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

ANNOVERA (RING) (VAGINAL) ETHINYL ESTRADIOL; SEGESTERONE ACETATE
NDA Applicant: MAYNE PHARMA      NDA No.: 209627  Prod. No.: 001 RX (0.013MG/24HR;0.15MG/24HR)

Patents	Expiration	Change
Pat. No. 12303518 DP* System for providing birth control Pat. Sub. Date(s): 001: Jul 9, 2025 Claim Types: Method of administration; Product-by-process	Jun 21, 2039	New patent for this product

ARYNTA (SOLUTION) (ORAL) LISDEXAMFETAMINE DIMESYLATE
NDA Applicant: AZURITY      NDA No.: 219847  Prod. No.: 001 RX (10MG/ML)

Patents	Expiration	Change
Pat. No. 11576878 DP* Oral solutions comprising lisdexamfetamine salts Pat. Sub. Date(s): 001: Jun 27, 2025 Claim Types: Formulation	Aug 30, 2040	New product in Orange Book

ATZUMI (POWDER) (NASAL) DIHYDROERGOTAMINE MESYLATE
NDA Applicant: SATSUMA PHARMS      NDA No.: 217901  Prod. No.: 001 RX (EQ 5.2MG BASE)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Apr 30, 2028	New exclusivity for this product

AUGTYRO (CAPSULE) (ORAL) REPOTRECTINIB
NDA Applicant: BRISTOL      NDA No.: 218213  Prod. No.: 001 RX (40MG); 002 RX (160MG)

Patents	Expiration	Change
Pat. No. 12310968 Chiral diaryl macrocycles and uses thereof Pat. Sub. Date(s): All strengths: Jun 25, 2025 Claim Types: Method of use Use Code: U-3755: Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)	Jul 20, 2036	New patent for this product

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (CAPSULE, TABLET) (ORAL) AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE
NDA Applicant: VERASTEM INC      NDA No.: 219616  Prod. No.: 001 RX (EQ 0.8MG BASE;EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 7897792 DS* DP* Coumarin derivative having antitumor activity Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Compound; Composition	Feb 9, 2027	New patent for this product
Pat. No. 7928109 DS* DP* Sulfonyl amide derivatives for the treatment of abnormal cell growth Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Compound; Composition	Aug 21, 2029	New patent for this product
Pat. No. 8247411 DS* DP* Sulfonyl amide derivatives for the treatment of abnormal cell growth Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Compound; Composition	Apr 17, 2028	New patent for this product
Pat. No. 11400090 Coumarin Derivative For Therapy Or Prophylaxis Of A Cell Proliferative Disorder Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-4196: Treatment of adult patients with kras-mutated recurrent low-grade serous ovarian cancer (lgsoc) who have received prior systemic therapy, in combination with defactinib	Oct 29, 2038	New patent for this product
Pat. No. 11517573 Therapeutic compositions, combinations, and methods of use Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: Method of use Use Code: U-4196: Treatment of adult patients with kras-mutated recurrent low-grade serous ovarian cancer (lgsoc) who have received prior systemic therapy, in combination with defactinib Use Code: U-4205: Treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy, in combination with avutometinib	Sep 11, 2040	New patent for this product
Pat. No. 11873296 DP* Solid forms of a dual RAF/MEK inhibitor Pat. Sub. Date(s): 001: Jun 3, 2025 Claim Types: New polymorph, salt or hydrate Use Code: U-4196: Treatment of adult patients with kras-mutated recurrent low-grade serous ovarian cancer (lgsoc) who have received prior systemic therapy, in combination with defactinib	Dec 29, 2042	New patent for this product

BAQSIMI (POWDER) (NASAL) GLUCAGON
NDA Applicant: AMPHASTAR PHARMS INC      NDA No.: 210134  Prod. No.: 001 RX (3MG)

Patents	Expiration	Change
Pat. No. 10894133 DP* Device for dispensing a fluid product Pat. Sub. Date(s): None Claim Types: Device	Jan 3, 2038	This patent is no longer listed for this product

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

Patents	Expiration	Change
Pat. No. 12329740 Rescue treatment of post operative nausea and vomiting Pat. Sub. Date(s): All strengths: Jul 2, 2025 Claim Types: Method of use Use Code: U-2754: Treatment of post-operative nausea and vomiting Use Code: U-3467: Prevention and treatment of post-operative nausea and vomiting	Feb 9, 2038	New patent for this product

BRUKINSA (TABLET) (ORAL) ZANUBRUTINIB
NDA Applicant: BEONE MEDICINES USA      NDA No.: 218785  Prod. No.: 001 RX (160MG)

Patents	Expiration	Change
Pat. No. 9447106 DS* DP* Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Compound; Composition; Method of use; Formulation Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New product in Orange Book
Pat. No. 10570139 Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New product in Orange Book
Pat. No. 10927117 DS* DP* Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydrop- yrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: New polymorph, salt or hydrate; Process; Composition	Aug 15, 2037	New product in Orange Book
Pat. No. 11142528 DP* Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Composition; Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Apr 22, 2034	New product in Orange Book
Pat. No. 11591340 (Crystalline Form Of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- Hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, Preparation, And Uses Thereof Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: New polymorph, salt or hydrate; Process; Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3727: Treatment of adult patients with small lymphocytic lymphoma (SLL) who have received at least one prior therapy Use Code: U-3728: Treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy Use Code: U-3729: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (sll) who have received at least one prior therapy	Aug 15, 2037	New product in Orange Book
Pat. No. 11701357 Treatment of B cell cancers using a combination comprising Btk inhibitors Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use; Dosaage regimen Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Jun 24, 2039	New product in Orange Book
Pat. No. 11786531 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New product in Orange Book
Pat. No. 11851437 DS* DP* Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition	Aug 15, 2037	New product in Orange Book
Pat. No. 11884674 Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Aug 15, 2037	New product in Orange Book
Pat. No. 11896596 Methods of treating B-cell proliferative disorder Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New product in Orange Book
Pat. No. 11911386 Methods Of Treating B-cell Proliferative Disorder Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-3715: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3716: Treatment of adult patients with waldenstrom's macroglobulinemia (WM) receiving a moderate CYP3A inducer Use Code: U-3717: Treatment of adult patients with small lymphocytic lymphoma (SLL) receiving a moderate CYP3A inducer Use Code: U-3718: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) receiving a moderate CYP3A inducer, who have received at least one anti-CD20-based regimen Use Code: U-3719: Treatment of adult patients with mantle cell lymphoma (MCL) receiving a moderate CYP3A inducer, who have received at least one prior therapy Use Code: U-3720: Treatment of adult patients with chronic lymphocytic leukemia (CLL) receiving a moderate CYP3A inducer Use Code: U-3875: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) receiving a moderate cyp3a inducer, in combination with obinutuzumab, after two or more lines of systemic therapy	Jan 19, 2043	New product in Orange Book
Pat. No. 11970500 Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Method of use Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Aug 15, 2037	New product in Orange Book
Pat. No. 12233069 DP* Oral solid tablet comprising Bruton's Tyrosine Kinase inhibitor and preparation method therefor Pat. Sub. Date(s): 001: Jun 30, 2025 Claim Types: Formulation; Composition	Jun 10, 2040	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication: I-817: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)	Jan 19, 2026	New product in Orange Book
Exclusivity Code: I - New Indication: I-936: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy	Mar 7, 2027	New product in Orange Book
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Aug 31, 2028	New product in Orange Book
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Jan 19, 2030	New product in Orange Book
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Mar 7, 2031	New product in Orange Book
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Nov 14, 2026	New product in Orange Book
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s)	Sep 14, 2028	New product in Orange Book

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
NDA Applicant: INTRA-CELLULAR      NDA No.: 209500  Prod. No.: 001 RX (EQ 42MG BASE); 002 RX (EQ 10.5MG BASE); 003 RX (EQ 21MG BASE)

Patents	Expiration	Change
Pat. No. 11753419 DP* DLR* 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders Pat. Sub. Date(s): All strengths: Oct 11, 2023 Claim Types: Compound; Method of use	Dec 10, 2040	New Delisting Request flag

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

Patents	Expiration	Change
Pat. No. 12303481 Levodopa dosing regimen Pat. Sub. Date(s): All strengths: Jun 20, 2025 Claim Types: Method of use; Method of administration Use Code: U-1649: Treatment of post-encephalitic Parkinsonism Use Code: U-219: Treatment of Parkinson's disease Use Code: U-4004: Treatment of parkinsonism that may follow carbon monoxide intoxication Use Code: U-4005: Treatment of parkinsonism that may follow manganese intoxication	Dec 21, 2041	New patent for this product

EPSOLAY (CREAM) (TOPICAL) BENZOYL PEROXIDE
NDA Applicant: MAYNE PHARMA      NDA No.: 214510  Prod. No.: 001 RX (5%)

Patents	Expiration	Change
Pat. No. 12350382 DP* Method for preparing particles comprising metal oxide coating and particles with metal oxide coating Pat. Sub. Date(s): 001: Jul 9, 2025 Claim Types: Process; Product-by-process	Feb 3, 2028	New patent for this product

ERLEADA (TABLET) (ORAL) APALUTAMIDE [GENERIC AB]
NDA Applicant: JANSSEN BIOTECH      NDA No.: 210951  Prod. No.: 001 RX (60MG); 002 RX (240MG)

Patents	Expiration	Change
Pat. No. 12303493 DP* Anticancer compositions Pat. Sub. Date(s): All strengths: Jun 16, 2025 Claim Types: Formulation; Process	Dec 3, 2035	New patent for this product
Pat. No. 12303497 Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Pat. Sub. Date(s): All strengths: Jun 16, 2025 Claim Types: Method of use Use Code: U-4201: Dosage modification following grade 3 toxicity or intolerable side effect by discontinuing apalutamide until improvement to original grade or grade I in treatment of mcrpc patients that increases overall survival and progression free survival Use Code: U-4202: Improvement of overall survival and progression free survival in metastatic, castration-resistant prostate cancer (MCRPC) patients by treatment with 240 mg oral apalutamide in combination with androgen deprivation therapy	Jan 30, 2040	New patent for this product

FORFIVO XL (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE
NDA Applicant: TWI PHARMS      NDA No.: 022497  Prod. No.: 001 DISC (450MG)

Patents	Expiration	Change
Pat. No. 7674479 DP* Sustained-release bupropion and bupropion/mecamylamine tablets Pat. Sub. Date(s): 001: Nov 28, 2011 Claim Types: Formulation	Aug 23, 2028	New expiration date. Was previously Jun 25, 2027

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

Patents	Expiration	Change
Pat. No. 12324791 Mirdametinib treatment Pat. Sub. Date(s): 001: Jun 16, 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 patent for this product

GOMEKLI (CAPSULE) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS      NDA No.: 219389  Prod. No.: 001 RX (1MG); 002 RX (2MG)

Patents	Expiration	Change
Pat. No. 12324791 Mirdametinib treatment Pat. Sub. Date(s): All strengths: Jun 16, 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 patent for this product

HECTOROL (CAPSULE) (ORAL) DOXERCALCIFEROL [GENERIC AB]
NDA Applicant: SANOFI      NDA No.: 020862  Prod. No.: 001 RX (2.5MCG); 002 RX (0.5MCG); 003 RX (1MCG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection	Jun 11, 2028	New exclusivity for this product

IBTROZI (CAPSULE) (ORAL) TALETRECTINIB ADIPATE
NDA Applicant: NUVATION      NDA No.: 219713  Prod. No.: 001 RX (EQ 200MG BASE)

Patents	Expiration	Change
Pat. No. 9187489 DS* DP* Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors Pat. Sub. Date(s): 001: Jun 27, 2025 Claim Types: Composition; Method of use Use Code: U-4207: Treatment of patients with locally advanced or metastatic ros1-positive non-small cell lung cancer (NSCLC)	Jun 3, 2033	New product in Orange Book
Pat. No. 9751887 DS* DP* Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors Pat. Sub. Date(s): 001: Jun 27, 2025 Claim Types: Compound; Method of use Use Code: U-4207: Treatment of patients with locally advanced or metastatic ros1-positive non-small cell lung cancer (NSCLC)	Jun 3, 2033	New product in Orange Book
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	Jun 11, 2030	New product in Orange Book

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

Patents	Expiration	Change
Pat. No. 8354427 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): 001: Jan 26, 2015 Claim Types: Method of use Use Code: U-1311: Method of treating cystic fibrosis Use Code: U-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide	Jan 6, 2027 *PED	New expiration date. Was previously Jul 6, 2026
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020	Jun 21, 2028 PED	New expiration date. Was previously Dec 21, 2027

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. 8354427 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-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide Use Code: U-2528: Treatment of cystic fibrosis using ivacaftor in a patient age 6 months to <6 years who has a r117h mutation in the CFTR gene	Jan 6, 2027 *PED	New expiration date. Was previously Jul 6, 2026
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Apr 14, 2015 Claim Types: Formulation	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 29, 2019 Claim Types: Formulation; Method of use Use Code: U-2531: Treatment of CF 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 using the composition recited in claim 1 of US 10272046	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Apr 14, 2022 Claim Types: Formulation; Method of use Use Code: U-3339: 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 11147770	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Oct 11, 2023 Claim Types: Formulation; Method of use Use Code: U-3697: Treatment of CF in a patient age 1 month to <6 years 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 11752106	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
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	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-236: Treatment of cystic fibrosis (CF) in patients age 6 months to less than 12 months who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data	Oct 29, 2026 PED	New expiration date. Was previously Apr 29, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020	Jun 21, 2028 PED	New expiration date. Was previously Dec 21, 2027

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

Patents	Expiration	Change
Pat. No. 8354427 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-1905: Method of treating a patient having cystic fibrosis, the patient having a r117h mutation in CFTR, using n-(5-hydroxy-2,4-di-tert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide Use Code: U-2964: Treatment of cystic fibrosis using ivacaftor in a patient age 4 months to <6 years who has a R117H mutation in the CFTR gene	Jan 6, 2027 *PED	New expiration date. Was previously Jul 6, 2026
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: May 29, 2019 Claim Types: Formulation	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: May 29, 2019 Claim Types: Formulation; Method of use Use Code: U-2967: 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 10272046	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Apr 14, 2022 Claim Types: Formulation; Method of use Use Code: U-3339: 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 11147770	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): 003: Oct 11, 2023 Claim Types: Formulation; Method of use Use Code: U-3697: Treatment of CF in a patient age 1 month to <6 years 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 11752106	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
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	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Exclusivity	Expiration	Change
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-236: Treatment of cystic fibrosis (CF) in patients age 6 months to less than 12 months who have one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data	Oct 29, 2026 PED	New expiration date. Was previously Apr 29, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-338: For the treatment of cystic fibrosis (CF) in patients age 4 months and older who have one of the additional mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that have been identified as responsive to ivacaftor potentiation based on in vitro data and identified in the approval on December 21, 2020	Jun 21, 2028 PED	New expiration date. Was previously Dec 21, 2027

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. 8354427 Modulators of ATP-binding cassette transporters Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Method of use Use Code: U-3608: Treatment of cystic fibrosis using ivacaftor in a patient age 1 month to <4 months who has a R117H mutation in the CFTR gene	Jan 6, 2027 *PED	New expiration date. Was previously Jul 6, 2026
Pat. No. 8883206 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Formulation	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 10272046 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Formulation; Method of use Use Code: U-3605: 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 10272046	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11147770 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: May 30, 2023 Claim Types: Formulation; Method of use Use Code: U-3604: 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 11147770	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Pat. No. 11752106 DP* Pharmaceutical composition and administrations thereof Pat. Sub. Date(s): All strengths: Oct 11, 2023 Claim Types: Formulation; Method of use Use Code: U-3697: Treatment of CF in a patient age 1 month to <6 years 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 11752106	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
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	Aug 27, 2033 *PED	New expiration date. Was previously Feb 27, 2033
Exclusivity	Expiration	Change
Exclusivity Code: NPP - New patient population	Nov 3, 2026 PED	New expiration date. Was previously May 3, 2026
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-435: The treatment of cystic fibrosis (CF) in patients 1 month to less than 4 months of age who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data	Nov 3, 2030 PED	New expiration date. Was previously May 3, 2030

KATERZIA (SUSPENSION) (ORAL) AMLODIPINE BENZOATE
NDA Applicant: AZURITY      NDA No.: 211340  Prod. No.: 001 RX (EQ 1MG BASE/ML)

Patents	Expiration	Change
Pat. No. 12336984 Amlodipine formulations Pat. Sub. Date(s): 001: Jun 27, 2025 Claim Types: Method of use Use Code: U-3447: A method of treating coronary artery disease Use Code: U-3448: A method of treating hypertension	Oct 6, 2037	New patent for this product

KONVOMEP (FOR SUSPENSION) (ORAL) OMEPRAZOLE; SODIUM BICARBONATE
NDA Applicant: AZURITY      NDA No.: 213593  Prod. No.: 001 RX (2MG/ML;84MG/ML)

Patents	Expiration	Change
Pat. No. 12329752 DP* Compositions and kits for omeprazole suspension Pat. Sub. Date(s): 001: Jun 18, 2025 Claim Types: Formulation	Jul 16, 2039	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. 12318367 DP* Pharmaceutical composition Pat. Sub. Date(s): All strengths: Jul 1, 2025 Claim Types: Formulation; Solid osage form; Formulation claimed by its inherent performace characteristics	Mar 26, 2029	New patent for this product

LAMICTAL XR (TABLET, EXTENDED RELEASE) (ORAL) LAMOTRIGINE [GENERIC AB]
NDA Applicant: GLAXOSMITHKLINE LLC      NDA No.: 022115  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG); 004 RX (200MG); 005 RX (300MG); 006 RX (250MG)

Patents	Expiration	Change
Pat. No. 8637512 DP* Formulations and method of treatment Pat. Sub. Date(s): All strengths: Feb 12, 2014 Claim Types: Formulation	Jan 7, 2029	New expiration date. Was previously Jun 14, 2028

MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
NDA Applicant: ABBVIE      NDA No.: 209394  Prod. No.: 001 RX (100MG;40MG)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication I-967: (Code description not yet released by FDA)	Dec 10, 2028 PED	New exclusivity for this product

MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
NDA Applicant: ABBVIE      NDA No.: 215110  Prod. No.: 001 RX (50MG;20MG/PACKET)

Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication I-967: (Code description not yet released by FDA)	Dec 10, 2028 PED	New exclusivity for this product

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
NDA Applicant: SUMITOMO PHARMA      NDA No.: 214846  Prod. No.: 001 RX (1MG;0.5MG;40MG)

Patents	Expiration	Change
Pat. No. 12325714 DS* DP* Compositions of thienopyrimidine derivatives Pat. Sub. Date(s): 001: Jun 11, 2025 Claim Types: Solid osage form; Formulation	Sep 27, 2033	New patent for this product

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
NDA Applicant: KALEO INC      NDA No.: 215457  Prod. No.: 001 DISC (10MG/0.4ML (10MG/0.4ML))

Patents	Expiration	Change
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Jan 15, 2025	This patent is no longer listed for this product
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 12, 2028	This patent is no longer listed for this product
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Mar 21, 2025	This patent is no longer listed for this product
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Apr 30, 2025	This patent is no longer listed for this product
Pat. No. 11590286 DP* Devices, systems and methods for medicament delivery Pat. Sub. Date(s): None Claim Types: Device	Dec 12, 2026	This patent is no longer listed for this product

NEFFY (SPRAY) (NASAL) EPINEPHRINE
NDA Applicant: ARS PHARMS OPERATION      NDA No.: 214697  Prod. No.: 001 RX (2MG/SPRAY); 002 RX (1MG/SPRAY)

Patents	Expiration	Change
Pat. No. 12324838 DP* Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): All strengths: Jun 20, 2025 Claim Types: Device; Formulation	Feb 6, 2039	New patent for this product

NUBEQA (TABLET) (ORAL) DAROLUTAMIDE
NDA Applicant: BAYER HEALTHCARE      NDA No.: 212099  Prod. No.: 001 RX (300MG)

Patents	Expiration	Change
Pat. No. 8975254 DS* DP* [Extended 880 days (2.4 years)] Androgen receptor modulating compounds Pat. Sub. Date(s): 001: Aug 27, 2019 Claim Types: Compound; Method of use Use Code: U-4208: Treatment of adult patients with non-metastatic castration resistant prostate cancer (NMCRPC) Use Code: U-4209: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) Use Code: U-4210: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) in combination with docetaxel	Mar 25, 2033	New Use Code
Pat. No. 9657003 DS* DP* Androgen receptor modulating compounds Pat. Sub. Date(s): 001: Aug 27, 2019 Claim Types: Compound; Composition; Method of use Use Code: U-4208: Treatment of adult patients with non-metastatic castration resistant prostate cancer (NMCRPC) Use Code: U-4209: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) Use Code: U-4210: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) in combination with docetaxel	Oct 27, 2030	New Use Code
Pat. No. 10835515 DP* Carboxamide derivative and its diastereomers in stable crystalline form Pat. Sub. Date(s): 001: Dec 11, 2020 Claim Types: Composition; Method of use Use Code: U-2605: Treatment of patients with non-metastatic castration resistant prostate cancer Use Code: U-4208: Treatment of adult patients with non-metastatic castration resistant prostate cancer (NMCRPC) Use Code: U-4209: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) Use Code: U-4210: Treatment of adult patients with metastatic castration-sensitive prostate cancer (MCSPC) in combination with docetaxel	Jan 28, 2036	New Use Code
Pat. No. 12329742 DP* Pharmaceutical composition of darolutamide Pat. Sub. Date(s): 001: Jul 2, 2025 Claim Types: Formulation	May 14, 2042	New patent for this product

ORGOVYX (TABLET) (ORAL) RELUGOLIX
NDA Applicant: SUMITOMO PHARMA      NDA No.: 214621  Prod. No.: 001 RX (120MG)

Patents	Expiration	Change
Pat. No. 12325714 DS* DP* Compositions of thienopyrimidine derivatives Pat. Sub. Date(s): 001: Jun 11, 2025 Claim Types: Solid osage form; Formulation	Sep 27, 2033	New patent for this product
Pat. No. 12336990 Treatment of prostate cancer Pat. Sub. Date(s): 001: Jun 25, 2025 Claim Types: Method of use Use Code: U-3020: Treatment of adult patients with advanced prostate cancer	Sep 29, 2037	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. 12336980 Dosing regimen for a selective S1P1 receptor agonist Pat. Sub. Date(s): All strengths: Jul 8, 2025 Claim Types: Method of use Use Code: U-3103: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults using a dose titration schedule followed by a maintenance dose	Dec 10, 2035	New patent for this product

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. 12324787 DP* Kits for preparing and delivering purified corticotropin Pat. Sub. Date(s): 002: Jun 13, 2025 Claim Types: Kit; Formulation	Oct 27, 2043	New patent for this product

RADICAVA ORS (SUSPENSION) (ORAL) EDARAVONE
NDA Applicant: MITSUBISHI TANABE      NDA No.: 215446  Prod. No.: 001 RX (105MG/5ML)

Patents	Expiration	Change
Pat. No. 12310946 Pharmaceutical composition for oral administration of edaravone and method of administering same Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Method of use Use Code: U-4111: Treatment of amyotrophic lateral sclerosis by administering a liquid edaravone composition relative to the timing and type of food consumption	Nov 12, 2041	New patent for this product

RECORLEV (TABLET) (ORAL) LEVOKETOCONAZOLE
NDA Applicant: STRONGBRIDGE      NDA No.: 214133  Prod. No.: 001 RX (150MG)

Patents	Expiration	Change
Pat. No. 9918984 Methods and compositions for treating diabetes, metabolic syndrome and other conditions Pat. Sub. Date(s): 001: Jan 27, 2022 Claim Types: Method of use Use Code: U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative	May 3, 2028	New expiration date. Was previously Jan 10, 2026

RELISTOR (SOLUTION) (SUBCUTANEOUS) METHYLNALTREXONE BROMIDE
NDA Applicant: SALIX PHARMS      NDA No.: 021964  Prod. No.: 001 RX (12MG/0.6ML (12MG/0.6ML)); 002 RX (8MG/0.4ML (8MG/0.4ML)); 003 RX (12MG/0.6ML (12MG/0.6ML))

Patents	Expiration	Change
Pat. No. 12303592 DP* Formulations for parenteral delivery of compounds and uses thereof Pat. Sub. Date(s): All strengths: Jun 12, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process; Drug in a container Use Code: U-4197: Treatment of oic in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care Use Code: U-4198: Treatment of opioid-induced constipation (oic) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation	Aug 3, 2027	New patent for this product

REXULTI (TABLET) (ORAL) BREXPIPRAZOLE [GENERIC AB]
NDA Applicant: OTSUKA      NDA No.: 205422  Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (1MG); 004 RX (2MG); 005 RX (3MG); 006 RX (4MG)

Exclusivity	Expiration	Change
Exclusivity Code: M - Miscellaneous: M-315: Information added to section 14 of the labeling to describe study 6 (nct03198078), to fulfill postmarketing requirement 4205-1	May 9, 2028	New exclusivity for this product

ROZLYTREK (CAPSULE) (ORAL) ENTRECTINIB
NDA Applicant: GENENTECH INC      NDA No.: 212725  Prod. No.: 001 RX (100MG); 002 RX (200MG)

Patents	Expiration	Change
Pat. No. 8299057 DS* DP* Substituted indazole derivatives active as kinase inhibitors Pat. Sub. Date(s): All strengths: Sep 13, 2019 Claim Types: Compound; Process; Composition; Intermediate	Mar 10, 2032	New expiration date. Was previously Mar 1, 2029

RYALTRIS (SPRAY, METERED) (NASAL) MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
NDA Applicant: GLENMARK SPECLT      NDA No.: 211746  Prod. No.: 001 RX (0.025MG/SPRAY;0.665MG/SPRAY)

Patents	Expiration	Change
Pat. No. 12303635 DS* DP* Dispensing device and pharmaceutical composition for the treatment of rhinitis Pat. Sub. Date(s): 001: Jun 6, 2025 Claim Types: Device	Apr 8, 2039	New patent for this product

SYMDEKO (COPACKAGED) (TABLET) (ORAL) IVACAFTOR; IVACAFTOR, TEZACAFTOR
NDA Applicant: VERTEX PHARMS INC      NDA No.: 210491  Prod. No.: 001 RX (150MG;150MG, 100MG); 002 RX (75MG;75MG, 50MG)

Patents	Expiration	Change
Pat. No. RE50453 DS* DP* Indole derivatives as CFTR modulators Pat. Sub. Date(s): All strengths: Jul 9, 2025 Claim Types: Compound; Composition	May 1, 2027	New patent for this product

TARPEYO (CAPSULE, DELAYED RELEASE) (ORAL) BUDESONIDE
NDA Applicant: CALLIDITAS      NDA No.: 215935  Prod. No.: 001 RX (4MG)

Patents	Expiration	Change
Pat. No. 12311057 DP* Pharmaceutical compositions Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use; Method of administration Use Code: U-4085: Reduction in loss of kidney function in adults with primary immunoglobulin a nephropathy (igan) who are at risk of disease progression, by release of budesonide from the formulation Use Code: U-4086: Reduction of proteinuria in adults with primary immunoglobulin a nephropathy (igan) who are at risk of disease progression, by release of budesonide from the formulation Use Code: U-4204: Treatment of primary immunoglobulin a nephropathy (IGAN) in adults at risk of rapid disease progression, by release of budesonide from the formulation	Jan 23, 2043	New patent for this product

TRYPTYR (SOLUTION/DROPS) (OPHTHALMIC) ACOLTREMON
NDA Applicant: ALCON LABS INC      NDA No.: 217370  Prod. No.: 001 RX (0.003%)

Patents	Expiration	Change
Pat. No. 9095609 DP* Ophthalmic composition comprising ws-12 and methods to treat xerophthalmia Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Formulation claimed by its inherent performace characteristics Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Sep 8, 2031	New patent for this product
Pat. No. 9433679 Use of TRMP8 for treating opthalmic diseases or conditions involving tearing Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Method of use Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Sep 8, 2031	New patent for this product
Pat. No. 10028920 Methods for treating occular irritation involving tearing by administering modulators of TRPM8 Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Method of use Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Sep 8, 2031	New patent for this product
Pat. No. 11850221 DP* Ophthalmic pharmaceutical compositions and uses thereof Pat. Sub. Date(s): 001: Jun 20, 2025 Claim Types: Formulation; Drug in a container Use Code: U-1900: Treatment of the signs and symptoms of dry eye disease (DED)	Dec 16, 2042	New patent for this product
Exclusivity	Expiration	Change
Exclusivity Code: NCE - New chemical entity	May 28, 2030	New exclusivity for this product

TRYVIO (TABLET) (ORAL) APROCITENTAN
NDA Applicant: IDORSIA      NDA No.: 217686  Prod. No.: 001 RX (12.5MG)

Patents	Expiration	Change
Pat. No. 12297189 DP* Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan Pat. Sub. Date(s): 001: Jun 5, 2025 Claim Types: Formulation; New polymorph, salt or hydrate; Process	Feb 26, 2038	New patent for this product

UBRELVY (TABLET) (ORAL) UBROGEPANT
NDA Applicant: ABBVIE      NDA No.: 211765  Prod. No.: 001 RX (50MG); 002 RX (100MG)

Patents	Expiration	Change
Pat. No. 12310953 DP* Pharmaceutical formulations for the treatment of migraine Pat. Sub. Date(s): All strengths: Jun 25, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics	Jan 30, 2035	New patent for this product

VALTOCO (SPRAY) (NASAL) DIAZEPAM
NDA Applicant: NEURELIS INC      NDA No.: 211635  Prod. No.: 001 RX (5MG/SPRAY); 002 RX (7.5MG/SPRAY); 003 RX (10MG/SPRAY)

Patents	Expiration	Change
Pat. No. 12324852 Administration of benzodiazepine compositions Pat. Sub. Date(s): All strengths: Jun 27, 2025 Claim Types: Method of use Use Code: U-4173: Nasal administration of diazepam for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older	Oct 16, 2032	New patent for this product
Pat. No. 12337061 Administration of benzodiazepine compositions Pat. Sub. Date(s): All strengths: Jun 27, 2025 Claim Types: Method of use Use Code: U-4173: Nasal administration of diazepam for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older	Jun 13, 2032	New patent for this product

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM)

Patents	Expiration	Change
Pat. No. 8399446 Methods of treating hypertriglyceridemia Pat. Sub. Date(s): None Claim Types: Method of use Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia	Feb 9, 2030	This patent is no longer listed for this product

VASOSTRICT (SOLUTION) (INTRAVENOUS) VASOPRESSIN [GENERIC AP]
NDA Applicant: ENDO OPERATIONS      NDA No.: 204485  Prod. No.: 003 RX (40UNITS/100ML (0.4UNITS/ML)); 005 RX (20UNITS/100ML (0.2UNITS/ML)) NDA No.: 204485  Prod. No.: 004 DISC (60UNITS/100ML (0.6UNITS/ML)); 006 DISC (50UNITS/50ML (1UNITS/ML))

Patents	Expiration	Change
Pat. No. 12186362 DP* Vasopressin formulations for use in treatment of hypotension Pat. Sub. Date(s): All strengths: Jan 16, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Drug in a container	Jan 30, 2035	New patent for this product

VYKAT XR (TABLET, EXTENDED RELEASE) (ORAL) DIAZOXIDE CHOLINE
NDA Applicant: SOLENO THERAP      NDA No.: 216665  Prod. No.: 001 RX (25MG); 002 RX (75MG); 003 RX (150MG)

Patents	Expiration	Change
Pat. No. 12343348 Methods for treating subjects with Prader-Willi syndrome or Smith-Magenis syndrome Pat. Sub. Date(s): All strengths: Jul 3, 2025 Claim Types: Method of use Use Code: U-4211: Treating hyperphagia and reducing hyperphagic aggressive behaviors in prader-willi syndrome patients	Nov 12, 2035	New patent for this product

WELIREG (TABLET) (ORAL) BELZUTIFAN
NDA Applicant: MERCK SHARP DOHME      NDA No.: 215383  Prod. No.: 001 RX (40MG)

Patents	Expiration	Change
Pat. No. RE49948 DS* DP* Aryl ethers and uses thereof Pat. Sub. Date(s): 001: May 28, 2024 Claim Types: Compound; Composition; Method of use Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery Use Code: U-4176: Treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-i or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor Use Code: U-4195: Treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (ppgl)	Sep 5, 2034	New Use Code
Pat. No. 9908845 DS* DP* Aryl ethers and uses thereof Pat. Sub. Date(s): 001: Sep 9, 2021 Claim Types: Compound; Composition; Method of use Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery Use Code: U-4176: Treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-i or programmed death-ligand 1 inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor Use Code: U-4195: Treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (ppgl)	Sep 5, 2034	New Use Code
Exclusivity	Expiration	Change
Exclusivity Code: I - New Indication I-968: (Code description not yet released by FDA)	May 14, 2028	New exclusivity for this product

WIDAPLIK (TABLET) (ORAL) AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
NDA Applicant: GEORGE MEDICINES      NDA No.: 219423  Prod. No.: 001 DISC (EQ 1.25MG BASE;0.625MG;10MG); 002 DISC (EQ 2.5MG BASE;1.25MG;20MG); 003 DISC (EQ 5MG BASE;2.5MG;40MG)

Patents	Expiration	Change
Pat. No. 10322117 DP* Compositions for the treatment of hypertension Pat. Sub. Date(s): All strengths: Jul 3, 2025 Claim Types: Formulation	Jan 23, 2038	New product in Orange Book
Pat. No. 10799487 DP* Compositions for the treatment of hypertension Pat. Sub. Date(s): All strengths: Jul 3, 2025 Claim Types: Formulation; Method of use Use Code: U-3448: A method of treating hypertension	Jan 23, 2038	New product in Orange Book

XACIATO (GEL) (VAGINAL) CLINDAMYCIN PHOSPHATE
NDA Applicant: ORGANON LLC      NDA No.: 215650  Prod. No.: 001 RX (EQ 2% BASE)

Patents	Expiration	Change
Pat. No. 12303563 DP* Topical formulations and treatments Pat. Sub. Date(s): 001: Jun 16, 2025 Claim Types: Formulation	Sep 22, 2036	New patent for this product

XENLETA (TABLET) (ORAL) LEFAMULIN ACETATE
NDA Applicant: HONG KONG      NDA No.: 211672  Prod. No.: 001 RX (EQ 600MG BASE)

Patents	Expiration	Change
Pat. No. 8071643 DS* DP* [Extended 1529 days (4.2 years)] Pleuromutilin derivatives for the treatment of diseases mediated by microbes Pat. Sub. Date(s): 001: Sep 17, 2019 Claim Types: Compound; Composition	Mar 25, 2033	New expiration date. Was previously Jan 16, 2029

XENLETA (SOLUTION) (INTRAVENOUS) LEFAMULIN ACETATE
NDA Applicant: HONG KONG      NDA No.: 211673  Prod. No.: 001 RX (EQ 150MG BASE/15ML (EQ 10MG BASE/ML))

Patents	Expiration	Change
Pat. No. 8071643 DS* DP* [Extended 1529 days (4.2 years)] Pleuromutilin derivatives for the treatment of diseases mediated by microbes Pat. Sub. Date(s): 001: Sep 17, 2019 Claim Types: Compound; Composition	Mar 25, 2033	New expiration date. Was previously Jan 16, 2029

XIFYRM (SOLUTION) (INTRAVENOUS) MELOXICAM
NDA Applicant: AZURITY      NDA No.: 218395  Prod. No.: 001 RX (30MG/ML (30MG/ML))

Patents	Expiration	Change
Pat. No. 12263176 DP* Pharmaceutical liquid compositions of meloxicam Pat. Sub. Date(s): 001: Jun 6, 2025 Claim Types: Formulation; Product-by-process	Jul 31, 2041	New product in Orange Book

XOFLUZA (FOR SUSPENSION) (ORAL) BALOXAVIR MARBOXIL
NDA Applicant: GENENTECH INC      NDA No.: 214410  Prod. No.: 002 RX (30MG/PACKET); 003 RX (40MG/PACKET)

Patents	Expiration	Change
Pat. No. 8927710 DP* Substituted polycyclic carbamoylpyridone derivative Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Compound; Composition; Method of use	May 5, 2031	New strength or variation of this product
Pat. No. 8987441 DS* DP* Substituted polycyclic carbamoyl pyridone derivative prodrug Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Compound	Sep 21, 2031	New strength or variation of this product
Pat. No. 9815835 DP* Substituted polycyclic carbamolypyridone derivative Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Compound; Composition; Method of use	Jun 14, 2030	New strength or variation of this product
Pat. No. 10392406 DS* Substituted polycyclic pyridone derivatives and prodrugs thereof Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Compound	Apr 27, 2036	New strength or variation of this product
Pat. No. 10633397 Substituted polycyclic pyridone derivatives and prodrugs thereof Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Method of use Use Code: U-2816: Method for treating influenza Use Code: U-3000: Method for post-exposure prophylaxis of influenza	Apr 27, 2036	New strength or variation of this product
Pat. No. 10759814 DS* DP* Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: New polymorph, salt or hydrate; Composition	Aug 9, 2037	New strength or variation of this product
Pat. No. 11261198 DP* Process for preparing substituted polycyclic pyridone derivative and crystal thereof Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Compound; Process; New polymorph, salt or hydrate	Sep 25, 2038	New strength or variation of this product
Pat. No. 11306106 Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Method of use Use Code: U-2816: Method for treating influenza Use Code: U-3000: Method for post-exposure prophylaxis of influenza	Aug 9, 2037	New strength or variation of this product
Pat. No. 11925648 DP* Solid dosage form having excellent stability Pat. Sub. Date(s): All strengths: Jun 26, 2025 Claim Types: Formulation	Apr 21, 2041	New strength or variation of this product

YUTREPIA (POWDER) (INHALATION) TREPROSTINIL SODIUM
NDA Applicant: LIQUIDIA TECH      NDA No.: 213005  Prod. No.: 001 RX (EQ 0.0265MG BASE/INH); 002 RX (EQ 0.053MG BASE/INH); 003 RX (EQ 0.0795MG BASE/INH); 004 RX (EQ 0.106MG BASE/INH)

Patents	Expiration	Change
Pat. No. 10898494 Dry powder treprostinil for the treatment of pulmonary hypertension Pat. Sub. Date(s): All strengths: Jun 13, 2025 Claim Types: Method of use Use Code: U-4200: Method of treating pulmonary arterial hypertension or pulmonary hypertension associated with interstitial disease by administering treprostinil or a salt thereof by using an inhalation device	May 5, 2037	New patent for this product
Pat. No. 11660304 Dry powder treprostinil for the treatment of pulmonary hypertension Pat. Sub. Date(s): All strengths: Jun 13, 2025 Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Use Code: U-4200: Method of treating pulmonary arterial hypertension or pulmonary hypertension associated with interstitial disease by administering treprostinil or a salt thereof by using an inhalation device	May 5, 2037	New patent for this product
Pat. No. 11712442 Dry powder treprostinil for the treatment of pulmonary hypertension Pat. Sub. Date(s): All strengths: Jun 13, 2025 Claim Types: Method of use Use Code: U-4199: Definition use code method of treating pulmonary arterial hypertension or pulmonary hypertension associated with interstitial disease by administering treprostinil or a salt thereof by using an inhalation device	May 5, 2037	New patent for this product
Pat. No. 11744835 DP* Dry powder treprostinil for the treatment of pulmonary hypertension Pat. Sub. Date(s): All strengths: Jun 13, 2025 Claim Types: Method of use	May 5, 2037	New patent for this product
Pat. No. 11744836 DP* Dry powder treprostinil for the treatment of pulmonary hypertension Pat. Sub. Date(s): All strengths: Jun 13, 2025 Claim Types: Method of use; Device	May 5, 2037	New patent for this product

ZEPZELCA (POWDER) (INTRAVENOUS) LURBINECTEDIN
NDA Applicant: JAZZ      NDA No.: 213702  Prod. No.: 001 RX (4MG/VIAL)

Patents	Expiration	Change
Pat. No. 12324806 Method of treating SCLC and managing hepatotoxicity Pat. Sub. Date(s): 001: Jul 7, 2025 Claim Types: Method of use Use Code: U-4212: Treating metastatic SCLC after platinum chemotherapy with lurbinectedin monotherapy by reducing the dose for grade >=3 hepatotoxicity from 3.2 to 2.6 mg/m2 and 2.6 to 2.0 mg/m2 lurbinectedin within 35 days of the higher dose if hepatotoxicity ‚grade 1	May 29, 2040	New patent for this product

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 12310956 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 001: Jun 26, 2025 Claim Types: Formulation; Method of use Use Code: U-3748: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older	Jun 7, 2037	New patent for this product

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
NDA Applicant: ARCUTIS      NDA No.: 215985  Prod. No.: 002 RX (0.15%)

Patents	Expiration	Change
Pat. No. 12310956 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 002: Jun 26, 2025 Claim Types: Formulation; Method of use Use Code: U-3970: Topical treatment of mild to moderate atopic dermatitis	Jun 7, 2037	New patent for this product

ZORYVE (FOAM) (TOPICAL) ROFLUMILAST
NDA Applicant: ARCUTIS      NDA No.: 217242  Prod. No.: 001 RX (0.3%)

Patents	Expiration	Change
Pat. No. 9907788 Inhibition of crystal growth of roflumilast Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Jun 7, 2037	New Use Code
Pat. No. 11129818 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Aug 25, 2037	New Use Code
Pat. No. 11819496 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 001: Dec 26, 2023 Claim Types: Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Jun 7, 2037	New Use Code
Pat. No. 11992480 Method for reducing side effects from administration of phosphodiesterase-4 inhibitors Pat. Sub. Date(s): 001: Jun 26, 2024 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Jun 7, 2037	New Use Code
Pat. No. 12005051 Topical roflumilast formulation having improved delivery and plasma half life Pat. Sub. Date(s): 001: Jul 10, 2024 Claim Types: Method of improving a treatment Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Jun 7, 2037	New Use Code
Pat. No. 12310956 Topical roflumilast formulation having improved delivery and plasma half-life Pat. Sub. Date(s): 001: Jun 26, 2025 Claim Types: Formulation; Method of use Use Code: U-3773: Topical treatment of seborrheic dermatitis in patients 9 years of age and older Use Code: U-4203: Topical treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older	Jun 7, 2037	New patent for this product

ZUSDURI (POWDER) (INTRAVESICAL) MITOMYCIN
NDA Applicant: UROGEN PHARMA      NDA No.: 215793  Prod. No.: 001 RX (40MG/VIAL)

Exclusivity	Expiration	Change
Exclusivity Code: NP - New product	Jun 12, 2028	New product in Orange Book