You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 21, 2024

FORTEO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Try a Trial

Drug patent expirations by year for FORTEO
Drug Prices for FORTEO

See drug prices for FORTEO

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 021318-002 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
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
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Lilly FORTEO teriparatide SOLUTION;SUBCUTANEOUS 021318-001 Nov 26, 2002 ⤷  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
EuroGenerics Holdings B.V. Qutavina teriparatide EMEA/H/C/005388
Qutavina 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Withdrawn no yes no 2020-08-27
Theramex Ireland Limited Livogiva teriparatide EMEA/H/C/005087
Livogiva 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2020-08-27
Accord Healthcare S.L.U. Sondelbay teriparatide EMEA/H/C/005827
Sondelbay 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 have been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Authorised no yes no 2022-03-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FORTEO

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

Country Patent Number Title Estimated Expiration
South Korea 100482703 ⤷  Try a Trial
China 100581607 ⤷  Try a Trial
European Patent Office 1417972 Solutions stabilisées de Tériparatide (Stabilized teriparatide solutions) ⤷  Try a Trial
European Patent Office 1059933 PROCEDE PERMETTANT D'AUGMENTER LA SOLIDITE ET LA RIGIDITE OSSEUSE ET DE REDUIRE L'INCIDENCE OU LA GRAVITE D'UNE FRACTURE (METHOD OF INCREASING BONE TOUGHNESS AND STIFFNESS AND REDUCING FRACTURES) ⤷  Try a Trial
Cyprus 1113343 ⤷  Try a Trial
Czech Republic 302401 Farmaceutická kompozice obsahující stabilizovaný roztok teriparatidu, zpusob její prípravy a nádobka s jejím obsahem (Pharmaceutical composition containing stabilized teriparatide solution, process for its preparation and vial containing thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.