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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Summary for FORTEO
| International Patents: | 37 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 42 |
| Clinical Trials: | 74 |
| Patent Applications: | 1,117 |
| Drug Prices: | Drug price information for FORTEO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FORTEO |
| What excipients (inactive ingredients) are in FORTEO? | FORTEO excipients list |
| DailyMed Link: | FORTEO at DailyMed |
Recent Clinical Trials for FORTEO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universidad de Valparaiso | Phase 4 |
| Universidade Federal Fluminense | Phase 4 |
| RANI Therapeutics | Phase 1 |
Pharmacology for FORTEO
| Drug Class | Parathyroid Hormone Analog |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-002 | Jun 25, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Lilly | FORTEO | teriparatide | SOLUTION;SUBCUTANEOUS | 021318-001 | Nov 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | |
| Sun Pharmaceutical Industries Europe B.V. | Teriparatide Sun | teriparatide | EMEA/H/C/005793 Teriparatide SUN is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). 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 (see section 5.1). |
Authorised | no | no | no | 2022-11-18 | |
| >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 |
|---|---|---|---|
| Japan | 2007530240 | ⤷ Sign Up | |
| European Patent Office | 1417972 | Solutions stabilisées de Tériparatide (Stabilized teriparatide solutions) | ⤷ Sign Up |
| Spain | 2215268 | ⤷ Sign Up | |
| Portugal | 2907522 | ⤷ Sign Up | |
| Cyprus | 1113343 | ⤷ Sign Up | |
| Croatia | P20000755 | ⤷ Sign Up | |
| Brazil | 9813463 | ⤷ Sign Up | |
| >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.
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