APPROVED DRUG PRODUCTS
`with
`THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`The products in this list have been approved under section 505 of the
`Federal Food, Drug, and Cosmetic Act. This volume is current through
`December 31, 2009.
`
`30th EDITION
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF PHARMACEUTICAL SCIENCE
`OFFICE OF GENERIC DRUGS
`
`2010
`
`Sandoz Inc.
`Exhibit 1025-0001
`
`JOINT 1025-0001
`
`

`
`30TS EDITION - 2010 - APPROVED DRUG PRODUCTS LIST
`PRESCRIPTION DRUG PRODUCT LIST 3- 306 (of 393)
`
`PAROXET INE HYDROCHLORI DE
`
`EQ 10MG BASE
`EQ 20MG BASE
`N020031 001
`Dec 29, ]992
`EQ 3_.___~0MG ~S~EE
`N__02003~I 00.~2
`Dec 29, ~992
`EQ 40MG BAS~E
`N020031 00.~3
`Dec 29,
`TABLET, EXTENDED RELEASE; ORAL
`N020031 005
`Dec 29, 199~
`PAROXETINE HYDROCHLORIDE
`MYLAN
`
`TABLET; ORAL
`PAROXETINE HYDROCHLORIDE
`TEVA
`ZYDUs PHARMs USA
`
`AB
`~
`~
`AB
`AB
`
`E__Q 40MG BASE
`~Q 10~G--~-~
`EQ 20MG BASE
`EQ 30MG BASE
`EQ 40MG BASE
`
`PAXIL
`"---’--
`GLAXOSMITHKLINE
`
`AB
`~___
`AB
`AB +
`
`AB
`AB
`
`PAXIL CR
`GLAX0~MITHKLINE
`
`AB
`AB
`
`EQ 12.5MG BASE
`EQ 25MG BA~E
`
`EQ 12.5MG BASE
`
`PAXIL CR ~
`+ GLAXOSMITHKLINE
`
`EQ 37.5MG BASE
`
`PAROXETINE MESYLATE
`
`TABLET; ORAL
`PEXEVA
`NOVEN THERAP
`
`PAZOPANIB HYDROCHLORIDE
`
`TABLET; ORAL
`VOTRIENT
`GLAXoSMITHKLINE
`
`+
`
`EQ 10MG BASE
`EQ 20MG BASE
`EQ 30MG BASE
`EQ 40MG BASE
`
`EQ 200MG BASE
`EQ 400MG BASE
`
`250 UNITS/ML
`
`~ 00_/~ Au~ ~, ~0~
`~ 00.~I
`Mar 07,
`~ 00.~2
`Mar 07, 2007
`A077584 00_~3
`Mar 07, 2007
`A077584 004
`-- -- ~
`Mar 07,
`
`A077873 0__~i Jun 29,
`A077873 002 Jun 29, 200~
`~
`
`N020936 00.~I
`N020936 002
`
`Feb 16, 1999
`Feb ]6, 1999
`
`N020936 003
`
`Dec 06, 200~
`
`N021299 001
`N021299 002
`N021299 003
`N021299 004
`
`Jul 03, 20~3
`Jul 03, 2003
`Jul 03, 2003
`Jul 03, 20~3
`
`N022465 001
`N022465 002
`
`Oct ]9, 20~9
`Oct ]9, 2009
`
`N019818 001 Mar 21,
`
`PEGADEMASE BOVINE
`
`INJECTABLE; INJECTION
`ADAGEN
`+ ENZON PHARMs
`
`PEGAPTANIB SODIUM
`
`INJECTABLE; INTRAVITREAL
`MACUGEN
`+ EYETECH INC
`
`PEGVISOMANT
`
`INJECTABLE; SUBCUTANEouS
`SOMAVERT
`+ PHARMAcIA AND UPJOHN
`+
`
`PEMETREXED DISODIUM
`
`INJECTABLE; IV (INFUSION)
`
`EQ 0.3MG ACID/0.09ML
`
`N021756 001 Dec 17, 20%4
`
`]0MG/VIAL
`]5MG/VIAL
`20MGiVIAL
`
`LILLY
`
`+
`+
`
`EQ 100MG BASE/VIAL
`EQ 500MG BASE/VIAL
`
`N02iI06 00]
`N02]I06 002
`N021]06 003
`
`Mar 25, 20~
`Mar 25, 20~i
`Mar 25, 20{<?
`
`N021462 002 Sep 07, 20<~
`N021462 00l Feb 04, 2004
`
`Sandoz Inc.
`Exhibit 1025-0002
`
`JOINT 1025-0002
`
`

`
`30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST
`
`ADA 145 of 197
`
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`Seere~f~tnote~rin~ationr~ardingrepo~ ~ntent
`
`PATENT NO
`
`A[pL/PROD
`NO
`.:~oxETINE MESYLATE - PEXEVA
`!~021299 001 5874447
`5874447
`5874447
`6703408
`
`o._~oXETINE MESYLATE - PEXEVA
`~021299 002 5874447
`5874447
`5874447
`6703408
`
`~ETINE MESYLATE - PEXEVA
`
`~021299 003 5874447
`5874447
`5874447
`6703408
`
`~.~OXETINE MESYLATE - PEXEVA
`M021299 004 5874447
`5874447
`5874447
`6703408
`
`PATENT
`EXPIRATION
`DATE
`
`PATENT
`CODES
`
`PATENT
`DELIST
`REQUESTED
`
`EXCLUSIVITY
`EXCLUSIVITY EXPIRATION
`DATE
`CODE(S)
`
`Jun ]0, 2017
`Jun I0, 2017
`Jun ]0, 2017
`Oct 21, 2022
`
`Jun i0, 2017
`Jun i0, 2017
`Jun i0, 2017
`Oct 21, 2022
`
`Jun i0, 2017
`Jun i0, 2017
`Jun i0, 2017
`Oct 21, 2022
`
`Jun i0, 2017
`Jun i0, 2017
`Jun i0, 2017
`Oct 21, 2022
`
`U-46
`U-518
`U-286
`
`U-286
`U-46
`U-518
`
`0-286
`U-46
`U-518
`
`U-286
`U-46
`U-518
`
`DP
`
`DP
`
`DP
`
`DP
`
`[AZOPANIB HYDROCHLORIDE - VOTRIENT
`N022465 001 7105530
`Dec 19, 2021
`7262203
`Dec 19, 2021
`pAZ0PANIB HYDROCHLORIDE - VOTRIENT
`N022465 002 7105530
`Dec 19, 2021
`7262203
`Dec 19, 2021
`
`DS DP
`DS DP
`
`DS DP
`DS DP
`
`~
`~
`
`’
`
`?~APTANIB SODIUM - MACUGEN
`N021756 001 5919455
`5932462
`6011020
`6051698
`6113906
`6147204
`6426335
`~EGVISOMANT - SOMAVERT
`~ N021106 001 5350836
`5681809
`5849535
`5958879
`6057292
`6583115
`
`[EGVISOMANT - SOMAVERT
`N021106 002 5350836
`5681809
`5849535
`5958879
`6057292
`6583115
`
`~EG-_E~VISOMANT - SOMAVERT
`N021106 003 5350836
`5681809
`5849535
`5958879
`6057292
`6583115
`
`Oct 27, 2013
`Aug 03, 2016
`Jan 04, 2017
`May 19, 2015
`Oct 27, 2013
`Jun ii, 2010
`Jun ii, 2010
`
`Sep 27, 2011
`Sep 27, 2011
`Mar 25, 2017
`Sep 27, 2011
`Sep 21, 2015
`Sep 27, 2011
`
`Sep 27, 2011
`Sep 27, 2011
`Mar 25, 2017
`Sep 27, 2011
`Sep 21, 2015
`Sep 27, 2011
`
`Sep 27, 2011
`Sep 27, 2011
`Mar 25, 2017
`Sep 27, 2011
`Sep 21, 2015
`Sep 27, 2011
`
`DS
`DS
`DS
`DS
`DS
`DS
`
`DS
`
`DS
`
`DS
`
`P~_ETREXED DISODIUM - ALIMTA
`N021462 001 5217974
`5344932
`
`Mar 29, 2011
`Jul 24, 2016
`
`DS DP
`
`NCE
`
`Oct 19, 2014
`
`NCE
`
`Oct 19, 2014
`
`NCE
`
`Dec 17, 2009
`
`ODE
`
`Mar 25, 2010
`
`ODE
`
`Mar 25, 2010
`
`ODE
`
`Mar 25, 2010
`
`1-601
`1-571
`ODE
`
`Jul 02, 2012
`Sep 26, 2011
`Feb 04, 2011
`
`U-622
`
`U-622
`
`U-507
`U-507
`
`U-507
`U-507
`U-507
`
`U-507
`U-507
`
`U-507
`U-507
`U-507
`
`U-507
`U-507
`
`U-507
`U-507
`U-507
`
`U-551
`
`Sandoz Inc.
`Exhibit 1025-0003
`
`JOINT 1025-0003
`
`

`
`30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST ADA 146 of
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST ....
`See report footnote for information regarding report content
`
`PATENT NO
`
`APPL / PROD
`NO
`PEMETREXED DISODIUM - ALIMTA
`N021462 002 5217974
`5344932
`
`EXPIRATION
`DATE
`
`PATENT
`CODES
`
`DELIST
`REQUESTED
`
`EXCLUSIVITY EXPIRATION
`DATE
`CODE ( S )
`
`Mar 29, 2011
`Jul 24, 2016
`
`DS DP
`
`U-551
`
`1-601
`1-571
`ODE
`
`Jul 02, 2012
`Sep 26, 2011
`Feb 04, 201
`
`PEMIROLAST POTASSIUM - ALAMAST
`N021079 001 5034230 Jan 02, 2011
`Jul 02, 2011
`5034230*PED
`
`DP U-184
`U-184
`
`PENCICLOVIR SODIUM - DENAVIR
`N020629 001 5075445
`5840763
`5866581
`5916893
`6124304
`6469015
`6573378
`6579981
`
`Sep 24, 2010
`Sep 01, 2015
`Sep 04, 2014
`Sep 01, 2015
`Sep 04, 2014
`Oct 22, 2019
`Sep 24, 2010
`Jun 17, 2020
`CALCIUM TRISODIU~
`
`U-501
`U-501
`U-501
`U-501
`U-501
`
`U-501
`
`PENTETATE CALCIUM TRISODIUM - PENTETATE
`NCE
`N021749 001 ODE
`
`Aug II, 2~9
`AUg II, 2011
`
`PENTETATE ZINC TRISODIUM - PENTETATE ZINC TRISODIUM
`N021751 001
`
`NCE
`ODE
`
`Aug
`Aug
`
`PENTOSAN POLYSULFATE SODIUM - ELMIRON
`Jan 19, 2010
`N020193 001 5180715
`
`U-159
`
`PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST
`CHEMICAL WARFARE AGENTS
`May 30, 2015
`N021084 001 5607979
`
`PERFLUTREN - DEFINITY
`N021064 001 5547656
`5769080
`6033645
`6146657
`6528039
`6773696
`
`PERGOLIDE MESYLATE - PERMAX
`N019385 001 5114948
`
`PERGOLIDE MESYLATE - PERMAi<
`N019385 002 5114948
`
`PERGOLIDE MESYLATE - PERMAX
`N019385 003 5114948
`
`PERINDOPRIL ERBUMINE - ACEON
`N020184 001 5162362
`
`PERINDOPRIL ERBUMINE - ACEON
`N020184 002 5162362
`
`PERINDOPRIL ERBUMINE - ACEON
`N020184 003 5162362
`
`Apt 05, 2011
`Jul 20, 2010
`Jun 19, 2016
`Dec 22, 2009
`Apr 05, 2011
`Apt 05, 2011
`
`DS
`DS
`DS
`
`U-665
`
`Oct 19, 2009
`
`Oct 19, 2009
`
`Oct 19, 2009
`
`Nov i0, 2009
`
`DS DP U-531
`
`Nov i0, 2009
`
`DS DP U-531
`
`Nov i0, 2009
`
`DS DP U-531
`
`PHENTOLAMINE MESYLATE - ORAVERSE
`N022159 001 6764678 May ii, 2021
`May ii, 2021
`6872390
`Jun 20, 2023
`7229630
`Oct 17, 2023
`7569230
`Apt 21, 2025
`7575757
`
`U-967
`
`U-967
`
`DP
`DP
`
`DP
`
`NP
`
`May 09, 2
`
`Sandoz Inc.
`Exhibit 1025-0004
`
`JOINT 1025-0004
`
`

`
`30TH EDITION - 2010 - APPROVED DRUG PRODUCTS LIST
`
`PATENT AND EXCLUSIVITY TERMS
`
`ADB 33 of 45
`
`PATENT USE
`
`u-507
`
`u-508
`
`u-509
`
`u-510
`
`U-511
`U-512
`U-513
`U-514
`U-515
`
`U-516
`U-517
`U-518
`U-519
`U-520
`U-521
`
`U-522
`
`U-523
`U-524
`U-525
`U-526
`
`U-527
`U-528
`U-529
`U-530
`
`U-531
`
`U-532
`
`U-533
`U-534
`
`U-535
`U-536
`U-537
`
`U-538
`
`U-539
`U-540
`U-541
`U-542
`U-543
`U-544
`U-545
`
`U-546
`U-547
`U-548
`
`U-549
`U-550
`U-551
`
`ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY AND/OR
`MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE
`METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER PATTERN
`FOR AT LEAST THREE WEEKS
`TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO ARE
`REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
`TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (STAGE
`IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES OR WHO HAVE
`NOT TOLERATED OTHER THERAPIES
`USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
`USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA
`METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
`PREVENTION OF OVULATION IN A WOMAN
`TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES
`AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
`METHOD OF TREATING A PSYCHOTIC DISEASE
`STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
`OBSESSIVE COMPULSIVE DISORDER
`POST OPERATIVE NAUSEA AND VOMITING
`PREMENOPAUSAL OSTEOPOROSIS
`METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B
`RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
`TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE OLIGONUCLEOTIDE
`CAPABLE OF HYBRIDIZING WITH CMV MRNA
`METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED MAMMAL
`METHOD OF TREATING DIARRHEA
`METHOD OF TREATING PARASITIC INFECTIONS
`METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED RELEASE
`COMPOSITION
`METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION BIOADHESIVE
`PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
`ONCE DAILY TREATMENT OE ASTHMA WITH NEBULIZED BUDESONIDE
`TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES,
`SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS, REDUCTION
`OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
`TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN WITH
`OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES
`TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
`BRONCHO DILATOR
`ERECTILE DYSFUNCTION
`HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
`DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
`TREATMENT OF SOCIAL ANXIETY DISORDER
`CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
`TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC
`INSUFFICIENCY, WITH EPLERENONE
`FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE ENOUGH
`THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK OF INITIATING
`COMBINATION THERAPY IN THESE PATIENTS
`TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER’S TYPE
`TREATMENT OF FUNGAL INFECTIONS
`METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-I
`METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
`TREATMENT OF SCHIZOPHRENIA
`TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
`METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS MYOCARDIAL
`INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS THROMBOSIS IN A
`POSTOPERATIVE HUMAN PATIENT
`USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
`MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
`A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER AND
`EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
`USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
`TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
`METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC ACID
`
`Sandoz Inc.
`Exhibit 1025-0005
`
`JOINT 1025-0005