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Serving leading biopharmaceutical companies globally:

Fuji
UBS
Covington
Boehringer Ingelheim
Fish and Richardson
Deloitte
Baxter
Medtronic
Dow
US Army

Generated: December 15, 2017

DrugPatentWatch Database Preview

Par Sterile Products Company Profile

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What is the competitive landscape for PAR STERILE PRODUCTS, and what generic alternatives to PAR STERILE PRODUCTS drugs are available?

PAR STERILE PRODUCTS has twenty-eight approved drugs.

There are seven US patents protecting PAR STERILE PRODUCTS drugs and there have been three Paragraph IV challenges on PAR STERILE PRODUCTS drugs in the past three years. There is one tentative approval on PAR STERILE PRODUCTS drugs.

There are three patent family members on PAR STERILE PRODUCTS drugs in three countries and thirty-nine supplementary protection certificates in eleven countries.

Summary for Par Sterile Products

International Patents:3
US Patents:7
Tradenames:26
Ingredients:26
NDAs:28
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Par Sterile ProductsDANTRIUMdantrolene sodiumINJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsDELESTROGENestradiol valerateINJECTABLE;INJECTION009402-004Approved Prior to Jan 1, 1982AORXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsKETALARketamine hydrochlorideINJECTABLE;INJECTION016812-003Approved Prior to Jan 1, 1982APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsBUPRENORPHINE HYDROCHLORIDEbuprenorphine hydrochlorideINJECTABLE;INJECTION206586-001Jul 28, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsVASOSTRICTvasopressinSOLUTION;IV (INFUSION)204485-002Dec 17, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsMEROPENEMmeropenemINJECTABLE;INJECTION204139-002Jun 9, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsVASOSTRICTvasopressinSOLUTION;IV (INFUSION)204485-001Apr 17, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Par Sterile ProductsBREVITAL SODIUMmethohexital sodiumINJECTABLE;INJECTION011559-003Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsDANTRIUMdantrolene sodiumCAPSULE;ORAL017443-001Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsMELPHALAN HYDROCHLORIDEmelphalan hydrochlorideINJECTABLE;INJECTION204773-001Aug 22, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Par Sterile Products

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Par Sterile ProductsDANTRIUMdantrolene sodiumCAPSULE;ORAL017443-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile ProductsDANTRIUMdantrolene sodiumINJECTABLE;INJECTION018264-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile ProductsDANTRIUMdantrolene sodiumCAPSULE;ORAL017443-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Par Sterile ProductsDANTRIUMdantrolene sodiumCAPSULE;ORAL017443-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV activity for PAR STERILE PRODUCTS drugs

Drugname Dosage Strength Tradename Submissiondate
epinephrineInjection1 mg/mL ampulesADRENALIN3/9/2016
levothyroxine sodiumfor Injection200 mcg/vialLEVOTHYROXINE SODIUM5/1/2015
levothyroxine sodiumfor Injection100 mcg/vial and 500 mcg/vialLEVOTHYROXINE SODIUM4/14/2015
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsARGATROBAN12/16/2011
argatrobanInjection100 mg/mL, 2.5 mL vialsARGATROBAN9/24/2007

International Patent Family for Par Sterile Products Drugs

Country Document Number Estimated Expiration
Australia2016233682► Subscribe
World Intellectual Property Organization (WIPO)2016149028► Subscribe
Canada2978464► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Par Sterile Products Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0004France► SubscribePRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
C0008Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
00071Netherlands► SubscribePRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920
C0004Belgium► SubscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
C/GB02/027United Kingdom► SubscribePRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Baxter
Teva
Healthtrust
Cipla
Mallinckrodt
Fish and Richardson
Express Scripts
Argus Health
Novartis
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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