BRIXADI (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: BRAEBURN      NDA No.: 210136  Prod. No.: 001 RX (8MG/0.16ML (50MG/ML)); 002 RX (16MG/0.32ML (50MG/ML)); 003 RX (24MG/0.48ML (50MG/ML)); 004 RX (32MG/0.64ML (50MG/ML)); 005 RX (64MG/0.18ML (356MG/ML)); 006 RX (96MG/0.27ML (356MG/ML)); 007 RX (128MG/0.36ML (356MG/ML))

Patents	Expiration	Change
Pat. No. 12161640 DP* Opioid formulations Pat. Sub. Date(s): All strengths: Jan 8, 2025 Claim Types: Method of use Use Code: U-4100: A method of treating moderate to severe opioid use disorder by administering buprenorphine once weekly	Jul 26, 2032	New patent for this product

BYDUREON BCISE (SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 209210  Prod. No.: 001 RX (2MG/0.85ML (2MG/0.85ML))

Patents	Expiration	Change
Pat. No. 7563871 DP* Polymer-based sustained release device Pat. Sub. Date(s): None Claim Types: Formulation	Oct 15, 2024 *PED	This patent is no longer listed for this product
Pat. No. 9238076 DP* Polymer-based sustained release device Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin Use Code: U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin Use Code: U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies Use Code: U-2597: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin as add-on to metformin Use Code: U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less Use Code: U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise Use Code: U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication Use Code: U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea	Oct 15, 2024 *PED	This patent is no longer listed for this product

BYDUREON; BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 022200  Prod. No.: 001 DISC (2MG/VIAL); 002 DISC (2MG)

Patents	Expiration	Change
Pat. No. 7563871 DP* Polymer-based sustained release device Pat. Sub. Date(s): None Claim Types: Formulation	Oct 15, 2024 *PED	This patent is no longer listed for this product
Pat. No. 9238076 DP* Polymer-based sustained release device Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2588: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with dapagliflozin and metformin Use Code: U-2589: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with basal insulin or basal insulin plus metformin Use Code: U-2590: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione, or combination of any two of these therapies Use Code: U-2599: Improving glycemic control in adults with Type 2 diabetes mellitus by administering an exenatide formulation as an adjunct to diet and exercise to provide a release profile having a ratio of C-max to C-avg of about 3 or less Use Code: U-3188: Improving glycemic control in patients 10 years of age and older with Type 2 diabetes mellitus by administering a sustained-release exenatide formulation as an adjunct to diet and exercise Use Code: U-3189: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with insulin alone or insulin plus one other oral antidiabetic medication Use Code: U-3190: As an adjunct to diet and exercise to improve glycemic control in patients 10 to 17 years of age with Type 2 diabetes mellitus in combination with metformin and/or sulfonylurea	Oct 15, 2024 *PED	This patent is no longer listed for this product

BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: IPSEN      NDA No.: 215498  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)

Patents	Expiration	Change
Pat. No. 12187812 IBAT inhibitors for the treatment of liver diseases Pat. Sub. Date(s): All strengths: Feb 11, 2025 Claim Types: Method of use Use Code: U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC) Use Code: U-3648: Method of treating cholestatic pruritus in patients 12 months or older suffering from alagille syndrome (ALGS)	Nov 8, 2031	New patent for this product

CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.: 212888  Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))

Patents	Expiration	Change
Pat. No. 12178815 Regimens for treating HIV infections and AIDS Pat. Sub. Date(s): All strengths: Jan 13, 2025 Claim Types: Method of use Use Code: U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg	Jul 18, 2038	New patent for this product

CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS INC      NDA No.: 208692  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE)

Patents	Expiration	Change
Pat. No. 8497284 C-met modulators and method of use Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1220: Treatment of renal cell carcinoma Use Code: U-1480: Treatment of advanced renal cell carcinoma Use Code: U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib	Sep 24, 2024	This patent is no longer listed for this product

CALQUENCE (CAPSULE) (ORAL) ACALABRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 210259  Prod. No.: 001 RX (100MG)

Patents	Expiration	Change
Pat. No. 9796721 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1- yl)-N-(pyridin-2-yl)benzamide Pat. Sub. Date(s): 001: Nov 28, 2017 Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-2667: Treatment of adult patients with small lymphocytic leukemia Use Code: U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab Use Code: U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab Use Code: U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia Use Code: U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab Use Code: U-4108: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation in combination with bendamustine and rituximab	Jul 1, 2036	New Use Code
Pat. No. 10167291 DP* Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide Pat. Sub. Date(s): 001: Jan 24, 2019 Claim Types: Composition; Method of use Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-2667: Treatment of adult patients with small lymphocytic leukemia Use Code: U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab Use Code: U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab Use Code: U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia Use Code: U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab	Jul 1, 2036	New Use Code
Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Pat. Sub. Date(s): 001: May 22, 2019 Claim Types: Method of use Use Code: U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily Use Code: U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily Use Code: U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily Use Code: U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab Use Code: U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab Use Code: U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily Use Code: U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily Use Code: U-4109: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation by administering 100 mg of acalabrutinib twice daily in combination with bendamustine and rituximab	Jan 21, 2035	New Use Code

CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.: 216387  Prod. No.: 001 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Pat. Sub. Date(s): 001: Sep 1, 2022 Claim Types: Method of use Use Code: U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily Use Code: U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily Use Code: U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily Use Code: U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab Use Code: U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab Use Code: U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily Use Code: U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily Use Code: U-4109: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation by administering 100 mg of acalabrutinib twice daily in combination with bendamustine and rituximab	Jan 21, 2035	New Use Code
Pat. No. 11059829 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate Pat. Sub. Date(s): 001: Sep 1, 2022 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-2667: Treatment of adult patients with small lymphocytic leukemia Use Code: U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab Use Code: U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab Use Code: U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia Use Code: U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab Use Code: U-4108: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation in combination with bendamustine and rituximab	Jul 1, 2036	New Use Code

CHLORAPREP WITH TINT (SPONGE) (TOPICAL) CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
NDA Applicant: BECTON DICKINSON CO      NDA No.: 020832  Prod. No.: 002 OTC (2%;70% (26ML)); 005 OTC (2%;70% (10.5ML)); 007 OTC (2%;70% (3ML))

Patents	Expiration	Change
Pat. No. 6991394 DP* Liquid applicator with a mechanism for fracturing multiple ampoules Pat. Sub. Date(s): None Claim Types: Device; Process	Jan 31, 2024	This patent is no longer listed for this product

CHLORHEXIDINE GLUCONATE (CLOTH) (TOPICAL) CHLORHEXIDINE GLUCONATE
NDA Applicant: SAGE PRODS      NDA No.: 021669  Prod. No.: 001 OTC (2%)

Patents	Expiration	Change
Pat. No. 7066916 Disinfectant delivery system, and method of providing alcohol-free disinfection Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-737: Disinfection of patient skin prior to an invasive procedure	Feb 17, 2024	This patent is no longer listed for this product

COMBIVENT RESPIMAT (SPRAY, METERED) (INHALATION) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021747  Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)

Patents	Expiration	Change
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties Pat. Sub. Date(s): None Claim Types: Device	Aug 26, 2024	This patent is no longer listed for this product

COMPLERA (TABLET) (ORAL) EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 202123  Prod. No.: 001 RX (200MG;EQ 25MG BASE;300MG)

Patents	Expiration	Change
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-257: Treatment of HIV infection	Jan 13, 2024	This patent is no longer listed for this product

CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: aminoketone == opioid antagonist
NDA Applicant: NALPROPION      NDA No.: 200063  Prod. No.: 001 RX (90MG;8MG)

Patents	Expiration	Change
Pat. No. 7462626 Compositions for affecting weight loss Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1583: For chronic weight management for treating overweight or obesity	Jul 20, 2024	This patent is no longer listed for this product
Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1586: For effect on blood glucose parameters in patients with insulin resistance	Jul 20, 2024	This patent is no longer listed for this product
Pat. No. 11278544 Compositions for affecting weight loss Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1583: For chronic weight management for treating overweight or obesity	Apr 21, 2024	This patent is no longer listed for this product

COSELA (POWDER) (INTRAVENOUS) TRILACICLIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACOSMOS      NDA No.: 214200  Prod. No.: 001 RX (EQ 300MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 12168666 DS* DP* Morphic forms of trilaciclib and methods of manufacture thereof Pat. Sub. Date(s): 001: Jan 13, 2025 Claim Types: New polymorph, salt or hydrate; Composition	Nov 13, 2040	New patent for this product

CRENESSITY (CAPSULE) (ORAL) CRINECERFONT
NDA Applicant: NEUROCRINE      NDA No.: 218808  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG)

Patents	Expiration	Change
Pat. No. 10905690 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 11311544 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 11730739 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 12128033 DS* Synthetic methods for preparation of 4-(2-chloro-4-methoxy-5-methylphenyl)-n-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-n-prop-2-ynyl-1,3-thiazol-2-amine Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Compound; Method of use; New polymorph, salt or hydrate Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jun 9, 2041	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 13, 2029	New exclusivity for this product

CRENESSITY (SOLUTION) (ORAL) CRINECERFONT
NDA Applicant: NEUROCRINE      NDA No.: 218820  Prod. No.: 001 RX (50MG/ML)

Patents	Expiration	Change
Pat. No. 10905690 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): 001: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 11311544 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): 001: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 11730739 Treatment of congenital adrenal hyperplasia Pat. Sub. Date(s): 001: Jan 10, 2025 Claim Types: Method of use Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jan 21, 2035	New patent for this product
Pat. No. 12128033 DS* Synthetic methods for preparation of 4-(2-chloro-4-methoxy-5-methylphenyl)-n-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-n-prop-2-ynyl-1,3-thiazol-2-amine Pat. Sub. Date(s): 001: Jan 10, 2025 Claim Types: Compound; Method of use; New polymorph, salt or hydrate Use Code: U-4049: Adjunctive treatment of classic congenital adrenal hyperplasia (CAH)	Jun 9, 2041	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 13, 2029	New exclusivity for this product

CREXONT (CAPSULE, EXTENDED RELEASE) (ORAL) CARBIDOPA; LEVODOPA
Drug Classes: aromatic amino acid decarboxylation inhibitor
NDA Applicant: IMPAX      NDA No.: 217186  Prod. No.: 001 RX (35MG;140MG); 002 RX (52.5MG;210MG); 003 RX (70MG;280MG); 004 RX (87.5MG;350MG)

Patents	Expiration	Change
Pat. No. 12194150 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Jan 22, 2025 Claim Types: Method of use Use Code: U-219: Treatment of Parkinson's disease	Dec 21, 2041	New patent for this product
Pat. No. 12201596 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Feb 5, 2025 Claim Types: Method of use; Method of administration; Formulation claimed by its inherent performace characteristics Use Code: U-1649: Treatment of post-encephalitic Parkinsonism Use Code: U-4004: Treatment of parkinsonism that may follow carbon monoxide intoxication Use Code: U-4005: Treatment of parkinsonism that may follow manganese intoxication	Dec 21, 2041	New patent for this product

DEFENCATH (SOLUTION) (N/A) HEPARIN SODIUM; TAUROLIDINE
Drug Classes: anticoagulant == unfractionated heparin
NDA Applicant: CORMEDIX      NDA No.: 214520  Prod. No.: 001 RX (3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)); 002 RX (5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML))

Patents	Expiration	Change
Pat. No. 8541393 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Pat. Sub. Date(s): None Claim Types: Formulation; Process Use Code: U-3774: A catheter lock solution to reduce catheter-related bloodstream infections in adult patients receiving hemodialysis through a central venous catheter	Nov 2, 2024	This patent is no longer listed for this product
Pat. No. 9339036 DS* DP* Antimicrobial locking solutions comprising taurinamide derivatives and biologically acceptable salts and acids, with the addition of small concentrations of heparin Pat. Sub. Date(s): None Claim Types: Formulation	Nov 2, 2024	This patent is no longer listed for this product

DESCOVY (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE [GENERIC AB]
Drug Classes: HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 208215  Prod. No.: 001 RX (200MG;EQ 25MG BASE); 002 RX (120MG;EQ 15MG BASE)

Patents	Expiration	Change
Pat. No. 7390791 DS* DP* [Extended 1076 days (2.9 years)] Prodrugs of phosphonate nucleotide analogues Pat. Sub. Date(s): 001: May 2, 2016; 002: Feb 4, 2022 Claim Types: Compound; Composition; Formulation	Jul 7, 2025 *PED	New expiration date. Was previously Oct 17, 2025 *PED

DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 022287  Prod. No.: 001 RX (30MG); 002 RX (60MG)

Patents	Expiration	Change
Pat. No. 8722084 DP* Controlled release preparation Pat. Sub. Date(s): None Claim Types: Formulation	Apr 15, 2024 *PED	This patent is no longer listed for this product
Pat. No. 8784885 DP* Controlled release preparation Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1552: For healing of all grades of erosive esophagitis (EE) Use Code: U-1553: To maintain healing of EE and relief of heartburn Use Code: U-1554: For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal disease (GERD)	Apr 15, 2024 *PED	This patent is no longer listed for this product

DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208056  Prod. No.: 001 DISC (30MG)

Patents	Expiration	Change
Pat. No. 8784885 DP* Controlled release preparation Pat. Sub. Date(s): None Claim Types: Formulation; Method of use	Apr 15, 2024 *PED	This patent is no longer listed for this product

DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: corticosteroid
NDA Applicant: OCULAR THERAPEUTIX      NDA No.: 208742  Prod. No.: 001 RX (0.4MG)

Patents	Expiration	Change
Pat. No. 9254267 DP* Composite hydrogel drug delivery systems Pat. Sub. Date(s): None Claim Types: Process	Sep 11, 2024	This patent is no longer listed for this product

DIFFERIN (GEL) (TOPICAL) ADAPALENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.: 021753  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 7737181 DP* Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders Pat. Sub. Date(s): None Claim Types: Formulation	Aug 29, 2024	This patent is no longer listed for this product

DIFICID (TABLET) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.: 201699  Prod. No.: 001 RX (200MG)

Patents	Expiration	Change
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation	Jan 15, 2024 *PED	This patent is no longer listed for this product

DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.: 213138  Prod. No.: 001 RX (40MG/ML)

Patents	Expiration	Change
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof Pat. Sub. Date(s): None Claim Types: Compound; Composition; Formulation	Jan 15, 2024 *PED	This patent is no longer listed for this product

DRIZALMA SPRINKLE (CAPSULE, DELAYED REL PELLETS) (ORAL) DULOXETINE HYDROCHLORIDE [Has competitive generic]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: SUN PHARM      NDA No.: 212516  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE); 004 RX (EQ 60MG BASE)

Patents	Expiration	Change
Pat. No. 12171742 DP* Duloxetine sprinkles Pat. Sub. Date(s): All strengths: Jan 10, 2025 Claim Types: Formulation	Apr 13, 2037	New patent for this product

DUAVEE (TABLET) (ORAL) BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Drug Classes: estrogen agonist/antagonist
NDA Applicant: WYETH PHARMS      NDA No.: 022247  Prod. No.: 001 RX (EQ 20MG BASE;0.45MG)

Patents	Expiration	Change
Pat. No. 6479535 DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-594: Prevention of postmenopausal osteoporosis Use Code: U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause	May 6, 2024	This patent is no longer listed for this product

DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.: 211911  Prod. No.: 001 RX (10MCG)

Patents	Expiration	Change
Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant	Apr 30, 2024	This patent is no longer listed for this product

DUTREBIS (TABLET) (ORAL) LAMIVUDINE; RALTEGRAVIR POTASSIUM
Drug Classes: HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse == human immunodeficiency virus type 1 integrase strand transfer
NDA Applicant: MERCK SHARP DOHME      NDA No.: 206510  Prod. No.: 001 DISC (150MG;EQ 300MG BASE)

Patents	Expiration	Change
Pat. No. 7169780 DS* DP* N-substituted hydroxypyrimidinone carboxamide inhibitors of HIV integrase Pat. Sub. Date(s): None Claim Types: Compound; Composition	Apr 3, 2024 *PED	This patent is no longer listed for this product

DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP      NDA No.: 202236  Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)

Patents	Expiration	Change
Pat. No. 8163723 Combination of azelastine and steroids Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1667: Treatment of allergic rhinitis, including seasonal allergic rhinitis Use Code: U-644: Treatment of seasonal allergic rhinitis Use Code: U-707: Allergic rhinitis Use Code: U-77: Treatment of symptoms of seasonal allergic rhinitis Use Code: U-81: Relief of symptoms associated with seasonal allergic rhinitis	Feb 29, 2024 *PED	This patent is no longer listed for this product

ENSACOVE (CAPSULE) (ORAL) ENSARTINIB HYDROCHLORIDE
NDA Applicant: XCOVERY      NDA No.: 218171  Prod. No.: 001 RX (EQ 25MG BASE); 002 RX (EQ 100MG BASE)

Patents	Expiration	Change
Pat. No. 8551995 DS* Kinase inhibitor compounds Pat. Sub. Date(s): All strengths: Jan 17, 2025 Claim Types: Compound	Feb 9, 2029	New patent for this product
Pat. No. 9126947 DS* Substituted pyridazine carboxamide compounds Pat. Sub. Date(s): All strengths: Jan 17, 2025 Claim Types: Compound; Composition	Nov 29, 2031	New patent for this product
Pat. No. 9296724 DS* Substituted pyridazinecarboxamides as kinase inhibitors Pat. Sub. Date(s): All strengths: Jan 17, 2025 Claim Types: Compound; Method of use Use Code: U-4099: Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an alk-inhibitor	Jun 18, 2029	New patent for this product
Pat. No. 10899744 DS* Crystalline form of compound suppressing protein kinase activity, and application thereof Pat. Sub. Date(s): All strengths: Jan 17, 2025 Claim Types: New polymorph, salt or hydrate; Formulation; Method of use; Process Use Code: U-4099: Treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an alk-inhibitor	Jun 1, 2037	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Dec 18, 2029	New exclusivity for this product

ENTRESTO (TABLET) (ORAL) SACUBITRIL; VALSARTAN [GENERIC AB]
Drug Classes: angiotensin II receptor blocker
NDA Applicant: NOVARTIS PHARMS CORP      NDA No.: 207620  Prod. No.: 001 RX (24MG;26MG); 002 RX (49MG;51MG); 003 RX (97MG;103MG)

Patents	Expiration	Change
Pat. No. 7468390 DP* Methods of treatment and pharmaceutical composition Pat. Sub. Date(s): None Claim Types: Formulation; Kit	May 27, 2024 *PED	This patent is no longer listed for this product

ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VELOXIS PHARMS INC      NDA No.: 206406  Prod. No.: 001 RX (EQ 0.75MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 4MG BASE)

Patents	Expiration	Change
Pat. No. 7994214 DP* Solid dispersions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation; Product-by-process; Process	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8486993 DP* Solid dispersions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation; Product-by-process; Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8586084 Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8591946 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation; Product-by-process	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8617599 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8623410 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8623411 Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8889185 Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 8889186 Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 9161907 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-1752: Prophylaxis of organ rejection	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 9757362 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 9763920 DP* Solid dispersions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Formulation; Product-by-process	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 10548880 Solid dispersions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations Use Code: U-2678: Prophylaxis of organ rejection in de novo transplant patient	Aug 30, 2024	This patent is no longer listed for this product
Pat. No. 11077096 DP* Modified release compositions comprising tacrolimus Pat. Sub. Date(s): None Claim Types: Product-by-process; Process	Aug 30, 2024	This patent is no longer listed for this product