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Generated: July 27, 2017
What is the competitive landscape for LILLY, and what generic alternatives to LILLY drugs are available?
LILLY has one hundred and thirty approved drugs.| Patents: | 26 |
| Tradenames: | 119 |
| Ingredients: | 102 |
| NDAs: | 130 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | METHYLTESTOSTERONE | methyltestosterone | TABLET;BUCCAL, SUBLINGUAL | 080256-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Lilly | FORTEO | teriparatide recombinant human | INJECTABLE;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-003 | Nov 21, 2003 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Lilly | PROZAC WEEKLY | fluoxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 021235-001 | Feb 26, 2001 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Lilly | CIALIS | tadalafil | TABLET;ORAL | 021368-001 | Nov 21, 2003 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lilly | EVISTA | raloxifene hydrochloride | TABLET;ORAL | 020815-001 | Dec 9, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lilly | ZYPREXA | olanzapine | TABLET;ORAL | 020592-001 | Sep 30, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lilly | ZYPREXA ZYDIS | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021086-004 | Apr 6, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lilly | SYMBYAX | fluoxetine hydrochloride; olanzapine | CAPSULE;ORAL | 021520-005 | Dec 24, 2003 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Lilly | ZYPREXA | olanzapine | TABLET;ORAL | 020592-006 | Sep 9, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
pemetrexed disodium | For Injection | 750 mg/vial | ALIMTA | 10/6/2016 |
teriparatide | Injection | 250 mcg/mL, 2.4 mL prefilled Pen | FORTEO | 7/27/2015 |
pemetrexed disodium | For Injection | 1000 mg/vial | ALIMTA | 6/27/2012 |
duloxetine hydrochloride | Delayed-release Capsules | 40 mg | CYMBALTA | 5/10/2012 |
tadalafil | Tablets | 2.5 mg | CIALIS | 10/14/2008 |
duloxetine hydrochloride | Delayed-release Capsules | 20 mg, 30 mg and 60 mg | CYMBALTA | 8/4/2008 |
pemetrexed disodium | For Injection | 100 mg/vial | ALIMTA | 7/1/2008 |
olanzapine and fluoxetine hydrochloride | Capsules | 3 mg/25 mg | SYMBYAX | 5/8/2008 |
pemetrexed disodium | For Injection | 500 mg/vial | ALIMTA | 2/4/2008 |
tadalafil | Tablets | 5 mg, 10 mg and 20 mg | CIALIS | 11/21/2007 |
gemcitabine | For Injection | 2 g/vial | GEMZAR | 8/24/2007 |
atomoxetine hydrochloride | Capsules | 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg | STRATTERA | 5/29/2007 |
gemcitabine | For Injection | 1g/vial | GEMZAR | 11/14/2005 |
gemcitabine | For Injection | 200 mg/vial | GEMZAR | 11/1/2005 |
olanzapine and fluoxetine hydrochloride | Capsules | 6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg and 12 mg/50 mg | SYMBYAX | 1/10/2005 |
| Patent Number | Expiration Date |
|---|---|
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,127,542 | Tetracyclic derivatives, process of preparation and use | ► Subscribe | |||||||||||||||||||||||||||
| 7,857,791 | Medication dispensing apparatus with gear set having drive member accommodating opening | ► Subscribe | |||||||||||||||||||||||||||
| 6,451,807 | Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor | ► Subscribe | |||||||||||||||||||||||||||
| 4,996,206 | N-(pyrrolo[2,3-d]pyrimidin-3-ylacyl)-glutamic acid derivatives | ► Subscribe | |||||||||||||||||||||||||||
| 6,841,167 | .beta.-carboline pharmaceutical compositions | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Singapore | 98384 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9811127 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 9703985 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1311828 | ► Subscribe | |||||||||||||||||||||||||||
| Hungary | 0300477 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00597 | Netherlands | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121 | ||||||||||||||||||||||||||
| C0012 | Belgium | ► Subscribe | PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927 | ||||||||||||||||||||||||||
| 2005 | Austria | ► Subscribe | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 | ||||||||||||||||||||||||||
| 081 | Luxembourg | ► Subscribe | PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125 | ||||||||||||||||||||||||||
| 0181 | Netherlands | ► Subscribe | 300181, 20101210, EXPIRES: 20151209 | ||||||||||||||||||||||||||
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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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