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

AKYNZEO (POWDER; SOLUTION) (INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
NDA Applicant: HELSINN HLTHCARE      NDA No.: 210493  Prod. No.: 002 RX (EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)) NDA No.: 210493  Prod. No.: 001 DISC (EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 12208109 DP* Physiologically balanced injectable formulations of fosnetupitant Pat. Sub. Date(s): All strengths: Feb 20, 2025 Claim Types: Formulation; Process	Jun 2, 2037	New patent for this product

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. 12187739 DP* Diaryl macrocycle polymorph Pat. Sub. Date(s): 001: Feb 21, 2025 Claim Types: New polymorph, salt or hydrate	Jul 5, 2036	New patent for this product

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 002 RX (160MG)

Patents	Expiration	Change
Pat. No. 12187739 DP* Diaryl macrocycle polymorph Pat. Sub. Date(s): 002: Feb 21, 2025 Claim Types: New polymorph, salt or hydrate	Jul 5, 2036	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-483: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy	Jun 13, 2031	New exclusivity for this product

BRAFTOVI (CAPSULE) (ORAL) ENCORAFENIB
NDA Applicant: ARRAY BIOPHARMA INC      NDA No.: 210496  Prod. No.: 002 RX (75MG) NDA No.: 210496  Prod. No.: 001 DISC (50MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-957: In combination with cetuximab and mfolfox6, for the treatment of patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test	Dec 20, 2027	New exclusivity for this product

BRYNOVIN (SOLUTION) (ORAL) SITAGLIPTIN HYDROCHLORIDE
NDA Applicant: AZURITY      NDA No.: 219122  Prod. No.: 001 RX (EQ 25MG BASE/ML)

Patents	Expiration	Change
Pat. No. 11944621 DP* Oral gliptin compositions and method for preparation thereof Pat. Sub. Date(s): 001: Feb 21, 2025 Claim Types: Formulation	Oct 23, 2040	New patent for this product

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

Patents	Expiration	Change
Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Pat. Sub. Date(s): 001: Nov 28, 2017 Claim Types: 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-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 11, 2032	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-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-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-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	Jul 1, 2036	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-960: In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)	Jan 16, 2028	New exclusivity for this product

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

Patents	Expiration	Change
Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Pat. Sub. Date(s): 001: Sep 1, 2022 Claim Types: 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-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 11, 2032	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-960: In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT)	Jan 16, 2028	New exclusivity for this product

COPIKTRA (CAPSULE) (ORAL) DUVELISIB
NDA Applicant: SECURA      NDA No.: 211155  Prod. No.: 001 RX (15MG); 002 RX (25MG)

Patents	Expiration	Change
Pat. No. 12213983 Treatment of cancers using PI3 kinase isoform modulators Pat. Sub. Date(s): All strengths: Mar 5, 2025 Claim Types: Method of use Use Code: U-2412: For the treatment of patients with chronic lymphocytic leukemia (CLL) and/or small lymphocytic leukemia (SLL)	Apr 26, 2035	New patent for this product

DETECTNET (SOLUTION) (INTRAVENOUS) COPPER CU-64 DOTATATE
NDA Applicant: CURIUM      NDA No.: 213227  Prod. No.: 001 RX (4mL (1mCi/ML))

Patents	Expiration	Change
Pat. No. 10383961 [Extended 313 days (0.9 years)] PET tracer for imaging of neuroendocrine tumors Pat. Sub. Date(s): 001: Oct 1, 2020 Claim Types: Diagnostic or surgical method Use Code: U-2951: Use of Cu-64 dotatate with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETS) in adult patients	Jul 2, 2033	New expiration date. Was previously Aug 23, 2032

EMBLAVEO (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; AZTREONAM
NDA Applicant: ABBVIE      NDA No.: 217906  Prod. No.: 001 RX (EQ 0.5GM BASE/VIAL;1.5GM/VIAL)

Patents	Expiration	Change
Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)] Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-4147: Treatment of complicated intra-abdominal bacterial infections in adult patients	Jan 7, 2026	New product in Orange Book
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Formulation	Nov 12, 2026	New product in Orange Book
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: New polymorph, salt or hydrate	Aug 12, 2031	New product in Orange Book
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Formulation	Oct 8, 2030	New product in Orange Book
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Product-by-process; Process	Jun 15, 2032	New product in Orange Book
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Product-by-process; Process	Jun 15, 2032	New product in Orange Book
Pat. No. 9695122 DS* DP* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Pat. Sub. Date(s): 001: Mar 7, 2025 Claim Types: Formulation; Compound; Composition	Jun 15, 2032	New product in Orange Book

EVRYSDI (TABLET) (ORAL) RISDIPLAM
NDA Applicant: GENENTECH INC      NDA No.: 219285  Prod. No.: 001 RX (5MG)

Patents	Expiration	Change
Pat. No. 9586955 DS* DP* Compounds for treating spinal muscular atrophy Pat. Sub. Date(s): 001: Mar 5, 2025 Claim Types: Compound; Composition	Feb 8, 2033	New product in Orange Book
Pat. No. 9969754 DS* DP* Compounds for treating spinal muscular atrophy Pat. Sub. Date(s): 001: Mar 5, 2025 Claim Types: Compound Use Code: U-1943: Treatment of spinal muscular atrophy	May 11, 2035	New product in Orange Book
Pat. No. 11534444 Treatment of SMA Pat. Sub. Date(s): 001: Mar 5, 2025 Claim Types: Method of use Use Code: U-1943: Treatment of spinal muscular atrophy	Oct 4, 2038	New product in Orange Book
Pat. No. 11827646 Compounds for treating spinal muscular atrophy Pat. Sub. Date(s): 001: Mar 5, 2025 Claim Types: Method of use Use Code: U-1943: Treatment of spinal muscular atrophy	Jan 25, 2036	New product in Orange Book
Pat. No. 12122789 DS* DP* Forms of pyrido[1,2-a]pyrimidin-4-one derivatives, its formulation and its process of making Pat. Sub. Date(s): 001: Mar 5, 2025 Claim Types: New polymorph, salt or hydrate; Composition; Kit	Apr 15, 2041	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-270: Information added to clinical pharmacology section	Oct 3, 2026	New product in Orange Book
Exclusivity Code: NCE - New chemical entity	Aug 7, 2025	New product in Orange Book

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 002 RX (10MG)

Patents	Expiration	Change
Pat. No. 12213988 Methods of treating chronic kidney disease with dapagliflozin Pat. Sub. Date(s): 002: Mar 4, 2025 Claim Types: Method of use Use Code: U-4140: Reducing the risk of sustained egfr decline, end-stage kidney disease, cv death, and hospitalization for heart failure in adults with CKD at risk of progression and without Type II diabetes after at least 4 months of treatment	Apr 1, 2041	New patent for this product

FOTIVDA (CAPSULE) (ORAL) TIVOZANIB HYDROCHLORIDE
NDA Applicant: AVEO PHARMS      NDA No.: 212904  Prod. No.: 001 RX (EQ 0.89MG BASE); 002 RX (EQ 1.34MG BASE)

Patents	Expiration	Change
Pat. No. 7166722 DS* DP* N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-n'-(5-methyl-3-isoxaz- olyl)urea salt in crystalline form Pat. Sub. Date(s): All strengths: Apr 6, 2021 Claim Types: New polymorph, salt or hydrate; Process	Nov 16, 2028	New patent for this product

GILENYA (CAPSULE) (ORAL) FINGOLIMOD HYDROCHLORIDE [GENERIC AB]
NDA Applicant: NOVARTIS      NDA No.: 022527  Prod. No.: 001 RX (EQ 0.5MG BASE)

Patents	Expiration	Change
Pat. No. 8324283 DP* Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol Pat. Sub. Date(s): None Claim Types: Method of use	Sep 29, 2026 *PED	This patent is no longer listed for this product
Pat. No. 9187405 S1P receptor modulators for treating relapsing-remitting multiple sclerosis Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-2613: Treatment of relapsing-remitting sclerosis (MS)	Dec 25, 2027 *PED	This patent is no longer listed for this product

GOMEKLI (TABLET, FOR SUSPENSION) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219379  Prod. No.: 001 RX (1MG)

Patents	Expiration	Change
Pat. No. 11066358 DS* Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11084780 DS* Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11453641 Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11571402 DP* Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Formulation	Feb 17, 2041	New product in Orange Book
Pat. No. 11806321 Non-linear dosing of mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of administration Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11806322 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11819487 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11839595 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of Use claimed by its inherent performace characteristics Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11883375 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 12011424 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use; Method of administration Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12029711 DP* Dosage forms of mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Formulation; Method of use; Dosage regimen Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 15, 2044	New product in Orange Book
Pat. No. 12037306 Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12090128 DP* Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Formulation Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12220390 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Feb 11, 2030	New product in Orange Book

GOMEKLI (CAPSULE) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219389  Prod. No.: 001 RX (1MG)

Patents	Expiration	Change
Pat. No. 11066358 DS* Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11084780 DS* Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11453641 Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11806321 Non-linear dosing of mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of administration Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11806322 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11819487 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11839595 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of Use claimed by its inherent performace characteristics Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11883375 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4131: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (pn) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 12011424 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use; Method of administration Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12029711 DP* Dosage forms of mirdametinib Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Formulation; Method of use; Dosage regimen Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 15, 2044	New product in Orange Book
Pat. No. 12037306 Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12220390 Mirdametinib treatment Pat. Sub. Date(s): 001: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Feb 11, 2030	New product in Orange Book

GOMEKLI (CAPSULE) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219389  Prod. No.: 002 RX (2MG)

Patents	Expiration	Change
Pat. No. 11066358 DS* Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11084780 DS* Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate	Feb 17, 2041	New product in Orange Book
Pat. No. 11453641 Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11806321 Non-linear dosing of mirdametinib Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of administration Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11806322 Mirdametinib treatment Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11819487 Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 11839595 Mirdametinib treatment Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of Use claimed by its inherent performace characteristics Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 11883375 Mirdametinib treatment Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of use Use Code: U-4131: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (pn) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Pat. No. 12029711 DP* Dosage forms of mirdametinib Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Formulation; Method of use; Dosage regimen Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 15, 2044	New product in Orange Book
Pat. No. 12037306 Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Feb 17, 2041	New product in Orange Book
Pat. No. 12220390 Mirdametinib treatment Pat. Sub. Date(s): 002: Feb 14, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection	Mar 16, 2043	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Feb 11, 2030	New product in Orange Book

GRAFAPEX (POWDER) (INTRAVENOUS) TREOSULFAN
NDA Applicant: MEDEXUS      NDA No.: 214759  Prod. No.: 001 RX (1GM/VIAL); 002 RX (5GM/VIAL)

Patents	Expiration	Change
Pat. No. 7199162 Use of treosulfan for patient conditioning before bone marrow or blood stem cell transplantation Pat. Sub. Date(s): All strengths: Feb 20, 2025 Claim Types: Method of use; Method of administration Use Code: U-4142: Administering treosulfan as a preparative regimen for allogeneic stem cell transplantation	Oct 12, 2025	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jan 21, 2030	New exclusivity for this product

HETLIOZ (CAPSULE) (ORAL) TASIMELTEON [GENERIC AB]
NDA Applicant: VANDA PHARMS INC      NDA No.: 205677  Prod. No.: 001 RX (20MG)

Patents	Expiration	Change
Pat. No. 12201604 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Feb 18, 2025 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon Use Code: U-3865: Treatment of non-24-hour sleep-wake disorder by administering tasimelteon	Jan 25, 2033	New patent for this product

HETLIOZ LQ (SUSPENSION) (ORAL) TASIMELTEON
NDA Applicant: VANDA PHARMS INC      NDA No.: 214517  Prod. No.: 001 RX (4MG/ML)

Patents	Expiration	Change
Pat. No. 12201604 Treatment of circadian rhythm disorders Pat. Sub. Date(s): 001: Feb 18, 2025 Claim Types: Method of use Use Code: U-3003: Treatment of nighttime sleep disturbances in Smith-Magenis syndrome by administering tasimelteon	Jan 25, 2033	New patent for this product

IDOSE TR (IMPLANT) (INTRACAMERAL) TRAVOPROST
NDA Applicant: GLAUKOS      NDA No.: 218010  Prod. No.: 001 RX (75MCG)

Patents	Expiration	Change
Pat. No. 12201555 DS* DP* Drug eluting ocular implant Pat. Sub. Date(s): 001: Feb 20, 2025 Claim Types: Device	Feb 14, 2031	New patent for this product
Pat. No. 12201557 DS* DP* Drug eluting ocular implant and method of treating an ocular disorder Pat. Sub. Date(s): 001: Feb 20, 2025 Claim Types: Method of use; Method of administration Use Code: U-4129: Method of lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension	Jun 18, 2030	New patent for this product

IMBRUVICA (SUSPENSION) (ORAL) IBRUTINIB
NDA Applicant: PHARMACYCLICS LLC      NDA No.: 217003  Prod. No.: 001 RX (70MG/ML)

Patents	Expiration	Change
Pat. No. 12201690 DP* Formulations/compositions comprising ibrutinib Pat. Sub. Date(s): 001: Feb 20, 2025 Claim Types: Formulation	Jun 14, 2039	New patent for this product

INJECTAFER (SOLUTION) (INTRAVENOUS) FERRIC CARBOXYMALTOSE
NDA Applicant: AM REGENT      NDA No.: 203565  Prod. No.: 001 RX (750MG IRON/15ML (50MG IRON/ML)); 002 RX (500MG IRON/10ML (50MG IRON/ML)); 003 RX (1GM IRON/20ML (50MG IRON/ML)); 004 RX (100MG IRON/2ML (50MG IRON/ML))

Patents	Expiration	Change
Pat. No. 7612109 DS* DP* Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes Pat. Sub. Date(s): 001: Sep 12, 2013; 002: Feb 2, 2021; 003: May 21, 2021; 004: Mar 4, 2022 Claim Types: Formulation; Process	Feb 5, 2026	New expiration date. Was previously Feb 5, 2025

INVOKANA (TABLET) (ORAL) CANAGLIFLOZIN
NDA Applicant: JANSSEN PHARMS      NDA No.: 204042  Prod. No.: 001 RX (100MG); 002 RX (300MG)

Patents	Expiration	Change
Pat. No. 10617668 DP* Pharmaceutical formulations Pat. Sub. Date(s): None Claim Types: Formulation; Method of use Use Code: U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients Use Code: U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients Use Code: U-2794: Treatment of Type 2 diabetes mellitus with 100 mg canagliflozin per day Use Code: U-2795: Treatment of Type 2 diabetes mellitus with 300 mg canagliflozin per day Use Code: U-2796: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day Use Code: U-2797: Reduction of risk of major adverse cardiovascular events in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day Use Code: U-2798: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 100 mg canagliflozin per day Use Code: U-2799: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of type 2 diabetes mellitus patients with 300 mg canagliflozin per day Use Code: U-493: Treatment of Type 2 Diabetes Mellitus	Nov 11, 2031 *PED	This patent is no longer listed for this product

INZIRQO (FOR SUSPENSION) (ORAL) HYDROCHLOROTHIAZIDE
NDA Applicant: NOVITIUM PHARMA      NDA No.: 219141  Prod. No.: 001 RX (10MG/ML)

Patents	Expiration	Change
Pat. No. 11878022 DP* Hydrochlorothiazide compositions Pat. Sub. Date(s): 001: Feb 28, 2025 Claim Types: Formulation; Method of Use claimed by its inherent performace characteristics Use Code: U-4138: Treatment of edema in patients who are in need of an oral liquid suspension of hydrochlorothiazide Use Code: U-4139: Treatment of hypertension in patients who are in need of an oral liquid suspension of hydrochlorothiazide	Jan 23, 2044	New patent for this product

IQIRVO (TABLET) (ORAL) ELAFIBRANOR
NDA Applicant: IPSEN      NDA No.: 218860  Prod. No.: 001 RX (80MG)

Patents	Expiration	Change
Pat. No. 12233038 Methods of treatment of cholestatic diseases Pat. Sub. Date(s): 001: Mar 12, 2025 Claim Types: Method of use Use Code: U-1854: Treatment of primary biliary cholangitis (PBC)	Mar 30, 2037	New patent for this product

IZERVAY (SOLUTION) (INTRAVITREAL) AVACINCAPTAD PEGOL SODIUM
NDA Applicant: ASTELLAS      NDA No.: 217225  Prod. No.: 001 RX (EQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML))

Patents	Expiration	Change
Pat. No. 7579456 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Pat. Sub. Date(s): 001: Aug 31, 2023 Claim Types: Composition	Feb 14, 2026	New expiration date. Was previously Feb 14, 2025
Pat. No. 9617546 DS* Aptamer therapeutics useful in the treatment of complement-related disorders Pat. Sub. Date(s): 001: Aug 31, 2023 Claim Types: Compound; Method of use Use Code: U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye	Feb 14, 2026	New expiration date. Was previously Feb 14, 2025

JAYPIRCA (TABLET) (ORAL) PIRTOBRUTINIB
NDA Applicant: LOXO ONCOL      NDA No.: 216059  Prod. No.: 001 RX (50MG); 002 RX (100MG)

Patents	Expiration	Change
Pat. No. 12220401 DS* DP* Compounds useful as kinase inhibitors Pat. Sub. Date(s): All strengths: Mar 5, 2025 Claim Types: Compound; Composition; Method of use Use Code: U-3518: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl) after at least two lines of systemic therapy, including a BTK inhibitor Use Code: U-4144: Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CCL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor	Dec 16, 2036	New patent for this product

JOURNAVX (TABLET) (ORAL) SUZETRIGINE
NDA Applicant: VERTEX PHARMS INC      NDA No.: 219209  Prod. No.: 001 RX (50MG)

Patents	Expiration	Change
Pat. No. 11834441 DS* DP* Substituted tetrahydrofurans as modulators of sodium channels Pat. Sub. Date(s): 001: Feb 20, 2025 Claim Types: Compound; New polymorph, salt or hydrate; Composition; Method of use Use Code: U-4125: Treatment of moderate to severe acute pain in adults using suzetrigine	Dec 4, 2040	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jan 30, 2030	New exclusivity for this product

KALYDECO (TABLET) (ORAL) IVACAFTOR
NDA Applicant: VERTEX PHARMS      NDA No.: 203188  Prod. No.: 001 RX (150MG)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: None Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 3, 2013 Claim Types: Method of use Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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: Dec 1, 2013 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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: Jul 17, 2014 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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: Jul 5, 2017 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-1311: Method of treating cystic fibrosis	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Jun 1, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Feb 28, 2023 Claim Types: Method of use Use Code: U-3530: Treatment of CF in a patient age 6 years and older who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029

KALYDECO (GRANULE) (ORAL) IVACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 207925  Prod. No.: 001 RX (50MG/PACKET); 002 RX (75MG/PACKET)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Apr 14, 2015 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Apr 14, 2015 Claim Types: Method of use Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide Use Code: U-2527: Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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): All strengths: Apr 14, 2015 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): All strengths: Apr 14, 2015 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): All strengths: Jul 5, 2017 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-2530: Treatment of CF in a patient age 6 months to < 6 years who has one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Jun 9, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3528: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12214083 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 21, 2025 Claim Types: Formulation; Method of use Use Code: U-4126: Treatment of CF in a patient age 6 months to <6 years who has in the CFTR gene at least one responsive mutation based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 12,214,083	Feb 27, 2033	New patent for this product

KALYDECO (GRANULE) (ORAL) IVACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 207925  Prod. No.: 003 RX (25MG/PACKET)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: May 29, 2019 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: May 29, 2019 Claim Types: Method of use Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-1906: Method of treating a patient having cystic fibrosis, such as a patient having a G551D mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide Use Code: U-2963: Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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): 003: May 29, 2019 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): 003: May 29, 2019 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): 003: May 29, 2019 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-2966: Treatment of CF in a patient age 4 months to <6 years who has one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Jun 9, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Feb 28, 2023 Claim Types: Method of use Use Code: U-3528: Treatment of CF in a patient age 4 months to <6 years who has one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12214083 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Feb 21, 2025 Claim Types: Formulation; Method of use Use Code: U-4128: Treatment of CF in a patient age 4 months to <6 years who has in the CFTR gene at least one responsive mutation based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 12,214,083	Feb 27, 2033	New patent for this product

KALYDECO (GRANULE) (ORAL) IVACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 207925  Prod. No.: 004 RX (5.8MG/PACKET); 005 RX (13.4MG/PACKET)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Method of use Use Code: U-3609: Treatment of cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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): All strengths: May 30, 2023 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): All strengths: May 30, 2023 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): All strengths: May 30, 2023 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-3606: Treatment of CF in a patient age 1 month to <4 months who has at least one CFTR mutation responsive to ivacaftor based on clinical and/or in vitro assay data using a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Method of use Use Code: U-3603: Treatment of CF in a patient age 1 month to <4 months who has at least one mutation in the CFTR gene that is responsive to ivacaftor based on clinical and/or in vitro assay data using the composition recited in claim 1 of us 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12214083 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 21, 2025 Claim Types: Formulation; Method of use Use Code: U-4127: Treatment of CF in a patient age 1 month to <4 months who has in the CFTR gene at least one responsive mutation based on clinical and/or in vitro assay data using the composition recited in claim 1 of US 12,214,083	Feb 27, 2033	New patent for this product

KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
NDA Applicant: ASTRAZENECA      NDA No.: 213756  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)

Patents	Expiration	Change
Pat. No. 12220403 DP* Pharmaceutical composition Pat. Sub. Date(s): All strengths: Feb 14, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process	Mar 26, 2029	New patent for this product

LAZCLUZE (TABLET) (ORAL) LAZERTINIB MESYLATE
NDA Applicant: JANSSEN BIOTECH      NDA No.: 219008  Prod. No.: 001 RX (EQ 80MG BASE); 002 RX (EQ 240MG BASE)

Patents	Expiration	Change
Pat. No. 12138351 DP* Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof Pat. Sub. Date(s): All strengths: Feb 13, 2025 Claim Types: Formulation; New polymorph, salt or hydrate; Process	Apr 13, 2041	New patent for this product

LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
NDA Applicant: EISAI INC      NDA No.: 206947  Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)

Patents	Expiration	Change
Pat. No. 12226409 Treatment of hepatocellular carcinoma Pat. Sub. Date(s): All strengths: Mar 7, 2025 Claim Types: Method of use; Dosage regimen Use Code: U-4146: First-line treatment of patients with unresectable hepatocellular carcinoma (HCC) using dosage modifications for adverse reactions	May 15, 2038	New patent for this product

LIVTENCITY (TABLET) (ORAL) MARIBAVIR
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 215596  Prod. No.: 001 RX (200MG)

Patents	Expiration	Change
Pat. No. 12213989 Use of maribavir in treatment regimens Pat. Sub. Date(s): 001: Feb 27, 2025 Claim Types: Method of use Use Code: U-4137: Treating post-transplant cmv infection/disease refractory to ganciclovir, valganciclovir, cidofovir or foscarnet by administering 1200 mg maribavir twice daily, where the patient is concomitantly exposed to or receiving phenytoin or phenobarbital	Nov 18, 2042	New patent for this product

LODOCO (TABLET) (ORAL) COLCHICINE
NDA Applicant: AGEPHA PHARMA FZ      NDA No.: 215727  Prod. No.: 001 RX (0.5MG)

Patents	Expiration	Change
Pat. No. 12233035 Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent and statin Pat. Sub. Date(s): 001: Feb 27, 2025 Claim Types: Method of use Use Code: U-4132: A method of treating and/or reducing the risk of a cardiovascular event in a patient	Nov 1, 2033	New patent for this product

LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC      NDA No.: 214665  Prod. No.: 001 RX (120MG); 002 RX (320MG); 003 RX (240MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-962: In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy	Jan 16, 2028	New exclusivity for this product

LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
NDA Applicant: AVADEL CNS      NDA No.: 214755  Prod. No.: 001 RX (4.5GM/PACKET); 002 RX (6GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)

Patents	Expiration	Change
Pat. No. 12226377 DP* Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state Pat. Sub. Date(s): All strengths: Feb 21, 2025 Claim Types: Formulation claimed by its inherent performace characteristics	Jul 21, 2037	New patent for this product

MERCAPTOPURINE (SUSPENSION) (ORAL) MERCAPTOPURINE [GENERIC AB]
NDA Applicant: HIKMA      NDA No.: 216418  Prod. No.: 001 RX (20MG/ML)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Aug 25, 2025	New product in Orange Book

MYHIBBIN (SUSPENSION) (ORAL) MYCOPHENOLATE MOFETIL
NDA Applicant: AZURITY      NDA No.: 216482  Prod. No.: 001 RX (200MG/ML)

Patents	Expiration	Change
Pat. No. 12226526 DP* Mycophenolate oral suspension Pat. Sub. Date(s): 001: Feb 21, 2025 Claim Types: Formulation Use Code: U-1752: Prophylaxis of organ rejection	Aug 16, 2039	New patent for this product

NEXTSTELLIS (TABLET) (ORAL) DROSPIRENONE; ESTETROL
NDA Applicant: MAYNE PHARMA      NDA No.: 214154  Prod. No.: 001 RX (3MG;14.2MG)

Patents	Expiration	Change
Pat. No. 12233074 DP* Contraceptive methods with improved pearl index Pat. Sub. Date(s): 001: Mar 6, 2025 Claim Types: Method of use Use Code: U-3152: Use by females of reproductive potential to prevent pregnancy	Feb 9, 2043	New patent for this product

NORLIQVA (SOLUTION) (ORAL) AMLODIPINE BESYLATE
NDA Applicant: CMP DEV LLC      NDA No.: 214439  Prod. No.: 001 RX (EQ 1MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12005141 DP* Pharmaceutical solution of amlodipine Pat. Sub. Date(s): 001: Jun 28, 2024 Claim Types: Formulation; Method of use Use Code: U-3309: NORLIQVA is indicated for the treatment of hypertension, to lower blood pressure in adults and children 6 years of age and older Use Code: U-3310: NORLIQVA is indicated for the symptomatic treatment of chronic stable angina Use Code: U-3311: NORLIQVA is indicated for the treatment of confirmed or suspected vasospastic angina	Feb 24, 2041	New Use Code
Pat. No. 12226528 DP* Pharmaceutical solution of amlodipine Pat. Sub. Date(s): 001: Feb 27, 2025 Claim Types: Formulation; Method of use Use Code: U-3309: NORLIQVA is indicated for the treatment of hypertension, to lower blood pressure in adults and children 6 years of age and older Use Code: U-3310: NORLIQVA is indicated for the symptomatic treatment of chronic stable angina Use Code: U-3311: NORLIQVA is indicated for the treatment of confirmed or suspected vasospastic angina	Feb 24, 2041	New patent for this product

NUZYRA (TABLET) (ORAL) OMADACYCLINE TOSYLATE
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209816  Prod. No.: 001 RX (EQ 150MG BASE)

Patents	Expiration	Change
Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof Pat. Sub. Date(s): 001: Jul 23, 2019 Claim Types: Method of use; Composition Use Code: U-1569: Treatment of bacterial skin and skin structure infections	Oct 24, 2030	New expiration date. Was previously Mar 5, 2029; New Drug Substance/Drug Product flag

NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209817  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)

Patents	Expiration	Change
Pat. No. 9265740 DP* Minocycline compounds and methods of use thereof Pat. Sub. Date(s): 001: Jul 23, 2019 Claim Types: Method of use; Composition	Oct 24, 2030	New expiration date. Was previously Mar 5, 2029

ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 206038  Prod. No.: 001 RX (125MG;200MG)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 7973038 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Oct 21, 2016 Claim Types: Method of use Use Code: U-1973: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Method of use Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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: Jul 22, 2015 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: New polymorph, salt or hydrate; Composition	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Composition	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Use Code: U-1718: Method of treating cystic fibrosis in patients who have the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Use Code: U-1910: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using the dosage unit of claim 1 of U.S. patent no. 8,716,338	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8741933 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Method of use Use Code: U-1717: Method of treating cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene Use Code: U-1909: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and lumacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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: Jul 22, 2015 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Method of use Use Code: U-1717: Method of treating cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene Use Code: U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor	Jan 2, 2030 *PED	New expiration date. Was previously Jul 2, 2029
Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Pat. Sub. Date(s): 001: Jul 22, 2015 Claim Types: Composition	Jun 11, 2031 *PED	New expiration date. Was previously Dec 11, 2030
Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 001: Oct 21, 2016 Claim Types: Method of use Use Code: U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 001: Oct 21, 2016 Claim Types: Composition; Method of use; Kit Use Code: U-1912: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using a dosage unit as defined in claim 1 of U.S. Patent no. 9,192,606	Mar 29, 2030 *PED	New expiration date. Was previously Sep 29, 2029
Pat. No. 9216969 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Mar 15, 2016 Claim Types: Formulation	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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: Jul 5, 2017 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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: May 2, 2018 Claim Types: Method of use; Formulation Use Code: U-2276: Method of treating cystic fibrosis in a patient age 6 or older homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10076513 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Pat. Sub. Date(s): 001: Oct 18, 2018 Claim Types: Formulation; Process; Method of use Use Code: U-2411: Treatment of cystic fibrosis in a patient age 12 years or older who is homozygous for the F508DEL mutation in the CFTR gene using the tablet comprising lumacaftor as recited in claim 1, 19, or 21 of U.S. Patent No. 10,076,513 and ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 001: Apr 23, 2020 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2777: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Jun 11, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11052075 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Pat. Sub. Date(s): 001: Aug 4, 2021 Claim Types: Formulation; Method of use Use Code: U-3181: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using the tablet according to claim 1 of U.S. Patent No. 11,052,075, where the tablet further comprises ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 001: Feb 28, 2023 Claim Types: Method of use Use Code: U-3529: Treatment of CF in a patient age 6 years and older who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 001: Sep 18, 2024 Claim Types: Method of use Use Code: U-3984: Treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028

ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 206038  Prod. No.: 002 RX (125MG;100MG)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 7973038 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Method of use Use Code: U-1973: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Method of use Use Code: U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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: Oct 21, 2016 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: New polymorph, salt or hydrate; Composition	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Composition	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Use Code: U-1910: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using the dosage unit of claim 1 of U.S. patent no. 8,716,338	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8741933 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Method of use Use Code: U-1909: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and lumacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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: Oct 21, 2016 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Method of use Use Code: U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor	Jan 2, 2030 *PED	New expiration date. Was previously Jul 2, 2029
Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Composition	Jun 11, 2031 *PED	New expiration date. Was previously Dec 11, 2030
Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Method of use Use Code: U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Composition; Method of use; Kit Use Code: U-1912: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using a dosage unit as defined in claim 1 of U.S. Patent no. 9,192,606	Mar 29, 2030 *PED	New expiration date. Was previously Sep 29, 2029
Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 002: Oct 21, 2016 Claim Types: Formulation	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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: Jul 5, 2017 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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: May 2, 2018 Claim Types: Method of use; Formulation Use Code: U-2276: Method of treating cystic fibrosis in a patient age 6 or older homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 002: Apr 23, 2020 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2777: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 002: Jun 11, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11052075 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Pat. Sub. Date(s): 002: Aug 4, 2021 Claim Types: Formulation; Method of use Use Code: U-3181: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using the tablet according to claim 1 of U.S. Patent No. 11,052,075, where the tablet further comprises ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 002: Feb 28, 2023 Claim Types: Method of use Use Code: U-3529: Treatment of CF in a patient age 6 years and older who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 002: Sep 18, 2024 Claim Types: Method of use Use Code: U-3984: Treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028

ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 211358  Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 7973038 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Method of use Use Code: U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Method of use Use Code: U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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): All strengths: Sep 6, 2018 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: New polymorph, salt or hydrate; Composition	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Composition	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Use Code: U-2396: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor as recited in claim 1 of us patent 8716338 and ivacaftor	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8741933 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Method of use Use Code: U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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): All strengths: Sep 6, 2018 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Method of use Use Code: U-2375: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor Form I and ivacaftor	Jan 2, 2030 *PED	New expiration date. Was previously Jul 2, 2029
Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Composition	Jun 11, 2031 *PED	New expiration date. Was previously Dec 11, 2030
Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Method of use Use Code: U-2375: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor Form I and ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Composition; Method of use; Kit Use Code: U-2397: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of us patent 9192606	Mar 29, 2030 *PED	New expiration date. Was previously Sep 29, 2029
Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: Sep 6, 2018 Claim Types: Formulation	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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): All strengths: Sep 6, 2018 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-2376: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): All strengths: Sep 6, 2018 Claim Types: Method of use; Formulation Use Code: U-2376: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): All strengths: Apr 23, 2020 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2778: Treatment of cystic fibrosis in patients 2 to 5 years old who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Jun 11, 2020 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Feb 28, 2023 Claim Types: Method of use Use Code: U-3526: Treatment of CF in a patient age 1 to <6 years and weighing 7 kg or more who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): All strengths: Sep 18, 2024 Claim Types: Method of use Use Code: U-3983: Treatment of cystic fibrosis in patients aged 1 year to 5 years who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-408: Treatment of cystic fibrosis (CF) in patients aged 1 year to less than 2 years who are homozygous for the F508DEL mutation in the CFTR gene	Mar 2, 2030 PED	New expiration date. Was previously Sep 2, 2029

ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 211358  Prod. No.: 003 RX (94MG/PACKET;75MG/PACKET)

Patents	Expiration	Change
Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Compound; Composition	Nov 20, 2027 *PED	New expiration date. Was previously May 20, 2027
Pat. No. 7973038 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Method of use Use Code: U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
Pat. No. 8324242 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Method of use Use Code: U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor	Feb 5, 2028 *PED	New expiration date. Was previously Aug 5, 2027
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): 003: Sep 26, 2022 Claim Types: Composition; Compound	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: New polymorph, salt or hydrate; Composition	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Composition	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Use Code: U-3426: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor as recited in claim 1 of US patent 8716338 and ivacaftor	Mar 20, 2031 *PED	New expiration date. Was previously Sep 20, 2030
Pat. No. 8741933 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Method of use Use Code: U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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): 003: Sep 26, 2022 Claim Types: Formulation	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Method of use Use Code: U-3427: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor form I and ivacaftor	Jan 2, 2030 *PED	New expiration date. Was previously Jul 2, 2029
Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Composition	Jun 11, 2031 *PED	New expiration date. Was previously Dec 11, 2030
Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Method of use Use Code: U-3427: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor form I and ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Composition; Method of use; Kit Use Code: U-3428: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of US patent 9192606	Mar 29, 2030 *PED	New expiration date. Was previously Sep 29, 2029
Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Formulation	May 8, 2027 *PED	New expiration date. Was previously Nov 8, 2026
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): 003: Sep 26, 2022 Claim Types: Method of use; Process; New polymorph, salt or hydrate Use Code: U-3429: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
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): 003: Sep 26, 2022 Claim Types: Method of use; Formulation Use Code: U-3429: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor	Jun 28, 2027 *PED	New expiration date. Was previously Dec 28, 2026
Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-3430: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Sep 26, 2022 Claim Types: Formulation	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 11564916 Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Feb 28, 2023 Claim Types: Method of use Use Code: U-3526: Treatment of CF in a patient age 1 to <6 years and weighing 7 kg or more who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916	Feb 13, 2030 *PED	New expiration date. Was previously Aug 13, 2029
Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Pat. Sub. Date(s): 003: Sep 18, 2024 Claim Types: Method of use Use Code: U-3983: Treatment of cystic fibrosis in patients aged 1 year to 5 years who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432	Jun 4, 2029 *PED	New expiration date. Was previously Dec 4, 2028
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-408: Treatment of cystic fibrosis (CF) in patients aged 1 year to less than 2 years who are homozygous for the F508DEL mutation in the CFTR gene	Mar 2, 2030 PED	New expiration date. Was previously Sep 2, 2029

OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
NDA Applicant: NOVO      NDA No.: 209637  Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML)); 002 RX (4MG/3ML (1.34MG/ML)); 003 RX (8MG/3ML (2.68MG/ML)); 004 RX (2MG/3ML (0.68MG/ML))

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-961: To reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease	Jan 28, 2028	New exclusivity for this product

PAXLOVID (COPACKAGED) (TABLET) (ORAL) NIRMATRELVIR; RITONAVIR
NDA Applicant: PFIZER      NDA No.: 217188  Prod. No.: 001 RX (150MG;100MG)

Exclusivity	Expiration	Change
Exclusivity Code: D - New Dosing Schedule D-195: (Code description not yet released by FDA)	Jan 31, 2028	New exclusivity for this product

PHYTONADIONE (INJECTABLE) (INJECTION) PHYTONADIONE [GENERIC AB]
NDA Applicant: CIPLA      NDA No.: 214966  Prod. No.: 001 RX (1MG/0.5ML)

Exclusivity	Expiration	Change
Exclusivity Code: CGT - Competitive generic therapy	Sep 6, 2025	New exclusivity for this product

PLUVICTO (SOLUTION) (INTRAVENOUS) LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
NDA Applicant: NOVARTIS      NDA No.: 215833  Prod. No.: 001 RX (27mCi/ML)

Patents	Expiration	Change
Pat. No. 12208102 Methods of treating cancer Pat. Sub. Date(s): 001: Feb 27, 2025 Claim Types: Method of use Use Code: U-3345: For treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (MCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy	Sep 18, 2041	New patent for this product

PONVORY (TABLET) (ORAL) PONESIMOD
NDA Applicant: VANDA PHARMS INC      NDA No.: 213498  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG); 006 RX (7MG); 007 RX (8MG); 008 RX (9MG); 009 RX (10MG); 010 RX (20MG)

Patents	Expiration	Change
Pat. No. RE43728 DS* DP* Thiazolidin-4-one derivatives Pat. Sub. Date(s): All strengths: Apr 14, 2021 Claim Types: Composition; Compound; Process	Nov 16, 2029	New expiration date. Was previously Nov 16, 2025

PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
NDA Applicant: ANI PHARMS      NDA No.: 008975  Prod. No.: 002 RX (80 UNITS/ML)

Patents	Expiration	Change
Pat. No. 12233105 Methods for storing and warming purified corticotropin compositions Pat. Sub. Date(s): 002: Mar 5, 2025 Claim Types: Method of Use claimed by its inherent performace characteristics; Method of administration Use Code: U-3904: Acute exacerbations of multiple sclerosis Use Code: U-3905: Allergic conjunctivitis Use Code: U-3906: Anterior segment inflammation Use Code: U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis Use Code: U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis Use Code: U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis Use Code: U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis Use Code: U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis Use Code: U-3912: Atopic dermatitis Use Code: U-3913: Chorioretinitis Use Code: U-3914: Diffuse posterior uveitis and choroiditis Use Code: U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis) Use Code: U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus Use Code: U-3917: Iridocyclitis Use Code: U-3918: Iritis Use Code: U-3919: Keratitis Use Code: U-3920: Optic neuritis Use Code: U-3921: Serum sickness Use Code: U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa Use Code: U-3923: Severe erythema multiforme (stevens-johnson syndrome) Use Code: U-3924: Severe psoriasis Use Code: U-3925: Symptomatic sarcoidosis Use Code: U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus	Oct 27, 2043	New patent for this product