Orange Book Companion (R)
What's New for Vol. 44, Supp. 09
Changes to patent and exclusivity information

In the What's New that logged-in subscribers see, the tradename of each drug is a link to the full patent/exclusivity portfolio of the drug. If you would like that have that very useful feature, please subscribe! It is only $295/year for your whole company or organization! Click the link at the top of this page for more info.

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


AQNEURSA (FOR SUSPENSION) (ORAL) LEVACETYLLEUCINE
NDA Applicant: INTRABIO      NDA No.:
219132  Prod. No.: 001 RX (1GM/PACKET)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 24, 2029New product in Orange Book

BRYHALI (LOTION) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH      NDA No.:
209355  Prod. No.: 001 RX (0.01%)
PatentsExpirationChange
Pat. No. 12076403 DP*
Pharmaceutical formulations containing corticosteroids for topical administration
Pat. Sub. Date(s): 001: Sep 24, 2024
Claim Types: Formulation
Nov 2, 2031New patent for this product

BYNFEZIA PEN (SOLUTION) (SUBCUTANEOUS) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: SUN PHARM      NDA No.:
213224  Prod. No.: 001 RX (7MG/2.8ML (2.5MG/ML))
PatentsExpirationChange
Pat. No. 10342850 DP*
Octreotide injection
Pat. Sub. Date(s): 001: Feb 10, 2020
Claim Types: Formulation
May 15, 2038New product in Orange Book

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
Drug Classes: atypical antipsychotic
NDA Applicant: INTRA-CELLULAR      NDA No.:
209500  Prod. No.: 001 RX (EQ 42MG BASE)
PatentsExpirationChange
Pat. No. 12090155 DP*
Methods
Pat. Sub. Date(s): 001: Oct 4, 2024
Claim Types: Method of use
Use Code: U-4000: Treatment of depressive episodes or major depressive episodes associated with bipolar II disorder
Jul 7, 2040New patent for this product

COMBOGESIC IV (SOLUTION) (INTRAVENOUS) ACETAMINOPHEN; IBUPROFEN SODIUM
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: HIKMA      NDA No.:
215320  Prod. No.: 001 RX (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))
PatentsExpirationChange
Pat. No. 12083087
Aqueous formulation comprising paracetamol and ibuprofen
Pat. Sub. Date(s): 001: Oct 8, 2024
Claim Types: Method of use; Formulation
Use Code: U-3744: Method of treating mild to moderate pain in adults
Use Code: U-3745: Method of treating moderate to severe pain in adults as an adjunct to opioid analgesics
Jul 17, 2035New patent for this product

DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX      NDA No.:
202103  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (70MG); 004 RX (100MG)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Mar 2, 2025New exclusivity for this product

DASATINIB (TABLET) (ORAL) DASATINIB [GENERIC AB]
Drug Classes: kinase inhibitor
NDA Applicant: APOTEX      NDA No.: 203180  Prod. No.: 001 RX (80MG); 002 RX (140MG)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Mar 2, 2025New exclusivity for this product

DEXMEDETOMIDINE HYDROCHLORIDE (SOLUTION) (INTRAVENOUS) DEXMEDETOMIDINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: SOMERSET      NDA No.:
218112  Prod. No.: 001 RX (EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)); 002 RX (EQ 1MG BASE/10ML (EQ 100MCG BASE/ML))
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 30, 2025New product in Orange Book

DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC      NDA No.:
216285  Prod. No.: 001 DISC (3.5MG)
PatentsExpirationChange
Pat. No. 12090231
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Oct 9, 2024
Claim Types: Dosaage regimen
Use Code: U-2553: Prevention of pregnancy in females of reproductive age
Jun 28, 2031New patent for this product

DUOBRII (LOTION) (TOPICAL) HALOBETASOL PROPIONATE; TAZAROTENE
Drug Classes: corticosteroid == retinoid
NDA Applicant: BAUSCH      NDA No.:
209354  Prod. No.: 001 RX (0.01%;0.045%)
PatentsExpirationChange
Pat. No. 12076403 DP*
Pharmaceutical formulations containing corticosteroids for topical administration
Pat. Sub. Date(s): 001: Sep 24, 2024
Claim Types: Formulation
Nov 2, 2031New patent for this product

ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: VELOXIS PHARMS INC      NDA No.:
206406  Prod. No.: 001 RX (EQ 0.75MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 4MG BASE)
PatentsExpirationChange
Pat. No. 12083103
Tacrolimus for improved treatment of transplant patients
Pat. Sub. Date(s): All strengths: Sep 12, 2024
Claim Types: Method of use; Formulation claimed by its inherent performace characteristics
Use Code: U-2678: Prophylaxis of organ rejection in de novo transplant patient
May 30, 2028New patent for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: JAZZ PHARMS RES      NDA No.:
210365  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationChange
Pat. No. 12064399
Use of cannabinoids in the treatment of epilepsy
Pat. Sub. Date(s): 001: Sep 19, 2024
Claim Types: Method of use
Use Code: U-3988: Use for the treatment of focal seizures associated with Lennox-Gastaut syndrome
Use Code: U-3989: Use for the treatment of focal seizures associated with tuberous sclerosis complex
Jun 17, 2035New patent for this product

FEMLYV (TABLET, ORALLY DISINTEGRATING) (ORAL) ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: progestin
NDA Applicant: MILLICENT PR      NDA No.:
218718  Prod. No.: 001 RX (0.02MG;1MG)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Jul 22, 2027New exclusivity for this product

FILSPARI (TABLET) (ORAL) SPARSENTAN
Drug Classes: endothelin and angiotensin II receptor antagonist
NDA Applicant: TRAVERE      NDA No.:
216403  Prod. No.: 001 RX (200MG); 002 RX (400MG)
PatentsExpirationChange
Pat. No. 9993461
Method for treating disorders associated with glomerular function
Pat. Sub. Date(s): All strengths: Mar 14, 2023
Claim Types: Method of use
Use Code: U-3269: Treatment of primary immunoglobulin a nephropathy (IGAN) in adults at risk of rapid disease progression
Use Code: U-3993: Treatment of primary immunoglobulin a nephropathy (IGAN) in adults at risk for disease progression
Mar 29, 2030New Use Code
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-493: To slow kidney function decline in adults with primary immunoglobulin a nephropathy (IGAN) who are at risk for disease progression, excluding the use provided for in the indication approved on february 17, 2023Sep 5, 2031New exclusivity for this product

FUROSCIX (SOLUTION) (SUBCUTANEOUS) FUROSEMIDE
Drug Classes: loop diuretic
NDA Applicant: SCPHARMACEUTICALS      NDA No.:
209988  Prod. No.: 001 RX (80MG/10ML (8MG/ML))
ExclusivityExpirationChange
Exclusivity Code: NP - New product Oct 7, 2025New exclusivity for this product

GEMTESA (TABLET) (ORAL) VIBEGRON
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: UROVANT      NDA No.:
213006  Prod. No.: 001 RX (75MG)
PatentsExpirationChange
Pat. No. 12102638
Use Of Vibegron To Treat Overactive Bladder
Pat. Sub. Date(s): 001: Oct 7, 2024
Claim Types: Method of use
Use Code: U-3045: Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Mar 22, 2040New patent for this product

HYDROCORTISONE SODIUM SUCCINATE (INJECTABLE) (INJECTION) HYDROCORTISONE SODIUM SUCCINATE [GENERIC AP]
NDA Applicant: CIPLA      NDA No.:
214050  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 25, 2025New exclusivity for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL      NDA No.:
215390  Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)
PatentsExpirationChange
Pat. No. 12090140
Non-sedating dexmedetomidine treatment regimens
Pat. Sub. Date(s): All strengths: Sep 18, 2024
Claim Types: Method of use
Use Code: U-3986: A method of treating agitation associated with schizophrenia or bipolar I or II disorder
Jan 12, 2043New patent for this product

IVABRADINE HYDROCHLORIDE (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: INGENUS PHARMS LLC      NDA No.:
214051  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Jan 11, 2025New expiration date. Was previously Jan 15, 2025

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))
PatentsExpirationChange
Pat. No. 12016875
Methods for treating or preventing ophthalmological conditions
Pat. Sub. Date(s): 001: Oct 1, 2024
Claim Types: Method of administration; Method of use
Use Code: U-3673: Treatment of geographic atrophy secondary to age-related macular degeneration by administerting avacincaptad pegol to the eye
Jul 11, 2034New patent for this product

KISQALI (TABLET) (ORAL) RIBOCICLIB SUCCINATE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
209092  Prod. No.: 001 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 8962630
Pyrrolopyrimidine compounds and their uses
Pat. Sub. Date(s): 001: Apr 3, 2017
Claim Types: Method of use
Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer
Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy
Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Dec 9, 2029New Use Code
Pat. No. 9416136
Pyrrolopyrimidine compounds and their uses
Pat. Sub. Date(s): 001: Apr 3, 2017
Claim Types: Method of use
Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer
Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy
Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Aug 20, 2029New Use Code
Pat. No. 9868739
Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo- [2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
Pat. Sub. Date(s): 001: Jun 5, 2018
Claim Types: Method of use
Use Code: U-1981: In combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer
Use Code: U-2355: In combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
Use Code: U-2356: In combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy
Use Code: U-3265: In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3266: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men, for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3975: In combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, for the treatment of adult patients with hr-positive, HER2-negative advanced or metastatic breast cancer
Use Code: U-3999: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Nov 9, 2031New Use Code
Pat. No. 12064434 DP*
Ribociclib tablet
Pat. Sub. Date(s): 001: Sep 13, 2024
Claim Types: Formulation
Apr 14, 2036New patent for this product
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-950: In combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrenceSep 17, 2027New exclusivity for this product

KISQALI FEMARA CO-PACK (COPACKAGED) (TABLET) (ORAL) LETROZOLE; RIBOCICLIB SUCCINATE
Drug Classes: aromatase inhibitor == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
209935  Prod. No.: 001 RX (2.5MG;EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 8962630
Pyrrolopyrimidine compounds and their uses
Pat. Sub. Date(s): 001: May 19, 2017
Claim Types: Method of use
Use Code: U-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3264: As initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Dec 9, 2029New Use Code
Pat. No. 9416136
Pyrrolopyrimidine compounds and their uses
Pat. Sub. Date(s): 001: May 19, 2017
Claim Types: Method of use
Use Code: U-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3264: As initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Aug 20, 2029New Use Code
Pat. No. 9868739
Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo- [2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
Pat. Sub. Date(s): 001: Jun 5, 2018
Claim Types: Method of use
Use Code: U-2505: Treatment of pre/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3264: As initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
Use Code: U-3998: Adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence
Nov 9, 2031New Use Code
Pat. No. 12064434 DP*
Ribociclib tablet
Pat. Sub. Date(s): 001: Sep 13, 2024
Claim Types: Formulation
Apr 14, 2036New patent for this product
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-951: For the adjuvant treatment of adults with hormone receptor (hr)-positive, human epidermal growth factor receptor 2(her2)-negative stage ii and iii early breast cancer at high risk of recurrenceSep 17, 2027New exclusivity for this product

KORLYM (TABLET) (ORAL) MIFEPRISTONE [GENERIC AB]
Drug Classes: progestin antagonist
NDA Applicant: CORCEPT THERAP      NDA No.:
202107  Prod. No.: 001 RX (300MG)
PatentsExpirationChange
Pat. No. 12097210
Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Pat. Sub. Date(s): 001: Sep 25, 2024
Claim Types: Method of administration; Method of use
Use Code: U-1643: Treating Cushing's syndrome
Jun 19, 2037New 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)
PatentsExpirationChange
Pat. No. 9593098 DS* DP*
Compounds and compositions for modulating EGFR mutant kinase activities
Pat. Sub. Date(s): All strengths: Sep 17, 2024
Claim Types: Compound; Method of use; Composition
Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab
Oct 13, 2035New patent for this product
Pat. No. 11453656 DS* DP*
Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Pat. Sub. Date(s): All strengths: Sep 17, 2024
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Apr 18, 2038New patent for this product
Pat. No. 11850248
Therapies with 3rd generation EGFR tyrosine kinase inhibitors
Pat. Sub. Date(s): All strengths: Sep 17, 2024
Claim Types: Method of use
Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab
Aug 1, 2041New patent for this product
Pat. No. 11879013
Combination therapies with bispecific anti-EGFR/c-Met antibodies and third generation EGFR tyrosine kinase inhibitors
Pat. Sub. Date(s): All strengths: Sep 17, 2024
Claim Types: Method of use; Dosaage regimen
Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab
May 21, 2040New patent for this product
Pat. No. 11981659
Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same
Pat. Sub. Date(s): All strengths: Sep 17, 2024
Claim Types: Method of use; New polymorph, salt or hydrate
Use Code: U-3985: First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations, in combination with amivantamab
Apr 18, 2038New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Aug 19, 2029New exclusivity for this product

LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: EISAI INC      NDA No.:
206947  Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 12083112
Combination of a PD-1 antagonist and a VEGFR/FGFR/RET tyrosine kinase inhibitor for treating cancer
Pat. Sub. Date(s): All strengths: Oct 3, 2024
Claim Types: Method of use; Method of administration; Kit
Use Code: U-3996: First-line treatment of adults patients with advanced renal cell carcinoma by administering LENVIMA in combination with pembrolizumab
Use Code: U-3997: Treatment of patients with PMMR/NOT MSI-H advanced endometrial carcinoma, have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation, by administering LENVIMA in combination with pembrolizumab
Mar 3, 2036New patent for this product

LEQSELVI (TABLET) (ORAL) DEURUXOLITINIB PHOSPHATE
NDA Applicant: SUN PHARM INDS INC      NDA No.:
217900  Prod. No.: 001 RX (EQ 8MG BASE)
PatentsExpirationChange
Pat. No. 12076323
Treatment of hair loss disorders with deuterated JAK inhibitors
Pat. Sub. Date(s): 001: Oct 1, 2024
Claim Types: Method of use; Method of administration
Use Code: U-3976: Treatment of adult patients with alopecia areata
May 4, 2037New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Jul 25, 2029New exclusivity for this product

LITFULO (CAPSULE) (ORAL) RITLECITINIB TOSYLATE
Drug Classes: kinase inhibitor
NDA Applicant: PFIZER      NDA No.:
215830  Prod. No.: 001 RX (EQ 50MG BASE)
PatentsExpirationChange
Pat. No. 12077533
Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides
Pat. Sub. Date(s): 001: Oct 2, 2024
Claim Types: Method of use
Use Code: U-3994: Method of treating severe alopecia areata in adults and adolescents 12 years and older by administering ritlectinib
Dec 3, 2034New patent for this product

LIVDELZI (CAPSULE) (ORAL) SELADELPAR LYSINE
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
217899  Prod. No.: 001 RX (EQ 10MG BASE)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-486: Treatment of primary biliary cholangitis (PBC) in adults who have had an inadequate response to ursodeoxycholic acid (UDCA), or in patients unable to tolerate UDCAAug 14, 2031New exclusivity for this product

LIVMARLI (SOLUTION) (ORAL) MARALIXIBAT CHLORIDE
Drug Classes: ileal bile acid transporter (IBAT) inhibitor
NDA Applicant: MIRUM      NDA No.:
214662  Prod. No.: 002 RX (EQ 19MG BASE/ML)
ExclusivityExpirationChange
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 13, 2030New exclusivity for this product
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 13, 2031New exclusivity for this product
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 29, 2028New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-490: Treatment of cholestatic pruritas in patients 12 months of age to less than 5 years of age with progressive familial intrahepatic cholestasis (PFIC)Jul 24, 2031New exclusivity for this product

LOCAMETZ (POWDER) (INTRAVENOUS) GALLIUM GA-68 GOZETOTIDE
NDA Applicant: NOVARTIS      NDA No.:
215841  Prod. No.: 001 RX (N/A)
PatentsExpirationChange
Pat. No. 12109277
Methods And Kits For Preparing Radionuclide Complexes
Pat. Sub. Date(s): 001: Oct 8, 2024
Claim Types: Diagnostic or surgical method
Use Code: U-4002: Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer
Mar 9, 2036New patent for this product

LUPKYNIS (CAPSULE) (ORAL) VOCLOSPORIN
Drug Classes: calcineurin-inhibitor immunosuppressant
NDA Applicant: AURINIA      NDA No.:
213716  Prod. No.: 001 RX (7.9MG)
PatentsExpirationChange
Pat. No. 7332472 DS* DP*
Cyclosporine analogue mixtures and their use as immunomodulating agents
Pat. Sub. Date(s): 001: Feb 11, 2021
Claim Types: Formulation; Method of use
Use Code: U-3056: Treatment of patients with active lupus nephritis
Oct 17, 2025New expiration date. Was previously Oct 17, 2024

LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ABBVIE ENDOCRINE INC      NDA No.:
020517  Prod. No.: 003 RX (45MG)
PatentsExpirationChange
Pat. No. 9617303
Sustained-release composition and method for producing the same
Pat. Sub. Date(s): 003: Oct 4, 2024
Claim Types: Method of use
Use Code: U-4001: Treatment of advanced prostatic cancer
Mar 22, 2028New patent for this product

MAYZENT (TABLET) (ORAL) SIPONIMOD
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: NOVARTIS      NDA No.:
209884  Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 1MG BASE)
PatentsExpirationChange
Pat. No. 12071402 DP*
Immunosuppressant formulations
Pat. Sub. Date(s): All strengths: Sep 26, 2024
Claim Types: Formulation
Jan 5, 2032New patent for this product

MIPLYFFA (CAPSULE) (ORAL) ARIMOCLOMOL CITRATE
NDA Applicant: ZEVRA DENMARK      NDA No.:
214927  Prod. No.: 001 RX (EQ 47MG BASE); 002 RX (EQ 62MG BASE); 003 RX (EQ 93MG BASE); 004 RX (EQ 124MG BASE)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Sep 20, 2029New product in Orange Book

MYHIBBIN (SUSPENSION) (ORAL) MYCOPHENOLATE MOFETIL
NDA Applicant: AZURITY      NDA No.:
216482  Prod. No.: 001 RX (200MG/ML)
PatentsExpirationChange
Pat. No. 12097284 DP*
Mycophenolate oral suspension
Pat. Sub. Date(s): 001: Sep 27, 2024
Claim Types: Formulation
Aug 16, 2039New patent for this product
Pat. No. 12097285 DP*
Mycophenolate oral suspension
Pat. Sub. Date(s): 001: Sep 27, 2024
Claim Types: Formulation; Method of use
Use Code: U-1752: Prophylaxis of organ rejection
Aug 16, 2039New patent for this product

MYRBETRIQ (TABLET, EXTENDED RELEASE) (ORAL) MIRABEGRON [GENERIC AB]
Drug Classes: beta-3 adrenergic agonist
NDA Applicant: APGDI      NDA No.:
202611  Prod. No.: 001 RX (25MG); 002 RX (50MG)
PatentsExpirationChange
Pat. No. 12097189
Pharmaceutical composition for modified release
Pat. Sub. Date(s): All strengths: Oct 2, 2024
Claim Types: Method of use
Use Code: U-2996: Administration of an extended release tablet for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
Use Code: U-3670: Administration of an extended release tablet for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more
Sep 28, 2029New patent for this product

NALBUPHINE HYDROCHLORIDE (INJECTABLE) (INJECTION) NALBUPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist/antagonist
NDA Applicant: SOMERSET THERAPS LLC      NDA No.:
216049  Prod. No.: 001 RX (10MG/ML); 002 RX (20MG/ML)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 30, 2025New product in Orange Book

NALBUPHINE HYDROCHLORIDE (INJECTABLE) (INJECTION) NALBUPHINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist/antagonist
NDA Applicant: SOMERSET THERAPS LLC      NDA No.: 216050  Prod. No.: 001 RX (10MG/ML); 002 RX (20MG/ML)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 24, 2025New product in Orange Book

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.:
214313  Prod. No.: 001 RX (EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)); 003 RX (EQ 16MG BASE/250ML (EQ 64MCG BASE/ML))
PatentsExpirationChange
Pat. No. 12097170 DP*
Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
Pat. Sub. Date(s): All strengths: Sep 30, 2024
Claim Types: Drug in a container; Method of use
Use Code: U-3995: To restore blood pressure in adult patients with acute hypotensive states
Mar 8, 2041New patent for this product

ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
203496  Prod. No.: 001 RX (EQ 0.125MG BASE); 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE); 005 RX (EQ 5MG BASE)
PatentsExpirationChange
Pat. No. 9604901 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Pat. Sub. Date(s): All strengths: Mar 28, 2017
Claim Types: Product-by-process
Dec 15, 2028New Delisting Request flag

ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA      NDA No.:
214621  Prod. No.: 001 RX (120MG)
PatentsExpirationChange
Pat. No. 12097198
Treatment of prostate cancer
Pat. Sub. Date(s): 001: Sep 25, 2024
Claim Types: Method of use; Dosaage regimen
Use Code: U-3020: Treatment of adult patients with advanced prostate cancer
Sep 29, 2037New patent for this product

ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE      NDA No.:
213388  Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
PatentsExpirationChange
Pat. No. 12083227 DP*
Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
Pat. Sub. Date(s): 001: Oct 8, 2024
Claim Types: Formulation; Method of use
Use Code: U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Aug 20, 2038New patent for this product

ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC      NDA No.:
206038  Prod. No.: 001 RX (125MG;200MG); 002 RX (125MG;100MG)
PatentsExpirationChange
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-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
Dec 4, 2028New patent for this product

ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC      NDA No.: 211358  Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET); 003 RX (94MG/PACKET;75MG/PACKET)
PatentsExpirationChange
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
Dec 4, 2028New patent for this product

PLENVU (FOR SOLUTION) (ORAL) ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
NDA Applicant: SALIX      NDA No.:
209381  Prod. No.: 001 RX (7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM)
PatentsExpirationChange
Pat. No. 12083179 DP*
Colon cleansing compositions and method of use
Pat. Sub. Date(s): 001: Sep 18, 2024
Claim Types: Formulation; Kit; Method of use
Use Code: U-2310: For cleansing of the colon in preparation for colonoscopy in adults
Sep 10, 2033New patent for this product

PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.:
209939  Prod. No.: 001 RX (240MG); 002 RX (480MG)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Aug 30, 2027New exclusivity for this product

PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209940  Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Aug 30, 2027New exclusivity for this product

PREVYMIS (PELLETS) (ORAL) LETERMOVIR
Drug Classes: CMV DNA terminase complex inhibitor
NDA Applicant: MSD      NDA No.: 219104  Prod. No.: 001 RX (20MG/PACKET); 002 RX (120MG/PACKET)
PatentsExpirationChange
Pat. No. RE46791 DS* DP*
Substituted dihydroquinazolines
Pat. Sub. Date(s): All strengths: Sep 25, 2024
Claim Types: Compound; Process; Composition; Method of use
Jan 18, 2029New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Aug 30, 2027New exclusivity for this product
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) Jun 5, 2030New exclusivity for this product
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 8, 2024New exclusivity for this product

PROTONIX IV (INJECTABLE) (INTRAVENOUS) PANTOPRAZOLE SODIUM [GENERIC AP]
Drug Classes: proton pump inhibitor
NDA Applicant: WYETH PHARMS      NDA No.:
020988  Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Aug 12, 2027New exclusivity for this product

PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS      NDA No.:
008975  Prod. No.: 002 RX (80 UNITS/ML) NDA No.: 008975  Prod. No.: 001 DISC (40 UNITS/ML)
PatentsExpirationChange
Pat. No. 12102662
Methods For Storing And Warming Purified Corticotropin Compositions
Pat. Sub. Date(s): All strengths: Oct 4, 2024
Claim Types: Process
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, 2043New patent for this product

REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
021272  Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML); 006 RX (0.1MG/ML); 007 RX (0.2MG/ML); 008 RX (0.4MG/ML)
PatentsExpirationChange
Pat. No. 9604901 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Pat. Sub. Date(s): 001: Mar 28, 2017; 002: Mar 28, 2017; 003: Mar 28, 2017; 004: Mar 28, 2017; 005: Aug 24, 2021; 006: Oct 20, 2023; 007: Oct 20, 2023; 008: Oct 20, 2023
Claim Types: Product-by-process
Dec 15, 2028New Delisting Request flag

REMODULIN (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 208276  Prod. No.: 001 DISC (20MG/20ML (1MG/ML)); 002 DISC (50MG/20ML (2.5MG/ML)); 003 DISC (100MG/20ML (5MG/ML)); 004 DISC (200MG/20ML (10MG/ML))
PatentsExpirationChange
Pat. No. 9604901 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018
Claim Types: Product-by-process
Dec 15, 2028New Delisting Request flag

REYVOW (TABLET) (ORAL) LASMIDITAN SUCCINATE
NDA Applicant: ELI LILLY AND CO      NDA No.:
211280  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
PatentsExpirationChange
Pat. No. 12071423 DP*
Processes and intermediate for the large-scale preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemisuccinate, and preparation of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide acetate
Pat. Sub. Date(s): All strengths: Sep 20, 2024
Claim Types: Formulation
Jul 6, 2040New patent for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)
PatentsExpirationChange
Pat. No. 12077545 DP*
Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Pat. Sub. Date(s): All strengths: Sep 27, 2024
Claim Types: Formulation
Oct 17, 2036New patent for this product

RYALTRIS (SPRAY, METERED) (NASAL) MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
Drug Classes: corticosteroid == H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: GLENMARK SPECLT      NDA No.:
211746  Prod. No.: 001 RX (0.025MG/SPRAY;0.665MG/SPRAY)
PatentsExpirationChange
Pat. No. 12064442
Treatment of allergic rhinitis using a combination of mometasone and olopatadine
Pat. Sub. Date(s): 001: Sep 12, 2024
Claim Types: Method of use
Use Code: U-3297: Treatment of seasonal allergic rhinitis by nasaly administering a combination of olopatadine hydrochloride and mometasone furoate
Sep 4, 2034New patent for this product

SLYND (TABLET) (ORAL) DROSPIRENONE [GENERIC AB]
Drug Classes: progestin
NDA Applicant: EXELTIS USA INC      NDA No.:
211367  Prod. No.: 001 RX (4MG)
PatentsExpirationChange
Pat. No. 12090231
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Oct 9, 2024
Claim Types: Dosaage regimen
Use Code: U-2553: Prevention of pregnancy in females of reproductive age
Jun 28, 2031New patent for this product

SOFDRA (GEL, METERED) (TOPICAL) SOFPIRONIUM BROMIDE
NDA Applicant: BOTANIX SB      NDA No.:
217347  Prod. No.: 001 RX (EQ 12.45% BASE (EQ 72MG BASE/ACTUATION))
PatentsExpirationChange
Pat. No. 8147809 DS* DP*
Soft anticholinergic esters
Pat. Sub. Date(s): 001: Sep 26, 2024
Claim Types: Compound; Composition
Mar 26, 2027New patent for this product
Pat. No. 11566000 DS* DP*
Crystalline form of sofpironium bromide and preparation method thereof
Pat. Sub. Date(s): 001: Sep 26, 2024
Claim Types: Formulation; Product-by-process
May 22, 2040New patent for this product
Pat. No. 11584715 DS* DP*
Crystalline form of sofpironium bromide and preparation method thereof
Pat. Sub. Date(s): 001: Sep 26, 2024
Claim Types: Formulation; New polymorph, salt or hydrate; Product-by-process
May 22, 2040New patent for this product

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.:
211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 12090126
Methods of administering solriamfetol to lactating women
Pat. Sub. Date(s): All strengths: Sep 27, 2024
Claim Types: Method of use
Use Code: U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol
Dec 30, 2042New patent for this product

TABRECTA (TABLET) (ORAL) CAPMATINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS PHARM      NDA No.:
213591  Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 12084449
Imidazotriazines and imidazopyrimidines as kinase inhibitors
Pat. Sub. Date(s): All strengths: Oct 2, 2024
Claim Types: Method of use
Use Code: U-2813: Use for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a mesenchymal-epithelial transition (MET) exon 14 skipping mutation
Nov 19, 2027New patent for this product

TAZAROTENE (CREAM) (TOPICAL) TAZAROTENE [GENERIC AB]
Drug Classes: retinoid
NDA Applicant: PADAGIS ISRAEL      NDA No.:
217075  Prod. No.: 001 RX (0.05%)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 8, 2025New exclusivity for this product

TEZRULY (SOLUTION) (ORAL) TERAZOSIN HYDROCHLORIDE
Drug Classes: alpha adrenergic blocker
NDA Applicant: NOVITIUM PHARMA      NDA No.:
218139  Prod. No.: 001 DISC (EQ 1MG BASE/ML)
PatentsExpirationChange
Pat. No. 11224572 DP*
Stable oral liquid composition of terazosin
Pat. Sub. Date(s): 001: Sep 24, 2024
Claim Types: Formulation; Method of use
Use Code: U-3990: Treatment of hypertension in patients who are in need of a liquid composition of terazosin
Use Code: U-3991: Treatment of symptomatic benign prostatic hyperplasia (BPH) in patients who are in need of a liquid composition of terazosin
Jan 18, 2042New patent for this product

THEOPHYLLINE (TABLET, EXTENDED RELEASE) (ORAL) THEOPHYLLINE [GENERIC AB]
Drug Classes: methylxanthine
NDA Applicant: STRIDES PHARMA      NDA No.:
215312  Prod. No.: 001 RX (300MG)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Mar 26, 2025New exclusivity for this product

TWYNEO (CREAM) (TOPICAL) BENZOYL PEROXIDE; TRETINOIN
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP      NDA No.:
214902  Prod. No.: 001 RX (3%;0.1%)
PatentsExpirationChange
Pat. No. 12070629 DP*
Core stabilized microcapsules, method of their preparation and uses thereof
Pat. Sub. Date(s): 001: Sep 18, 2024
Claim Types: Formulation; Method of use
Use Code: U-3987: Topical treatment of acne
Dec 30, 2030New patent for this product

TYVASO (SOLUTION) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
022387  Prod. No.: 001 RX (0.6MG/ML)
PatentsExpirationChange
Pat. No. 9604901 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Pat. Sub. Date(s): 001: Mar 28, 2017
Claim Types: Product-by-process
Dec 15, 2028New Delisting Request flag

TYVASO DPI (POWDER) (INHALATION) TREPROSTINIL
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.:
214324  Prod. No.: 001 RX (0.016MG/INH); 002 RX (0.032MG/INH); 003 RX (0.048MG/INH); 004 RX (0.064MG/INH)
PatentsExpirationChange
Pat. No. 9604901 DS* DLR*
Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Pat. Sub. Date(s): All strengths: Jun 17, 2022
Claim Types: Product-by-process
Dec 15, 2028New Delisting Request flag

UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE      NDA No.:
211765  Prod. No.: 002 RX (100MG)
PatentsExpirationChange
Pat. No. 12070450
Treatment of migraine
Pat. Sub. Date(s): 002: Sep 25, 2024
Claim Types: Method of use
Use Code: U-3992: Acute treatment of migraine with or without aura in a patient undergoing treatment with a weak or moderate CYP3A4 inducer
Dec 22, 2041New patent for this product

VEVYE (SOLUTION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: HARROW EYE      NDA No.:
217469  Prod. No.: 001 RX (0.1%)
PatentsExpirationChange
Pat. No. 12059449 DP*
Ophthalmic composition for treatment of dry eye disease
Pat. Sub. Date(s): 001: Sep 11, 2024
Claim Types: Method of use; Method of improving a treatment
Use Code: U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).
Apr 1, 2042New patent for this product

VOYDEYA (TABLET) (ORAL) DANICOPAN
NDA Applicant: ALEXION PHARMS INC      NDA No.:
218037  Prod. No.: 001 RX (50MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 12076319
Therapeutic regimens for treatment of paroxysmal nocturnal hemoglobinuria
Pat. Sub. Date(s): All strengths: Sep 24, 2024
Claim Types: Method of use
Use Code: U-3933: Treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab
Aug 2, 2038New patent for this product

VYNDAMAX (CAPSULE) (ORAL) TAFAMIDIS
NDA Applicant: FOLDRX PHARMS      NDA No.:
212161  Prod. No.: 001 RX (61MG)
PatentsExpirationChange
Pat. No. 7214695 DS* DP*
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Pat. Sub. Date(s): 001: May 30, 2019
Claim Types: Compound; Composition
Dec 19, 2025New expiration date. Was previously Dec 19, 2024
Pat. No. 7214696
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Pat. Sub. Date(s): 001: May 30, 2019
Claim Types: Method of use
Use Code: U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
Dec 19, 2025New expiration date. Was previously Dec 19, 2024

VYNDAQEL (CAPSULE) (ORAL) TAFAMIDIS MEGLUMINE
NDA Applicant: FOLDRX PHARMS      NDA No.:
211996  Prod. No.: 001 RX (20MG)
PatentsExpirationChange
Pat. No. 7214695 DS* DP*
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Pat. Sub. Date(s): 001: May 30, 2019
Claim Types: Compound; Composition
Dec 19, 2025New expiration date. Was previously Dec 19, 2024
Pat. No. 7214696
Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Pat. Sub. Date(s): 001: May 30, 2019
Claim Types: Method of use
Use Code: U-2524: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM)
Dec 19, 2025New expiration date. Was previously Dec 19, 2024

XHANCE (SPRAY, METERED) (NASAL) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: OPTINOSE US INC      NDA No.:
209022  Prod. No.: 001 RX (0.093MG)
PatentsExpirationChange
Pat. No. 12083270
Delivery device and method
Pat. Sub. Date(s): 001: Oct 2, 2024
Claim Types: Method of administration
Use Code: U-2133: Method of delivering fluticasone propionate to a nasal airway
Apr 4, 2031New patent for this product

XOFLUZA (TABLET) (ORAL) BALOXAVIR MARBOXIL
Drug Classes: polymerase acidic (PA) endonuclease inhibitor
NDA Applicant: GENENTECH INC      NDA No.:
210854  Prod. No.: 002 RX (40MG); 003 RX (80MG) NDA No.: 210854  Prod. No.: 001 DISC (20MG**)
PatentsExpirationChange
Pat. No. 12064438 DP*
Pharmaceutical preparation excellent in light stability and dissolution property
Pat. Sub. Date(s): All strengths: Sep 16, 2024
Claim Types: Formulation
Oct 9, 2039New patent for this product

YORVIPATH (SOLUTION) (SUBCUTANEOUS) PALOPEGTERIPARATIDE
NDA Applicant: ASCENDIS PHARMA BONE      NDA No.:
216490  Prod. No.: 001 RX (EQ 0.168MG TERIPARATIDE/0.56ML (EQ 0.168MG TERIPARATIDE/0.56ML)); 002 RX (EQ 0.294MG TERIPARATIDE/0.98ML (EQ 0.294MG TERIPARATIDE/0.98ML)); 003 RX (EQ 0.42MG TERIPARATIDE/1.4ML (EQ 0.3MG TERIPARATIDE/ML))
PatentsExpirationChange
Pat. No. 8906847 DS* DP*
Prodrug comprising a drug linker conjugate
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Prodrug
Use Code: U-3982: Treatment of hypoparathyroidism in adults
Apr 30, 2031New patent for this product
Pat. No. 11590207
Dosage regimen for a controlled-release PTH compound
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Method of use; Method of administration
Use Code: U-3982: Treatment of hypoparathyroidism in adults
Sep 28, 2037New patent for this product
Pat. No. 11759504 DP*
PTH compounds with low peak-to-trough ratios
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Formulation
Sep 28, 2037New patent for this product
Pat. No. 11857603
PTH compounds with low peak-to-trough ratios
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Method of use
Use Code: U-3982: Treatment of hypoparathyroidism in adults
Sep 28, 2037New patent for this product
Pat. No. 11890326 DS* DP*
Controlled-release PTH compound
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Compound
Sep 28, 2037New patent for this product
Pat. No. 11918628 DS* DP*
Controlled-release PTH compound
Pat. Sub. Date(s): All strengths: Sep 5, 2024
Claim Types: Compound; Formulation
Sep 28, 2037New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Aug 9, 2027New exclusivity for this product

ZOKINVY (CAPSULE) (ORAL) LONAFARNIB
Drug Classes: farnesyltransferase inhibitor
NDA Applicant: SENTYNL THERAPS INC      NDA No.:
213969  Prod. No.: 001 RX (50MG); 002 RX (75MG)
PatentsExpirationChange
Pat. No. 7838531
Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Pat. Sub. Date(s): All strengths: Feb 24, 2021
Claim Types: Method of use
Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)
Jul 26, 2025New expiration date. Was previously Jul 26, 2024
Pat. No. 8828356
Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis
Pat. Sub. Date(s): All strengths: Feb 24, 2021
Claim Types: Method of use
Use Code: U-3070: Reducing the risk of mortality in Hutchinson-Gilford progeria syndrome (HGPS)
Oct 17, 2025New expiration date. Was previously Oct 17, 2024

ZURNAI (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALMEFENE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: PURDUE PHARMA LP      NDA No.:
218590  Prod. No.: 001 RX (EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML))
ExclusivityExpirationChange
Exclusivity Code: NP - New product Aug 7, 2027New exclusivity for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 14 October 2024
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