Orange Book Companion (R)
What's New for Vol. 42, Supp. 08
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.


ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: OTSUKA PHARM CO LTD      NDA No.:
202971  Prod. No.: 001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX (300MG); 004 RX (400MG)
PatentsExpirationChange
Pat. No. 11344547
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Pat. Sub. Date(s): All strengths: Jun 24, 2022
Claim Types: Method of use
Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
Use Code: U-3245: Maintenance monotherapy treatment of bipolar I disorder
Use Code: U-814: Treatment of schizophrenia
Sep 24, 2033New Use Code
Pat. No. 11400087
Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Pat. Sub. Date(s): All strengths: Aug 29, 2022
Claim Types: Method of use
Use Code: U-1632: Treatment of schizophrenia, with efficacy in treating acute episodes of schizophrenia
Use Code: U-3245: Maintenance monotherapy treatment of bipolar I disorder
Use Code: U-814: Treatment of schizophrenia
Sep 24, 2033New patent for this product

AMVUTTRA (SOLUTION) (SUBCUTANEOUS) VUTRISIRAN
NDA Applicant: ALNYLAM PHARMS INC      NDA No.:
215515  Prod. No.: 001 RX (25MG/0.5ML (25MG/0.5ML))
PatentsExpirationChange
Pat. No. 11401517 DS* DP*
Modified double-stranded RNA agents
Pat. Sub. Date(s): 001: Aug 31, 2022
Claim Types: Compound; Composition; Method of use; Method of administration
Use Code: U-3396: AMVUTTRA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
Aug 14, 2035New patent for this product

ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: ALKERMES INC      NDA No.:
207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
PatentsExpirationChange
Pat. No. 11406632
Aripiprazole formulations having increased injection speeds
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Claim Types: Method of use; Kit
Use Code: U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Mar 19, 2035New patent for this product

BELRAPZO (SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: EAGLE PHARMS      NDA No.:
205580  Prod. No.: 001 RX (100MG/4ML (25MG/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) Dec 7, 2022New exclusivity for this product

BLUDIGO (SOLUTION) (INTRAVENOUS) INDIGOTINDISULFONATE SODIUM
NDA Applicant: PROVEPHARM SAS      NDA No.:
216264  Prod. No.: 001 RX (40MG/5ML (8MG/ML))
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Jul 8, 2027New exclusivity for this product

CABENUVA KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR; RILPIVIRINE
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) == Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI)
NDA Applicant: VIIV HLTHCARE      NDA No.:
212888  Prod. No.: 001 RX (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)); 002 RX (600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))
PatentsExpirationChange
Pat. No. 11389447
Aqueous suspensions of TMC278
Pat. Sub. Date(s): All strengths: Aug 17, 2022
Claim Types: Method of use
Use Code: U-3405: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg by monthly administration of rilpivirine suspension as part of combination therapy
Jun 30, 2027New patent for this product

CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
216387  Prod. No.: 001 RX (EQ 100MG BASE)
PatentsExpirationChange
Pat. No. 7459554 DS*
Imidazopyrazine tyrosine kinase inhibitors
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Compound
Nov 24, 2026New product in Orange Book
Pat. No. 9290504 DS* DP*
4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Compound; Composition
Jul 11, 2032New product in Orange Book
Pat. No. 9758524
4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Method of use
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Jul 11, 2032New product in Orange Book
Pat. No. 10239883
4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Method of use
Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia
Use Code: U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Jul 11, 2032New product in Orange Book
Pat. No. 10272083
Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Method of use
Use Code: U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily
Use Code: U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
Use Code: U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily
Use Code: U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
Use Code: U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab
Use Code: U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily
Use Code: U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily
Jan 21, 2035New product in Orange Book
Pat. No. 11059829 DS* DP*
Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia
Use Code: U-2667: Treatment of adult patients with small lymphocytic leukemia
Use Code: U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab
Use Code: U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab
Use Code: U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia
Use Code: U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab
Jul 1, 2036New product in Orange Book

CLINDAMYCIN PHOSPHATE (GEL) (TOPICAL) CLINDAMYCIN PHOSPHATE [GENERIC AB2]
Drug Classes: Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives == lincosamide antibacterial
NDA Applicant: AMNEAL      NDA No.:
214668  Prod. No.: 001 RX (EQ 1% BASE)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Feb 1, 2023New exclusivity for this product

DEFINITY RT (INJECTABLE) (INTRAVENOUS) PERFLUTREN
NDA Applicant: LANTHEUS MEDCL      NDA No.:
021064  Prod. No.: 002 RX (6.52MG/ML)
PatentsExpirationChange
Pat. No. 11395856 DS* DP*
Lipid-encapsulated gas microsphere compositions and related methods
Pat. Sub. Date(s): 002: Aug 18, 2022
Claim Types: Formulation; Process; Method of administration
Use Code: U-665: Method of using the drug substance/drug product for ultrasound imaging
Dec 28, 2035New patent for this product

DROSPIRENONE (TABLET, CHEWABLE) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.:
216285  Prod. No.: 001 RX (3.5MG)
PatentsExpirationChange
Pat. No. 11413249
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Aug 22, 2022
Claim Types: Method of use
Use Code: U-2553: Prevention of pregnancy in females of reproductive age
Jun 28, 2031New patent for this product

ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Immunological Agents:Immunosuppressants == 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. 11419823 DP*
Stabilized tacrolimus composition
Pat. Sub. Date(s): All strengths: Aug 24, 2022
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
May 30, 2028New patent for this product

EPCLUSA (TABLET) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
208341  Prod. No.: 001 RX (400MG;100MG); 002 RX (200MG;50MG)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-277: Updates the US prescribing information with clinical data regarding the use of sofosbuvir and velpatasvir for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in people who inject drugs (PWID), including those on medication-assisted treatment (MAT) for opioid use disorderApr 27, 2025New exclusivity for this product

EPCLUSA (PELLETS) (ORAL) SOFOSBUVIR; VELPATASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 214187  Prod. No.: 001 RX (150MG;37.5MG/PACKET); 002 RX (200MG;50MG/PACKET)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-277: Updates the US prescribing information with clinical data regarding the use of sofosbuvir and velpatasvir for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in people who inject drugs (PWID), including those on medication-assisted treatment (MAT) for opioid use disorderApr 27, 2025New exclusivity for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: GW RES LTD      NDA No.:
210365  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationChange
Pat. No. 11400055
Use of cannabidiol in the treatment of epilepsy
Pat. Sub. Date(s): 001: Aug 31, 2022
Claim Types: Method of use
Use Code: U-3071: Use for the treatment of seizures in patients with tuberous sclerosis complex
Oct 13, 2035New patent for this product
Pat. No. 11406623
Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
Pat. Sub. Date(s): 001: Aug 31, 2022
Claim Types: Method of improving a treatment
Use Code: U-3233: Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus
Mar 1, 2041New patent for this product

EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: PACIRA PHARMS INC      NDA No.:
022496  Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
PatentsExpirationChange
Pat. No. 11426348 DP*
Compositions of bupivacaine multivesicular liposomes
Pat. Sub. Date(s): All strengths: Sep 2, 2022
Claim Types: Formulation claimed by its inherent performace characteristics; Method of use
Use Code: U-3380: Method of treating pain, for example, via infiltration for local analgesia or via interscalene brachial plexus nerve block for regional analgesia
Jan 22, 2041New patent for this product

FENOPROFEN CALCIUM (CAPSULE) (ORAL) FENOPROFEN CALCIUM [GENERIC AB]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: RISING      NDA No.:
214475  Prod. No.: 001 RX (EQ 400MG BASE)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Feb 11, 2023New exclusivity for this product

FINTEPLA (SOLUTION) (ORAL) FENFLURAMINE HYDROCHLORIDE
Drug Classes: Anticonvulsants:Anticonvulsants, Other
NDA Applicant: ZOGENIX INC      NDA No.:
212102  Prod. No.: 001 RX (EQ 2.2MG BASE/ML)
PatentsExpirationChange
Pat. No. 11406606
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Method of use
Use Code: U-3406: Use of fenfluramine at reduced amounts with stiripentol for the treatment of seizures associated with Dravet syndrome
Use Code: U-3407: Use of fenfluramine at reduced amounts with stiripentol for the treatment of seizures associated with Lennox Gastaut syndrome
Feb 2, 2038 *PEDNew patent for this product

FIRDAPSE (TABLET) (ORAL) AMIFAMPRIDINE PHOSPHATE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other == potassium channel blocker
NDA Applicant: CATALYST PHARMS      NDA No.:
208078  Prod. No.: 001 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 10626088 DP*
Determining degradation of 3,4-diaminopyridine
Pat. Sub. Date(s): 001: Aug 9, 2022
Claim Types: Compound; New polymorph, salt or hydrate
Feb 25, 2037New patent for this product

GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: AMICUS THERAP US      NDA No.:
208623  Prod. No.: 001 RX (EQ 123MG BASE)
PatentsExpirationChange
Pat. No. 8592362 DLR*
Method to predict response to pharmacological chaperone treatment of diseases
Pat. Sub. Date(s): 001: Sep 5, 2018
Claim Types: Method of use
Use Code: U-2371: The treatment of Fabry patients
Feb 12, 2029New Delisting Request flag
Pat. No. 11426396 DS*
Methods of treating Fabry patients having renal impairment
Pat. Sub. Date(s): 001: Sep 2, 2022
Claim Types: Formulation
May 30, 2038New patent for this product

GENOSYL (GAS) (INHALATION) NITRIC OXIDE [Has competitive generic]
NDA Applicant: VERO BIOTECH      NDA No.:
202860  Prod. No.: 001 RX (800PPM)
PatentsExpirationChange
Pat. No. 11383059
Conversion of nitrogen dioxide (NO.sub.2) to nitric oxide (NO)
Pat. Sub. Date(s): 001: Aug 11, 2022
Claim Types: Process; Method of administration
Use Code: U-3037: A method of delivering nitric oxide to a patient
Aug 18, 2025New patent for this product

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.:
201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
PatentsExpirationChange
Pat. No. RE46965 DP*
Intermediates for the preparation of analogs of Halichondrin B
Pat. Sub. Date(s): 001: Aug 7, 2018
Claim Types: Compound; Composition
Jul 8, 2027 *PEDNew expiration date. Was previously Jan 8, 2027
Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)]
Macrocyclic analogs and methods of their use and preparation
Pat. Sub. Date(s): 001: Nov 30, 2010
Claim Types: Compound; Process
Jan 20, 2024 *PEDNew expiration date. Was previously Jul 20, 2023

ICLUSIG (TABLET) (ORAL) PONATINIB HYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.:
203469  Prod. No.: 001 RX (EQ 15MG BASE); 002 RX (EQ 45MG BASE); 003 RX (EQ 30MG BASE); 004 RX (EQ 10MG BASE)
PatentsExpirationChange
Pat. No. 11384086 DS* DP*
Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1- yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt
Pat. Sub. Date(s): All strengths: Aug 3, 2022
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia
Use Code: U-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domain
Use Code: U-1948: A method for treating chronic myeloid leukemia
Dec 12, 2033New patent for this product

IMBRUVICA (CAPSULE) (ORAL) IBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PHARMACYCLICS INC      NDA No.:
205552  Prod. No.: 001 RX (140MG)
PatentsExpirationChange
Pat. No. 7514444 DS* DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Dec 12, 2013
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8008309 DS* DP* [Extended 320 days (0.9 years)]
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Dec 12, 2013
Claim Types: Compound; Composition
May 13, 2028 *PEDNew expiration date. Was previously Nov 13, 2027
Pat. No. 8476284
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Dec 12, 2013
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8497277
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Dec 12, 2013
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8563563
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2219: Treatment of chronic small lymphocytic leukemia
Oct 26, 2027 *PEDNew expiration date. Was previously Apr 26, 2027; New Use Code
Pat. No. 8697711 DS* DP*
Inhibitors of Bruton'S tyrosine kinase
Pat. Sub. Date(s): 001: May 13, 2014
Claim Types: Compound; Composition; Process
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8703780
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: May 13, 2014
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8735403 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Jun 18, 2014
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8754090
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Jun 26, 2014
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 8754091 DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Jul 1, 2014
Claim Types: Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8952015
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Sep 1, 2017
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8957079 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 16, 2015
Claim Types: Compound; Composition; Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8999999
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Apr 28, 2015
Claim Types: Method of use
Use Code: U-1683: Treatment for chronic lymphocytic leukemia with 17p deletion
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9125889
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Sep 25, 2015
Claim Types: Method of use
Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9181257 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Dec 8, 2015
Claim Types: Composition
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 9296753 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Apr 18, 2016
Claim Types: New polymorph, salt or hydrate; Formulation
Apr 30, 2034 *PEDNew expiration date. Was previously Oct 30, 2033
Pat. No. 9540382
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Jan 30, 2017
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Feb 18, 2034 *PEDNew expiration date. Was previously Aug 18, 2033; New Use Code
Pat. No. 9713617 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Aug 28, 2017
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9725455 DS*
Crystalline forms of a bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Aug 28, 2017
Claim Types: New polymorph, salt or hydrate
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9795604
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Oct 27, 2017
Claim Types: Method of use
Use Code: U-2150: Treatment of chronic graft-versus-host disease
Use Code: U-2969: Treatment of adult patients with cyclosporin-resistant, steroid-dependent/refractory, or steroid resistant chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034; New Use Code
Pat. No. 9801881
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Nov 6, 2017
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9801883
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Nov 6, 2017
Claim Types: Method of use
Use Code: U-2159: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9814721
Use of inhibitors of Bruton'S tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Nov 29, 2017
Claim Types: Method of use
Use Code: U-1947: Treatment of marginal zone lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10004746
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Jul 16, 2018
Claim Types: Method of use
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10016435
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Aug 3, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10106548 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Oct 26, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10125140 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Nov 16, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10294231 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: May 23, 2019
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10294232 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: May 23, 2019
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10463668
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Nov 20, 2019
Claim Types: Method of use
Use Code: U-2654: Treatment of refractory chronic graft-versus-host disease
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10478439
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Dec 10, 2019
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Use Code: U-2665: Treatment of chronic graft versus host disease after failure of one or more lines of systemic therapy
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10653696
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Jun 12, 2020
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10695350
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Jul 14, 2020
Claim Types: Method of use
Use Code: U-2846: Treatment of chronic graft versus host disease refractory to systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10751342
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Sep 10, 2020
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2943: Treatment of relapsed or refractory chronic lymphocytic leukemia
Use Code: U-2944: Treatment of relapsed or refractory small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10752634 DP*
Crystalline forms of a brutons tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Sep 10, 2020
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10961251 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Apr 16, 2021
Claim Types: Compositon of a new polymorph, salt or hydrate as a product-by-process
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033

IMBRUVICA (CAPSULE) (ORAL) IBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PHARMACYCLICS INC      NDA No.: 205552  Prod. No.: 002 RX (70MG)
PatentsExpirationChange
Pat. No. 7514444 DS* DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8008309 DS* DP* [Extended 320 days (0.9 years)]
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Compound; Composition
May 13, 2028 *PEDNew expiration date. Was previously Nov 13, 2027
Pat. No. 8476284
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8497277
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8563563
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2219: Treatment of chronic small lymphocytic leukemia
Oct 26, 2027 *PEDNew expiration date. Was previously Apr 26, 2027; New Use Code
Pat. No. 8697711 DS* DP*
Inhibitors of Bruton'S tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Compound; Composition; Process
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8703780
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8735403 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8754090
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 8754091 DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8952015
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8957079 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Compound; Composition; Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8999999
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2228: Treatment of small lymphocytic leukemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 9125889
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9181257 DS*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Composition
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 9296753 DS*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: New polymorph, salt or hydrate; Formulation
Apr 30, 2034 *PEDNew expiration date. Was previously Oct 30, 2033
Pat. No. 9540382
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Feb 18, 2034 *PEDNew expiration date. Was previously Aug 18, 2033; New Use Code
Pat. No. 9713617 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9725455 DS*
Crystalline forms of a bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: New polymorph, salt or hydrate
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9795604
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-2969: Treatment of adult patients with cyclosporin-resistant, steroid-dependent/refractory, or steroid resistant chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 9801881
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9801883
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-2159: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9814721
Use of inhibitors of Bruton'S tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Jan 19, 2018
Claim Types: Method of use
Use Code: U-1947: Treatment of marginal zone lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10004746
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Jul 16, 2018
Claim Types: Method of use
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10016435
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Aug 3, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10106548 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Oct 26, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10125140 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Nov 16, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10294231 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: May 23, 2019
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10294232 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: May 23, 2019
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10463668
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 002: Nov 20, 2019
Claim Types: Method of use
Use Code: U-2654: Treatment of refractory chronic graft-versus-host disease
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10478439
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 002: Dec 10, 2019
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Use Code: U-2665: Treatment of chronic graft versus host disease after failure of one or more lines of systemic therapy
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10653696
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 002: Jun 12, 2020
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10695350
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 002: Jul 14, 2020
Claim Types: Method of use
Use Code: U-2846: Treatment of chronic graft versus host disease refractory to systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10751342
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 002: Sep 10, 2020
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2943: Treatment of relapsed or refractory chronic lymphocytic leukemia
Use Code: U-2944: Treatment of relapsed or refractory small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10961251 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 002: Apr 16, 2021
Claim Types: Compositon of a new polymorph, salt or hydrate as a product-by-process
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033

IMBRUVICA (TABLET) (ORAL) IBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PHARMACYCLICS INC      NDA No.: 210563  Prod. No.: 001 RX (140MG)
PatentsExpirationChange
Pat. No. 7514444 DS* DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8008309 DS* DP* [Extended 320 days (0.9 years)]
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Compound; Composition
May 13, 2028 *PEDNew expiration date. Was previously Nov 13, 2027
Pat. No. 8476284
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8497277
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8563563
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Oct 26, 2027 *PEDNew expiration date. Was previously Apr 26, 2027; New Use Code
Pat. No. 8697711 DS* DP*
Inhibitors of Bruton'S tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Compound; Composition; Process
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8703780
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8735403 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8754090
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 8754091 DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8952015
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8957079 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Compound; Composition; Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8999999
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 9125889
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9181257 DS*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Composition
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 9296753 DS*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: New polymorph, salt or hydrate; Formulation
Apr 30, 2034 *PEDNew expiration date. Was previously Oct 30, 2033
Pat. No. 9655857 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 9725455 DS*
Crystalline forms of a bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: New polymorph, salt or hydrate
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9795604
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-2969: Treatment of adult patients with cyclosporin-resistant, steroid-dependent/refractory, or steroid resistant chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 9801881
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 9801883
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-2159: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Use Code: U-2243: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9814721
Use of inhibitors of Bruton'S tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1947: Treatment of marginal zone lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10004746
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Jul 17, 2018
Claim Types: Method of use
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10010507 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Jul 17, 2018
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10016435
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Aug 2, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10106548 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Oct 26, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10125140 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Nov 16, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10213386 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Mar 8, 2019
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10463668
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Nov 15, 2019
Claim Types: Method of use
Use Code: U-2654: Treatment of refractory chronic graft-versus-host disease
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10478439
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Dec 10, 2019
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Use Code: U-2665: Treatment of chronic graft versus host disease after failure of one or more lines of systemic therapy
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10653696
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): 001: Jun 12, 2020
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10695350
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): 001: Jul 13, 2020
Claim Types: Method of use
Use Code: U-2846: Treatment of chronic graft versus host disease refractory to systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10751342
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): 001: Sep 10, 2020
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2943: Treatment of relapsed or refractory chronic lymphocytic leukemia
Use Code: U-2944: Treatment of relapsed or refractory small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10752634 DP*
Crystalline forms of a brutons tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Sep 10, 2020
Claim Types: Formulation
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10828259 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Nov 18, 2020
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10961251 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): 001: Apr 16, 2021
Claim Types: Compositon of a new polymorph, salt or hydrate as a product-by-process
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033

IMBRUVICA (TABLET) (ORAL) IBRUTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PHARMACYCLICS INC      NDA No.: 210563  Prod. No.: 002 RX (280MG); 003 RX (420MG); 004 RX (560MG)
PatentsExpirationChange
Pat. No. 7514444 DS* DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8008309 DS* DP* [Extended 320 days (0.9 years)]
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Compound; Composition
May 13, 2028 *PEDNew expiration date. Was previously Nov 13, 2027
Pat. No. 8476284
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8497277
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8563563
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Oct 26, 2027 *PEDNew expiration date. Was previously Apr 26, 2027; New Use Code
Pat. No. 8697711 DS* DP*
Inhibitors of Bruton'S tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Compound; Composition; Process
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8703780
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8735403 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Compound
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8754090
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 8754091 DP*
Inhibitors of bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8952015
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026; New Use Code
Pat. No. 8957079 DS* DP*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Compound; Composition; Formulation
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 8999999
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 9125889
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9181257 DS*
Inhibitors of Bruton's tyrosine kinase
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Composition
Jun 28, 2027 *PEDNew expiration date. Was previously Dec 28, 2026
Pat. No. 9296753 DS*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: New polymorph, salt or hydrate; Formulation
Apr 30, 2034 *PEDNew expiration date. Was previously Oct 30, 2033
Pat. No. 9655857 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 9725455 DS*
Crystalline forms of a bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: New polymorph, salt or hydrate
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 9795604
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-2969: Treatment of adult patients with cyclosporin-resistant, steroid-dependent/refractory, or steroid resistant chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Use Code: U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 9801881
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9801883
Use of inhibitors of bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-2159: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma
Use Code: U-2243: Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 9814721
Use of inhibitors of Bruton'S tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Mar 6, 2018
Claim Types: Method of use
Use Code: U-1947: Treatment of marginal zone lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10004746
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Jul 17, 2018
Claim Types: Method of use
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10010507 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Jul 17, 2018
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10016435
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Aug 2, 2018
Claim Types: Method of use
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10106548 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Oct 26, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10125140 DS* DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Nov 16, 2018
Claim Types: New polymorph, salt or hydrate; Composition
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033
Pat. No. 10213386 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Mar 8, 2019
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10463668
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): All strengths: Nov 15, 2019
Claim Types: Method of use
Use Code: U-2654: Treatment of refractory chronic graft-versus-host disease
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10478439
Use of inhibitors of bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): All strengths: Dec 10, 2019
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Use Code: U-1650: Treatment of Waldenstrom's macroglobulinemia
Use Code: U-1684: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-1947: Treatment of marginal zone lymphoma
Use Code: U-2241: Treatment of small lymphocytic lymphoma with 17p deletion
Use Code: U-2242: Treatment of chronic lymphocytic leukemia with 17p deletion
Use Code: U-2665: Treatment of chronic graft versus host disease after failure of one or more lines of systemic therapy
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10653696
Use of inhibitors of Bruton's tyrosine kinase (BTK)
Pat. Sub. Date(s): All strengths: Jun 12, 2020
Claim Types: Method of use
Use Code: U-1456: Treatment of mantle cell lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031
Pat. No. 10695350
Methods of treating and preventing graft versus host disease
Pat. Sub. Date(s): All strengths: Jul 13, 2020
Claim Types: Method of use
Use Code: U-2846: Treatment of chronic graft versus host disease refractory to systemic therapy
Apr 24, 2035 *PEDNew expiration date. Was previously Oct 24, 2034
Pat. No. 10751342
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Pat. Sub. Date(s): All strengths: Sep 10, 2020
Claim Types: Method of use
Use Code: U-1491: Treatment of chronic lymphocytic leukemia
Use Code: U-1946: Treatment of small lymphocytic lymphoma
Use Code: U-2943: Treatment of relapsed or refractory chronic lymphocytic leukemia
Use Code: U-2944: Treatment of relapsed or refractory small lymphocytic lymphoma
Dec 3, 2031 *PEDNew expiration date. Was previously Jun 3, 2031; New Use Code
Pat. No. 10828259 DP*
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Nov 18, 2020
Claim Types: Formulation
Sep 3, 2036 *PEDNew expiration date. Was previously Mar 3, 2036
Pat. No. 10961251 DP*
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Pat. Sub. Date(s): All strengths: Apr 16, 2021
Claim Types: Compositon of a new polymorph, salt or hydrate as a product-by-process
Dec 3, 2033 *PEDNew expiration date. Was previously Jun 3, 2033

INREBIC (CAPSULE) (ORAL) FEDRATINIB HYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: IMPACT      NDA No.:
212327  Prod. No.: 001 RX (EQ 100MG BASE)
PatentsExpirationChange
Pat. No. 11400092
Methods of treating myeloproliferative disorders
Pat. Sub. Date(s): 001: Aug 30, 2022
Claim Types: Method of use
Use Code: U-3409: Treating adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis, monitoring thiamine levels and administering thiamine or a thiamine equivalent
Sep 24, 2039New patent for this product

KYNMOBI (FILM) (SUBLINGUAL) APOMORPHINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant: SUNOVION PHARMS INC      NDA No.:
210875  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (25MG); 005 RX (30MG)
PatentsExpirationChange
Pat. No. 11419769 DP*
Sublingual films
Pat. Sub. Date(s): All strengths: Sep 6, 2022
Claim Types: Formulation; Method of use
Use Code: U-2825: Treatment of 'off' episodes in patients with Parkinson's disease
Dec 16, 2031New patent for this product

KYZATREX (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: MARIUS PHARMS LLC      NDA No.:
213953  Prod. No.: 001 RX (100MG); 002 RX (150MG); 003 RX (200MG)
PatentsExpirationChange
Pat. No. 10576089 DP*
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Pat. Sub. Date(s): All strengths: Aug 26, 2022
Claim Types: Method of use
Use Code: U-2506: Method of treating testosterone deficiency
Dec 31, 2030New patent for this product
Pat. No. 10576090 DP*
Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols
Pat. Sub. Date(s): All strengths: Aug 26, 2022
Claim Types: Formulation
Dec 31, 2030New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Jul 27, 2025New exclusivity for this product

LOKELMA (FOR SUSPENSION) (ORAL) SODIUM ZIRCONIUM CYCLOSILICATE
NDA Applicant: ASTRAZENECA      NDA No.:
207078  Prod. No.: 001 RX (5GM/PACKET); 002 RX (10GM/PACKET)
PatentsExpirationChange
Pat. No. 11406662 DS*
Microporous zirconium silicate for the treatment of hyperkalemia
Pat. Sub. Date(s): All strengths: Sep 7, 2022
Claim Types: New polymorph, salt or hydrate
Feb 10, 2032New patent for this product

MEKINIST (TABLET) (ORAL) TRAMETINIB DIMETHYL SULFOXIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
204114  Prod. No.: 001 RX (EQ 0.5MG); 003 RX (EQ 2MG) NDA No.: 204114  Prod. No.: 002 DISC (EQ 1MG)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-895: Trametinib is indicated in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment optionsJun 22, 2025New exclusivity for this product

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.:
214846  Prod. No.: 001 RX (1MG;0.5MG;40MG)
PatentsExpirationChange
Pat. No. 8058280 DS*
Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Pat. Sub. Date(s): 001: Jun 21, 2021
Claim Types: Compound; Composition; Process
Jan 28, 2024

NYMALIZE (SOLUTION) (ORAL) NIMODIPINE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine calcium channel blocker
NDA Applicant: AZURITY      NDA No.:
203340  Prod. No.: 002 RX (6MG/ML)
PatentsExpirationChange
Pat. No. 11413277 DP*
Non-aqueous liquid nimodipine compositions
Pat. Sub. Date(s): 002: Aug 25, 2022
Claim Types: Formulation claimed by its inherent performace characteristics; Method of improving a treatment
Use Code: U-2804: A method for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms
Apr 16, 2038New patent for this product

OPZELURA (CREAM) (TOPICAL) RUXOLITINIB PHOSPHATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == Janus kinase (JAK) inhibitor == kinase inhibitor
NDA Applicant: INCYTE CORP      NDA No.:
215309  Prod. No.: 001 RX (EQ 1.5% BASE)
PatentsExpirationChange
Pat. No. 8822481
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Jun 12, 2028New Use Code
Pat. No. 9079912
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Dec 12, 2026New Use Code
Pat. No. 9974790
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Dec 12, 2026New Use Code
Pat. No. 10610530
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
Jun 12, 2028New Use Code
Pat. No. 10869870
Topical formulation for a JAK inhibitor
Pat. Sub. Date(s): 001: Oct 20, 2021
Claim Types: Method of use
Use Code: U-3229: For topical short-term, non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
Use Code: U-3404: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older
May 20, 2031New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-896: Indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and olderJul 18, 2025New exclusivity for this product

PHEXXI (GEL) (VAGINAL) CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Electrolyte/Mineral Replacement == Contraceptives:Contraceptives, Other
NDA Applicant: EVOFEM INC      NDA No.:
208352  Prod. No.: 001 RX (1%;1.8%;0.4%)
PatentsExpirationChange
Pat. No. 11337989
Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
Pat. Sub. Date(s): 001: Sep 6, 2022
Claim Types: Method of use
Use Code: U-1: Prevention of pregnancy
Mar 15, 2033New patent for this product

POSIMIR (SOLUTION, EXTENDED RELEASE) (INFILTRATION) BUPIVACAINE
Drug Classes: Anesthetics:Local Anesthetics == amide local anesthetic
NDA Applicant: INNOCOLL      NDA No.:
204803  Prod. No.: 001 RX (660MG/5ML (132MG/ML))
PatentsExpirationChange
Pat. No. 11400019 DP*
Sustained release drug delivery systems with reduced impurities and related methods
Pat. Sub. Date(s): 001: Sep 1, 2022
Claim Types: Formulation; Drug in a container
Jan 12, 2041New patent for this product

PROAIR HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [GENERIC AB2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationChange
Pat. No. 11395889 DP*
Dose counter for inhaler having an anti-reverse rotation actuator
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Part of a dosage form
May 18, 2031New patent for this product

QINLOCK (TABLET) (ORAL) RIPRETINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: DECIPHERA PHARMS      NDA No.:
213973  Prod. No.: 001 RX (50MG)
PatentsExpirationChange
Pat. No. 11395818 DP*
Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-- 3-yl)-2-fluorophenyl)-3-phenylurea
Pat. Sub. Date(s): 001: Aug 11, 2022
Claim Types: Formulation
Dec 30, 2040New patent for this product

QVAR 80; QVAR 40 (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant: TEVA BRANDED PHARM      NDA No.:
020911  Prod. No.: 001 DISC (0.08MG/INH**); 002 DISC (0.04MG/INH**)
PatentsExpirationChange
Pat. No. 11395889 DP*
Dose counter for inhaler having an anti-reverse rotation actuator
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Claim Types: Part of a dosage form
May 18, 2031New patent for this product

QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant: NORTON WATERFORD      NDA No.:
207921  Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)
PatentsExpirationChange
Pat. No. 11395888 DP*
Inhalers and related methods
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Claim Types: Device; Method of use
Jan 26, 2038New patent for this product
Pat. No. 11395889 DP*
Dose counter for inhaler having an anti-reverse rotation actuator
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Claim Types: Part of a dosage form
May 18, 2031New patent for this product

RYALTRIS (SPRAY, METERED) (NASAL) MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations == Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines == H1 receptor antagonist == histamine-1 (H1) inhibitor == mast cell stabilizer
NDA Applicant: GLENMARK SPECIALTY      NDA No.:
211746  Prod. No.: 001 RX (0.025MG/SPRAY;0.665MG/SPRAY)
PatentsExpirationChange
Pat. No. 11400101
Treatment of allergic rhinitis using a combination of mometasone and olopatadine
Pat. Sub. Date(s): 001: Aug 25, 2022
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

RYANODEX (FOR SUSPENSION) (INTRAVENOUS) DANTROLENE SODIUM
Drug Classes: Antispasticity Agents == skeletal muscle relaxant
NDA Applicant: EAGLE PHARMS      NDA No.:
205579  Prod. No.: 001 RX (250MG/VIAL)
PatentsExpirationChange
Pat. No. 7758890 DP*
Treatment using dantrolene
Pat. Sub. Date(s): 001: Jul 28, 2014
Claim Types: Formulation
Jun 30, 2025New expiration date. Was previously Jul 1, 2025
Pat. No. 8604072 DP*
Treatment using dantrolene
Pat. Sub. Date(s): 001: Jul 28, 2014
Claim Types: Method of use
Jul 20, 2022New expiration date. Was previously Dec 24, 2022

SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
215358  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE)
PatentsExpirationChange
Pat. No. 11407735 DS*
Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(- 1H-pyrazol-5-yl)pyridine-3-carboxamide
Pat. Sub. Date(s): All strengths: Aug 23, 2022
Claim Types: New polymorph, salt or hydrate
May 14, 2040New patent for this product

SLYND (TABLET) (ORAL) DROSPIRENONE
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins
NDA Applicant: EXELTIS USA INC      NDA No.:
211367  Prod. No.: 001 RX (4MG)
PatentsExpirationChange
Pat. No. 11413249
Synthetic progestogens and pharmaceutical compositions comprising the same
Pat. Sub. Date(s): 001: Aug 22, 2022
Claim Types: Method of use
Use Code: U-2553: Prevention of pregnancy in females of reproductive age
Jun 28, 2031New patent for this product

TAFINLAR (CAPSULE) (ORAL) DABRAFENIB MESYLATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.:
202806  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 75MG BASE)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-894: Dabrafenib is indicated in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment optionsJun 22, 2025New exclusivity for this product

TPOXX (CAPSULE) (ORAL) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.:
208627  Prod. No.: 001 RX (200MG)
PatentsExpirationChange
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Pat. Sub. Date(s): 001: Aug 9, 2018
Claim Types: Method of use
Use Code: U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg
Sep 4, 2031New expiration date. Was previously May 3, 2027

TPOXX (SOLUTION) (INTRAVENOUS) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.: 214518  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationChange
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Pat. Sub. Date(s): 001: Jun 10, 2022
Claim Types: Method of use
Use Code: U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Sep 4, 2031New expiration date. Was previously May 3, 2027

TREANDA (POWDER; SOLUTION) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: CEPHALON      NDA No.:
022249  Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL) NDA No.: 022249  Prod. No.: 003 DISC (45MG/0.5ML (90MG/ML)); 004 DISC (180MG/2ML (90MG/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) Dec 7, 2022New exclusivity for this product

WAKIX (TABLET) (ORAL) PITOLISANT HYDROCHLORIDE
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: HARMONY      NDA No.:
211150  Prod. No.: 001 RX (EQ 4.45MG BASE); 002 RX (EQ 17.8MG BASE)
PatentsExpirationChange
Pat. No. 8207197 DS* DP*
Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine
Pat. Sub. Date(s): All strengths: Sep 11, 2019
Claim Types: New polymorph, salt or hydrate; Process; Composition
Mar 7, 2030New expiration date. Was previously Feb 25, 2029

XALKORI (CAPSULE) (ORAL) CRIZOTINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: PF PRISM CV      NDA No.:
202570  Prod. No.: 001 RX (200MG); 002 RX (250MG)
PatentsExpirationChange
Pat. No. 7825137
Method of treating abnormal cell growth
Pat. Sub. Date(s): 001: Sep 14, 2011; 002: None
Claim Types: Method of use
Use Code: U-3057: Treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive
Use Code: U-3058: Treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive
Use Code: U-3403: Method of reversing or inhibiting the progress of unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive in adult and pediatric patients 1 year of age and older
May 12, 2027New Use Code
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-897: Treatment of adult and pediatric patients 1 year of age and older with unresectable, recurrent or refractory inflammatory myofibroblastic tumor (IMT) that is anaplastic lymphoma kinase (ALK) positiveJul 14, 2025New exclusivity for this product

ZORYVE (CREAM) (TOPICAL) ROFLUMILAST
Drug Classes: Respiratory Tract/ Pulmonary Agents:Phosphodiesterase Inhibitors, Airways Disease == phosphodiesterase 4 inhibitor
NDA Applicant: ARCUTIS      NDA No.:
215985  Prod. No.: 001 RX (0.3%)
PatentsExpirationChange
Pat. No. 9884050 DP*
Inhibition of crystal growth of roflumilast
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Composition; Formulation
Jun 7, 2037New patent for this product
Pat. No. 9907788 DP*
Inhibition of crystal growth of roflumilast
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Method of use
Use Code: U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)
Jun 7, 2037New patent for this product
Pat. No. 10940142 DP*
Inhibition of crystal growth of roflumilast
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Formulation
Jun 7, 2037New patent for this product
Pat. No. 11129818 DP*
Topical roflumilast formulation having improved delivery and plasma half life
Pat. Sub. Date(s): 001: Aug 19, 2022
Claim Types: Method of improving a treatment
Use Code: U-3408: Topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. (1)
Aug 25, 2037New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Jul 29, 2025New 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: 16 September 2022
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