Parathyroid Hormone Analog Drug Class List

Drugs in Drug Class: Parathyroid Hormone Analog

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	BONSITY	teriparatide	SOLUTION;SUBCUTANEOUS	211939-001	Oct 4, 2019		RX	No	No
Apotex	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	211097-001	Nov 16, 2023	AP	RX	No	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-002	Aug 9, 2024		RX	Yes	No
Ascendis Pharma Bone	YORVIPATH	palopegteriparatide	SOLUTION;SUBCUTANEOUS	216490-001	Aug 9, 2024		RX	Yes	Yes
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-002	Jun 25, 2008	AP	RX	Yes	Yes
Lilly	FORTEO	teriparatide	SOLUTION;SUBCUTANEOUS	021318-001	Nov 26, 2002		DISCN	No	No			Y
Teva Pharms Usa	TERIPARATIDE	teriparatide	SOLUTION;SUBCUTANEOUS	208569-001	Nov 16, 2023	AP	RX	No	No

Parathyroid Hormone Analog Market Analysis and Financial Projection

The Parathyroid Hormone (PTH) Analog Market is experiencing robust growth driven by rising osteoporosis and hypoparathyroidism rates, advances in biotechnology, and an aging global population. Concurrently, the patent landscape reflects intense innovation focused on drug delivery, synthesis methods, and therapeutic combinations.

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Market Dynamics

Growth Drivers

• Rising Disease Burden: Osteoporosis and hypoparathyroidism prevalence fuels demand for PTH analogs like teriparatide (Forteo) and abaloparatide (Tymlos) [1][4][13].
• Aging Population: Over 200 million people globally suffer from osteoporosis, with PTH analogs becoming first-line anabolic therapies [3][5].
• Revenue and CAGR: The market was valued at $1.5B in 2022 and is projected to reach $4B+ by 2030–2033, with a CAGR of 7.5–8.9% [1][5][13]. North America leads (40% market share), while Asia-Pacific grows rapidly due to healthcare investments [13][4].

Key Players and Competition

• Dominant Companies: Pfizer (Forteo: $40B revenue), Eli Lilly (teriparatide), and Abbott Laboratories drive R&D and commercialization [1][4][7]. New entrants like Radius Health (Tymlos) focus on novel formulations [3].
• Strategic Collaborations: Partnerships between pharmaceutical firms and research institutions expand product pipelines [1][17].

Therapeutic Applications

• Primary Uses: Treatment of osteoporosis (postmenopausal women, glucocorticoid-induced) and hypoparathyroidism [7][11].
• Emerging Trends: Exploration of transdermal patches and oral/nasal delivery to enhance compliance [3][17].

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Patent Landscape

Key Innovations and Patents

Patent Focus	Examples	Assignees/Inventors
Synthesis Methods	Improved purity/yield for abaloparatide via fragment coupling (CN106146648B) [9]	Chinese inventors
Drug Delivery	PEG-conjugated controlled-release PTH(1-34) (US11918628B2) [12]	Ascendis Pharma
Stable Formulations	Enhanced storage stability of PTHrP analogs (US8148333B2) [15]	Multiple assignees
Combination Therapies	Co-administration with bisphosphonates/calcitonin for osteoporosis (US-RE40850-E) [2]	SOD Conseils Rech Applic (FR)
Non-Invasive Delivery	Nasal/oral formulations using Intravail®/ProTek® for teriparatide (US8076290) [17]	Aegis Therapeutics (licensed to Azelon)

Litigation and IP Strategy

• Patent Expirations: Older patents like US5589452A (expired) [16] have opened pathways for generics, while newer IP focuses on biologics and delivery systems.
• Legal Disputes: Cases such as the Japanese patent (JP2022) highlight disputes over administration protocols for fracture inhibition [11].

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Future Outlook

• Innovation Priorities: Extended-release formulations, cost-effective biosimilars, and expanded applications (e.g., bone regeneration) [12][17].
• Regional Expansion: Asia-Pacific and Latin America offer growth avenues due to rising healthcare access [5][13].
• Challenges: Regulatory hurdles, high production costs, and pricing pressures in emerging markets [5][13].

"Non-injectable PTH analogs could revolutionize osteoporosis treatment by improving patient compliance and market reach." – Industry Report [17]

The PTH analog market is poised for sustained growth, underpinned by demographic trends and cutting-edge IP. Companies investing in delivery technologies and global partnerships will likely dominate this evolving sector.

References

1. https://github.com/vandelmanize/Market-Research-Report-List-1/blob/main/parathyroid-hormone-analog-market.md
2. https://pubchem.ncbi.nlm.nih.gov/patent/US-RE40850-E
3. https://www.seattlejointsurgeon.com/system/resources/W1siZiIsIjIwMTkvMDYvMjEvMTUvNDAvMzAvZDBhOGMyYmYtYzJjNC00OTJlLTkyMDgtZmU0MDUxODYyOWExL3Nob3RzLXRvLWdyb3ctYm9uZS5wZGYiXV0/shots-to-grow-bone.pdf
4. https://rivercountry.newschannelnebraska.com/story/52127458/Parathyroid-Hormone-AnalogMarket
5. https://github.com/meghajagadale2711/InsightSphere/blob/main/Parathyroid-Hormone-Analog-Market-Size-and-Opportunity-Analysis.md
6. https://patents.google.com/patent/US6921750B2/en
7. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021318Orig1s054.pdf
8. https://sites.google.com/view/precisionpulseresearch/home/report/parathyroid-hormone-analog-market-by-application
9. https://patents.google.com/patent/CN106146648B/en
10. https://academic.oup.com/mend/article/22/1/156/2684081
11. https://www.ip.courts.go.jp/app/files/hanrei_en/235/003235.pdf
12. https://www.pharmaceutical-technology.com/data-insights/ascendis-pharma-gets-grant-for-controlled-release-parathyroid-hormone-conjugate-for-medical-treatment/
13. https://www.cognitivemarketresearch.com/parathyroid-hormone-analog-market-report
14. https://www.pnas.org/doi/10.1073/pnas.1301674110
15. https://patents.google.com/patent/US8148333B2/en
16. https://patents.google.com/patent/US5589452A/en
17. https://www.biospace.com/aegis-therapeutics-llc-awarded-patent-for-parathyroid-hormone-pth-peptide-drug-formulations-suitable-for-metered-nasal-spray-and-oral-delivery
18. https://www.fiercebiotech.com/biotech/unigene-laboratories-granted-us-patent-for-peptide-based-technology-for-treatment-of