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Last Updated: March 19, 2024

FORTEO Drug Patent Profile


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When do Forteo patents expire, and when can generic versions of Forteo launch?

Forteo is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in twenty-five countries.

The generic ingredient in FORTEO is teriparatide. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the teriparatide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Forteo

A generic version of FORTEO was approved as teriparatide by APOTEX on November 16th, 2023.

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Drug patent expirations by year for FORTEO
Drug Prices for FORTEO

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Recent Clinical Trials for FORTEO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
RANI TherapeuticsPhase 1
Radius Health, Inc.Phase 4
Daniel HorwitzPhase 4

See all FORTEO clinical trials

Pharmacology for FORTEO
Paragraph IV (Patent) Challenges for FORTEO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORTEO Injection teriparatide 250 mcg/mL, 2.4 mL prefilled Pen 021318 1 2015-07-27

US Patents and Regulatory Information for FORTEO

FORTEO is protected by one US patents.

Patents protecting FORTEO

Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FORTEO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-002 Jun 25, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for FORTEO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
STADA Arzneimittel AG Movymia teriparatide EMEA/H/C/004368
Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2017-01-11
Eli Lilly Nederland B.V. Forsteo teriparatide EMEA/H/C/000425
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and nonvertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no no no 2003-06-10
Gedeon Richter Plc. Terrosa teriparatide EMEA/H/C/003916
Terrosa is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2017-01-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FORTEO

When does loss-of-exclusivity occur for FORTEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05231731
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 26052
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0509269
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 57897
Estimated Expiration: ⤷  Try a Trial

China

Patent: 33864
Estimated Expiration: ⤷  Try a Trial

Patent: 0581607
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0191242
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 32628
Estimated Expiration: ⤷  Try a Trial

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9497
Estimated Expiration: ⤷  Try a Trial

Patent: 0601801
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 32628
Estimated Expiration: ⤷  Try a Trial

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 45180
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7829
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 68982
Estimated Expiration: ⤷  Try a Trial

Patent: 74233
Estimated Expiration: ⤷  Try a Trial

Patent: 07530240
Estimated Expiration: ⤷  Try a Trial

Patent: 07530241
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06011230
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 411
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9099
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 6161
Estimated Expiration: ⤷  Try a Trial

Patent: 064955
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 32628
Estimated Expiration: ⤷  Try a Trial

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 818
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 32629
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0606885
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 0763051
Estimated Expiration: ⤷  Try a Trial

Patent: 060131946
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 69671
Estimated Expiration: ⤷  Try a Trial

Patent: 28788
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FORTEO around the world.

Country Patent Number Title Estimated Expiration
China 1308545 ⤷  Try a Trial
Peru 20001089 METODO PARA INCREMENTAR LA DUREZA Y RESISTENCIA OSEA ⤷  Try a Trial
Malaysia 129227 METHOD FOR INCREASING BONE TOUGHNESS AND STIFFNESS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.