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Generated: September 24, 2017
What is the competitive landscape for HOSPIRA, and what generic alternatives to HOSPIRA drugs are available?
HOSPIRA has five hundred and eight approved drugs.| Patents: | 7 |
| Tradenames: | 328 |
| Ingredients: | 201 |
| NDAs: | 508 |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-003 | Mar 13, 2013 | ► Subscribe | ► Subscribe | ||||||||
Hospira | BRETYLOL | bretylium tosylate | INJECTABLE;INJECTION | 017954-001 | Approved Prior to Jan 1, 1982 | ► Subscribe | ► Subscribe | ||||||||
Hospira | TRACRIUM PRESERVATIVE FREE | atracurium besylate | INJECTABLE;INJECTION | 018831-001 | Nov 23, 1983 | ► Subscribe | ► Subscribe | ||||||||
Hospira Inc | NIPENT | pentostatin | INJECTABLE;INJECTION | 020122-001 | Oct 11, 1991 | ► Subscribe | ► Subscribe | ||||||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-002 | Mar 13, 2013 | ► Subscribe | ► Subscribe | ||||||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | ► Subscribe | ► Subscribe | ||||||||
Hospira | PRECEDEX | dexmedetomidine hydrochloride | INJECTABLE;INJECTION | 021038-001 | Dec 17, 1999 | ► Subscribe | ► Subscribe | ||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
dexmedetomidine | Injection | 4 mcg/mL, 20 mL vials | PRECEDEX | 9/30/2015 |
dexmedetomidine | Injection | 4 mcg/mL, 50 mL and 100 mL vials | PRECEDEX | 12/26/2013 |
argatroban in sodium chloride | Injection | 1 mg/mL, 50 mL vials | ARGATROBAN | 12/16/2011 |
dexmedetomidine | Injection | 100 mcg/mL | PRECEDEX | 4/8/2009 |
argatroban | Injection | 100 mg/mL, 2.5 mL vials | ARGATROBAN | 9/24/2007 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,436,033 | Methods of treatment using a dexmedetomidine premix formulation | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2806706 | ► Subscribe | |||||||||||||
| Bulgaria | 104797 | ► Subscribe | |||||||||||||
| Japan | 4606581 | ► Subscribe | |||||||||||||
| Japan | 5927680 | ► Subscribe | |||||||||||||
| Mexico | 2013003629 | ► Subscribe | |||||||||||||
| China | 1295473 | ► Subscribe | |||||||||||||
| Taiwan | 552136 | ► Subscribe | |||||||||||||
| Japan | 5990832 | ► Subscribe | |||||||||||||
| Brazil | 9909872 | ► Subscribe | |||||||||||||
| Norway | 20004931 | ► 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.
Export unavailable in trial.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00523 | Netherlands | ► Subscribe | PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||
| 2015000111 | Germany | ► Subscribe | PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728 | ||||||||||||
| C0035 | France | ► Subscribe | PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128 | ||||||||||||
| C0042 | France | ► Subscribe | PRODUCT NAME: HEXYL AMINOLEVULINATE; NAT. REGISTRATION NO/DATE: NL 30979 20050812; FIRST REGISTRATION: SE - 19 227 20040917 | ||||||||||||
| 41/2009 | Austria | ► Subscribe | PRODUCT NAME: PACLITAXEL ALBUMIN | ||||||||||||
| /2014 | Austria | ► Subscribe | PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230 | ||||||||||||
| 0812 | Netherlands | ► Subscribe | PRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124 | ||||||||||||
| 90062-5 | Sweden | ► Subscribe | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 | ||||||||||||
| C/GB08/018 | United Kingdom | ► Subscribe | PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712 | ||||||||||||
| C0022 | France | ► Subscribe | PRODUCT NAME: DAPTOMYCINE; REGISTRATION NO/DATE: EU/1/05/328/001-002 20060119 | ||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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